Infertility: Medical and Social Choices

May 1988

NTIS order #PB88-196464
Recommended Citation:

U.S. Congress, Office of Technology Assessment, Infertility: Medical and Social Choices,

OTA-BA-358 (Washington, DC: U.S. Government Printing Office, May 1988).

Library of Congress Catalog Card Number 87-619894

For sale by the Superintendent of Documents

U.S. Government Printing Office, Washington, DC 20402-9325

(order form can be found in the back of this report)
Foreword

From the 1978 birth of Louise Brown, conceived through in vitro fertilization, through

last year’s Baby M case on surrogate motherhood, much attention has focused on new

options available to help infertile couples form a family. Still, most infertile couples who

seek help are treated with conventional drug therapy or surgery. In this assessment,

OTA analyzes the scientific, economic, legal, and ethical considerations involved in both

conventional and novel reproductive technologies.

The report was requested by the Senate Committee on Veterans’ Affairs and the

Subcommittee on Human Resources and Intergovernmental Relations of the House

Committee on Government Operations. It illustrates a range of options for congressional

action in nine principal areas of public policy related to infertility:

•

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●

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collecting data on reproductive health;

preventing infertility;

information to inform and protect consumers;

providing access to infertility services;

reproductive health of veterans;

transfer of human eggs, sperm, and embryos;

recordkeeping;

surrogate motherhood; and

reproductive research.

In gathering information for this study, OTA staff made site visits to 10 in vitro

fertilization clinics, three sperm banks, two Veterans’ Administration hospitals, and one

large private medical practice that provides infertility treatment not involving novel

reproductive technologies. The site visits were made in California, Louisiana, Maryland,

New York, Texas, Virginia, Washington, and Australia.

OTA was assisted in preparing this study by a panel of advisors and reviewers selected

for their expertise and diverse points of view on the issues covered in the assessment.

Advisory panelists and reviewers were drawn from medicine, academia, the pharmaceutical industry, professional societies, religious groups, family planning groups, Federal

agencies, and infertile couples, Written comments were received from 72 reviewers

on the penultimate draft of the assessment. Comments on an appendix describing events

in 43 foreign nations were received from an additional 60 reviewers.

OTA gratefully acknowledges the contribution of each of these individuals. As with

all OTA reports, responsibility for the content is OTA’S alone.

u JOHN H. GIBBONS

Director
Infertility: Medical and Social choices

Advisory Panel

H. Tristram Engelhardt, Jr., Panel Chair

Center for Ethics, Medicine, and Public Issues

Baylor College of Medicine

Houston, TX

Nancy J. Alexander

Jones Institute for Reproductive Medicine

Norfolk, VA

Lori B. Andrews

American Bar Foundation

Chicago, IL

Ricardo H, Asch

University of California (Irvine) Medical Center

Orange, CA

Benjamin G. Brackett

University of Georgia College of Veterinary

Medicine

Athens, GA

William G. Bremner

University of Washington School of Medicine

Seattle, WA

Arthur L. Caplan

Institute for Biomedical Ethics

University of Minnesota

Minneapolis, MN

Daniel R. Curry

Abbott Laboratories

Abbott Park, IL

Alan H. DeCherney

Yale University School of Medicine

New Haven, CT

Gary D. Hodgen

Jones Institute for Reproductive Medicine

Norfolk, VA

Patricia A. King

Georgetown University Law Center

Washington, DC

John H. Mather

Paralyzed Veterans

Washington, DC

Susan G. Mikesell

RESOLVE, Inc.

Washington, DC

of America

Father Albert S. Moraczewski

Pope John XXIII Center

Houston, TX

Barbara Katz Rothman

Baruch College

The City University of New York

New York, NY

Cappy Miles Rothman

Century City Hospital IVF Center

Los Angeles, CA

Sherman J. Silber

St. Luke’s Hospital

St. Louis, MO

Joe Leigh Simpson

The University of Tennessee, Memphis

Memphis, TN

Keith Snyder

Vietnam Veterans of America, Inc.

Washington, DC

Thomas G. Wiggans

Serono Laboratories, Inc.

Randolph, MA

NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the advisory panel

members. The panel does not, however, necessarily approve, disapprove, or endorse this report. OTA assumes full

responsibility for the report and the accuracy of its contents.

iv
Infertility: Medical and Social Choices

Roger C. Herdman, OTA Assistant Director, Health and Life Sciences Division

Gretchen S. Kolsrud, Biological Applications Program Manager

OTA Project Staff

Gary B. Ellis, Project Director

Tim P. Condon, Analyst

R. Alta Charo, Legal Analyst

Gladys B. White, Analyst

E. Blair Wardenburg, Research Analyst

Support Staff

Sharon Kay Oatman, Administrative Assistant

Linda S. Ray ford, Secretary/word Processing Specialist

Barbara V. Ketchum, Clerical Assistant

Contractors

Linda Starke, Editor, Washington DC

George Annas, Boston University, Boston, MA

Baruch A. Brody, Baylor College of Medicine, Houston, TX

Center for Reproductive Studies, Cedars-Sinai Medical Center, Los Angeles, CA

Luba Djurdjinovic, Genetic Counseling Program, Binghamton, NY

Peter J. Fagan, Johns Hopkins Medical Institution, Baltimore, MD

Robert A. Godke, Louisiana State University, Baton Rouge, LA

Charles P. Hall, Jr., Temple University, Philadelphia, PA

Helen Bequaert Holmes, Hartford College, Amherst, MA

Gilah Langner, Washington, DC

James A. McGregor, University of Colorado Health Sciences Center, Denver, CO

Arnold Raphaelson, Temple University, Philadelphia, PA

John A. Robertson, University of Texas at Austin, Austin, TX

Anthony R. Scialli, Columbia Hospital for Women, Washington, DC

Constance H. Shapiro, Cornell University, Ithaca, NY

Michael R. Soules, University of Washington, Seattle, WA

Emanuel D. Thorne, Washington, DC
Workshop on Prevention of Infertility

Michael R. Soules, Workshop Chair

University of Washington

G. David Adamson

Palo Alto, CA

Carolyn B. Coulam

Methodist Center for Reproduction and

Transplantation Immunology

Indianapolis, IN

David Eschenbach

University of Washington

Seattle, WA

Julia Evans

Infertility Counseling Center

Seattle, WA

Pattei Hardman

University of Washington

Seattle, WA

John F.P. Kerin

Cedars-Sinai Medical Center

Los Angeles, CA

Alvin M. Matsumoto

University of Washington

Seattle, WA

Donald E. Moore

University of Washington

Seattle, WA

Beth A. Mueller

Fred Hutchinson Cancer Research Center

Seattle, WA

Charles H. Muller

University of Washington

Seattle, WA

Seattle, WA

Miles J. Novy

Oregon Regional Primate Research Center

Beaverton, OR

C. Alvin Paulsen

University of Washington

Seattle, WA

Stephen R. Plymate

Madigan Army Medical Center

Tacoma, WA

Sander S. Shapiro

University of Wisconsin

Madison, WI

Leon R. Spadoni

University of Washington

Seattle, WA

Robert J. Stillman

George Washington University

Washington, DC

Sergio C. Stone

University of California, Irvine

Orange, CA

Sam Wasser

University of Washington

Seattle, WA

Pal Wolner-Hannsen

University of Washington

Seattle, WA

Paul W. Zarutskie

University of Washington

Seattle, WA

NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critiques provided by the workshop participants. The workshop participants do not, however, necessarily approve, disapprove, or endorse this report. OTA

assumes full responsibility for the report and the accuracy of its contents.

vi
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Contents

Page

Chapter 1. Summary, Policy Issues, and Options for Congressional Action . . . . . 3

Chapter 2. Introduction. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35

Chapter 3. Demography of Infertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

Chapter 4. Factors Contributing to Infertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Chapter 5. Prevention of Infertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Chapter 6. Diagnosis of Infertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

Chapter 7. Treatment of Infertility . . . . . . . . . . . . . . . . . . . . . . ................117

Chapter 8. Infertility Services and Costs . . . . . . . . . . . . . . . . . . . . . .............139

Chapter 9. Quality Assurance for Research and Clinical Care . ...............165

Chapter 10. Reproductive Health of Veterans . . . . . . . . . . . . . . . . . . . . . . . . . ....189

Chapter 11. Ethical Considerations . . . . . . . . . . . . . . . . . . . . . . . ...............203

Chapter 12. Constitutional Considerations. . . . . . . . . . . . . . . . . . . . . . ...........219

Chapter 13. Legal Considerations: Artificial Insemination, In Vitro Fertilization,

Embryo Transfer, and Gamete Intrafallopian Transfer . ...................239

Chapter 14. Legal Considerations: Surrogate Motherhood . ..................267

Chapter 15. Frontiers of Reproductive Technology . ........................293

Appendix A. IVF Sites Offering GIFT in the United States . ..................311

Appendix B. Self-Administered Preconception Questionnaire . ................321

Appendix C. Fetal Research Laws Possibly Affecting IVF . ...................324

Appendix D. Feminist Views on Reproductive Technologies. . ................326

Appendix E. International Developments. . . . . . . . . . . . . . . . . . . . . . ............329

Appendix F. Religious Perspectives ., . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..364

Appendix G. OTA Survey of Surrogate Mother Matching Services . ...........369

Appendix H. List of Contractor Documents . . . . . . . . . . . . . . . . . . . . . ..........377

Appendix I. Acknowledgments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............378

Appendix J. Glossary of Acronyms and Terms. ., . . . . . . . . . . . . . . . . . . . . .. ....382

Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ....391

vii
chapter 1

Summary, Policy Issues, and

Options for Congressional Action
CONTENTS

Page

How Big a Problem Is Infertility? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

What Factors Contribute to Infertility) and Can It Be Prevented? . . . . . . . . . . . . . 6

How Is Infertility Diagnosed and Treated? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

Who Assures the Quality of Infertility Treatment? . . . . . . . . . . . . . . . . . . . . . . . . 9

How Much Does Infertility Cost? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

What Ethical Issues Are Involved? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

What Does the Law Say? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Is Surrogate Motherhood Hereto Stay? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

What Reproductive Health Care Do Veterans Receive? . . . . . . . , , . . . . . . . . . . . . . 13

What Have Other Countries Done? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

Where Do Reproductive Technologies Go From Here? . . . . . . . . . . . . . . . . . . . . . 14

Policy Issues and Options for Congressional Action. . . . . . . . . . . . . . . . . . . . 15

Issue: Should the Federal Government improve collection of data on

reproductive health?. . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . ..., . . . . 15

Issue: Should efforts toward prevention of infertility be enhanced? . . . . . . . . 17

Issue: Should the Federal Government ensure that consumers of selected

infertility services have the information to make informed choices? . . . . 18

Issue: Preexisting mechanisms for gaining access to infertility diagnostic and

treatment services adequate? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Issue: Should the Veterans’ Administration provide infertility diagnosis and

treatment? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Issue: Should the transfer of human gametes and embryos be regulated? . . . . 24

Issue: Should anyone accepting or transferring human gametes keep

nonidentifying genetic records on behalf of the potential child? . . . . . . . 25

Issue: Should commercialized surrogate motherhood be regulated by the

Federal Government? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

Issue:Do some areas of reproductive research require additional support? . . . 29

Boxes

Box No. Page

l-A. Infertility’s Emotional Toll . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

l-B. The Lifelong Legacy of Infertility. . . . . . . . . . . . . . . . . . . . . . . . . . . 9

Figures

Figure No. Page

l-l. Infertility in the United States, 1982 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

l-2. infertility and Age, 1982. . . . . . . . . . . . . . . . . ., .’. . . . . . . . . . . . . . . . . . . . . . . . 4

l-3. Married Couples and Infertility, 1965-82 . . . . . . . . . . . . . . . . . . . . . +. . . . . . . . 5

l-4. Surgically Sterile Couples, 1965-82 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5

l-5. Physician Office Visits for Infertility, 1966-84 . . . . . . . . . . . . . . . . . . . . . . . . . . 5

l-6. Membership in Infertility Professional Organizations, 1965-86 . . . . . . . . . . . . 5

Tables

Table No. Page

l-l. Prevention of Infertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7

l-2. Some Causes of Increasing Requests for Infertility Services in the 1980s . . . 14
Chapter 1

Summary, Policy Issues, and

Options for Congressional Action

This report is about the estimated 2 million to

3 million American couples who want to have a

baby, but who either need medical help to do so

or will remain frustrated in their desire.

In response to requests from the Senate Committee on Veterans’ Affairs and the Subcommittee on Human Resources and Intergovernmental

Relations of the House Committee on Government

Operations, this assessment presents the scientific, legal, economic, and ethical issues surrounding infertility. Specifically, it assesses medically

assisted conception, surgically assisted conception—including in vitro fertilization (IVF) and

gamete intrafallopian transfer (GIFT) -artificial insemination, basic research supporting reproductive technologies, and surrogate motherhood.

It is important to note that infertility is not only

a personal medical problem, but also in some ways

a social construct. It is in part a manifestation of

the American commitment to a complex, pluralistic society, in which childbearing is balanced, for

example, with education or career goals. This

study does not examine reasons, for example, why

a couple may postpone forming a family. Instead,

it is limited to technologies that help establish a

pregnancy. Certain allied issues, such as management of pregnancy, prenatal diagnosis including

embryo biopsy, termination of pregnancy, fetal

research, child health, adoption, and alternate

family arrangements involving child sharing, are

also beyond the scope of this report.

HOW BIG A PROBLEM

Infertility, generally defined as the inability

of a couple to conceive after 12 months of intercourse without contraception, affects an

estimated 2.4 million married couples (data

from 1982) and an unknown number of wouldbe parents among unmarried couples and singles.

It is an important personal and societal problem:

IS INFERTILITY?

. Infertility is often an unexpected disappointment, affecting an individual’s perception of

self and place in the larger scheme of generations backward and forward in time.

● Infertility frustrates one of the most basic human desires—that is, to have children.

The sole reliable sources of demographic in-

●

●

●

●

●

Diagnosis and treatment are costly, timeconsuming, intrusive, and carry about an

even chance of failure.

Avenues for prevention of infertility are uncertain.

The substantial number of involuntarily childless people hinders the development of families, long regarded as the backbone of American society.

Sexual behavior for both partners experiencing the stress of infertility may change radically and induce marital strife.

Involuntarily childless couples may have to

contend with family disharmony in addition

to their personal disappointment.

formation about infertility in the United States

are national surveys conducted by the National

Center for Health Statistics (NCHS). The most

recent was conducted in 1982; a new survey began in 1988, and data will be available in 1989.

In 1982, an estimated 8.5 percent of married

couples with wives aged 15 to 44 were infen

tile, 38.9 percent were surgically sterile, and 52.6

percent were fertile, or more precisely, fecund

(see figure l-l). It is important to note that surgical sterilization masks some couples who were

infertile anyway. (If those who were surgically

sterile are excluded from the population base, the

2.4 million couples account for 13.9 percent of

the remaining 17.3 million couples.) Infertility

generally increases with age (see figure 1-2).

3
4 ● infertility: Medical and Social Choices

Figure l.l.– Infertility in the United States, 1982

Married couples, 15-44 years

Surgicallv sterile

Fecunda

a Potentially able to conceive.

SOURCE: Office of Technology Assessment, 1988.

35

30

25

E

a

2 15

s’

10

5

0

2.1 “/”b

1

15 to 1 9

Infertile

The overall incidence of infertility remained

relatively unchanged between 1965 and 1982

(see figure 1-3). One age group, married couples

with wives age 20 to 24, exhibited an increase

in infertility (from 3.6 percent infertile in 1965

to 10.6 percent infertile in 1982). This increase

may be linked to the rate of gonorrhea in this age

group–a rate that tripled between 1960 and 1977.

Childlessness, or primary infertility, has increased and affects about 1.0 million couples. Secondary infertility (in which couples have at least

one biological child) has decreased and affects

about 1.4 million couples. Surgical sterilization has

increased dramatically (see figure 1-4). Certain couples are more likely than others to be infertile:

The incidence among blacks, for example, is 1.5

times higher than among whites.

It is noteworthy that not all infertile couples seek

treatment. An estimated 51 percent of couples

with primary infertility and 22 percent with sec -

ondary infertility seek treatment.

Figure 1.2.–lnfertility and Age, 1982

13.6%

10.60/0

20 to 2 4

8.70/,

25 to 2 9

—

30 to 34

24.60/o

35 to 3 9

Age of wife

aPercent of married couples, excluding those surgically sterilized, who are infertile.

bLikely an underestimate because married teenagers have not yet had time to discover that they are infertile.

27.20/o

SOURCE: Adapted from W.D. Mosher, “infertility: Why Business is Booming,” American Demographics 9:42-43, 1987.
Ch. l—Summary, Policy Issues, and Options for Congressional Action . 5

Figure 1-3.–Married Couples and Infertility, 1965-82

3,000,000

1

(11.2YO)

(10.3”/0)

(8.5%)

2,000,000

Yea r

SOURCE: Office of Technology Assessment, 1988.

Figure 1-4.—Surgically Sterile Couples,a 1965.82

11,000,000

t

(percent of

married couples)

/

(38.9?AO)

10,000,000

t /

9,000,000 “

8,000,000 “

7,000,000

6,000,000

5,000,000

4,000,000 :/,(15,80/o) , , ,

1965 1970 1975 1980 1985

Yea r

%ne or both partners surgically sterilized.

SOURCE: Office of Technology Assessment, 1988.

Although there has been no increase in either

the number of infertile couples or the overall incidence of infertility in the population, the number of office visits to physicians for infertility services rose from about 600,000 in 1968 to about 1.6

million in 1984 (see figure 1-5). Concomitant increases occurred in the memberships of the American College of Obstetricians and Gynecologists,

the American Fertility Society (AFS), and the American Urological Association, the three chief professional organizations for physicians who treat infertile patients [see figure 1-6).

Figure l-5.— Physician Office Visits

for Infertility, 1966.84

2,000,000

1,500,000 I

o~

1965 1970 1975 1980 1985

Year

SOURCE: Office of Technology Assessment, 1988

Figure 1-6.—Membership in Infertility

Professional Organizations, 1965-86

6,000

5,000

4,000

3,000

2,000

American Urological Association

membership, 1965-87

I 1 1 1 I I

10,000

b’

American Fertiiity Society

membership, 1985-88

7,500

5,000

2,500

“ 1965 1970 1975 1980 1985

Year

SOURCE: Office of Technology Assessment, 1988.
—

6 ● Infertility: Medical and Social Choices

WHAT FACTORS CONTRIBUTE TO INFERTILITY,

AND CAN IT BE PREVENTED?

Three factors most often contribute to infe~

tility among women: problems in ovulation,

blocked or scarred fallopian tubes, and endometriosis (the presence in the lower abdomen

of tissue from the uterine lining). Infections

with sexually transmitted diseases (STDS)) principally chlamydia and gonorrhea, are an important cause of damaged fallopian tubes. Among

men, most cases of infertility are a consequence of abnormal or too few sperm. For as

many as one in five infertile couples, a cause is

never found.

Preventing infertility is difficult. Factors that

contribute to abnormal or too few sperm, for example, are largely unknown. Other factors, like

endometriosis, are not amenable to prevention.

Nevertheless, prevention strategies are desirable,

because they may help some couples avoid the

considerable emotional and economic costs associated with infertility treatment, and they may preempt some infertility that would be wholly untreatable.

Infertility resulting from sexually trans=

mitted disease~an estimated 20 percent of

the cases in the United States-is the most

preventable. In these instances, prevention of infertility equals prevention (and rapid and effective treatment) of sexually transmitted diseases.

The risk of infertility increases with the number

of times a person has chlamydia or gonorrhea,

the duration and severity of each infection, and

any delay in instituting treatment.

Effective public health initiatives aimed at preventing STDS and infertility include efforts in the

following areas:

● health education of patients and public health

professionals;

●

●

●

●

disease definition, including long-term sequelae of STDS;

optimal treatment and improved clinical

service;

partner tracing and patient counseling; and

research, including the social, psychological,

and biologic aspects of STDS,

It is noteworthy that changes in sexual behavior,

attitudes about discussing sex, and health education wrought by the epidemic of acquired immunodeficiency syndrome (AIDS) could have the

salutary effect of preventing some infertility due

to STDS.

The calculus of infertility includes the age

of the prospective mother. The probability of

infertility increases somewhat after age 30 and

significantly more after age 35. Although no one

social prescription fits all couples in all circumstances seeking to conceive, biology dictates that

to maximize the chance of natural conception, a

couple should maximize the number of months

or years devoted to attempting it. A woman’s reproductive lifespan is circumscribed, and whenever the decision to procreate is made, the chance

of success generally depends on the number of

months during which conception is attempted.

The probability of conception is reduced both

by delaying childbearing and by condensing

attempts into a relatively short time period.

A promising area of research in prevention is

the identification of behavioral, physiological, and

environmental risk factors for infertility. one goal

of such research is to help young adults take measures to preserve their future fertility. Table 1-1

summarizes preventive approaches for some

known and hypothesized risk factors for infertility.

HOW IS INFERTILITY DIAGNOSED AND TREATED?

Infertile patients obtain care from an estimated Fertility is the product of interaction be

45,600 physicians: 20,600 obstetrician-gynecolo- tween two people and so the infertile patnent

gists, 17,500 general or family practitioners, 6,100 is in effect the infertile couple. Examination of

urologists, and 1,400 surgeons. Sophisticated or the male is simplified by the fact that his reproinnovative procedures for treating infertility cases ductive organs and sperm are readily accessible.

are most likely to be available in urban areas and This accessibility is not, however, accompanied

at university medical centers. bv better and more varied treatments for the male.
Ch. l—Summary, Policy Issues, and Options for Congressional Action ● 7

Table 1-1 .—Prevention of Infertility

Factors predisposing individuals toward infertility and preventive steps available

Sexually transmitted diseases (STDS) and pelvic inflammatory disease (PID):

● Careful selection of possible sexual partners. Health education to discourage unprotected sexual encounters. Monogamy. Forthright inquiry and

check of sexual partners for risks of STDS.

● Contraception by means of condoms. Use condoms routinely with new sex partner. Media campaign to encourage condom use,

● Periodic screening for STDS, if sexually active; STDS in both males and females are commonly asymptomatic.

c Changes in societal attitudes about STDS to lessen stigma of diagnostic examination for them.

● Recognize findings of STDS and seek medical care. Ensure that correct treatment is given for yourself and partner, with followup,

c Media campaign to encourage men and women with genital discharge to be checked for STDS.

● Rapid, adequate management of PID to reduce risk of sequelae.

Pelvic infections after birth, abortion, surgery, or invasive diagnostic testing:

● Ensure that optimally safe birth and surgical services are available.

● Use prophylactic antibiotics in high-risk situations to prevent infection.

Exercise, poor nutrition, and stress:

● Recognize that regular strenuous exercise (i ,e., exceeding 60 minutes daily), rapid weight loss, low body fat, and stress may cause decreased

fertility, Women are at higher risk than men,

Smoking, environmental toxins, and drugs:

● Smoking, as well as other substance abuse, reduces reproductive potential and should be avoided. Environmental exposures are inadequately

studied, but appear more common in males. Semen analysis can be performed.

Endometriosis:

● If strong family history for endometriosis exists, consider oral contraception and possible specific endometriosis suppression. Oral contraceptives

may suppress endometriosis even in those not at high risk.

● Early diagnosis and treatment in symptomatic women. Conservative surgical approaches.

Cryptorchidism and varicocele:

● Undescended, especially intra-abdominal, testes should be treated as promptly as possible. Benefits of surveillance and treatment of varicocele

are controversial.

Chemotherapy and radiation:

● Risks of gonadal damage must be considered and, if appropriate, gamete collection or protection of the gonads should be performed,

Intercurrent illnesses:

● Many acute and chronic diseases cause anovulation or decreased spermatogenesis. Prevention of these effects is by treatment of the primary disease.

Inadequate knowledge of reproduction:

● Ensure that information on reproduction is available from parents, schools, clergy, and other sources.

Inadequate medical treatment:

● Couples with difficulty conceiving should educate themselves about fertility and seek specialized care before infertility is prolonged,

Lack of perspective about reproduction:

c Discuss family life with parents, peers, and professionals. Formulate life plan that allows adequate time for reproductive goals.

SOURCE Off Ice of Technology Assessment, 1988

This is due, in part, to a continued lack of knowledge about male reproductive physiology. Female

reproductive health can be estimated through a

variety of indirect indicators (e.g., menstrual

regularity, hormone levels, properties of cervical

mucus) and direct methods (e.g., tissue biopsy,

laparoscopy, ultrasound imaging). Even with sophisticated diagnostic technology, however, no fertility test can positively predict a woman’s ability

to conceive or maintain a pregnancy.

Among infertile couples seeking treatment,

85 to 90 percent are treated with conventional

medical and surgical therapy. Medical treatment ranges from instructing the couple in the

relatively simple methods of pinpointing ovulation to more complex treatments involving ovulation induction with powerful fertility drugs and

artificial insemination, Surgical treatments also

span a wide spectrum of complexity, ranging from

ligation of testicular veins for eliminating

varicocele to delicate microsurgical repair of reproductive tract structures in both men and

women. Beyond being physically invasive, treatment is often emotionally taxing (see box l-A). Ovulation induction, surgery, and artificial insemination are the most widespread and successful

approaches to overcoming infertility.

Two noncoital reproductive technologiesIVF and gamete intrafallopian transfer (GIFT)—

offer hope to as many as 10 to 15 percent of

the infertile couples who could not be successfully treated otherwise. These techniques are

being practiced with increasing frequency but

proficiency varies widely. Some 70 to 80 medical teams in the United States have established

a record of some success with IVF, and proficiency

with GIFT is increasing. However, the remainder

of the 169 IVF/GIFT programs in this country have

had little or no success to date.

Counseling is an important and often underutilized component of infertility treatment.
8 “ Infertility: Medical and Social Choices

Box l-A.— Infertility’s Emotional Toll

Crazy Feelings Are Normal

You are sitting in the waiting room of your doctor’s office. You have been trying to have a baby for

3 years and things are not happening the way you had planned. You have been on clomiphene for a year.

Lately you cry at the drop of a hat—when you see a diaper commercial on television, see a pregnant woman

at the grocery store, or get an invitation to a baby shower. The whole world seems to be having babies.

You always thought of yourself as competent, able to handle anything. Now you feel depressed every

month when your period begins. You are beginning to think that having a baby is the only thing that will

make your life worthwhile. You feel odd, different. Everyone can have a baby. What’s wrong with me?

You may start to wonder if you are getting a little crazy.

You find yourself experiencing feelings that you have never had before. Sometimes you are depressed

when you never used to be, or you avoid situations that have anything to do with children. Over the last

6 months, the entries in your private diary include:

I must have done something wrong to deserve this. I feel sad and alone.

I have to keep an important part of my life secret. I’m afraid my husband will give up on me.

I have nobody I can taIk to about this. We don ‘t have fun anymore.

Sex on schedule takes all the joy out of making love. We don ‘t fit in with our friends; they all seem to be into

Nobody understands how I feel, even my husband. children.

I’m angry all the time. My family can’t support me like they used to, especial[v

I feel as if everything in my life is on hold. on special occasions when children are the center of

I’m always tired late[y. attention.

I’ve lost my self-confidence. If I could just stop trying so hard, maybe 1 could get

I feel like a failure in everything in my life. pregnant.

Feelings of Helplessness and Responsibility

It is 2 p.m. You are sitting with your wife in the doctor’s office, waiting to be told what to do next

to get your wife pregnant. You gave a semen sample 2 days ago to some lab person. You are sure that

humiliating experience was just the beginning of many more. You are wondering how bad your sperm are.

You think about your wife and how tense you feel when her period is due. It used to be, when you

were first married and didn’t yet want a baby, that you kept track of her period to make sure she wasn’t

pregnant. Now you are still counting days, but for the opposite reason. Times sure have changed; in the

old days, you never gave infertility a thought.

You are afraid to ask how she is feeling and are ambivalent about listening to her talk about symptoms

that sound like she is pregnant. You begin to get hopeful, yet worry about feeling let down when her period

begins.

What if the doctor suggests a specialist, another semen sample, surgery on your testes? Don’t they

know how much you hate masturbating in the bathroom while they wait outside? You wonder if your

wife will want to be with you if you can’t give her a child. How will you explain to your family that you

can’t continue their name? What if your wife wants to use donor sperm? Can she possibly understand

how defective and inadequate this makes you feel? The aloneness and disconnectedness is intense.

Your wife has always been your best friend, your confidant. How can you tell her how angry you

feel that struggling to have this baby has created a distance between you? How can you tell her how sad

you feel when she starts her period? How can you tell her how helpless you feel? How responsible you feel.

You stifle all that. She needs your support.

She asks if you hurt. You abbreviate your answer, thinking that it will be easier for her. You miss the

old easy way you had with each other. Last week, you lashed out in a way that made it seem like you

don’t have any feelings about all that the two of you have been through. It only takes one sperm to impregnate an egg, so what’s the big deal about the number and how well they move and what they look like?

Most of all, you just hope the doctor will tell you what to do.

Source S G Mlkesell and A Hammond, I,]cfmsed Ps\,choIoglsts Washington, IX, personal communications, Oct 3(I and Dec 23, 1987
Ch. l—Summary, Policy Issues, and Options for Congressional Action ● 9

Patients may derive psychological support from ●

professional counseling at an infertility clinic,

counselors in private practice, or community sup- ●

port groups. One nationwide support group for

infertile people, Resolve, has 47 chapters na- ●

tionwide.

●

As many as half the infertile couples seek1s further treatment worth the pain, expense,

and disruption?

Is adoption or childlessness becoming an acceptable option?

Is treatment costing so much that other goals

are sacrificed?

If it is not yet time to stop, when will it be?

ing treatment will ultimately be unsuccessful, Conception is a matter of chance, and embryonic

despite trying various avenues of treatment. loss is a normal phenomenon in mammalian reKnowing when to stop treatment is an individual production. Yet for those unable to have the child

matter for each infertile couple. A decision often they want, infertility can be a lifelong legacy (see

comes as couples ask themselves: box l-B).

Box l-B.—The Lifelong Legacy of Infertility

Some infertile couples, confronted with the rather limited options by which they can enlarge their

families, make the conscious choice to live their lives without children, perhaps deciding to channel their

energies into work, recreation, creative endeavors, or philanthropic efforts. For some couples, this is fine.

They feel their lives are full. For others, however, it is more difficult. They may worry about being the

last of their genetic line. Some talk about being confronted prematurely with a sense of their own mortality.

For those who are troubled by their infertility, childlessness may disappear as a source of unhappiness

during midlife, not to appear again until the late elderly years, and then as lack of an emotional and economic resource rather than as part of an identity crisis. Often the times we are most vulnerable to selfdoubt are around life’s milestones: retirement, menopause, or developments in the lives of family and friends,

particularly those with children.

Some couples fear the isolation and loneliness of growing old alone, and from time to time they may

wonder whether they will be able to handle the process of aging without an adult child or grandchildren

to support them and offer company. In fact, as friends of the childless couple rejoice in births of grandchildren, the infertile couple may find that they feel social isolation emerging once again in their lives.

SOURCE of fl[ 1, of I (,( h[l(ll(l&\Aswbim(,llt 1988

WHO ASSURES THE QUALITY OF INFERTILITY TREATMENT?

With treatments for infertility growing more the practice of medically assisted conception. They

sophisticated, it is increasingly important for pa- have promulgated guidelines on gamete and partients to understand the realistic likelihood that

these procedures will succeed, and to have reasonable assurance of quality care. Success rates

among IVF clinics, for example, vary widely; nearly

half have yet to achieve a live birth following IVF.

Professional societies—voluntary organizations

of practitioners—such as the American Association of Tissue Banks, the American College of Obstetricians and Gynecologists, and the American

Fertility Society have made efforts to regularize

ticipant screening, physician training, and clinic

staffing. Compliance with such guidelines, however, is voluntary.

Couples seeking the most talked-about new

reproductive technology, IVF, are often in a

quandary over assessing practitioners’ skills.

Is IVF experimental or is it a proven medical

therapy? In 1988, no blanket answer to that

question is possible. Just as some physicians in

IVF programs in the United States are proven practitioners of the art, others are as yet unproven.
10 ● /n fertility: Medical and Social Choices

In 1986, the American Fertility Society concluded that a procedure (e.g., IVF) done for the

first time by a practitioner or for the first time

at a particular facility should be viewed as experimental, implying that after some number of attempts, the procedure is no longer experimental.

AFS also stated that charges should be reduced

until a clinic has established itself with a reasonable success rate, implying that a reasonable success rate characterizes the clinic as no longer providing experimental treatment. These lines of

reasoning leave unclear whether it is the number of times IVF has been used or the success with

which it is used that determines its experimental

status.

Regulation of noncoital reproductive techniques has been primarily a matter for individual States, despite avenues of Federal authority. Regulation of quality control and of

monitoring, safety, recordkeeping, inspection and

licensing, obligations of mothers and fathers, and

requirements for sperm donor screening are well

within the traditional bounds of State responsibility related to medical practice and matters of

family law. Federal activity in assisted reproduction has consisted largely of supporting national

commissions to study scientific, legal, and ethical

issues.

HOW MUCH DOES INFERTILITY COST?

The dollar value of the personaL familiaL and

societal losses caused by infertility is inestimable. Americans spent, however about $1 billion on medical care in 1987 to combat infertility. Approximately 7 percent of the total was

spent on IVF. Some 14)000 attempts at IVF were

performed in 1987. In other words, IVF was undertaken by less than 1 percent of the estimated

number of infertile couples in the United States

who sought treatment.

Costs to individual couples receiving care for

infertility vary dramatically, depending on the

severity of their problem and their perseverance

in seeking treatment. A complete diagnostic workup typically costs $2)500 to $3)000, although most

couples do not require such an extensive workup.

Medical treatment may cost an additional $2,OOO

to $8,000; in the extreme, medical treatment may

cost more than $22,000. Further, because conception is a precisely timed biological event, infertility diagnosis and treatment often involve the costs

of time away from work and may involve travel

and hotel costs.

Many private health insurers do not cover

infertility per se or provide only limited coverage, yet in practice a substantial portion of

infertility expenditures are reportedly reimbursed. Some individual procedures are covered,

particularly if they are not identified as part of

an overall treatment for infertility. In other instances, some physicians find disingenuous ways

to invoice for infertility services, so as to obtain

reimbursement from insurers for their patients.

Treatment related to IVF is specifically excluded

from coverage by the majority of health plans,

but substantial reimbursement occurs for the various components of IVF treatment (e.g., hormonal

stimulation), Subterfuge by some physicians in order to obtain reimbursement for their patients

from insurers is reported to include invoicing for

egg retrieval for IVF under the guise of “aspirating a trapped oocyte.”

IVF patients undertake an estimated two IVF

cycles on average, with most of them ceasing treatment after that for financial reasons, prior to

achieving a successful pregnancy. Broader insurance coverage would likely lead to more patients

attempting IVF and to more IVF attempts per patient, with consequent greater individual success.

Arkansas, Hawaii, Maryland, Massachusetts,

and Texas have mandated that insurers cover

IVF, although in limited fashion.

The 3.o million current civilian employees of

the Federal Government are covered by 435 different health plans nationwide, The large, nationwide plans participating in the Federal Employees Health Benefits Plan (FEHBP) cover many

traditional medical and surgical treatments for infertility, but exclude coverage of IVF, reversals

of sterilization, and artificial insemination. Assure -
Ch. l—Summary, Policy Issues, and Options for Congressional Action ● 1 1

ing that from 2,500 to 3,000 civilian Federal em- each, extending insurance coverage under FEHBP

ployees undertake an average of two IVF cycles for IVF would cost an estimated $25 million.

WHAT ETHICAL ISSUES ARE INVOLVED?

A wide range of conflicting established

moral viewpoints makes the development of

public policy related to infertility difficult.

Where there are pluralities of viewpoints and

a lack of any single established moral approach, uniform solutions are questionable.

Recent years have seen the appearance of several ethical analyses of reproductive technologies,

with most leading to pronouncements that a particular technology is either ethically acceptable

or not. In 1987, for example, the Roman Catholic

Church issued its Instruction on Respect for Hu -

man Life in Its Origin and on the Dignity of Procreation. The Church supported basic medical and

surgical treatment for infertility but opposed

nearly all other techniques for diagnosing and

treating infertility.

Similar analyses examine at least six themes:

● The right to reproduce. Procreation is seen

by most as a fundamental facet of being human. Differing views about the relative importance of procreation have spawned disagreement over how to balance a claim to

reproduce against other needs. Critical unanswered questions are whether infertile couples have the right to use the gametes or bodies of others, and the right to financial

assistance to obtain treatment they might not

otherwise be able to afford.

. The moral status of an embryo. IVF and the

ability to freeze embryos raise questions

about appropriate treatment of embryos that

are likely to be debated for sometime to come.

While some recognize embryos as full persons from the moment of fertilization, others

claim an embryo has no moral status whatsoever. Still others contend embryos have significant moral standing, although not equal

to that of a person. The unresolved debate

about how to view and handle human embryos has impeded the growth of new knowl-

●

●

●

●

edge about fertility, infertility, and contraception.

Bonding between parent and child. Parentchild bonding is important both to parents

and to the developing personality of the child.

Conception that involves the efforts of a third

party may redefine parenthood. The use of

reproductive technologies raises questions

about the minimum requirements for bonding and the meaning of parent-child

relationships—and what they ought to be.

Research with patients. Infertile patients

have a right to know when treatment is a

proven medical therapy and when it amounts

to an experimental trial. Further, because of

their often intense effort to conceive, infertile patients are particularly vulnerable to

abuses of the researcher-subject relationship.

Truth-telling and confidentiality. The intimate nature of infertility diagnosis and treatment and the use of donor gametes complicates simple ethical imperatives to tell the

truth and to hold personal information in confidence.

Responsibilities of one generation to

another. Parents, physicians; and researchers have a duty to refrain from using reproductive technologies in ways that might harm

future generations.

Most religious traditions in the United States

view necessary medical or surgical treatments for

infertility as acceptable and hold them to be desirable. There is general acceptance of the morality

of artificial insemination by husband, considerable hesitation about artificial insemination by

donor, and even less support for artificial insemination of single women. Most religions support

IVF or gamete intrafallopian transfer using the

married couple’s own sperm and eggs as long as

no embryos are discarded. Surrogate motherhood

is largely opposed in any form.
12 ● Infertility: Medical and Social Choices

WHAT DOES

The U.S. Constitution has been interpreted

to preclude almost any kind of governmental

effort to prevent competent individuals from

marrying and exercising their innate fertility.

Yet there is no explicit statement in the Constitution of either a right to procreate or a right

to privacy. Court decisions do not clearly state

whether such rights extend to a right to obtain

medical services, to use donor gametes, to use a

surrogate mother, or to pay for these three

avenues of overcoming infertility, Nevertheless,

any governmental effort to regulate or ban any

aspect of noncoital reproduction is certain to be

subjected to judicial scrutiny.

Issues likely to be before the courts in the coming years include regulation of medical treatments

using a couple’s own gametes, restrictions on use

of embryos not transferred, payment for undergoing medical procedures that carry some risk

(e.g., ova donation), payment for embryos and

their transfer, and the government’s obligation to

pay for or otherwise provide infertility services

for poor people.

Noncoital reproduction introduces two

prominent complications into family law, traditionally the domain of the States First, when

donor gametes are used, the legal identification of a child’s mother and father may come

into question. A majority of States have already

rearranged presumptions of legal paternity following the conception of a child by donor insemination. Some problems remain when the donor

wishes to have some legal relationship with the

child or when the recipient is unmarried. States

THE LAW SAY?

have not yet begun to grapple with egg or embryo donation. These are more complicated because the gestational mother may or may not intend to raise the child. Therefore, models based

on artificial insemination—which balance rearing

and genetic paternity—are insufficient to cover

cases requiring balancing of rearing, gestational,

and genetic maternity.

Second, when extracorporeal embryos are

at issue, questions arise concerning the legitimacy of actions with embryos (e.g., sale, transfer to nongenetic relations, or disposal) and,

further, concerning who may make decisions

concerning embryos. At least two State legislatures have considered the problems raised by ex -

tracorporeal embryos. Louisiana has tried to give

them the legal status of a child—meaning, among

other things, they cannot be sold or discarded—

but the law has yet to face a constitutional challenge based on its possible conflict with related

Supreme Court decisions.

Florida has outlawed the sale of embryos. This

has not yet been challenged as an interference

with the right to procreate. The question has

largely been avoided as physicians have been careful to obtain the opinions and consent of the

genetic parents before doing anything with an embryo. It remains unclear whether an embryo has

status as the property of the genetic parents

(meaning it can be disposed of as they please) or

as analogous to that of a child of the genetic parents (meaning it is protected by State law from

parental actions that are harmful), or some other

status as yet unenunciated.

IS SURROGATE MOTHERHOOD HERE TO STAY?

Surrogate motherhood is more a social solution Surrogate motherhood may occur in two ways.

to infertility than it is a medical technology. It burst A woman maybe artificially inseminated with the

into American consciousness in 1987 with satu- sperm of a man who intends to be the rearing

ration media coverage of the Baby M case, when parent of the resulting child. Or a woman may

a woman changed her mind and wanted to keep be the recipient of a transferred embryo and carry

the baby she bore, but was forced to yield the to term a baby to whom she is genetically unchild to the biological father who had hired her. related. The former procedure is far more comThe legal status of surrogate motherhood ar- mon than the latter, although surrogacy involvrangements is today unsettled and likely to ing embryo transfer could become more common

stay that way for some time to come. in the future.
Ch. l—Summary, Policy Issues, and Options for Congressional Action ● 13

About 600 surrogate mother arrangements have

been concluded to date. In a few of these, the participants indicated that they had either changed

their intentions or been otherwise dissatisfied with

the outcome. About 15 surrogate mother matching services are active in the United States, and

as many as 100 surrogate mother arrangements

may be concluded annually over the next several

years. A typical contract involves a $10,000 fee

to the surrogate mother and an additional $20,000

to $30,000 in living expenses, medical expenses,

and attorneys’ fees. In such a circumstance, about

$1 out of every $4 actually goes to the surrogate

mother. Contracts often impose restrictions on a

surrogate’s personal habits during pregnancy (e.g.,

smoking, alcohol consumption, exercise) and conditions for medical care (e.g., mandatory amniocentesis).

WHAT REPRODUCTIVE HEALTH

The Veterans’ Administration (VA), the Nation’s

largest health care delivery system, offers only

limited treatment for infertility in its 172 medical

centers and 227 outpatient clinics. Since infertility treatment often involves the examination and

treatment of both partners, and the VA has authority to administer medical treatment solely to

veterans, the VA lacks authority to treat a nonveteran spouse of an infertile couple. Most important, the VA does not classify infertility as

a primary disability, thus severely limiting the

treatment available to veterans.

In 1985, about 16,000 male veterans and just

over 1,200 female veterans had known serviceconnected medical conditions that could lead to

infertility. (“Service-c onnected” refers to a disease,

injury, or other physical or mental defect incurred

during the time of active military service. It does

not necessarily imply active combat.) Among the

men, the conditions ranged from removal of the

testes or prostate to spinal cord injury. Among

the women, the conditions ranged from removal

WHAT HAVE OTHER

Eight other nations (Australia, Canada, Federal Republic of Germany, France, Israel, the

Netherlands, Sweden, and the United KingLegislation addressing surrogate mother

hood has been introduced in more than half

the State legislatures, and four States have

passed laws. In 1987, Louisiana enacted legislation inhibiting surrogacy; in contrast, Arkansas

has statutorily facilitated surrogate motherhood

under some circumstances. Nevada exempted lawful surrogacy from its ban on baby-selling, and

Kansas exempted surrogacy from prohibitions on

advertising. State court decisions have consistently

found surrogacy contracts to be unenforceable,

even though they have split on whether the contracts are illegal.

In the absence of Federal legislation or Federal judicial decisions, State legislatures and

courts are likely to continue to come to different conclusions about the desirability of commercialized surrogate motherhood.

CARE DO VETERANS RECEIVE?

of the ovaries to inflammation of the fallopian

tubes or cervix. The VA, however, performed few

procedures related to infertility among these

veterans.

Spinal cord injury, caused principally by battlefield trauma during wartime and vehicular

and diving accidents during peacetime, is of

special concern to both the VA (which supports 20 spinal cord injury centers) and veterans) advocacy groups. The current outlook for

fertility after spinal cord injury in paraplegic men

(although not women) is often poor. Erection and

ejaculatory dysfunction, compounded by infections of the urogenital tract, are common. VA research on electroejaculation and vibration-induced

ejaculation is likely to offer hope for fertility to

veterans—and ultimately nonveterans—with spinal cord injuries. Ironically, even when sperm are

obtained in this way by VA physicians, insemination of the veteran’s nonveteran wife cannot be

undertaken under VA auspices.

COUNTRIES DONE?

dom) have enacted legislation or issued major

Government reports on the use of noncoital

reproductive technologies. At least another 35
74 . /nfertility: Medical and Social Choices

countries and four international organizations

have had public debate, considered legislation, or

examined some aspect of this issue.

Artificial insemination by husband and donor

are generally considered acceptable techniques

worldwide. Several countries have legislation stating that children resulting from artificial insemination by donor are the legitimate offspring of

the woman and her consenting husband. IVF is

generally considered acceptable, provided it is

used only when medically necessary.

The use of artificial insemination and IVF by

unmarried couples, homosexual couples, and single men and women is more controversial. The

use of donor gametes in IVF is not universally accepted. oocyte donation is not as widely accepted

as sperm donation, largely because the technology is considered experimental. Acceptance of embryo donation varies widely.

Most controversial are the topics of surrogate

motherhood and research on human embryos.

Countries that do approve embryo research often

stipulate that embryos must be excess ones obtained through IVF, not created for research, and

they often impose a time limit after which research

must end (e.g., 14 days after fertilization). Surrogate motherhood has achieved little acceptance,

and several countries have taken steps to ban the

practice, especially its commercial use.

WHERE DO REPRODUCTIVE TECHNOLOGIES GO FROM HERE?

Speculation about reproductive technologies yet on the horizon has captured the public’s imagination like few other aspects of infertility treatment, although new reproductive

technologies are only one factor driving increased interest in infertility treatment (see table 1-2). The next decade will likely see proliferation of the practice of embryo freezing as an

adjunct to IVF, although if success in freezing eggs

comes about, that would obviate the need for most

embryo freezing. Cryopreservation of eggs before

fertilization, however, stands as a formidable technical task and may involve an insurmountable biological obstacle—damage to the fragile chromosomes of the oocyte.

Successful pregnancies following micromanipulation of a single sperm into an egg—recorded in

neither animals nor humans, to date—would mark

dramatic progress in the treatment of male infertility, most of which is caused by too few or abnormal sperm. Ethical and legal concerns regarding proper selection of one human sperm for

fertilization may ultimately limit the application

of this technology.

Techniques for screening sperm and ovum

donors for a limited number of genetic anomalies lie in the foreseeable future. The practical application of genetic screening by practitioners of

artificial insemination is uncertain, however, and

Table 1.2.—Some Causes of Increasing Requests for Infertility Services in the 1980s

Increasing proportion of Increasing number of Evolution of

More couples with infertile couples physicians providing More conducive new reproductive

primary infertility seeking care infertility services social milieu technologies

● Aging of the babyboom generation

● Deiayed childbearing;

more people in higher

risk age groups

c Childbearing

condensed into

shorter intervals

● Delayed conception

due to prior use of

oral contraceptives

. Decreased supply of

infants available for

adoption

. Heightened

expectations

● Larger number of

people in higher

income brackets with

infertility problems

● Larger percent of

infertile couples are

primarily infertile

Q Greater demand from

private patients

. More sophisticated

diagnosis and

treatment

s At least 169 sites in

the United States

offering in vitro

fertilization or gamete

intrafallopian transfer

● Baby-boom . Artificial insemination

generation expects to c Surrogate

control their own motherhood

fertility ● In vitro fertiIization

. Profamily movement (IVF)

. Increased discussion ● Gamete Intrafaliopian

of sexual matters due transfer (GIFT)

to the AIDS epidemic ● Cryopreservation

● Extensive media

coverage

SOURCE: Adapted from S.0. Aral and W. Cates, Jr., “The Increasing Concern With Infertility: Why Now?” Journal of the American Medicai Association 250:2327-2331, 1983.
Ch. l—Summary, Policy Issues, and Options for Congressional Action . 15

no amount of screening will exclude all donors

capable of transmitting genetic disorders.

Reliable separation of X- and Y-bearing sperm

for sex selection remains elusive despite many attempts. When sex selection of human sperm cells

becomes possible, its use will be limited by the

willingness of couples to undergo artificial insemination or IVF.

The development and use of techniques to select the sex of human embryos are likely to be

slowed because techniques developed thus far (for

cattle) involve splitting embryos into one part for

sexing and another part for transfer. Splitting or

biopsying human embryos is certain to be a contentious issue.

One technology of the present, IVF, is itself

a powerful means for unraveling mysteries of

the human reproductive process. The advent

of IVF permits researchers for the first time

to view human reproduction in progress. Understanding the interactions between sperm and

egg has potentially broad application not only for

conception, but for contraception as well. Researchers seeking Federal funding to work in this

area, however, have faced since 1980 the stifling

effects of a de facto moratorium on Federal funding of research involving human IVF.

POLICY ISSUES AND OPTIONS FOR CONGRESSIONAL ACTION

Nine policy issues related to infertility prevention and treatment were identified during the

course of this assessment. They are:

●

●

●

●

●

●

●

●

●

collecting data on reproductive health;

preventing infertility;

information to inform and protect consumers;

providing access to infertility services;

reproductive health of veterans;

transfer of human eggs, sperm, and embryos;

recordkeeping;

surrogate motherhood; and

reproductive research.

Associated with each policy issue are several

options for congressional action, ranging in each

case from taking no specific steps to making major changes. Some of the options involve direct

legislative action. Others involve the executive

branch but with congressional oversight or

direction.

The order in which the options are presented

does not imply their priority. Moreover, the options are not, for the most part, mutually exclusive: Adopting one does not necessarily disqualify

others in the same category or within any other

category. A careful combination of options might

produce the most desirable effects. It is important to keep in mind that changes in one area may

have repercussions in others.

ISSUE: Should the Federal Government improve collection of data on reproductive

health?

Federal support of collection of data on reproductive health is concentrated in two agencies of

the Public Health Service: the National Institutes

of Health (NIH) and the Centers for Disease Control (CDC), with its National Center for Health Statistics.

The Federal Government has an interest in collecting data in three areas of infertility: factors

contributing to infertility, its prevalence, and the

outcome of certain treatments. Few data are consistently collected on factors contributing to infertility at this time. An estimated 20 percent of

infertility is a result of sexually transmitted diseases. Gonorrhea, one of the two sexually transmitted diseases known to lead to pelvic inflammatory disease (PID) and thus to infertility, is a

reportable disease. But the other, chlamydia, is

not. Chlamydial infection is now the most common sexually transmitted disease, and it has significant adverse reproductive consequences, particularly for women.

Nor do much data exist on the prevalence of

infertility in the United States. The source most

often cited is the National Survey of Family Growth

(NSFG), a survey conducted periodically by the

National Center for Health Statistics to collect data
16 . Infertility: Medical and Social Choices

on fertility, family planning, and related aspects

of maternal and child health. Surveys were conducted in 1976 and 1982, and another began in

1988.

There is some concern in the United States that

the handling of embryos extracorporeally during

IVF might result in increased numbers of birth

defects or other health problems in the resulting

offspring. NIH has conducted a short-term study

of IVF babies born at the Jones Institute of Reproductive Medicine (Norfolk, VA), but no longterm followup is planned. NIH is beginning a study

of women undergoing IVF, but this will not focus

on the health of the resulting offspring. Thus,

there is currently no systematic Federal method

for registering the birth of IVF babies and for following the development and health of these individuals.

Option I: Take no action.

Absent action to make chlamydial infection a

reportable disease and thus commence a national

surveillance system, researchers and the Government will continue to rely on data obtained from

clinics, physician practices, and other health care

facilities for estimates of prevalence and incidence

of chlamydial infection.

NCHS expanded the questionnaire for the 1988

NSFG, adding more questions concerning infertility. Thus, available information on infertility will

improve even without congressional action. The

added questions will begin to fill in some of the

gaps, such as more information on some factors

contributing to infertility, on the prevalence of

male infertility, and on infertility treatment.

If Congress chooses not to request monitoring

of the health of babies resulting from IVF, the procedure’s potentially harmful or beneficial effects

on these babies may go undetected. Individual IVF

clinics may conduct their own research, but as

success rates and the methods of treatment can

vary widely between clinics, such research would

not be representative of all IVF clinics.

Option Z: Appropriate funds for the Secretary of

Health and Human Services to make grants to

State public health departments for the establishment of a national surveillance system on

chlamydial infection,

A national surveillance system is crucial for control and prevention of chlamydial infection as it

would provide quantitative estimates of incidence

and prevalence, a basis for identifying infected

individuals and those at risk, and a tool for evaluating control efforts. Compared with the piecemeal

reporting that now exists, a national system would

allow the Centers for Disease Control and the various State health departments to identify high-risk

groups and problem areas, thus enabling them

to target their funds for screening and education

in the appropriate populations and areas. The prevention and treatment of chlamydia that would

result from these efforts would likely lead to lower

rates of PID and thus to decreased rates of PIDrelated infertility.

A national surveillance system would require

State reporting laws or regulations. Reporting laws

not only provide accurate information on the extent and trend of the disease but also promote

the involvement of public health authorities in assuring adequate individual patient management

and in facilitating screening and education.

Although CDC has consistently recommended

that the States establish this surveillance system,

individual States are unlikely to do so without additional funds. Congress could appropriate funds

for the Secretary of Health and Human Services

to make grants to State public health departments,

thus helping them handle the costs of making

chlamydia a reportable disease.

Option 3: Direct the Secretary of Health and Human Services to enhance the collection of data

on infertility.

Congress could direct the Secretary of Health

and Human Services, through NCHS, to enhance

data collection on infertility. One way this could

be accomplished is by increasing the frequency

of data collection through a followup telephone

survey of the NSFG. Another improvement would

be increasing the sample size of the NSFG.

Few data are currently available on male infertility that are based on information drawn from

men themselves. NCHS plans to expand the NSFG

to include information on the frequency of male

infertility, but it will not obtain any information

on the factors that lead to it, as the questions will
Ch. l—Summary, Policy Issues, and Options for Congressional Action “ 1 7

still be addressed to women. To obtain such data

on men, a completely different survey addressing men’s reproductive health would be necessary. Thus, a third improvement to the collection

of data on infertility would be adding a survey

of male reproductive health.

Option 4: Establish a systematic method for registering the birth of IVF babies and for following the development and health of these infants.

For the first time in human history, babies are

being born following extracorporeal fertilization.

Although the incidence of birth defects following IVF does not appear to be disproportionately

large, the absence of developmental effects of ex -

tracorporeal embryo culture (and perhaps freezing) is not a certainty. Congress could direct the

Secretary of Health and Human Services to collect data on the health and development, including psychological development, of IVF babies from

birth to maturity to assess the effects of these techniques. The need for such a study could be reevaluated periodically, and the safety and efficacy

of other reproductive technologies (e.g., gamete

intrafallopian transfer) could also be reviewed

periodically. Documentation of good health among

individuals conceived by IVF would carry the side

benefit of ameliorating some public concern about

the procedure.

Pursuit of this option has several costs, particularly as the offspring of assisted conception increase in number. Singling out these individuals

for scrutiny raises ethical questions and may be

viewed as an intrusion into their privacy. Moreover, the size and cost of such an effort is likely

to grow rapidly. Finally, such monitoring forecloses the option of the parents not to reveal to

the child the circumstances of his or her conception.

ISSUE: Should efforts toward prevention of infertility be enhanced?

The Federal Government supports no identifiable activities expressly directed toward prevention of infertility. It supports several activities allied with prevention of infertility, such as NCHS

collection of descriptive data about infertile couples, contraceptive research funded by NIH and

the Agency for International Development, and

programs of the Centers for Disease Control that

aim to prevent sexually transmitted diseases. Yet

the link between these programs and the pre\~ention of infertility has never been prominently

forged. As a result, efforts to prevent infertility

are not well coordinated within the Federal Government.

Option 1: Take no action.

Under Section 318 of the Public Health Service

Act (42 U.S.C. 247c), the Secretary of Health and

Human Services, acting through the Centers for

Disease Control, is authorized to make grants for

the prevention and control of sexually transmitted

diseases. Inasmuch as STDS account for an estimated 20 percent of infertility, the Secretary’s authority could be used to support programs

directed toward prevention of some infertility.

Such activities have not been prominent, however,

and in the absence of congressional action this

situation is likely to continue. In addition, the bulk

of infertility is not addressed by programs for prevention of sexually transmitted diseases and is not

specifically addressed elsewhere by existing governmental authority.

Option 2: Amend the Public Health Service Act

to extend the program of grants for prevention and control of sexually transmitted diseases

to include prevention of infertility secondary

to sexually transmitted diseases.

Congress could amend the Public Health Service Act to extend specifically the Secretary’s authority to make grants for the prevention of infertility believed to be a consequence of sexually

transmitted diseases. To be effective, such an extension of authority would need to be accompanied by additional appropriated funds. Amending the Public Health Service Act in this way would

focus preventive efforts on the one important

preventable cause of infertility identified to date.

In addition, such congressional action would have

the salutary symbolic effect of raising the apparent priority given to infertility prevention.

A disadvantage of such action is that it might

appear to give disproportionate emphasis to STDS

as a cause of infertility at the expense of identifying other causes and preventive measures. Pursuit of this option would not address prevention
18 . Infertility: Medical and Social Choices

of the majority of cases of infertility, which are

not linked to STDS. For those cases, prevention

first requires additional research into the factors

leading to infertility.

Option 3: Evaluate Federal efforts to prevent infertility.

Congress could direct the Secretary of Health

and Human Services to report on Federal activities related to prevention of infertility. Because

some efforts in reproductive research fall outside

the purview of the Department of Health and Human Services, Congress could direct the Secretary to convene an interagency task force to assess preventive efforts. Or Congress could exercise

oversight by means of hearings on this subject.

Congressional evaluation of Federal efforts to prevent infertility is likely to identify a need for a

coordinated effort that goes beyond prevention

of sexually transmitted diseases to consideration

of causes of infertility that are not well understood.

Option 4: Establish a demonstration project for

identification of risks for infertility.

Beyond sexually transmitted diseases, there are

many suspected factors contributing to infertility but few confirmed culprits. Congress could

direct the Secretary of Health and Human Services to establish a long-term research effort aimed

at identifying exposures or behaviors in young

adulthood that predispose an individual to infertility. Such long-term, longitudinal research that

follows young adults through their reproductive

lives is difficult, expensive, and often exceeds the

active research lifespans of individual investigators. In instances like this, therefore, coordinated,

cooperative efforts (e.g., the Framingham Heart

Study) are required. such a study is critical for

ferreting out confirmed from suspected factors

contributing to infertility, and is likely to be a

prerequisite to organizing serious programs to

prevent whatever portion of infertility can be prevented.

Without a comprehensive longitudinal study to

identify risk factors for infertility, many of them

may never be fully defined and possible preventive steps may never be taken. On the other hand,

the result of such an undertaking maybe confirmation that a number of cases of infertility are

of unknown origin and not preventable.

Option 5: Enhance education in reproductive

health.

Education about reproductive health, as with

most education in the United States, is the responsibility of local jurisdictions and largely excluded

from the Federal purview. Knowledge of reproductive health is erratic and uneven among individuals of reproductive age; many myths and halftruths are believed as fact. This situation can have

important consequences for preventing infertility.

Congress could take at least two steps to enhance

education in reproductive health. First, Congress

could exercise oversight to see that the Secretary

of Health and Human Services, under Title X of

the Public Health Service Act, directs health clinics

receiving Title X funds to bolster the infertility

services offered to their patients. More than 4,OOO

clinics in the United States serve about 4.3 million people each year. Infertility services constitute about 1 percent of the clinics’ activities. This

existing network of clinics could make available

educational materials and counseling, for example, about the potential long-term infertility consequences of some family planning methods.

Second, Congress could direct the Secretary of

Education to develop a model curriculum for primary, secondary, and postsecondary students that

illustrates fundamental facts about reproductive

health and prevention of infertility. Although it

has long been objectionable to some segments of

American society, education in reproductive

health may be the most cost-effective means at

the disposal of the Federal Government for making long-term progress in preventing infertility.

ISSUE Should the Federal Government ensure

that consumers of selected infertility services have the information to make informed

choices?

Congress generally does not regulate medical

practice, with the exception of drawing broad criteria for care delivered at Veterans’ Administration hospitals or reimbursed by Federal insurance

programs. Nor are medical techniques subject to

consumer protection legislation, with the nota-
Ch. l—Summary, Policy Issues, and Options for Congressional Action “ 19

ble exception of Food and Drug Administration

regulations for testing drugs and devices, and for

regulating advertising of their indications and efficacy. Rather, quality assurance and consumer

protection issues are left to State legislatures,

professional societies, consumer groups, and

word-of-mouth. However, some have suggested

that the Federal Government take steps to ensure

that infertile individuals are made aware of the

efficacy of the treatments offered and of the success record of medical personnel with whom they

are consulting.

This has been particularly stressed with regard

to IVF, for several reasons:

●

●

☛

●

●

●

●

●

Aspects of the technique are still to some extent in a research phase.

Success rates vary considerably.

Success rates are reported in various, and

sometimes confusing, ways.

The procedure is carried out at times in freestanding clinics or other settings that are not

subject to all the usual hospital peer-review

practices.

Relevant professional societies do not yet have

accreditation programs directed specifically

at IVF.

As the procedure can entail months of drug

treatment and repeated surgeries, it can represent a serious health risk and constitutes

a major disruption of personal and professional activities.

IVF is often excluded from insurance coverage, and so maybe very costly to individuals.

The patient population for these services is

particularly vulnerable because it largely consists of individuals who have tried for many

years to have a much desired pregnancy.

Option 1: Take no action.

Congress could leave quality assurance and consumer protection efforts in the area of infertility

services to the individual States and medical

professional societies. Other medical services, such

as novel techniques for cancer therapy, have similarly suffered from varying success rates and vulnerable patient populations. Absent Federal action, it can be expected that State quality control

legislation (such as that enacted in Louisiana), consumer education by private organizations, and

medical society activity will attempt to protect patients from the risk, pain, disruption, and cost of

undergoing the procedure at clinics or hospitals

without a demonstrable success rate. But such efforts will inevitably be spotty for at least the next

several years.

By taking no action, Congress would avert bringing public scrutiny to a very private area of health

care. It is possible that Federal regulation of infertility services could change the character of

those services. Gamete donors, for example, may

be unwilling to participate, and recipients of gametes or embryos maybe uneasy about medically

assisted conception conducted in the spotlight of

Federal regulation.

Option 2: Encourage the use of a consensus review or conference on the use of IVF, gamete

intrafallopian transfer, and other innovative

treatments for infertility.

Short of regulating infertility treatment and research, Congress could facilitate greater data collection and voluntary adherence to guidelines developed by professional societies. This can be done

by authorizing the use of governmental agencies

or commissioning resources for efforts by professional societies, research institutes, or the insurance industry to hold consensus conferences and

to recommend protocols for highquality care. A

consensus conference, for example, could be used

to evaluate patient data and to recommend a protocol that lists the best indications for the use of

IVF as opposed to gamete intrafallopian transfer.

Conferences and reports could also be used to help

define a “successful” program; to distinguish experimental techniques, techniques with some possibility of success, and standard techniques; and

to make more uniform the minimum level of staffing for a program.

Congress could exercise oversight to encourage

NIH or the National Center for Health Services

Research and Health Care Technology Assessment

to review or hold a consensus conference on innovative infertility treatments. NIH consensus

conferences-of which more than 60 have been

held in the last decade-could be used to:

● influence the development of data collection

on the use of IVF, gamete intrafallopian trans -
20 . Infertility: Medical and Social Choices

fer, and other reproductive techniques;

● recommend indications for use;

● establish conventions for reporting successful outcomes; and

● define standards for laboratory equipment

and personnel training.

One important consideration regarding the

appropriateness of an NIH consensus conference

is whether the questions concerning the medical

technology are primarily scientific and clinical,

or primarily ethical or economic. The NIH conferences focus on the former. The Office of Health

Technology Assessment of the National Center for

Health Services Research and Health Care Technology Assessment, under the Office of the Assistant Secretary for Health, has authority to undertake review of less scientific issues, such as

safety, efficacy, cost effectiveness, and indications

for use of infertility treatments.

Congress could also commission a private research institute or professional society to review

current practice of selected infertility treatments

and to recommend indications for use, protocols

for patient selection, and minimal personnel staffing for clinics. Among the many nongovernmental entities with the resources to perform this function are the American Medical Association, the

Blue Cross/Blue Shield Association, and the Institute of Medicine at the National Academy of

Sciences.

Option 3: Extend consumer protection laws to

selected infertility services.

Congress could direct the Federal Trade Commission to exercise its authority under Section

5(a)(6) of the Federal Trade Commission Act to

examine whether advertisement of success rates

at various IVF or gamete intrafallopian transfer

clinics is misleading, and, if so, to issue appropriate regulations. Regulations could be issued, for

example, to standardize the ways in which success rates are reported, so that individuals are better able to make an informed choice about

whether and where to undergo a procedure.

Even such consumer regulation is not an effective means of directly regulating the quality of

the services offered, however. Regulating a medical service itself—for example, by setting standards for personnel and facilities—would be an unusual step, as such regulation does not generally

take place at the Federal level, with the exception

of setting quality control standards for Medicare

reimbursement.

ISSUE Are existing mechanisms for gaining access to infertility diagnostic and treatment

services adequate?

Currently, those who can afford to pay for infertility services out-of-pocket have the greatest

access. To consider use of newer medical technologies, infertile individuals need to be able to

pay anywhere from several hundred dollars to

more than $22,000. Individuals with some private

insurance coverage generally can expect to have

a large portion of their expenses covered during

the diagnostic phase, with considerable variability of coverage for infertility treatments. Although

the majority of health insurance plans have specifically excluded coverage for IVF treatment,

there may be a significant amount of reimbursement for the various components of such treatment (e.g., laparoscopy).

Under the Federal Medicaid Program, it is possible to receive reimbursement for infertility diagnosis and treatment if a person is designated as

categorically needy and if the State has a policy

to submit claims for the reimbursement of infertility diagnosis and treatment services under the

heading of “family planning services. ” States are

currently shifting away from the practice of submitting such claims as family planning services.

Under the Federal Medicare Program, it is possible to receive reimbursement for infertility diagnosis and treatment if a person has received Social Security disability benefits for more than 2

years and thus becomes entitled to Medicare coverage. It is not clear how many disabled individuals of reproductive age have actually sought or

received this coverage.

There are geographical as well as financial determinants of access to infertility diagnosis and

treatment. For the initial medical consultation regarding this problem, couples are most likely to

seek the advice of their gynecologist, general practitioner, or urologist. If the problem is serious

enough for referral to an infertility specialist, ac -
Ch. l—Summary, Policy Issues, and Options for Congressional Action . 21

cess to such care is likely to be reduced. Sophisticated infertility care is generally located in urban

areas. Innovative, experimental procedures for

more difficult infertility cases are more likely to

be available at universities and medical centers.

Option 1: Take no action.

If Congress takes no action, then access to physicians and diagnostic and medical care for infertility will continue to be determined by individual financial resources and geography. This may

lead to an inequitable distribution of infertility

services among socioeconomic classes or geographical areas. On the other hand, by taking no

action Congress will avoid imposing upon some

citizens a responsibility to support certain medical procedures they may consider purely elective

or immoral.

Option 2: Direct the Health Care Financing Admin -

istration of the Department of Health and Human Services to review and report on the extent of existing coverage for infertility diagnosis

and treatment services under the Medicaid and

Medicare Programs.

Current reporting schemes under Medicare and

Medicaid do not identify which diagnostic and

therapeutic infertility procedures are covered and

how much they cost. This information would provide an important basis for decisions about any

changes needed in the Medicaid and Medicare

Programs.

Option 3: Amend the existing Federal Medicaid

Program to add a new reimbursement category

for services related to the diagnosis and treatment of infertility.

Amending Medicaid coverage would establish

consistent national policy for infertility diagnosis

and treatment coverage. It would no longer be

at the discretion of the States to decide whether

or not to submit claims for reimbursement of infertility services under the heading of ‘(family planning services .“ This change in Medicaid reimbursement policy would likely result in increased

demand for reimbursements for infertility services. It could also be viewed as equivalent to a finding of ethical acceptability or unacceptability by

the Federal Government with regard to each procedure allowed.

Option 4: Amend Title 5 of the U.S. Code to provide that any carrier offering obstetrical benefits under the health benefits program for Federal employees shall also provide benefits for

medical procedures to overcome infertility, including procedures to achieve pregnancy and

to carry pregnancy to term.

Insurance programs for Federal workers could

be required to cover all diagnosis and treatment

of infertility. The existing Federal Employees

Health Benefits Program covers the costs of pregnancy and delivery and some forms of infertility

diagnosis and treatment. Less traditional techniques, such as IVF, gamete intrafallopian transfer, and artificial insemination, arguably merit similar coverage. Although such legislation would

benefit only the Federal work force, it could serve

as a model to private insurers and employers. Such

a model would provide a database of cost information upon which private plans could be constructed.

Implementation of this option could cause some

insurance carriers to drop obstetrical benefits enPhoto credit: Library of Congress
22 . /n fertility: Medical and Social Choices

tirely. Those carriers who expand their coverage

would likely increase the premiums charged Federal employees and the Government.

Option 5: Facilitate adoption, a social alternative

to infertility treatment.

Some couples seek medical or surgical treatment, or a surrogate mother, because adoption

is for them too difficult or time~consuming. Adopting through a public agency can entail a wait of

2 to 10 years and stringent eligibility criteria; private, independent adoption can be expensive and

take from 6 months to 5 years. Congress could

work to facilitate adoption by examining the results achieved under the Adoption Assistance and

Child Welfare Act of 1980, the Title IV funding

of child welfare (including foster care) and adoption assistance under that act, and the 1978 Child

Abuse Prevention and Treatment and Adoption

Reform Act. These programs could be used to develop a national database of adoptable children

for use by couples seeking private adoption, as

well as to remove barriers to the adoption of children with physical or mental handicaps, older children, or children of a different race.

Many available children in this country are

never adopted because individuals find the prospect of an interracial family, a difficult adjustment

period for an older child, or a lifetime of care for

a handicapped child to be too daunting. Further

incentives and social services could be used to help

ease these difficulties, and better use of a national

clearinghouse for all adoptable children may make

the process of adoption, even if lengthy, more manageable and successful. Even with more services,

however, such adoptions are not likely to be attractive to all individuals seeking to form a family. For some, the purpose in seeking infertility

treatment or a surrogate mother is to have a child

who is genetically related to at least one parent.

Adoption cannot satisfy this desire,

ISSUE: Should the VeteransJ Administration

provide infertility diagnosis and treatment?

For the VA to provide care to a veteran, at least

four conditions must be met: the veteran must

have a disability, the VA care must be for that disability, the care must be necessary, and the care

must constitute hospital care (including medical

treatments). These provisions mean that veterans

currently obtain only limited treatment for infertility from the VA.

During the IOOth Congress, on Dec. 4, 1987, the

Senate passed an amendment to Section 601(6)

of Title 38 of the U.S. Code. This would give the

VA authority to provide “services to achieve pregnancy in a veteran or a veteran’s spouse where

such services are necessary to overcome a serviceconnected disability impairing the veteran’s procreative ability,” A similar provision had been

passed by the Senate (but not the House of Representatives) during the 99th Congress.

Option I: Take no action.

The present position of the VA prevents it from

treating infertility since the agency does not interpret infertility to be a disability (defined as a

disease, injury, or other physical or mental defect). Although some infertility medical workup

may be performed, procedures such as IVF, gamete intrafallopian transfer, and artificial insemination may not be provided. In addition, the VA

lacks authority to treat a nonveteran spouse for

infertility.

Financial arguments for taking no action are supported by the fact of the aging of the veteran

population-increased expenditures by the VA for

costly and elective medical procedures may not

be justified. If additional funds are to be allocated

to the VA for health care, these funds might best

be used to improve and expand treatment of lifethreatening disorders. Further, taking no action

means the VA need not make judgments about

fitness for parenting.

On the other hand, the comparatively small

number of veterans with service connected infertility means the VA would not incur substantial

expenses in contracting for infertility services. In

addition, the VA’s mission is to provide health care

to eligible veterans. This health care is not limited

to life-threatening disorders, as evidenced by the

wide range of services the VA already provides.

Option 2: Direct the Administrator of the Veterans’

Administration to interpret disability to include

the inability to procreate.

If Congress proceeds with this action, the Veterans’ Administration could offer infertility treat -
Ch. l—Summary, Policy Issues, and Options for Congressional Action ● 2 3

ment under existing statues and regulations without other specific legislation. Treatment of the

nonveteran spouse, however, would remain beyond the authority of the VA. Therefore, treatment of infertility under this option would probably be restricted to specific cases of infertility

where the disorder was found solely in the veteran partner. This option would still permit the

VA to proscribe particular infertility treatments

as being experimental or too expensive, and to

limit its coverage to traditional medical or surgical therapy.

In a variation of this option, Congress could elect

to mandate that infertility be considered by the

VA a secondary disability or an inevitable consequence of disease and therefore compensable. InfertiIe veterans could then obtain some funds to

be treated privately,

Option 3: Amend Title 38 of the U.S. Code to

specify that infertility treatments including but

not limited to IVF, gamete intrafal]opian transfer, and artificial insemination may be provided

by the Veterans’ Administration.

These treatments could be made available only

to veterans with service-connected infertility but

not their spouses, only to veterans with serviceconnected infertility and their spouses, to all infertile veterans but not their spouses, or to all infertile veterans and their spouses. Forms of infertility treatment that do not require hospital care

especially require authorization through legislation, as VA regulations preclude such outpatient

treatment. The disadvantage of this course of action is that any listing of infertility services may

be viewed as exclusive and may not encompass

emerging technologies.

The VA could administer such treatment in several ways. Infertility treatment units could be set

up in all VA medical centers and offer services

such as hormonal workup, semen analysis, fertility drugs, IVF, gamete intrafallopian transfer, artificial insemination, and other reproductive technologies. Since many of these services and

treatments are not presently offered by VA medical centers, this option would involve a major commitment of funds to hire new staff such as

gynecologists, reproductive endocrinologists,

andrologists, reproductive tract microsurgeons

(where surgical facilities are available), and laboratory personnel. The VA’s relationship with

medical schools would be affected in that new af -

foliations would be needed, for example, with departments of obstetrics and gynecology.

A limited number of regional or district infertility treatment centers could be setup in various

VA Medical Centers, depending on the need. As

with the preceding approach, this would involve

hiring new staff and setting up infertility diagnostic and treatment laboratories. This would

probably be most successful if regional infertility

centers were established in VA hospitals closely

associated with academic or medical institutions

with programs for infertility treatment.

The VA could contract with other health care

providers that have infertility treatment programs

for the treatment of eligible veterans with infertility problems. Contract health care already exists within the VA for medical treatments such

as gynecological services not generally available

in a VA center. In addition, contract health care

may be provided if VA facilities are not within

a reasonable geographical distance. However, under the provisions for contract health care (38

U.S,C. 608), the eligibility for treatment is more

limited than in VA facilities.

The VA could provide infertility treatment in

some cases as part of the Civilian Health and Medical Program of the VA (CHAMPVA). This program

provides health care for survivors and dependents

of certain veterans. The criteria for eligibility are

that the veteran must have a total disability, permanent in nature, resulting from a serviceconnected disability. The disability rating must be

100 percent. This approach would most likely provide benefits to a very limited population, although

it may benefit veterans with spinal cord injuries

since these individuals are classified as having total or near-total disabilities.

It is important to note that CHAMPVA provides

the same health care benefits as the Civilian Health

and Medical Program of the Uniformed Services

(CHAMPUS). These benefits include coverage of

most types of infertility diagnostic and treatment

procedures. Under CHAMPUS, however, artificial

insemination, IVF, and gamete intrafallopian transfer are specifically excluded, as are any treatments
24 ● Infertility: Medical and Social Choices

that involve artificial conception. Although this

approach may allow for the medical treatment of

nonveteran spouses, other changes in CHAMPVA

eligibility and benefits may be needed.

Lastly, Congress and the VA could provide infertility treatment for veterans by making available a one-time voucher or grant to infertile couples for the cost of procedures such as artificial

insemination, IVF, and gamete intrafallopian transfer. These treatments would then be obtained

from health care providers other than the VA.

In most cases, grant-type benefits operate on an

actual expense basis, with the VA either paying

the bill directly or reimbursing up to a maximum

amount. Questions that arise with this approach

include the amount of the grant, and the responsibility of the VA to the couple and the offspring.

ISSUE: Should the transfer of human gametes

and embryos be regulated?

Sperm are sold by commercial sperm banks

throughout the United States and have been for

many years. The Food and Drug Administration

has authority, within its Center for Devices and

Radiological Health, to regulate tissues, including

semen. In 1988, FDA and professional societies

involved in artificial insemination laid out new

standards regarding storage and use of semen to

protect semen recipients from infection with human immunodeficiency virus.

Donation of unfertilized ova is today occurring

at a number of infertility clinics. A few have begun to pay women to undergo hormone stimulation and ovum retrieval, sometimes in the course

of voluntary sterilization by tubal ligation. ovum

banking using frozen ova has yet to become available, but considerable research is under way to

make this feasible.

Embryos that remain after IVF procedures are

not yet sold, as clinics and hospitals have chosen

instead to give parents the choice of having them

frozen, destroyed, or donated. No technological

obstacle exists to maintaining commercial embryo

banks, although there is still a significant rate of

embryo loss associated with freezing.

Option 1: Take no action.

Taking no action regarding the transfer of human gametes and embryos would be in keeping

with the strong tradition of nonintrusion of the

Federal Government into reproduction. If Congress takes no action, the majority of sperm banks

will probably continue to pay donors for their semen and to charge recipients for the sperm.

Screening of donors for genetic and infectious diseases will continue to vary among sperm banks,

influenced by the periodic promulgation of standards by various professional medical societies, and

inconsistently regulated by State laws.

Commercial embryo banking may develop, and

guidelines for selecting recipients and setting

prices could follow the model of sperm banking.

State laws may be passed affecting the circumstances of the sales, such as provisions concerning recordkeeping, anonymity, or pricing, while

other States may pass legislation banning the sales

altogether. It is not certain whether such bans

would withstand constitutional challenges based

on State interference with the right to procreate.

Option 2: Mandate national standards for protection of paid ovum donors.

Although sperm donation entails no appreciable physical risk to the donor, ovum donation requires either abdominal surgery or sonographicguided oocyte retrieval, both of which entail some

added risk of infection and other complications

to the donor. Women who donate extra eggs in

the course of their own infertility treatment face

no added risk.

Congress could enact legislation or direct the

Secretary of Health and Human Services to issue

regulations to protect ovum donors by requiring,

for example, that commercial sales of ova (or embryos) be allowed only with ova obtained during

a therapeutic or diagnostic procedure. This would

effectively bar the development of a pool of

women who are paid to undergo a medical procedure of some risk, when that procedure has

no ancillary benefit to themselves.

Some may object that such a bar would be discriminatory, as men could continue to earn money

by selling their sperm. Further, barring adult

women from doing this may be seen as inconsistent with the fact that they can choose to be paid

for other, more physically dangerous tasks.
Ch. l—Summary, Policy Issues, and Options for Congressional Action ● 2 5

Option 3: Mandate national standards for protection of recipients and offspring.

Congress could enact legislation directing the

Secretary of Health and Human Services to set

minimum standards for screening egg and sperm

donors for serious genetic disorders and infectious diseases that could be passed on to recipients of their gametes or the resulting children.

National standards could be based on adoption

of existing professional society guidelines, with

periodic reexamination of the efficacy of tests for

human genetic disorders. Even if such standards

were directed only at commercial gamete and embryo banks, they would provide significant guidance as to the minimum standard of care that

ought to be met by unregulated providers, such

as individual physicians.

Some may assert that national standards are

likely to take longer to develop and to revise than

those produced periodically by professional medical societies. Further, development of effective

standards would probably require some kind of

reporting and enforcement mechanism, unless the

standards are to be used only to create a presumptive standard of care for use in individual cases

of medical malpractice litigation.

Congress could also facilitate the development

of a national databank on gamete donors (as South

Africa has done), so that the number of donations

from any one person could be limited. This could

avoid the problem created when a single donor

is used to initiate a large number of pregnancies,

introducing some risk of unintended consanguinity among future marriage partners. This is of concern mainly in areas in which there are few donors

supplying sperm for a geographically isolated population.

Further, the databank could be used to allow

gamete banks to share information on the genetic

and physical health of donors. Combined with followup reporting on the offspring, such recordkeeping practices could also facilitate identification of donors shown to suffer from previously

undetected genetic disorders, making it possible

to prevent those persons from again selling

gametes.

Reports in several other countries have recommended that the number of donations per donor

be limited. In France, sperm banks keep strict

records and limit the number of donations per

person. The central organization of the sperm

banks in France, however, is quite different from

the large number of independent banks in the

United States. The Warnock Committee in the

United Kingdom proposed the most comprehensive plan, recommending that there be a central

registry of donors that must be checked every

time a clinic accepts a donor. South Africa does

this by law. Any registry of donors carries the

risk that it will decrease the willingness to donate

of those individuals who prefer anonymity.

Option 4: Ban commercial sales of embryos.

Congress could amend the National Organ

Transplant Act to outlaw the buying or selling of

embryos. Some view the sale of embryos as making the human body a commodity and therefore

unacceptable. others view the sale of embryos

as the unacceptable commercialization of a genetic

blueprint. Embryos are generally viewed as deserving especially respectful treatment, and sales

of embryos offends many persons who find it too

close to the sale of babies or who fear that embryo sales may lead to classification of some embryos as more desirable than others. Further, permitting the sale of embryos could in some cases

lead donors to undertake medical risks for pay.

On the other hand, such a ban could be viewed

as an intrusion that limits the freedom of donors

to engage in commerce. Further, a ban on commercial sales of embryos may be subject to constitutional attack as State interference with the

right to procreate.

A ban on commercial sales of embryos will not

necessarily greatly reduce the supply of gametes.

Some countries, such as France, do ban such sales,

and yet have managed to maintain successful

sperm donation programs. Nevertheless, the U.S.

market economy and culture may make such

comparisons inappropriate.

ISSUE: Should anyone accepting or transferring human gametes keep nonidentifying

genetic records on behalf of the potential

child?

Donation of human gametes is usually accompanied by an oral patient history including im-
.

26 . Infertility: Medical and Social Choices

portant genetic information that can become a

formal written record. Such information is routinely obtained by those who operate sperm banks

as they screen donors. Currently, however, the

type of information that is collected and the ways

in which it is maintained and transferred vary

greatly. This variation is particularly significant

because the predictive value of genetic history may

increase in coming years.

Option 1: Take no action.

If Congress takes no action, the transfer of such

information will continue to occur in an occasional

manner, and children born as a result of reproductive technologies that make use of donor gametes (i.e., IVF, gamete intrafallopian transfer, artificial insemination by donor, and surrogacy) will

not have access to genetic information that might

be vital to their health.

On the other hand, the medical community has

not achieved consensus on the utility of minimal

information about individuals’ genetic heritages.

The ethical and financial costs of collecting genetic information about gamete donors must be

weighed against its ultimate usefulness.

Absent any congressional action, individuals

who obtain or transfer human gametes (or embryos) may or may not adhere to the recommendations of professional associations such as the

American College of obstetricians and Gynecologists and the American Fertility Society to maintain a permanent record of minimal genetic

screening information. The AFS’S 1986 recommendations for a minimal genetic screen of gamete

donors specify that practitioners maintain a permanent record that preserves confidentiality. The

record should include the genetic workup and

other nonidentifying information and should be

made available on request-on an anonymous

basis–to the recipient or resulting offspring.

Concerns about establishing a child’s genetic endowment should be viewed in an important context: Some children born of married couples who

did not use medically assisted conception were

not sired by the father of record.

Option 2: Mandate that operators of sperm, ova,

and embryo repositories, or anyone who transfers these materials, maintain written records

detailing the nonidentifyinggenetic history of

all gamete donors and that this information be

available to the recipients of gametes or embryos and the eventual offspring.

If Congress were to enact such a law, or simply

encourage standardization of recordkeeping on

a voluntary basis, it would result in retention of

information that currently may be lost or deliberately discarded in the interest of protecting the

anonymity of gamete donors. It would reduce the

extent to which some members of future generations may suffer from genealogical bewilderment

resulting from the inaccessibility or loss of important information about their genetic endowments.

Such a law would somewhat increase the recordkeeping of those who are currently involved

in the storage and transfer of human gametes and

embryos, although much of this information is

already being collected, Although much pertinent

genetic information is already obtained in the

process of screening potential gamete donors, the

enactment of a new law would result in an increased recordkeeping burden for all such individuals. The occasional practice of mixing sperm

from more than one source would also increase

the complexity of such recordkeeping.

More complicated variations of this course of

action include maintenance of white blood cells

from gamete donors as a complete and retrievable genetic record, and recordkeeping with information that identifies the gamete donors. Both

raise serious concerns about logistics and privacy.

ISSUE: Should commercialized surrogate

motherhood be regulated by the Federal

Government?

Surrogate motherhood is an infrequent but increasingly popular arrangement used by infertile

couples, singles, and homosexuals as an alternative to adoption and perhaps infertility treatment

in their efforts to form a family. Surrogacy arrangements are based upon principles of contract

and family law, and therefore are largely within

the traditional domain of State legislative activity.

With surrogacy an interstate business, Congress

has the power under the Interstate Commerce

Clause of the U.S. Constitution to enact regulatory legislation, but, just as with respect to inter-
Ch. l—Summary, Policy Issues, and Options for Congressional Action . 27

state adoption activity, Congress may choose to

leave this area primarily to State and local oversight. Coordination of State legislative efforts has

not taken place, with the exception of activities

of committees of the National Conference of Commissioners on Uniform State Laws and of the

American Bar Association.

Option 1: Take no action.

Absent Federal direction, surrogate motherhood

is likely to be subject to extensive State legislative

debate and action over the next few years. State

legislation, when enacted, is likely to vary considerably, ranging from complete bans to only minimal oversight of contractual arrangements. This

period of State legislative activity maybe a useful

experiment for finding a workable legislative

scheme to either ban or promote the practice. Or

lengthy and complicated custody battles could ensue if courts must first decide which State’s law

applies to the case (so-called choice-of-law questions). The problem can become particularly acute

if the choice of using one State’s law rather than

another’s could essentially decide the case.

Lengthy custody suits are troubling because it becomes progressively more difficult to remove the

child from his or her initial home, regardless of

the merits of the case. Numerous custody battles

may exact a heavy toll on the families and children involved.

Option 2: Review developments in State law related to surrogate motherhood.

Congress could exercise oversight to examine

the trends in State law regarding surrogate

motherhood to ascertain whether Federal action

is necessary. Topics of interest could include State

legislation and case law on resolution of custody

disputes; development of standard contract provisions, including provisions relating to a surrogate’s choice of diet, medical care, and pregnancy continuance; fee structures; and protection

for offspring in the event of death or disability

of an adult participant.

Option 3: Facilitate development of State legislation related to surrogate motherhood.

Congress could authorize the use of challenge

grants to encourage States to explore approaches

to surrogate motherhood. Funds could be used

to finance studies of proposed legislation; to begin pilot projects for licensing of professional surrogate matching services or review of surrogate

contracts; to determine the need for home studies

of couples seeking a surrogate mother; or to carry

out research concerning the psychological impact

of surrogacy arrangements on a child, any siblings,

and the adult participants.

Option 4: Facilitate interstate cooperation and harmonization of State laws.

Congress could facilitate joint efforts by States

to develop a uniform approach to surrogate

motherhood. Congress could pass a joint resolution, for example, calling on States to adopt one

of the model laws now being developed by various professional groups, such as the American

Bar Association or the National Conference of

Commissioners on Uniform State Laws. Congress

could also draft such a model law itself, to be published in the Federal Register, as was done in a

1981 effort to harmonize State adoption laws with

respect to children with special needs.

Although neither a joint resolution nor model

legislation is binding upon the States, either could

be used to express the sense of Congress concerning the use of surrogate motherhood. Congress

could also encourage States to develop interstate

compacts in order to avoid difficult choice-of-law

problems in the event of a custody dispute surrounding an interstate arrangement, and to harmonize regulations concerning surrogate mother

matching and child placement. The Interstate

Compact on Placement of Children provides a

precedent for the use of such compacts in the area

of family law, in that case with respect to placing

children in foster care or adopting homes.

Option 5: Mandate national standards for surrogate motherhood arrangements or commercial intermediaries.

Congress could enact legislation directing the

Department of Health and Human Services to set

national standards for the practice of matching

surrogate mothers to individuals seeking to hire

them, or for the arrangements themselves. Such

standards could include medical or psychological screening for surrogates and prospective rear-
28 ● Infertility: Medical and Social Choices

ing parents; recordkeeping requirements to allow

children access to medical or personal data on

their genetic and gestational parents; limitations

on advertising techniques, referrals, and fees; and

licensing requirements for the commercial intermediaries. These standards could also include limitations on the substantive provisions of the contracts professionals might offer to the participants.

Limitations might include provisions concerning

the restrictions placed upon the surrogate’s lifestyle, choice of medical care, or right to terminate

her pregnancy, and those concerning presumptions of custody.

Some argue that, as with regard to adoption,

such regulation is best left to individual State legislatures. others assert that as an interstate business, and potentially international business, surrogate mother matching is an appropriate subject

of Federal attention.

In lieu of Federal licensing legislation or regulations, Congress could exercise its spending power

to attach conditions to the receipt of Federal funds

to require States to license professional surrogate

matching services. For example, conditions could

be attached to Federal funding for Aid to Families with Dependent Children, family planning

agencies, or adoption assistance programs. Some

of these programs are heavily dependent on Federal funding, and many States would probably feel

compelled to pass the necessary legislation,

Absent Federal action, a patchwork of State

legislative limitations and State court decisions is

likely to influence the substantive content of surrogacy contracts and the persons able to use them.

Option 6: Facilitate international agreements concerning transnational surrogacy arrangements.

Already in the brief history of commercialized

surrogate motherhood, women from other countries have contracted with American women to

act as surrogates, and vice versa. This may become more common in the future. Gestational surrogacy (i.e., where a woman carries a child to

whom she is genetically unrelated) may also become more common. Affluent couples, for example, could hire women from developing nations,

for whom a fee of far less than $10,000 would

still constitute a considerable sum.

To ensure that there is no confusion concerning the rights of these women, and to avoid conflicts of national law concerning maternity and

child custody in the event of a dispute, Congress

could work to facilitate international cooperation

and agreement on translational surrogacy arrangements. This could be accomplished by submitting proposals to amend one of the existing

child welfare agreements (e.g., the Hague Convention on International Parental Kidnapping), in order to state clearly who, at least initially, shall be

considered the mother and the father of a child,

and who shall have initial rights to physical

custody.

Option 7: Ban commercialized surrogate motherhood.

Congress could enact legislation to ban for-profit

surrogate motherhood, leaving individuals able

to engage in the practice as long as no money beyond actual expenses changed hands. Such a ban

would probably have the effect of drastically reducing the scope of the practice. It would, however, be subject to constitutional challenge by those

who assert that paying a surrogate mother is a

protected aspect of reproductive liberty.

Alternatively, Congress could outlaw commercial intermediaries while leaving individuals free

to make their own arrangements even if they involve payments to the surrogate. This too would

probably reduce the scope of the practice. And

while the same constitutional challenge could be

mounted, it would be somewhat more difficult

to maintain.

Bans on payments to surrogates or intermediaries or both could be designed as either civil

offenses (for which one pays a penalty) or criminal offenses (for which one can be fined or jailed).

Criminal penalties, particularly if directed toward

the individual surrogates and couples, are likely

to engender the most serious judicial challenges.

It is possible that any attempt to ban surrogate

motherhood may drive the practice—which in

some cases can be done without doctor or lawyer

—underground. This may reduce the frequency

of the practice, but increase the medical and legal risks to the participants.
Ch. l—Summary, Policy Issues, and Options for Congressional Action ● 2 9

ISSUE Do some areas of reproductive research

require additional support?

Federal support of human reproductive research is concentrated in two agencies of the Public Health Service: NIH (in particular, the National

Institute of Child Health and Human Development

and the National Institute of Environmental Health

Sciences) and CDC (in particular, the National Institute for Occupational Safety and Health and the

National Center for Health Statistics). In addition,

the National Science Foundation, the Environmental Protection Agency, the U.S. Department

of Agriculture, the Department of Defense, the

Department of Energy, the Agency for International Development, and the VA fund reproductive research involving humans or animals.

Option 1: Take no action.

In the absence of any targeted congressional action, research in broad areas of human and animal reproduction will continue to be supported

by the Federal agencies listed. Research in male

reproductive biology has historically lagged and

will likely continue to do so in the absence of a

special compensatory effort.

Research that involves fertilization of human

sperm and eggs is today in effect excluded from

Federal support because of the absence of an

Ethics Advisory Board (EAB) within the Department of Health and Human Services; such a board

is required to advise the Secretary as to the ethical

acceptability of such research (45 CFR 46.204(d)).

Without congressional oversight, the failure since

1980 of successive Secretaries of Health and Human Services to appoint an EAB is likely to continue. Consequently, questions surrounding the

interaction of sperm and egg—fundamental to an

understanding of conception and contraception—

remain largely uninvestigated.

In addition, research into the efficacy and risks

of some infertility treatments such as IVF and gamete intrafallopian transfer are largely uninves -

tigated and lie outside the sphere of Federal funding and peer review. Finally, in an era of

heightened concern about the ability of the United

States to compete internationally, it is noteworthy

that major developments in early embryo research

are most likely to occur in nations such as Australia and the United Kingdom, where the research

climate is more favorable.

Option Z: Expand Federal support for research

in male infertility.

With the principal cause of male infertility being abnormal or too few sperm, due to unknown

factors, efforts on prevention and treatment are

largely guesswork. Some contend that studies of

the reproductive health of men have been poorly

designed and are too inadequate to draw any firm

conclusions.

Congress could direct the Secretary of Health

and Human Services to convene an interagency

task force to report on the scope and adequacy

of Federal research efforts into the reproductive

health of men. Congress could direct the task force

to identify a coordinator and an appropriate lead

agency for a strengthened, government-wide effort to identify the causes of and treatments for

male infertility.

Such an effort would probably require a 5- to

10-year sustained commitment of additional funds

for research. The outcome of such a commitment

would likely be positive identification of some risk

factors for male infertility that are today unrecognized. In addition, long-sought-after progress in

development of male contraceptive methods is

likely to accompany advances in understanding

male infertility.

It is important to note that expanded Federal

support for research in male infertility does not

represent an alternative to continued research in

female infertility. Both are required for progress

in understanding infertility.

Option 3: Expand Federal support for research

on the psychology of participants in assisted

conception.

The positive and negative impacts of infertility

and novel reproductive technologies on the behavior of individuals and on society as a whole

have been little studied. Congress could exercise

oversight to see that the research agencies that

support the social, behavioral, and psychological

sciences place research on the psychology of participants in assisted reproduction high on their

priority lists.
30 . /nferti/ity: Medical and Social Choices

Photo cradit: David M. Phillips

Rabbit sperm fertilizing rabbit egg

Option 4: Direct the Secretary of Health and Human Services to review, solely for scientific

merit, research involving human sperm, eggs,

and early embryos.

In some other nations, Governments and advisory bodies have declared that it is acceptable to

do research with human sperm and eggs and with

embryos of not more than 14 days of age. Congress could direct the Secretary of Health and Human Services to consider in routine fashion

proposals to conduct such research (i.e., review

them solely for scientific merit) and specifically

exempt them from the regulatory requirement

for review by an EAB.

Option 5: Mandate the appointment of an Ethics

Advisory Board within the Department of

Health and Human Services.

In 1974, the Department of Health, Education,

and Welfare established an EAB to review research proposals that raise sensitive ethical questions. Since 1980, no Board has been appointed.

Areas of infertility research that raise sensitive

ethical questions, such as research into the events

surrounding human fertilization, are directly affected by the absence of an EAB. Such research

cannot be funded by the National Institutes of

Health without review by an Ethics Advisory

Board. Congressional oversight may be sufficient—

or legislation may be required—to resolve the

question of the failure of the Department of Health

and Human Services to abide by its own regulation requiring appointment of an EAB.

Option 6: Direct the Secretary of Health and Human Services to implement (and update as

needed) the 1979 recommendations of the

Ethics Advisory Board.

The 1979 report of the EAB of the Department

of Health, Education, and Welfare found that research involving human IVF is ethically acceptable. It concluded that “a broad prohibition of research involving human IVF is neither justified

nor wise.”

With regard to Federal support of research involving human IVF, the Board concluded that Federal involvement is ethically acceptable and might

help to resolve questions of risk and avoid abuse

by encouraging well-designed research by qualified scientists. Further, Federal involvement might

help shape the use of the procedures through regulation and by example. The conditions, for example, under which researchers could manipulate embryos that are not transferred following

IVF would almost certainly be defined in any federally supported research protocol.

Congress could mandate that the Secretary of

Health and Human Services incorporate the 1979

conclusions and recommendations of the EAB into

departmental practice, updating them as needed.

This action, along with appointment of an EAB,

would likely end the de facto moratorium on Federal support for research involving human IVF.

Increased research into the efficacy and risks of

IVF and allied procedures would provide a base

of knowledge to protect infertile couples who are

today readily availing themselves of such procedures.

Option 7: Direct the congressional Biomedical

Ethics Board to develop guidelines for federally funded research with human sperm, eggs,

and embryos.

Unlike the United Kingdom, Australia, and a

number of other nations, the U.S. Government

has not formally evaluated the prevailing ethical

standards surrounding reproductive technologies.

The congressional Biomedical Ethics Board was

established to report on the ethical issues arising
Ch. l—Summary, Policy Issues, and Options for Congressional Action “ 31

from the delivery of health care and biomedical motherhood, and other biological and social solu -

research, including the protection of human sub- tions to infertility. Such a report would establish

jects of such research. ethical guideposts for Federal agencies supporting research in these areas. In addition, it would

Congress could direct this Board to report on serve the valuable historical purpose of standing

the ethical implications of public policies related as a landmark of the limits on ethically acceptto artificial insemination, egg donation, cryopres - able research and clinical care as American sociervation of gametes and embryos, IVF, surrogate ety enters the 1990s.
Chapter 2

Introduction
CONTENTS

Defining Infertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Is Infertility a Disease? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Parents, Children, and Families . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The Human Reproductive Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sperm Production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Egg Production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fertilization and Early Development. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Public Understanding of Reproduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

The OTA Study. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter p references.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Boxes

35

36

37

38

40

40

40

43

43

44

BOX NO. Page

2-A. Impact of Infertility on a Couple . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

2-B. New Conceptions, New Vocabulary. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Figures

Figure No. Page

2-1. The Female Reproductive System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

2-2. The Male Reproductive System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

2-3. Relation Between Age, Oocyte Number, and Menopause . . . . . . . . . . . . . . . . 41

2-4. Time Line of Reproductive LOSS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Tables

Table No. Pag e

2-I. Some Landmarks in Reproductive Technology . . . . . . . . . . . . . . . . . . . . . . . . . 36

2-2. Stages of Embryonic and Fetal Development . . . . . . . . . . . . . . . . . . . . . . . . . . 42
Chapter 2

Introduction

About 3.8 million babies were born in the United

States in 1987. This report is about the portion

of those babies conceived with medical assistance

–babies who were desired but who could not be

routinely conceived or carried to term without

help. Most of all, this report is about the adult

men and women who undergo months and years

of invasive medical diagnosis and intervention in

order to have a baby.

Infertility has always been a concern for those

affected, but beginning with baby Louise Brown,

the first person conceived outside of a human

body, and continuing through the surrogate

mother case of Baby M, the public’s collective

imagination has been captured by new options

in the age-old process of procreation. At the same

time, new and provocative scientific, legal, economic, and ethical questions about conception

have arisen. Therefore, at the request of the Senate Committee on Veterans’ Affairs and of the Subcommittee on Human Resources and Intergovernmental Relations of the House Committee on

Government Operations, OTA undertook this

broad study of the factors leading to infertility

and of its prevention and treatment.

This report covers the scientific, legal, economic,

and ethical issues surrounding medically assisted

conception, surgically assisted conception (including in vitro fertilization and gamete intrafallopian

transfer), artificial insemination, basic research

supporting reproductive technologies, and surrogate motherhood. The recent attention to these

techniques should not obscure the fact that many

have been in existence for sometime (see table 2-l).

This report is limited to technologies that help

establish a pregnancy. Certain allied issues, such

as management of pregnancy, prenatal diagnosis

including embryo biopsy, termination of pregnancy, fetal research, child health, adoption, and

alternate family arrangements involving child

sharing are beyond the scope of this report. OTA

has recently reported elsewhere on technologies

for child health (9).

DEFINING INFERTILITY

The standard medical definition of infertility

is the inability of a couple to conceive after 12

months of intercourse without contraception.

There are several variations on this definition,

such as:

● the inability of a woman to conceive after 12

months of intercourse without contraception

(1);

● the inability to conceive a pregnancy after

a year or more of regular sexual relations

without contraception or the incapacity to

carry a pregnancy to a live birth (6);

● the inability of a woman to achieve a first

pregnancy after engaging in sexual activity

without using contraceptive methods for a

period of 2 years or longer (4);

● the inability of a couple to conceive after 2

years of intercourse without contraception

(2); and

● the inability of male and female gametes

(sperm and ova) to fertilize and appropriately

implant (3).

An ongoing study of the epidemiology of infertility conducted by the Centers for Disease Control reveals that the standard medical definition

of infertility is a poor predictor of future conception: Only 16 to 21 percent of couples meeting

this definition actually remain infertile throughout their lives (2). With an increase since 1980

in visits to physicians for infertility treatment (see

ch. 3), the choice of a definition has important

clinical implications. Under a more stringent def -

inition, the predictive value is more accurate and

interventions can be initiated with some precision.

If a broader definition is used, predictive value

decreases but interventions may be sought earlier

by a greater proportion of individuals who may

eventually need them. This OTA report adopts

the standard medical definition of infertility be3 5
36 lnfertility: Medical and Social Choices

Table 2-1.—Some Landmarks in Reproductive Technology

In animals In humans

1782

1799

1890s

1949

1951

1952

1953

1959

1972

1976

1978

1980

1981

1982

1983

1984

1985

1986

Use of artificial insemination in dogs

Pregnancy reported from artificial insemination

Birth from embryo transplantation in rabbits

Use of cryoprotectant to successfully freeze and thaw

animal sperm

First calf born after embryo transplantation

Live calf born after insemination with frozen sperm

Artificial insemination by donor

First reported pregnancy

sperm

after insemination with frozen

Live rabbit offspring produced from in vitro fertilization

(IVF)

Live offspring from frozen mouse embryos

First commercial surrogate motherhood arrangement

Transplantation of ovaries from one female to another

in cattle

Calf born after IVF

Sexing of embryos in rabbits

Cattle embryos split to produce genetically identical

twins

reported in United States

Baby born after IVF in United Kingdom

Baby born after IVF in Australia

Baby born after IVF in United States

Embryo transfer after uterine Iavage

Baby born in Australia from embryo that was frozen

and thawed

Baby born after gamete intrafallopian transfer (GIFT)

First gestational surrogacy arrangement reported in the

United States

Baby born in the United States from embryo that was

frozen and thawed

SOURCE Office of Technology Assessment, 1988.

cause it is most consistent with the accumulating

database regarding the behaviors of individuals

seeking infertility treatment (see ch. 3).

Factors that contribute to infertility maybe attributable to a man, a woman, or a couple as an

entity, or they may be unknown. Likewise, treatment may be directed toward a man, a woman,

or both together, In some instances, infertility may

resolve without treatment. Couples who have been

unable to conceive for months or years may suddenly do so with no medical assistance. In contrast, other couples may have conceived children

in the past but find themselves unable to conceive

again. In the broadest sense, infertile couples include not only those who are childless but also

those with fewer children than they desire. (See

box 2-A for a discussion of the impact of infertility on a couple. ) The important reasons for treating infertility as a shared condition do not obviate

concern for infertility as occasionally an individual problem, A young man, for example, who discovers he has a low sperm count may want that

investigated and, if possible, treated, even if he

is not at that time thinking of forming a family.

IS INFERTILITY A DISEASE?

Infertility has been characterized as a disease, clinical problems. The simple assertion that indisorder, disability, handicap, illness, syndrome, fertility is a disease has both advantages and discondition, or condition caused by disease. These advantages. For one thing, achieving a pregnancy

terms are used to describe, explain, and evaluate may not cure the underlying cause of infertility.
Ch. 2—Introduction 37

BOX 2-A. —Impact of Infertility on a Couple

Infertility is a painful private experience. The fertile world is unprepared to provide a comfortable

opening for the individual or couple who is experiencing the pain of wanting a child and not being able

to achieve a pregnancy and birth. Sadness, depression, and avoidance of baby showers, maternity shops,

children’s toys, and pregnant friends can often be misunderstood.

The couple finds that the infertility experience invades many areas of their lives. Work, at times the

only escape from other distresses, can become a place of deception and some risk. The business trip conflicts with scheduled intercourse. Frequent late arrivals due to doctor’s visits and irritability from stress

or drug side effects are disguised as some other illness or problem.

Partners often cannot even count on each other for the needed support and understanding. The acceptance of infertility and the road to its resolution are individual experiences. No two persons, married or

not, proceed through this process at the same pace. Learning to accept their infertility may put a terrible

strain on partners’ love for each other. Sometimes partners disagree on the medical efforts they are willing

to pursue in order to conceive a child. One person may wish to continue treatments, while the other may

be ready to stop. or, one may be willing to explore adoption while the other still wishes to pursue options

for having a genetically related baby. Even when both agree to pursue adoption, there may be disagreements such as whether to seek a baby of another ethnic group or perhaps with a disability. All these strains

may cause a reassessment of their commitment to have a baby or continue their marriage.

Some fertile partners are reluctant to discuss their own sadness for fear of making their mate feel

guilty or responsible. others make their anger clear. Some infertile people provocatively suggest that the

fertile partner could have a baby in a different relationship, calling into question whether they ought to

remain together, In some cases the efforts of the fertile individual to reassure the infertile partner may

prevent the fertile partner from acknowledging actual emotions of feeling trapped, angry, or immensely

sad at the couple’s predicament.

source oflw> of I whnrdog} Aw>ssment 1988

Some commentators therefore talk of technologies ogy. Others contend that disease terms identify

that result in pregnancy versus those that correct any underlying impairment in normal female

or male reproductive function. On the other hand,

calling infertility a disease and thereby placing it

within the medical model is often considered

advantageous in terms of acquiring insurance coverage or third-party payments of various types.

The concept of disease has been a bone of contention throughout the history of medicine. Some

physicians argue that all disease categories are

arbitrary and that the only meaningful entities

are patients and laws of physiology and patholreal objects or realities. To avoid this dispute, it

is useful to talk about infertility as a clinical problem for which the medical community can sometimes offer a remedy. Using this approach, it is

not necessary to ask whether infertility is a disease, and which partner has the disease. As a practical matter, this is important because many cases

of infertility can be attributed to subfertility in

both partners. This definition includes recognition of the fact that many couples are waiting

longer to have babies and expecting to procreate

in increasingly shorter periods of time.

PARENTS, CHILDREN, AND FAMILIES

The desire to have children and to become a ment of their infertility—people whose motiva -

parent is the reason infertile individuals seek treat- tions for having their own children vary. For some

ment for their infertility or choose adoption. This individuals, having children is an important feareport is about those who seek diagnosis and treat- ture of their life plans because of their own ex-
38 ● Infertility: Medical and Social Choices

periences as children; their desire to have a link

with the future or for emotional or genetic longevity; their desire to love, sustain, and endow

specific members of the next generation with tangible and intangible resources; or as an inexplicable part of their love for each other.

For a subset of this group, a genetic tie (i.e., a

blood relationship) to their children is extremely

important. Some couples seek specific forms of

infertility treatment in order that at least one of

the parents is genetically related to the child. In

addition, for some single men and women, reproductive techniques such as artificial insemination

by donor may serve to circumvent not infertility

but the lack of a partner of the opposite sex.

Children need nurturing to grow and thrive.

A close bond with at least one adult is an essential feature of a healthy childhood, although the

specific circumstances surrounding conception

and birth can and do vary. Whether or not any

variation in a natural event of human fertilization and birth ought to occur is the ethical question that is the source of extensive debate about

the use of the specific reproductive technologies

examined in this report (see ch. 11).

It is not necessary to describe all the current

social and demographic changes in families in order to focus on the procreative desires of couples

who may vary in lifestyle, social status, or marital configuration. Many argue that the desire to

procreate is a family centered desire by definition. Others argue that the desire to procreate

can and should be distinguished from the creation of a family, in order to recognize that a couple can be a family unto itself, that a person might

procreate for purposes apart from the creation

or enlargement of his or her personal family, or

that a person might, through adoption, create a

family without procreation. Regardless of how a

family is characterized by membership, form, or

function, those seeking and providing treatment

for infertility share a common interest in creating a new generation.

THE HUMAN REPRODUCTIVE PROCESS

Attempts to create a family typically involve coi- ● The male must produce an adequate numtus and conception without medical assistance. ber of normal sperm and must be able to deSingle individuals who choose to reproduce and posit them in the upper vagina at the approparent alone must use reproductive technologies priate time of the female cycle.

as a matter of necessity, but for most people, hu - ● The female must have at least one ovary and

man reproduction is a natural lifecycle event. To her ability to produce eggs (ovulatory mechunderstand the anatomic and physiological fea- anisms) must operate within a normal range

tures of infertility, it is necessary to consider the of levels. Also, hormone levels must be sufficonditions and processes of normal human repro- cient to stimulate the production of normal

duction. Many aspects of normal human repro- cervical mucus near the time of ovulation and

duction are not well understood, and there are to later support implantation of the embryo

areas in which additional research is needed. It and maintenance of pregnancy.

is also important to understand the process of fer - ● The quality and quantity of cervical mucus

tilization and the early phases of embryonic and must allow sperm to pass into the uterus.

fetal development in order to appreciate the tech- ● The oviducts must be open enough to allow

nical, legal, and ethical issues involved in the use fertilization as well as transport of the ovum

of reproductive technologies. from ovary to uterus. In addition, functioning tubal ciliary action is also required to asUnder normal circumstances, fertilization of an sist sperm to travel up the fallopian tubes.

egg, implantation of an embryo, and maintenance ● The uterus must be capable of supporting imof pregnancy depend on a series of complex and plantation of the embryo and fetal growth

interrelated events: throughout pregnancy (8).
Ch. 2—Introduction 39

In both men and women, the hypothalamus, an

area at the base of the brain, orchestrates the

body’s reproductive function (see figures 2-1 and

2-2). It receives neural and hormonal input from

other parts of the brain and endocrine glands,

and responds to these stimuli by secreting luteiniz -

ing hormone releasing hormone (LH-RH, also

Figure 2-1 .—The Female Reproductive System

Female Reproduotive Organs

Faltopian tube

Higher nervous centers

+

Hypothalamus -

*

Luteinizing -

SOURCE: C, Djerassi, The Politics of Contracept/o~ (New York: Norton, 1980).

Figure 2-2.—The Male Reproductive System

Male Reproductive Organs

1

_Epididymis ‘

1}

1 (sperm

) maturation

and storage)

Testis

1“ (Oontainhfj

\.

rmone Follicle-stimulating hormone

‘\,

(responsible ‘

for secondary

sex characteristics)

SOURCE: C, Djerassi, The Politics of Corrtraceptlon (New York: Norton, 1980).
40 . Infertility: Medical and Social Choices

known as gonadotropin releasing hormone or GnRH) and other hormones. LH-RH acts on the pituitary gland to promote secretion of two hormones,

luteinizing hormone (LH) and follicle-stimulating

hormone (FSH). Known as gonadotropins, LH and

FSH direct hormone and gamete production by

the testes and ovaries. The gonads release hormones in response to stimulation by LH and FSH,

and these gonadal hormones feed back to modulate the activity of the hypothalamus and pituitary gland (11). A defect at any point in the hypothalamic-pituitary -gonadal axis will interrupt the

normal pattern of reciprocal hormone secretion

among these organs. It is through the central nervous system that psychological, emotional, sensory, and environmental stimuli can profoundly

influence reproductive function.

Sperm Production

Sperm are produced continuously in the testes

from puberty throughout adulthood. The process begins with division of sperm cells (spermatogonia), which, in combination with supporting

(Sertoli) cells, makeup the long, coiled seminiferous tubules that constitute most of the testes. Interspersed Leydig cells produce male hormones

(androgens), notably testosterone, that affect both

sperm production and male sex characteristics.

Sperm production takes about 72 days, The final

stages of sperm maturation take place as sperm

exit the testis and pass through the long epididymis. Maturation involves changes in motility,

metabolism, and morphology. Sperm then leave

the body in the semen, a fluid consisting of secretions of the seminal vesicles, prostate, and glands

adjacent to the urethra. Ejaculation is a two-part

spinal reflex that involves emission, when the semen moves into the urethra, and ejaculation

proper, when it is propelled out of the urethra

at the time of orgasm.

Egg Production

The female germ cells, called oocytes or ova,

are in the two ovaries. They number several million in the fetal stage, are fewer than 1 million

at birth, and continue to decline markedly

throughout life. only about 400 to 500 oocytes

are actually ovulated during the period of female

fertility. In contrast to the continuing renewal of

germ cells throughout an adult male’s life, no new

oocytes are formed after the fetal stage in the female. Usually one oocyte matures each month in

a follicle on the ovary’s surface, and the follicles

also produce estrogen. At ovulation, the follicle

ruptures, and the oocyte is picked up by the

oviduct and propelled down to the uterus. The

ruptured follicle then changes to a yellowish protrusion on the ovary, called the corpus luteum,

which begins to secrete another hormone, progesterone, in addition to continued estrogen production. The corpus luteum regresses if pregnancy does not occur. These hormonal changes

prepare the uterus for a possible pregnancy, but

if pregnancy does not occur, the uterine lining

is sloughed off, producing the menstrual flow,

The female menstrual cycle averages 28 days

and may range from 26 to 30 days, normally ending with menstrual flow unless pregnancy occurs.

Variability in the length of the menstrual cycle

typically results from varying duration of the

preovulatory, or follicular, phase. It rarely results

from variations in the time from ovulation to

menstruation—the luteal phase—which usually

takes about 14 days.

Menopause, the cessation of menstrual cyclicity, occurs when the ovary is virtually depleted

of oocytes, and is marked by diminished production of ovarian estrogens, sudden body temperature fluctuations, and other changes over a longer

term. It occurs, on average, at about age 50 (see

figure 2-3), but ovulation may occur erratically

during the preceding 2-to 10-year period (5). The

study of menopause is becoming increasingly important as the number of women age 50 and older

(currently half the female population) continues

to grow. A woman who is 50 years old today can

expect to live to age 89. By the year 2000, women

will be spending a greater proportion of their lives

in the postmenopausal state due to the continually increasing length of life (10).

Fertilization and Early Development

Human reproduction is characterized by relatively long intervals during which conception is

impossible; in fact, fertilization can only take place

within about 1 day following ovulation. Fertiliza-
Ch. 2—Introduction c 41

Figure 2-3.—Relation Between Age, Oocyte Number,

and Menopause

250.000

200,00 0

50,00 0

100

o

0 20 30 40 50 60 70

Age in years

SOURCE Adapted from D R. Mattlson, MS. Nightingale, and K Sh!romlzu, “Effects of TOXIC Substances on Female Reproduction.” Enwrorrmenta/

F/ea/th Perspecf/ves 4843-52, 1983

tion usually occurs in the oviduct. When a sperm

and egg meet, the sperm penetrates the wall of

the egg and the genetic material from the sperm

and egg unite. The cell thus formed, containing

DNA from both sperm and egg, is called a zygote.

The zygote begins to divide, first into two cells,

then into four, then eight, and so on. The mass

of cells in the earliest stages is called a conceptus.

Cell division, or cleavage, continues as the early

embryo passes down the oviduct and develops into

a blastocyst through the next 3 or 4 days. The

blastocyst is a fluid-filled sphere of cells, resembling a balloon. Most of the cells of the blastocyst

are in the outer wall or trophectoderm, which

becomes the placenta. The fetus is derived from

a small cluster of embryonic cells inside the

sphere. The blastocyst starts to implant in the lining of the uterus about 6 to 7 days after ovulation, and at this point is referred to as an embryo.

The terms preimplantation embryo and preembryo are sometimes used to describe the mass of

dividing cells and the blastocyst up to 14 days after fertilization (l).

During the earliest stages of development, all

the cells are more or less equivalent. Once more

than 16 cells are present, the trophectoderm cells

start to become distinct from the internal cells

that ultimately become the fetus. Small and difficult to detect at first, other differences become

more pronounced as cell division and growth continue, and they form the foundation for the later

differentiation of tissues and organs.

During the second and third weeks after conception—about the time the first menstrual period

is missed—the development of the three embryonic layers of cells (endoderm, mesoderm, and

ectoderm) occurs as a group of cells called the

primitive streak initiates the development of the

nervous system. The primitive streak is also the

first landmark that reveals the future symmetry

of the human body.

The embryonic period takes place between the

end of week 2 and weeks 8 to 9 after conception.

This is a critical phase of development, during

which cell differentiation proceeds at an accelerated pace. During this period, the brain, eyes,

heart, upper and lower limbs, and other organs

are formed. At 8 to 9 weeks after conception, the

embryo makes the transition to a fetus, with most

subsequent development taking the form of

growth and specialization of organ function,

rather than the formation of new organs. Highly

complex systems, like the brain and nervous system, continue to develop long after the embryo

has become a fetus, and even after birth. Table

2-2 summarizes the timing of embryonic and subsequent fetal development.

Embryonic loss is a normal part of t he reproductive process. Only one-quarter to one-third of all

embryos conceived become live-born infants. The

remainder are lost at some stage between fertilization and the end of pregnancy, for example,

prior to implantation. Data on these are hard to

obtain, and estimates vary, because the loss of embryos is particularly high in the early stages, before clinical diagnosis of pregnancy is made (see

figure 2-4). The time line in this figure represents

what is currently conjectured to be the relative

amount of reproductive loss among a population

of 100 women at various stages of the reproductive cycle.

When pregnancy occurs, the ovarian corpus lu -

teum is maintained by another hormone, human

chorionic gonadotropin (hCG), secreted by the implanted embryo, and estrogen and progesterone

continue to be produced. With the most sensitive

laboratory tests, hCG can be detected in blood and
42 Infertility: Medical and Social Choices

urine as early as 6 to 9 days after conception, soon of over-the~counter home pregnancy tests; it is

after implantation of the primitive embryo into important to note, however, that elevated hCG

the uterine endometrium. Measurement of hCG levels can also be due to other factors, including

in urine as an indicator of pregnancy is the basis cancer.

Table 2-2.—Stages of Embryonic and Fetal Development

Time after Time after

Period conception Stage conception

Embryo

“Preembryo,” First week Zygote 1 to 2 days

“preimplantation Cleavage 2 to 4 days

embryo, ” or Blastocyst 4 to 6 days

“conceptus” Implantation begins 7 days

Embryonic 2 to 3 weeks Primitive streak 7 to 8 days

Gastrula 7 to 8 days

Neurula 20 days

3 to 5 weeks Limb buds 21 to 29 days

Heart beat 21 to 29 days

Tail-bud 21 to 29 days

Complete embryo 35 to 37 days

6 to 8 weeks Body definition 42 to 56 days

Fetus 9 to 40 weeks First fetal 56 to 70 days

Second fetal 70 to 140 days

Third fetal 140 to 280 days

SOURCE: Office of Technology Assessment, 1988, adapted from R.H. Blank, f?edefirrirrg Human Life.’ Reproductive Techrro/ogies and Social Pollcy (Boulder, CO: Westview Press, Inc., 1984).

Figure 2-4.—Time Line of Reproductive Loss

1009

i\

26 T 9~,

1

Weeks 2 3 6

t

I I

/

Cycle Ovulation Clinical

begins Fertilization

Implantation

pregnancy

1

~

T 23?

1

Live

birth

Biological processes Influencing Biological processes influencing

time to pregnancy spontaneous abortion and stillbirth

L

SOURCE: D.D. Baird, A.J. Wilcox, and C.R. Weinberg, “Use of Time to Pregnancy to Study Environmental Exposures,” Amedcan Journal of Epidemiology 124:470-480, 1986.
Ch. 2—Introduction . 43

PUBLIC UNDERSTANDING OF REPRODUCTION

Many Americans are misinformed about key

aspects of the relationship between the timing of

sex and pregnancy, according to the findings of

a 1986 national telephone survey of 802 adults,

split equally between men and women (7). (The

results of this survey have a 95-percent confidence

level, with error due to sampling and other random effects at plus or minus four percentage

points.) About one-third of the public said they

did not know what the term “ovulation” meant.

Only 10 percent of those surveyed accurately described ovulation as the release of an egg from

a woman’s ovary, while an additional 37 percent

gave less specific descriptions that included mention of a woman’s egg. One-fourth (26 percent)

of those surveyed believed that a woman could

become pregnant 10 or more days a month. The

largest subgroup to hold this incorrect belief were

18- to 24-year-olds (35 percent).

Americans revealed a great gap in knowledge

when asked “How long does the woman’s egg live

after it released from her ovary?” Slightly more

than half (51 percent) said they did not know. A

higher percentage of women (56 percent) than

men (47 percent) said “don’t know” in response

THE OTA

With this report, OTA assesses what it means

in the late 1980s for some couples to conceive and

form a family. Couples unable to conceive a child

without assistance and those unable to conceive

at all are faced with an array of technical and social means to assist reproduction. These procedures—some involving high technology and

others involving ordinary technology-raise a host

of novel issues in medicine, ethics, law, and economics. At times, they even require a new vocabulary (see box 2-B). The 13 chapters that follow describe methods of assisted conception and provide

a comprehensive examination of the issues raised

by their use.

to this question of the female reproductive system. The fertile Iife of the human egg is believed

by scientists to be an average of about 24 hours.

Half (53 percent) of those surveyed believed that

on average it takes 3 months or less of trying for

a couple to conceive; the actual average is at least

4 months. perhaps as a result of this underestimation of the time it takes the average couple to

conceive, half (53 percent) of those surveyed felt

a couple should seek medical advice if conception

did not occur after 6 months or less of trying.

An additional 28 percent said that medical advice

should be sought after 6 to 12 months of trying (7).

Overall, the study found that Americans exhibit

a definite lack of knowledge about many of the

facts relating to fertility and reproduction. The

low level of knowledge of the ovulation process

as well as poor understanding of the basic facts

about the male and female reproductive systems

were generally consistent across demographic

subgroups (7). These facets of the public’s misunderstanding and lack of information about human

reproduction are an important aspect of the social context of this OTA study.

STUDY

Beyond the concerns of an individual couple lies

perhaps the most difficult aspect of infertility prevention and treatment for public policy makers:

the question of the government’s role with respect

to assisted conception. In addressing this issue,

policymakers are subjecting to public discussion

sexual topics generally consigned to private conversation. Such discussion must be viewed in the

context of a sizable level of public ignorance about

human reproductive biology. A series of policy

issues and associated options for congressional

action are presented in this report in order to address the concerns of policy makers.
44 . Infertility: Medical and Social Choices

BOX 2-B.— New Conceptions, New Vocabulary

Expectations and obligations created by the use of noncoital reproductive techniques are shared among

the sperm or ovum donors, gestational mother, intended rearing parents, physicians, attorneys, commercial brokers, and resulting child. In many ways, the English language is inadequate to express all of these

possible relationships. For example, the term “sperm donor” can be misleading when in fact a man sells

his sperm; “sperm vendor” would be more accurate, but does not match common parlance.

“Surrogate mother” is a troubling term because of possible confusion over usage. The popular press

appears to use the term to cover both women who carry to term an embryo to which they are genetically

unrelated and women who are artificially inseminated with the sperm of a man who intends to be the

rearing parent of the resulting child when the women themselves will not be rearing parents. The legal

literature uses the term to refer almost exclusively to the latter situation, which in fact is far more common.

“Surrogate gestational mother” is the term used in legal parlance to cover the former situation.

An additional problem stems from the possibly prejudicial use of the term “surrogate” in the context

of a woman who is artificially inseminated (i.e., who is the genetic and gestational mother of the child).

This genetic and gestational relationship embodies the traditional definition of “mother. ” A woman’s prior

agreement to relinquish a child does not diminish this fact, as can be seen in the context of prebirth adoption arrangements. The term “surrogate mother” may imply that the surrogate in this situation is somewhat

less than a real mother. This is not true biologically and has not yet been determined legally,

For the purposes of this report, a woman with a genetic relationship to the child is called the “genetic

mother” or “ovum donor, ” as appropriate. The woman who is both genetically and gestationally the parent

of a child is called the “mother.” In the interests of clarity, she may be referred to as the “surrogate mother”

when describing surrogacy arrangements. If a woman carries to term a child to whom she is genetically

unrelated, she is referred to as the “gestational mother”; again, in the interests of clarity she may be referred to as the “surrogate gestational mother” in the context of surrogacy arrangements. Regardless of

their biological relation to a child, the persons who intend to raise the child are referred to as the “intended

rearing parents. ”

50[’RCE of fIce of I echnolog} ,4ssessment, 1988

CHAPTER 2 REFERENCES

1. American Fertility Society, Ethics Committee,

“Ethical Considerations of the New Reproductive Technologies,” Fertility and Sterility 46:lS94S, 1986.

2. Marchbanks, P., “Cancer and Steroid Hormone

Study,” presented at the Fifth Annual Reproductive Health Care in the 80’s Conference, Atlanta,

GA, Oct. 2, 1986.

3. McGregor, J, A., “Prevention of Infertility, ” prepared for the Office of Technology Assessment,

U.S. Congress, Washington, DC, March 1987.

4. Rachootin, P., and Olsen, J. “Social Selection in

Seeking Medical Care for Reduced Fecundity

Among Women in Denmark,” Journal of Epidemiology and Community Health 35:262-264,

1981.

5. Richardson, S. J., Senikas, V., and Nelson, J. F.,

“Follicular Development During the Menopausal

Transition: Evidence for Accelerated Loss and

Ultimate Exhaustion, ” Journal of Clinical Endocrinology and Metabolism 65:1231-1237, 1987.

6. Shapiro, C. H., “Psychological Aspects of Being

Infertile,” prepared for the Office of Technology Assessment, U.S. Congress, Washington, DC,

March 1987.

7. Strategic Information Research Corp., Results of

a National Survey of the American Public on

Fertility and Related Issues, Conducted for

Tambrands, Inc. (New York, NY: 1986).

8, Talbert, L. M., “Overview of the Diagnostic Evaluation,” Infertility: A Practical Guide for the

Physician, i?d cd., M .G. Hammond and L.M. Talbert (eds.) (Oradell, NJ: Medical Economics Books,

1985).

9. U.S. Congress, Office of Technology Assessment,

Healthy Children: Investing in the Future, OTA -

H.345 (Washington, DC: U.S. Government Printing Office, February 1988).

10. Utian, W. H., ‘(Overview on Menopause, ” American Journal of Obstetrics and Gynecology
Ch. Z—Introduction ● 4 5

11

156:1280-1283, 1987. of Testosterone and Follicle-Stimulating Hormone

\’eldhuis, J. D., King, J. C., Urban, R. J., et al., and Their Temporal Coupling With Luteinizing

“Operating Characteristics of the Male Hypo- Hormone)” Journal of Clinical Endocrinology and

thalamo-Pituitary -Gonadal Axis: Pulsatile Release Metabolism 65:929-941, 1987.

CONTENTS

NSFG Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..., . . . . . . . . . . . . . . . . . .

Definitions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Survey Results . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Survey Limitations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Infertility Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Who Provides Infertilitv Services? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Who Seeks Infertility Services? . ., . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . ,

Increased Use of Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Summarv and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 3 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

49

49

50

52

53

53

54

55

56

57

Box

Box No.

3-A. National Survey of Family Growth, 1988 . . . . . . . . . . . . . . . . . . . . . . .

Figures

Figure No..

3-1.Infertility Status, 1982 . . . . . . . . . . . . . . . . . . . .

3-2. Total Visits to Private Physicians for Infertility,1966-84

Tables

Table No.

. 

 . . . . . . .

3-1. Infertile Couples, 1965 and 1982 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

 

Page

5 0

Page

51

55

Page

. . . . . . 51

3-2. Infertility and Age, 1965 and 1982 . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..., . . . 52

3-3. Use of Services for infertility, 1982 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 54

3-4. Some Causes of Increasing Requests for Infertility Services in the 1980s . . . 56
Chapter 3

Demography of Infertility

Epidemiological studies of infertility attempt to

define variations in reproductive impairments for

men and women of different ages, races, and parities (the number of children born to a woman),

to illuminate historical trends, and to identify possible contributory factors. Three national demographic surveys-the 1965 National Fertility Study

(NFS); the 1976 National Survey of Family Growth

(NSFG), Cycle H; and the 1982 National Survey of

Family Growth, Cycle III—provide data on infertility in the United States, All three surveys describe couples with married women in their childbearing years (defined as age 15 to 44) in the

continental United States; the 1982 survey also

contains information on never-married women

of the same ages.

NSFG

In 1982, the NSFG surveyed a sample of 7,969

women of reproductive age, of whom 3,551 were

married. The data for each woman are multiplied

by the number of women she represents in the

population, so the 7)969 women interviewed represent the 54 million women aged 15 to 44 in the

United States. Thus, the data in this chapter represent national estimates (21).

The questions were addressed only to women,

so in married couples the wife spoke for herself

and her husband. Data from the surveys thus

measure infertility of the couple. They do not distinguish male and female factors related to infertility. This chapter refers to the “couple” instead

of the “wife” when presenting the data. Similar

data for men do not exist, as the Government collects little information on the reproductive health

of men.

Definitions

A couple’s reproductive ability is categorized

in three ways by demographers: surgically sterile (impossible to have a baby, whether by choice

or not); impaired fecundity (nonsurgically sterile

Cycle IV of the National Survey of Family Growth

began in early 1988. The baseline survey is being

repeated, and new questions have been added.

Portions of this survey are directly related to infertility (see box 3-A). Preliminary data will be published in 1989, with more reports to follow in 1990

and subsequently (19). Cycle V of the NSFG is

scheduled for 1992.

other sources of data concerning the availability and use of infertility services, such as a series

of surveys by the Alan Guttmacher Institute looking at private physicians and family planning organizations, are discussed in this chapter. In conjunction with the NSFG, these surveys yield a

description of infertility service providers.

DATA

or difficult or dangerous to have a baby); and fecund (no known physical problem). Many couples

classified as fecund actually have unknown fecundity—those using contraception, for example.

Fecundity refers to the potential of a couple to

reproduce. The medical profession prefers the

term fertility, which refers to actual conception

rates. Infertility is a medical term indicating 12

months of unprotected intercourse without conception (see ch. 2). Thus, infertility does not indicate sterility but instead highlights a population

that has trouble conceiving and may need medical assistance.

For this report, the term infertility rather than

impaired fecundity is used. The percentage of infertile couples is slightly less than the percentage

with impaired fecundity, as the latter category

includes couples for whom it is difficult or dangerous for the woman to maintain a pregnancy

(a category that includes miscarriage). Infertility

refers only to couples who have tried to conceive

and failed, not to couples who choose not to attempt conception (whether for medical or social

reasons).

49
50 ● Infertility: Medical and Social Choices

Box 3-A. National Survey of Family Growth, 1988

Cycle IV of the National Survey of Family Growth, conducted by the National Center for Health Statistics

between January 1988 and July 1988, asks approximately 10,600 women about their sex education, pregnancy history, ability to bear children and future plans, use of family planning and infertility services,

and socioeconomic data.

The chief questions regarding infertility asked by the 1988 NSFG include the following (questions from

previous surveys are similar):

c Some women find it physically impossible to have ● Have you (or your husband/partner) had an oper-

(more) children. As far as you know, is it physi- ation, or more than one operation, that would

cally possible or impossible for you, yourself to prevent you from conceiving a(nother) baby (toconceive a(nother) baby, that is, to get pregnant gether)?

(again)? ● What kind of operation, or operations, did you

● What about your (husband/partner)? Is it physi- (or your husband/partner) have that would precally possible or impossible for him to father vent you from conceiving a(nother) baby?

a(nother) child? ● Before the (first) operation was it impossible for

● What is the reason that it is physically impossi- you (and your husband/partner) to conceive

ble for you (and your husband/partner) to have a(nother) baby, was it difficult, or did you have

a(nother) baby? no problem at all?

● Some people are able to have a(nother) baby, but ● Have you (or your husband/partner) ever had

have difficulty getting pregnant or holding onto surgery or treatment to reverse a sterilization

the baby. As far as you know, is there any prob- operation?

lem or difficulty for you (and your husband/part- ● Have you ever been treated in a doctor’s office,

ner) to conceive or deliver a(nother) baby (after clinic, or emergency room for an infection in

this pregnancy)? your fallopian tubes, womb, or ovaries, also

● What is the reason it would be difficult for you called a pelvic infection, pelvic inflammatory disto have a(nother) baby? ease, or PID?

● Have you (or your husband/partner) ever been ● How many times have you been treated for PID?

to a doctor or clinic to talk about ways to help ● Have you ever heard of chlamydia?

you become pregnant? ● Has a doctor ever told you that you have chla-

● What kinds of medical treatment or advice have mydia?

you (or your husband/partner) had to help you ● Has a doctor ever told you that you have gon -

(become pregnant/prevent miscarriage)? orrhea?

● To which of the places llisted] did you (or your ● Has a doctor ever told you that you have endohusband/partner) go for that visit? metriosis?

● After you (or your husband/partner) went for

this treatment or advice, were you able to have

a baby?

SO~rRcE [1 S wpaflrn~nl of Health and Human Swwces Puhhc Health !jem ICY, Natwnal Center for Health Statistics, iWtiona/Surtfev ofi%ml!}(h-ow-th [~}dell’ fW’ashmgtcsm DC 1988)

Survey Results while secondary infertility (in which couples

have at least one biological child) declined,

In 1982, 8.5 percent (2.4 million) of married cou- from 2.5 million in 1965 to 1.4 million in 1982

pies were infertile, 38.9 percent (11.0 million) were (see table 3-1) (18). surgically sterile, and 52.6 percent (14.8 million)

were fecund (see figure 3-1). The number of infertile couples declined from 3.o million in The increase in primary infertility can be ex196S to 2.4 million in 1982. More importantly, plained partly by the fact that more couples are

primary infertility (childlessness) doubled, attempting to have children, as members of the

from 500,000 in 1965 to 1 million in 1982, baby-boom generation reach their childbearing
Ch. 3—Demography of Infertility ● 5 1

Figure 3-1 .–lnfertiiity Status, 1982

(married couples, wives aged 15 to 44)

Fecund

SOURCE: Office of Technology Assessment, 1968.

years and try to have their first baby. The decrease

in secondary infertility can be explained by the

increase in voluntary surgical sterilization (from

15.8 percent in 1965 to 38.9 percent in 1982). This

increase was due solely to the increase in sterilization for contraceptive purposes; the change in

noncontraceptive sterilization was slight (18,22).

Contraceptive sterilization masks a number of

women who might otherwise discover that they

were infertile, especially at ages 30 and older (22).

Although the percentage of couples infertile appears to have decreased over the past two decades (from 11.2 percent in 1965 to 8.5 percent

in 1982), this drop is entirely due to the rise in

surgical sterilization. Excluding the surgically

sterile, the percentage of couples infertile has

changed only slightly, rising from 13.3 to 13.9

percent (18).

Black couples are more likely than white

couples to be infertile; in 1982, the risk of infertility for black couples was 1.5 times that

for white couples (26). Many possible explanations for these higher rates have been presented,

although no data exist on the subject:

●

●

●

s

the higher incidence of sexually transmitted

diseases (STDS), as STDS account for an estimated 30 percent of infertility in some highrisk populations in the United States (26) and

may account for up to 20 percent of infertility overall (4) (the difference in rates of STD

between blacks and whites reflects the difference in other relevant demographic characteristics, such as urban dwelling, rather than

actual racial differences (7));

the greater use of intrauterine devices (which

can increase the likelihood of pelvic inflammatory disease);

environmental factors, such as occupational

hazards affecting reproduction (3o); and

complications or infections following child- —

birth or abortion (25).

Couples with wives having less than a high school

education were also more Iikely to be infertile

(2,16).

Within age groups, the only significant

change over time occurred in those 20 to 24

Tabie 3.1. infertiie Coupies, 1965 and 1982

All Excluding surgically sterile

Couples 1965 1982 1965 1982

Number of couples (millions)a

Total . . . . . . . . . . . . . . . . . . . . . . . 26.5 28.2 22.3 17.2

Childless . . . . . . . . . . . . . . . . . . . 3.5 5.1 3.2 4.6

1 or more children . . . . . . . . . . . 23.0 23,1 19.1 12.6

Number infertile (millions)

Total . . . . . . . . . . . . . . . . . . . . . . . 3.0 2.4 3.0 2.4

Childless . . . . . . . . . . . . . . . . . . . 0.5 1.0 0.5 1.0

1 or more children . . . . . . . . . . . 2.5 1.4 2.5 1.4

Percent infertile

Total . . . . . . . . . . . . . . . . . . . . . . . 11.2 8.5 13.3 13.9

Childless . . . . . . . . . . . . . . . . . . . 14.5 19.6 15.6 21.8

1 or more children . . . . . . . . . . . 10.9 6.1 13.1 11.1

%Vives 15 to 44 years old.

SOURCE: Adapted from W.D. Mosher, “infertility: Why Business Is Booming,” American Demographics 9:42-43, 1987.
52 ● Infertility: Medical and Social Choices

years old. In 1965, 4 percent of this group were

infertile; by 1982, 11 percent were infertile

(17,26). This increase may be linked to the tripled

gonorrhea rate of this age group between 1960

and 1977 (18), as well as to the factors mentioned

previously regarding the higher rates of infertility in black couples. This particular group is important, as one in three births in the United States

occurs to women 20 to 24 (22).

Data from the NSFG indicate that infertility increases with age: Excluding the surgically step

ile, 14 percent of married couples with wives

aged 30 to 34 are infertile, while 25% percent

of couples with wives aged 35 to 39 are infertile (see table 3-2) (18). To date, the influence of

age on female fertility has been examined more

closely than has its influence on male fertility. Although viable sperm production does decline with

age in humans (13), the effect of this on fertility

has not been determined (23).

In recent years there has been controversy in

the scientific and popular literature over the rate

at which a woman’s fertility decreases with age

(3,8,9,14,15,27). Studies have attempted to control for variables such as frequency of intercourse

(which is known to decrease as the length of marriage increases) and to examine societies that have

little evidence of deliberate fertility control. The

results are varied and widely debated, but all seem

to indicate that female fertility does decrease

somewhat before age 35 and significantly

more after age 35. The disagreement focuses primarily on the extent of the decrease when a

woman reaches age 30. Most of the available statistics are more useful for indicating the number

and types of women who are likely to need and

use infertility services than for estimating a

woman’s decreased fertility with age and the effects of delayed childbearing (15).

Survey Limitations

Available survey data may misrepresent the true

numbers of infertile couples. First, the boundary

of 1 year for the definition of infertility is somewhat arbitrary; many couples classified as infertile

after 1 year will conceive later without medical

assistance (15). In an unrandomized observational

study of 1,145 infertile couples, 41 percent of those

whose infertility problems were treated later conceived, while 35 percent of those untreated also

became pregnant (3). However, the l-year limit

has both a practical and a theoretical justification.

Practically, the NFS and NSFG are the only national

surveys to examine infertility status, and they use

the l-year definition. Most physicians use this definition as well (20). Furthermore, if an average

woman with no infertility problems has an approximate monthly probability of conception of

20 percent (0.2 as a proportion), 93 percent of

all women would theoretically conceive after 1

year of unprotected intercourse (12).

Second, the surveys did not directly ask whether

the respondent had ever tried to become pregnant (22), meaning that women who have always

used contraception, never had intercourse, or

never tried to become pregnant were assumed

to be fertile. A number of potentially infertile couples may be hidden in the groups of surgically

sterilized couples and couples using contraception. The authors corrected for one problem by

excluding the surgically sterile from some data

and thus removing the effects of the sharp rise

in surgical sterilization between 1965 and 1982.

However, couples using contraception who have

not been proved fertile are included in the category “fecund,” which may lead to an underestimation of the extent of infertility.

Third, the surveys refer to married couples with

wives aged 15 to 44. As a result, unmarried men

and women are not included in these figures (except in the 1982 data, when unmarried women

were also surveyed). Excluding unmarried couples may have resulted in an underestimate of the

absolute number of infertile couples. Finally, the

data only permit a guess at the populations at increased risk for infertility.

Table 3-2. Infertility and Age, 1965 and 1982 (percent)a

Age of wife 1965 1982

15 to 19 . . . . . . . . . . . . . . . . . . . . . . 0.6 2.1

20 to 24 . . . . . . . . . . . . . . . . . . . . . . 3.6 10.6

25 to 29 . . . . . . . . . . . . . . . . . . . . . . 7.2 8.7

30 to 34 . . . . . . . . . . . . . . . . . . . . . . 14.0 13.6

35 to 39 . . . . . . . . . . . . . . . . . . . . . . 18.4 24.6

40 to 44 . . . . . . . . . . . . . . . . . . . . . . 27.7 27.2

Total, 15 to 44. . . . . . . . . . . . . . . 13.3 13.9

ap~rcent of marrj~ couple9 excluding those surgically sterilized. Data are bas@

on samples. The only statistically significant change between 1965 and 1982

is the increase at age 20 to 24.

SOURCE: W.D, Mosher, “Infertility: Why Business Is Booming,” Arner{can Demographics 9:42-43, 1987.
Ch. 3—Demography of Infertility c 53

INFERTILITY

The National Survey of Family Growth provides

data on the infertility services most frequently received by the population. Overall, the 1982 survey reports the following services as most popular among female respondents: advice on the

timing of intercourse (I9 percent); general health

advice (18 percent); drugs to induce ovulation (17

percent); other advice (15 percent); and tests (12

percent). The most frequently reported infertility service for husbands was a sperm count (29).

Who Provides Infertility Services?

Providers of medical infertility treatment services typically fall into three categories:

●

●

●

primary care physicians,

specialized infertility centers that offer in

vitro fertilization (IVF), and

other centers offering infertility treatment.

In general, primary care physicians appear to

be the front-line providers of infertility treatment

services. According to one survey, patients seeking such services from primary care physicians

are served mainly by obstetrician/gynecologists

(66 percent), followed by urologists (22 percent)

(l). Most patients first discuss their concerns with

either an obstetrician/gynecologist (for a female)

or a urologist (for a male) or both.

Infertility care is also provided by other physicians. The Alan Guttmacher Institute (AGI) surveyed a sample of the 100,000 private physicians

in four specialties, and estimated that some 45

percent of them provide infertility care (1). These

45,600 physicians include 17,500 general/family

practitioners, 1,400 surgeons, 20)600 obstetrician/

gynecologists, and 6,100 urologists (1). The large

proportion of general and family practitioners is

explained by the large number of them in practice (about twice as many as obstetrician/gynecologists) as well as by their widespread geographical distribution (24).

Most obstetrician/gynecologists (96 percent) and

urologists (92 percent) provide at least some infertility services as part of their private office practice, although this may not be their area of specialization or greatest expertise. General/family

practitioners (35 percent) and general surgeons

SERVICES

(6 percent) were less likely to offer any infertility

services. Physicians practicing in the north central and western regions of the country, as well

as younger physicians, are slightly more likely than

other physicians to treat infertility (l).

Although virtually no private physicians provide all infertility treatment services, the vast majority of obstetrician/gynecologists provide basic

diagnostic services, as well as a substantial number of diagnostic/treatment services, including

clomiphene (91 percent), hysterosalpingograms

(89 percent), and laparoscopies (85 percent). Similarly, 83 percent of urologists provide basic physical exams and counseling, as well as semen analyses (l). Artificial insemination is also frequently

arranged with private physicians (28).

Most physicians who provide infertility services

refer patients elsewhere when necessary, usually

to another physician (l). However, for female patients, obstetrician/gynecologists are more likely

than general practitioners to make referrals to

infertility centers or clinics rather than to other

physicians. This may be due to the relatively complex services that such physicians already provide

for women, and the need for specialty referrals.

Estimates of the number of patients treated privately for infertility vary widely. Data from the

1980-81 National Ambulatory Medical Care Survey show that the number of office visits, by the

principal diagnosis of infertility, to physicians practicing obstetrics and gynecology averaged 556,000

annually (6). One analysis of this data estimated

that between 111,200 and 161,240 new infertility cases are diagnosed each year and that between

200,000 and 300)000 patients are treated for infertility annually (6).

The AGI study estimates that private physicians

in the United States see 1.55 million patients annually for infertility; this may include patients who

see more than one physician, as well as both partners in a couple. The National Survey of Family

Growth estimated that 1 million to 1.2 million couples consulted a physician about infertility problems in 1981; about 80 percent of the consults

(i.e., 800,000 to 950,000) were sought from private physicians (l).
54 . /n fertility: Medical and Social Choices

The second category of infertility service providers, IVF/infertility centers, is discussed in detail in chapter 8. In 1987, there were 169 clinics

in the United States offering IVF or gamete intra -

fallopian transfer (see app. A), but proficiency in

these techniques varied widely. Most centers offer a variety of the well~established infertility diagnostic and treatment services, except male microsurgery and artificial insemination. Many clinics

are more oriented toward the treatment of female

infertility than male infertility.

The last category of providers includes family

planning agencies in hospitals, health departments, and Planned Parenthood facilities. Under

the guidelines to Title X of the Public Health Service Act, family planning service grantees must

make basic infertility services available to clients

upon request. The AGI survey estimated that 70

percent of family planning agencies, or 1,712 agencies nationwide (compared with 45,OOO private

physicians), provide at least some basic infertility

services (e.g., physical exams, counseling, infection investigation, and basal body temperature instruction) (l). However, at least half the family

planning agencies responding to this question said

that they see fewer than 10 infertility patients per

year; lack of demand, lack of appropriately trained

staff and lab facilities, and the high costs of infertility services are among the reasons that this type

of agency accounts for a minimal amount of infertility services,

The category of “other” infertility service providers also includes an unknown (although probably small) number of centers that specialize in

infertility services but that do not provide IVF or

gamete intrafallopian transfer.

Who Seeks Infertility Services?

In 1982, couples with primary infertility were

twice as likely as couples with secondary infertility to seek infertility services; approximately half

of the women with primary infertility stated that

they or their husbands had ever sought services,

compared with approximately one quarter of the

women with secondary infertility (see table 3-3)

(10). Overall, 31.4 percent of infertile married couples had ever looked for infertility services. Cou -

Table 3-3. Use of Services for Infertility, 1982 (percent)

Women who ever

Infertility status sought servicesa

All infertile women . . . . . . . . . . . . . . . 31.4

Women with primary infertility . . . . . 51.2

Women with secondary infertility. . . 22.4

aWives 15 to 44 years old.

SOURCE: Adapted from M.B. Hirsch and W.D. Mosher, “Characteristics of infertile Women in the United States and Their Use of Infertility Services,”

Fertility and Sterility 47:61 S-625, 1987.

pies with older wives were more likely to have

used such services (11).

Although black couples are more likely to be

infertile, a larger proportion of white couples had

requested medical evaluation of their infertility

in the 3 years before the NSFG (11). In 1982, 18.6

percent of ever-married white women had used

services for infertility, compared with 13.5 percent of ever-married black women (11). (The category “ever-married women” is larger than the

category “currently married women, ” used previously in this report. However, the number of

divorced or separated women seeking infertility

services is likely to be relatively small.)

Based on the 1982 NSFG, it is estimated that

1 million evermarried women in the United

States stated in 1982 that they or their husbands had used infertility services in the past

year (11). In the same year, approximately 6 million (or one in six) ever-married women 15 to 44

years old stated that they or their husbands had

used such services at some point during their lives.

The NSFG estimates of the number of infertile

couples probably underestimate the number of

couples who might seek treatment for infertility.

The category “surgically sterile” hides a number

of couples who would have discovered infertility

problems had they not been sterilized. It also includes a number of individuals who may have

changed their minds about undergoing contraceptive sterilization. If the couple desires a future

birth, they may seek infertility services to overcome their self-imposed sterility. Second, couples

who are unable to have a live birth or who choose

not to conceive because it is difficult or dangerous for the woman to carry a pregnancy to term

are not included in the definition of infertility;
Ch. 3—Demography of Infertility ● 5 5

however, they might be candidates for some type demand for infertility services. A number of fac -

of infertility service (e.g., surrogate motherhood). tors have contributed to an increase in demand

despite the absence of an overall increase in inIncreased Use of Services fertility rates (see table 3-4):

Although the percentage of American couples ●

faced with infertility does not appear to have

grown, popular concern about infertility has increased, as has the demand for infertility services.

The greater demand for infertility services is

well documented. The estimated number of visits

to private physicians’ offices for consultation related to infertility rose from about 600,000 in 1968

to over 900,000 in 1972 to about 2 million in 1983,

then dropped to 1.6 million in 1984 (see figure 3-2).

Although the 20 to 24 year olds, for whom in- ●

fertility actually did increase, are an important

group, the growth of infertility among them is

not significant enough to account for the increased

The absolute number of couples with primary

infertility has risen with the aging of the babyboom generation; with delayed childbearing,

which exposes more couples to higher agespecific infertility rates; with the use of oral

contraceptives (which often delay conception,

thus inflating numbers of infertile couples);

and with the tendency of couples to classify

themselves as infertile more quickly (due to

a desire to condense childbearing into a

shorter interval, for example).

The proportion of couples seeking treatment

has risen due to the decreased number of infants available for adoption; the increased

awareness of various treatments available for

Figure 3-2.–Total Visits to Private Physicians for Infertility, 1966.84

2,000,000C

,/\\

1,600,000 “

,/ \ \

\

, @ ;

 - ‘ ,, ~ ,, / ’

1,200,000 -

/

Female /

,#’’----...w*- ,0-%.

. ##

800,000 “

-%, \ \ /

,0-

“%

,0+

/f . # 0 -. \v/’ ~

-u”””

. . . ~

.

AO” ~

“, f’ .

-

----- - :

.- < s

400,000 “ $,

! . . &. Male

n . & 1 1 1’ 1 I 1 1 1

“ 1966 1970 1975 1980 1984

2,000,000

1,600,000

1,200,000

[

800,000

400,000I

o

1 1 1 i i 1 1 1 1 I 1 1 I 1 1 1 1 1 I

1966 1970 1975 1980 1984

SOURCE: W. Cates, Jr., Director, Division of Sexually Transmitted Diseases, Center for Prevention Services, Centers for Disease Control, Atlanta, GA, personal communication, June 23, 1987
56 Infertility: Medical and Social Choices

Table 3-4.-Some Causes of Increasing Requests for Infertility Services in the 1980s

Increasing proportion of Increasing number of Evolution of

More couples with infertile couples physicians providing More conducive new reproductive

primary infertility seeking care infertility services social milieu technologies

● Aging of the baby- ● Decreased supply of ● Greater demand from . Baby-boom ● IVF

boom generation infants available for private patients generation expects to ● GIFT

● Delayed childbearing; adoption . More sophisticated control their own . Artificial insemination

more people in higher c Heightened diagnosis and fertility ● Surrogate

risk age groups expectations treatment ● Profamily movement motherhood

. Childbearing . Larger number of c At least 169 sites in . Increased discussion ● Cryopreservation

condensed into people in higher the United States of sexual matters due

shorter intervals income brackets with offering IVF or GIFT to the AIDS epidemic

. Delayed conception infertility problems . Extensive media

due to prior use of ● Larger percent of coverage

oral contraceptives infertile couples are

primarily infertile

SOURCE: Adapted from S.0. Aral and W. Cates, Jr., “The Increasing Gmcern With Infertility: Why Now?” Journa/ of the American Medical Association 250:2327-2331, 1983.

infertility; a greater proportion of couples in

higher socioeconomic brackets with infertility problems; and a larger number of couples with primary infertility.

Increasing numbers of physicians are providing infertility services.

The profamily movement has defined infertility as a major health problem. Sexual matters are generally discussed more openly as

SUMMARY AND

In 1982, approximately 8.5 percent of all married couples were infertile, 38.9 percent were surgically sterile, and 52.6 percent were fecund. Generally, black couples, couples with older wives,

and couples with the wife having less than a high

school education were at higher risk for infertility. The percentage of married couples who were

infertile decreased significantly between 1965 and

1982, although this decrease can largely be explained by the increase in surgical sterilization.

Excluding the surgically sterile, the percentage

of married couples infertile did not change significantly.

The number of infertile couples declined from

3.0 million in 1965 to 2.4 million in 1982. More

importantly, primary infertility (childlessness) doubled, from 500,000 in 1965 to 1 million in 1982,

while secondary infertility (in which couples have

at least one biological child) declined, from 2.5 million in 1965 to 1.4 million in 1982.

Female fertility decreases somewhat before age

35 and significantly more after age 35. There is

a result of the AIDS epidemic.

● Novel reproductive techniques used to treat

infertility have evolved.

Overall, the increase in requested infertility

services has likely surpassed any actual increase in the overall percentage of couples

with infertility.

CONCLUSIONS

considerable controversy over the extent of the

decrease, especially between ages 30 and 35.

Another cycle of the National Survey of Family

Growth began in early 1988 and will collect further information on all these trends; preliminary

data will be published in late 1989.

Infertility treatment is provided by primary care

physicians, specialized infertility centers, and

other centers (e.g., family planning clinics). Primary care physicians appear to be the front-line

providers of infertility services. Couples using infertility services are more likely to have primary

infertility, to be white, and to have wives who are

older. In 1982 only 31.4 percent of infertile married couples had ever sought services for infertility.

The demand for infertility services has increased

rapidly in recent years, despite the fact that the

actual incidence of infertility has not. The number of office visits to private physicians for infertility services rose from about 600,000 in 1968

to some 1.6 million in 1984.
Ch. 3—Demography of Infertility w 57

CHAPTER 3 REFERENCES

1. Alan Guttmacher Institute, Infertility Services in

the United States: Need, Accessibility and Utilization (New York, NY: 1985).

2. Aral, S.0., and Cates, W., “The Increasing Concern

With Infertility: Why Now?” Journal of the American Medical Association 250:2327-2331, 1983.

3. Bongaarts, J., “Infertility After Age 30: A False

Alarm,” New England Journal of Medicine 14:75-

78, 1982.

4. Cates, W., Jr., Director, Division of Sexually Transmitted Diseases, Centers for Disease Control, Atlanta, GA, personal communication, Apr. 28, 1987.

5. Collins, J. A., Wrixon, W., Janes, L. B., et al.,

“Treatment-Independent Pregnancy Among Infertile Couples,” New England Journal of Medicine

309:1201-1206, 1983.

6. Cooper, G., “The Magnitude and Consequences of

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“Infertility and Age: An Unresolved Issue, ” Family

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10. Hirsch, M. B., and Mosher, W. D., “Characteristics

11

12,

1 3 .

of Infertile Women in the United States and Their

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Horn, M. C., and Mosher, W. D., “Use of Services

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Brisbane Hospital, June 1985.

Johnson, L., Petty, C. S., and Neaves, W.B. “Influence of Age on S-perm Production and Testicular

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15. Menken, J., Trussell, J., and Larsen, U., “Age and

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United States,” American Journal of Public Health

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24

25.

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Orr, M.T., and Forrest, J. D., “The Availability of

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Pratt, W. F., Mosher, W. D., Bachrach, C. A., et al.,

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U.S. Congress, Office of Technology Assessment,

Reproductive Health Hazards in the Workplace,

OTA-BA-266 (Washington, DC: U.S. Government

Printing Office, 1985).
Chapter 4

Factors contributing

to Infertility
CONTENTS

Infection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sexually Transmitted Diseases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other Infectious Diseases. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Hormonal Disturbance. . . . . . . . . . . . . . . . . . . . . . . . . . . . ..., . . . . . . . . . . . . . . . . .

Polycystic Ovarian Disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cervical Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Hyperprolactinemia: Physiologic and Pathogenic , . . . . . . . . . . . . . . . . . . . . . . . .

Exercise . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . .

Poor Nutrition . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Stress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Endometriosis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Varicocele . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

External Factors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Contraception . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Abortion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . , . . . . . . . . . . . . . . . . .

Environment and Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Smoking . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Spinal Cord Injury. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,

Genetic and Chromosomal Abnormalities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Iatrogenic Factors. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Miscellaneous Factors . . . . . . . . . . . . . . . . . . . . . . . . . . ..., . . . . . . . . . . . . . . . . . . .

Unexplained Infertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Summary and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Chapter 4 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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Figure No. Page

4-1.Testicular Shield . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73

Tables

Table No. Page

4-1. Industrial Exposures That May Affect Reproductive Health . . . . . . . . . . . . . . 69

4-2. Summary of Effects of Physical Forces on Fertility . . . . . . . . . . . . . . . . . . . . . 70

4-3. Reproductive Consequences of Cancer and Cancer Therapy. . . . . . . . . . . . . . 72

4-4. Iatrogenic Causes of Infertility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
Chapter 4

Factors Contributing to Infertility

Current knowledge of the factors that contribute to infertility is limited. Classification of infertility due to any one condition is misleading, as

contributing factors are often multiple and the

boundaries between them are not clear. Those

covered in this chapter do not always fit neatly

into the categories in which they are discussed;

for example, there may be a genetic component

to endometriosis, yet the two are presented as

separate factors contributing to infertility.

Another problem arises when examining reasons for infertility. Should the underlying condition, such as a sexually transmitted disease (STD),

or the mechanism by which it leads to infertility,

such as tubal damage, be called the contributing

factor? For prevention, the underlying condition

is the important factor, as the disease can potentially be avoided. For treatment, however, the

mechanism is often more important; whatever

damage it has caused must be repaired or circumvented for pregnancy to occur.

Sometimes the mechanism by which a given condition results in infertility is not clear; sometimes

it is not clear what condition underlies a functional impairment. This chapter presents the current knowledge of factors contributing to infertility, whether they be an underlying condition,

its mechanism of action, or both.

INFECTION

Sexually Transmitted Diseases

Sexually transmitted diseases are the third most

common infectious diseases in the United States,

after the common cold and influenza. They account for an estimated 20 percent of infertility

in selected populations (29). Furthermore, they

are usually difficult to diagnose, especially in

women. STDS are most damaging to women and

children (excluding acquired immunodeficiency

syndrome, which is equally damaging to anyone

who contracts it, regardless of age or sex), although they affect males as well. The three STDS

that most affect fertility are gonorrhea, chlamydial

infection, and mycoplasmal infection.

Gonorrhea is an infection caused by the bacteria Neisseria gonorrhoeae. More than 760)000

cases were reported in 1987 (33). In women, if

the infection is not treated it can spread to the

uterus and fallopian tubes, causing pelvic inflammatory disease (PID), which can lead to infertility. In men, bacteria can directly affect semen quality by inducing phagocytosis or stimulating

production of antibodies (113). Also, untreated

genital infection can cause infertility in men by

creating inflammation or blockage in the upper

reproductive tract. For example, untreated infection can spread to the epididymis, causing epididy -

mitis. Epididymitis can impair fertility during the

infection as well as cause scarring that can partially or completely block sperm transport. Reports

from Nigeria and from the preantibiotic era indicate that various genital tract infection syndromes

are associated with male infertility (2)8,126). However, followup fertility studies of men with documented inflammation of the urethra, epididymis,

and/or testis or with accessory gland infection are

not available, so knowledge of the actual effect

of STDS on male fertility is scant.

Infection caused by Chlamuydia trachomatis is

the most common STD in the United States today,

infecting approximately 4 million people in 1985

(30,174). In women, chlamydial infection accounts

for one-quarter to one-half of the PID cases seen

each year (30). In men, chlamydial infections cause

approximately half the reported cases of nongonococcal urethritis and also half the estimated

SOO)OOO cases of acute epididymitis seen annually

(3o). In both men and women, chlamydial infection is more difficult to detect than gonococcal

infection, and thus may go untreated, resulting

in more harm (149).

Considerable controversy surrounds another

group of sexually transmitted organisms commonly found in the male and female reproduc61
62 . Infertility: Medical and Social Choices

tive tracts—mycoplasmas (24,76,82,149). Because

mycoplasmal infections often coincide with other

infections, it is difficult to determine whether the

mycoplasmas themselves actually cause tissue

damage (149).

Among sexually active women, a major cause

of impaired fertility is damage to the fallopian

tubes, and possibly the ovaries, caused by pelvic

inflammatory disease (28). If untreated, the bacteria that cause gonorrhea, chlamydial infection,

and other infections may ascend from the lower

genital tract through the endometrium (causing

endometritis) to the fallopian tubes (salpingitis),

and possibly to the ovaries (oophoritis) and pelvic peritoneum (peritonitis). Reduced fertility due

to PID probably stems primarily from physical

damage to the fallopian tubes (28,49,175,185):

Peritubal (around the tube) adhesions decrease

tubal mobility, which is essential for passage of

the ovulated egg. Blocked or deformed tubes can

severely obstruct the movement of both ova and

sperm that is necessary for fertilization. Bacterial

products or byproducts of inflammation can also

cause impaired function of the oviduct.

The majority of bacterial-based PID results from

one or more sexually transmitted diseases; N.

gonorrhoeae and C. trachomatis together account

for more than two-thirds of the 1 million cases

of PID seen each year (3). In 1982 approximately

14 percent of women between ages 15 and 44 reported being treated at least once for PID during

their lifetime (5). According to two estimates, a

woman with a gonococcal or chlamydial infection

has a 10-percent risk of developing PID, and from

10 to 20 percent of the approximately 1 million

women with PID each year will become infertile

(140,174). The likelihood of infertility increases

dramatically with increasing episodes of PID, from

an estimated 11.4 percent after one episode to

between 54.3 and 75 percent after three episodes

(183,185). The likelihood of infertility also increases with the severity of the PID (17,185).

Although more common in developing countries

than industrial ones, other genital tract infections

can lead to PID. Infections after birth, cesarean

sections, abortions, and many other obstetric or

gynecologic procedures can cause tubal damage.

Whether these infections actually lead to infertility is subject to some controversy (85,163).

Damaged or blocked tubes resulting from PID

may lead to another complication, ectopic pregnancy. An ectopic pregnancy is one that occurs

outside of the uterus, usually in a fallopian tube,

because the fertilized egg cannot travel to the

uterus through the damaged or blocked tube. PID

is not the only cause of ectopic pregnancy; congenital tubal malformation and tubal ligation are

other possible causes. The magnitude of PID’s influence on the increasing incidence of ectopic

pregnancy is controversial (7,36). From 1970

through 1983, the number of ectopic pregnancies in the United States quadrupled (31), possibly as a consequence of the increased occurrence

of PID (102,176). Some estimates indicate that 30

to 60 percent of ectopic pregnancies are associated with evidence of PID (176,178). The frequency

of tubal pregnancy increases sixfold to tenfold following a documented episode of PID (178,185).

The likelihood of infertility in turn increases after an ectopic pregnancy (119).

Douching may be related to both ectopic pregnancy and PID. One case-control study suggested

that women who douche weekly have a significantly higher risk of ectopic pregnancy than

women who never douche (37). It has also been

proposed that douching may be a risk factor for

PID (121).

Other Infectious Diseases

Past studies suggest that 30 percent of men with

bilateral postpubertal mumps orchitis develop

azoospermia (25). Approximately 2,982 men in the

United States contracted mumps in 1985, with 725

of them being postpubertal cases (32). Mumps does

not appear to be a major contributor to male infertility here, but rates of the disease have increased in recent years (27) and the number of

cases doubled between 1986 and 1987 (33).
Ch. 4—Factors Contributing to Infertility 63

HORMONAL DISTURBANCE

Polycystic Ovarian Disease

Researchers disagree on the cause of the malfunction in the hormonal system that leads to poly -

cystic ovarian disease, although many theories implicating the hypothalamus, the pituitary, the

ovaries, and the adrenals have been suggested (87).

However, the result of the disease-varies

clogged with cysts and few or no ovulations each

year-clearly undermines fertility (16,61).

Cervical Factors

The complex change of the cervical mucus of

the female at the time of ovulation is under hormonal control. The changes assist the survival and

transport of sperm. If the proper hormonal events

do not occur, fertilization and pregnancy become

much less likely, especially in the presence of other

causes of impaired fertility such as a low sperm

count in the male (53). Less commonly, insufficient mucus production due to physical destruction of endocervical tissue during surgery is also

associated with evidence of decreased sperm

transport (112). other possible causes of poor cervical mucus are secretory antibodies in the mucus, infection (cervicitis), and exposure to diethylstilbestrol (DES) (l). The effect of the change in

the cervical mucus on fertility is highly controversial (71), and it is not considered a frequent factor leading to infertility.

Hyperprolactinemia: Physiologic

and Pathogenic

In all mammals, including humans, lactation is

a key link in the reproductive cycle (133). Ovulatory suppression prevails during nursing and

serves as a primary means of birth spacing for

humans (130,150). Continued suckling keeps levels

of the hormone prolactin elevated to some degree

(83), and elevated levels of prolactin suppress ovulation by affecting both hypothalamic-pituitary

and ovarian processes (133). Lactation is not associated with any long-term fertility impairment.

However, hyperprolactinemia-the overproduction of the hormone prolactin—is identified as a

factor contributing to infertility (115). It is associated with impaired fertility in the presence and

absence of excessive milk production. Consistently

hyperprolactinemic women are almost always infertile (115).

Hyperprolactinemia can also be associated with

infertility in males, although it is rare in comparison with female cases. Hyperprolactinemia in men

is associated with decreased levels of testosterone and markedly decreased spermatogenesis (13),

but it is only significant when prolactin is markedly

elevated and related to a tumor (100).

Causes of hyperprolactinemia are diverse and

remain poorly understood. At least half the patients evaluated show evidence of pituitary tumor.

Various medications, hypothyroidism, stress, exercise, excessive breast stimulation during lovemaking, and other causes of chest wall stimulation

have been implicated in hyperprolactinemia.

Exercise

Considerable accumulated evidence indicates

that regular, strenuous exercise alters menstrual

function and temporarily impairs fertility in

women. In males, gonadal steroid production may

also be altered by rigorous training (104,186), but

exercise does not appear to have an effect on male

fertility. The frequency of amenorrhea (absence

of menstruation) or oligomenorrhea (infrequent

menstruation) among women participating in a

variety of activities varies from 2 to 51 percent

as opposed to 2 to 5 percent of more sedentary

women (26). In a prospective study of women with

previously normal menstrual cycles, fully 87 percent developed abnormality of these cycles when

engaged in a strenuous exercise program (21).

Hormonal abnormalities described include disordered gonadotropin release and levels, decreased estrogen levels, corpus luteum inadequacies, and complete anovulation (48,131)137,145,

146). Abnormalities appear greatest when exercise is most intense or when training becomes

more rigorous (103, I31), although a recent study

did not find training intensity of olympic-caliber
64 “ Infertility: Medical and Social Choices

marathon runners to be a key factor in loss of

menses (63). Researchers suggest that even moderate exercise by recreational women runners

(average 12.5 miles per week) reduces overall progesterone levels but does not delay luteal progesterone rises, which are suggestive of ovulation (48).

Mechanisms of menstrual irregularities associated with strenuous exercise regimens are not

completely understood. It has been suggested that

exercise results in changes in prolactins and endorphins, possibly affecting fertility (47)103). At

this time, little information exists on the relationship between exercise-associated menstrual alterations and long-term infertility.

Poor Nutrition

In women, it is generally accepted that sexual

maturation and continuation of cyclic ovulation

depends on achieving and maintaining an adequate amount of body fat as a proportion of total

body mass (59,60,166). Fatty tissue appears to

directly influence reproductive maturation and

function in both sexes by metabolizing both androgens and estrogens that, in turn, influence the

central nervous system, hypothalamus, pituitary,

and reproductive tract organs in complex ways

(59,166). Too little and (much less commonly) too

much adipose tissue have each been associated

with impaired fertility.

According to estimates of one researcher, completion of pregnancy and lactation requires approximately 50,000 calories–roughly the amount

of energy most normal women (26 to 28 percent

body fat) possess in body fat (59). Because fat is

the most labile and sustainable source of body

energy, possession of adequate fat stores may

serve as a physiologic precondition for conception and pregnancy. obesity is also associated with

anovulation, endometrial hyperplasia, and subsequent hemorrhage (35).

Stress

Interactions with surroundings can cause bodily

changes that impair fertility, yet the relationship

between stress (stimuli or conditions that perturb

homeostasis and require adaptation) and impaired

fertility is extraordinarily difficult to prove in

humans.

Input from the limbic system and other brain

centers affects the hypothalamus, the pituitary

gland, and the neurohormonal axis that orchestrates both the physical and behavioral aspects

of reproduction. This complicated system provides

ample opportunity for stress to interfere with the

homeostasis of the individual. In recent decades,

40 to 50 percent of infertility was attributed to

stress or emotional factors (143). Recent progress

in neuroendocrinology and reproductive medicine

has reduced this estimate to 5 percent or less (143).

However, some would argue that a certain percentage of idiopathic infertility may be stressrelated.

Critical reviews of the large volume of information regarding stress and fertility in different

lifestyles are available (38,39,1 11,189,190). In humans, evidence suggests that mild to severe emotional stress alters sexual behavior, interferes with

ovulation, depresses testosterone, and perhaps

interferes with spermatogenesis (111,143). In

women, anorexia nervosa can cause amenorrhea,

apparently independently of weight loss (69).

Anecdotal accounts indicate that anxiety can play

a role in infertility; for example, 10 percent of patients become pregnant after having made an appointment for or having had their first professional visit for infertility (46).

Neurotransmitters play central roles in adapting to stress. Furthermore, neurotransmitter roles

are not limited to effects on the central, peripheral,

or autonomic nervous system functions, but are

also directly involved in reproductive tract physiology (65). Understanding of increasingly unified

and shared concepts of organ system physiology

is growing rapidly. Yet, despite this information,

great difficulties persist in accurately attributing

individual cases of human infertility to stress,

whether primarily physical or psychological.
Ch. 4–Factors Contributing to Infertility ● 6 5

ENDOMETRIOSIS

Endometriosis is characterized by the presence

of cells of the uterine lining outside of the uterus.

The ovaries, fallopian tubes, pelvic peritoneum,

and visceral peritoneum are the most common

locations of endometrial implants, but other sites,

such as pleura, lung, and lymph nodes, have also

been reported (54). Endometriosis afflicts approximately 7 to 17 percent (studies range from 4 to

50 percent) of menstruating women (120).

When symptomatic, the process is classically

characterized by painful menstruation, painful

ovulation, painful intercourse, and infertility. Expression of each symptom varies and correlates

poorly with the physical extent of endometriosis.

One estimate states that 30 to 40 percent of women

with endometriosis are subfecund (93). Evidence

of endometriosis is frequently found in women

with otherwise unexplained impaired fertility.

There is some indication that pregnancy might

ameliorate the effects of endometriosis; however,

this claim is controversial (23).

Suggestions on how endometriosis might impair

fertility are multiple and not mutually exclusive;

they include interference with ovulation, ovum

transport, or implantation, or induction of early

spontaneous abortion (66,8 I). Clinical and laboratory animal evidence supports each of these mechanisms. These processes may be mediated in turn

by physical scarring; by increased destruction of

male or female gametes; by growing numbers of

activated peritoneal or tubal macrophages (cells

that ingest other cells); by altered tubal, ovulatory, or corpus Iuteum function because of altered

prostaglandin secretion; or by autoimmune phenomena (66,67). Overall, the precise mechanisms

contributing to infertility in conjunction with endometriosis when organic and structural abnormalities are absent remain poorly understood.
.

66 . Infertility: Medical and Social Choices

The development of endometriosis is also not

completely understood. With rare exception, it

is only ovulating and menstruating women who

develop the condition. Some women, however,

may beat greater risk. Genetic predisposition for

initiation and propagation of endometriosis has

been documented (132,152).

In general, theories on the development of endometriosis suggest that viable endometrial cells

or tissue are transported directly and grow in a

different location, that endometrial tissue arises

in situ from local tissues, or that a combination

of these processes holds. The first explanation has

the most support. Many observers have noted

“bits” of endometriosis within pelvic or other lymphatic areas “downstream” from the uterus. Vascular spread, primarily to the lung, is also possible and could account for rare cases where

endometriosis is noted in diverse locations of the

body.

Pelvic endometriosis is common and has been

linked to retrograde menstruation (menstrual flow

backwards through the uterine tubes) (138). Past

or anecdotal evidence has suggested that intraabdominal spillage of menstrual fluid during menses occurs in roughly one-third of ovulating

women. Blood has been detected in peritoneal

fluid of 90 percent of 52 women with unobstructed fallopian tubes undergoing laparoscopy

in the perimenstrual period (67). A larger study

in which elective laparoscopic sterilization was

performed during menstruation showed that

retrograde menstruation occurs in up to 78 percent of ovulating women (57 of 75 women, ages

26 to 48) (101).

VARICOCELE

A controversial contributor to male infertility ther killing the sperm or speeding up the sperm

is the testicular varicocele, or varicose vein of the production process too much.

testis. A varicocele is an abnormal dilation and

twisting of the veins carrying blood from the testes

back to the heart. Varicoceles most often occur

in the left testis, most likely due to a difference

in anatomy between the veins leaving the two

testes (16).

There is considerable controversy over the contribution of varicoceles to infertility. The estimated

incidence of clinically evident varicoceles in the

general male population varies from 8 to 23 percent. A recent study reported that a majority of

a group of fertile males had either palpable or

subclinical varicoceles (97). Whatever the inciExactly how varicoceles lead to infertility is un- dence or contributory role, many experts believe

clear; some suggestions are based on the possibil- that varicocele correction leads to improved ferity that the pooled blood overheats the testes, ei- tility (97).

EXTERNAL FACTORS

Contraception

Contraception—intentional, temporary infertility—is sometimes linked to unintentional, longterm infertility. Contraceptives are extensively

used, especially by young individuals whose reproductive years generally lie ahead of them. For

this reason, the association of contraceptive use

and fertility has been explored in detail.

overall, types of contraception used vary with

age, marital status, reproductive history, and race

(9). In 1982, surgical sterilization was the most

widely used method of contraception (18 percent).

Next in popularity were birth control pills (16 percent), condoms (7 percent), diaphragms (5 percent), and intrauterine devices (IUDS) (4 percent)

(9). About 2 percent of women used some form

of periodic abstinence. Withdrawal, douche, foam,

and suppositories were used by similarly small

percentages of women.
Ch. 4—Factors Contributing to Infertility . 6 7

Sterilization

Surgical sterilization is the most common form

of birth control used in older age groups (9). In

1982, approximately 39 percent of currently married couples of reproductive age had been surgically sterilized for contraceptive reasons (116).

Some of these couples may desire a reversal of

the procedure, with a smaller percent actually obtaining the reversal (20).

For reversal of contraceptive sterilization in

women, several factors are important in determining whether fertility can be restored: the surgical method initially used, tubal site, length of

tube remaining, and surgical skill in restoration

(180). Factors that are most important in male

sterilization reversal are time elapsed since sterilization, surgical technique originally used (180),

age at reversal (135), and skill of the surgeon.

Oral Contraceptives

Two studies of women with and without children who discontinued oral contraceptives in order to become pregnant demonstrate similar findings from vastly different parts of the world

(124,170). Both studies found a small but significant initial impairment of fertility in women who

discontinued pill use compared with women who

discontinued other contraceptive methods. The

magnitude of this relative decrease diminished

rapidly with time and was probably due to transient pill-associated amenorrhea and anovulation.

other data from smaller studies confirm these

findings (57). These modest fertility differentials

primarily concern older women or couples with

previously impaired fertility (155).

Estimates of the incidence of postpill amenorrhea range from 0.2 to 2.7 percent. Disagreement

persists as to whether this syndrome is specific

to pill use, is coincidental, or is related to the use

of birth control pills to suppress anovulatory menstrual bleeding originally. Postpill amenorrhea in

which no concomitant factors (e.g., weight loss,

prior oligomenorrhea, hyperprolactinemia, or

polycystic ovarian disease) (70,73) are found diminishes with time and responds quickly to ovulation induction (84).

Progesterone-only “minipills)” which act primarily by inducing local genital tract alterations rather

than inhibiting ovulation, are even less likely to

impair fertility than combination pills (98). Data

from several small studies suggest there is little

or no ovulatory suppression after discontinuing

minipills (57).

There is some evidence that oral contraceptive

use may actually protect against tubal infertility

(117). However, a recent study indicated no change

in a woman’s risk of tubal infertility with past use

of oral contraceptives overall (41). The same study

indicated that the association between tubal infertility and oral contraceptive use may vary with

the amount of estrogen and type of progestin in

the oral contraceptive used, with users of estrogen-dominant pills slightly more at risk for tubal

infertility. Finally, oral contraceptive use may provide some protection against uterine and ovarian

cancer and may decrease the frequency of ectopic

pregnancy (86).

Injectable Contraceptives

Much concern exists about the delay in the return of fertility following the use of various injectable hormonal contraceptives (56). However, no

evidence suggests that injectable permanently impair fertility. On average, the delay in return to

fertility following discontinuation of use results

from the time required to clear the drug from

the body (47). One such hormonal contraceptive,

Depo Provera, results in a median delay in conception of 5.5 to 7 months after the term of complete contraceptive protection ends (56). This is

1 to 4 months longer than the median conception

time following intrauterine device discontinuation

(56,57,125). A number of other injectable contraceptive formulations are less well studied but

none of them appear to decrease fertility after

the medication is metabolized (56)57).

Intrauterine Devices

Based on recent, well-controlled studies, IUD

use is thought to increase a woman’s risk for tubal

infertility (42)44). Women who did not have any

prior births and who had ever used an IUD were

about twice as likely to suffer from tubal infertility subsequently as women who had never used
68 ● lnferti/ity: Medical and Social Choices

an IUD. However, the risk varied by type of IUD

used, with the greatest risk being evident for the

Dalkon shield and the lowest risk apparent for

copper-containing devices. In one study (42), IUD

users who reported having only one sexual partner were not found to be at increased risk.

Earlier studies that followed up large populations of women who stopped using an IUD and

measured the length of time until conception

found that cumulative conception rates for IUD

users and nonusers were similar (161,169,172).

In most of these studies, however, the women

were married and had had a prior pregnancy.

Also, many of the studies included only women

who had used an IUD successfully; women who

had experienced medical complications associated

with IUD use were excluded from the analyses.

Both these factors would have the effect of masking an increased risk for infertility (117).

Some IUDS have been associated with an increased risk for PID (92,184) and this is thought

to be the reason for their association with tubal

Photo credit: AU Corp., Palo Alto, CA

Progestasert” intrauterine progesterone

contraceptive system.

infertility. IUDS were largely withdrawn from the

market in the 1980s because of their potential association with tubal infection. only one, the Progestasert” system (ALZA Corp., Palo Alto, CA) is

available in the United States. A copper-containing

IUD developed by researchers at the Population

Council and approved by the U.S. Food and Drug

Administration in 1984 is slated for marketing by

GynoPharma Inc. of Somerville, NJ, in 1988 (154).

This IUD, the T-380A, has been used in other countries since 1982.

Other Contraceptives

Use of most other effective forms of contraception is not linked to any specific fertility impairment beyond that associated with aging. However,

a recent study found that a greater proportion

of infertile women with abnormalities of the cervical mucus had previously used a diaphragm than

had fertile women (43). Effects on subsequent fertility caused by use of newer agents, such as the

progesterone antagonist RU486, remain unstudied

(40). Barrier methods have been shown to offer

protection against STDS (41).

Abortion

Approximately 90 million births occur worldwide each year (40) and some 33 million to 60 million abortions (both legal and illegal) (64). In the

United States, approximately 3.7 million births and

1.6 million legal abortions are recorded annually

(77).

The impact of induced abortion on subsequent

fertility has been extensively reviewed (45,79,80).

With the exception of an early study from Greece

(162), where abortion is illegal and therefore is

primarily carried out in unsanitary conditions,

these studies indicate there is no increased risk

for infertility following legal induced abortion. Indeed, two studies report significantly shortened

interpregnancy intervals following abortion

(78,158). These findings are most probably explained, however, by enhanced fertility in women

with unplanned pregnancies rather than any enhanced fertility due to the abortion itself.
Ch. 4—Factors Contributing to Infertility ● 69

Environment and Drugs

Currently no reliable estimates can be made of

reproductive risk from environmental factors. Until recently, little attention was paid to environmental and drug-induced infertility and subfecundity. However, four health hazards–ionizing

radiation, lead, ethylene oxide, and dibromochloropropane—are regulated in part because of their

effects on the reproductive system. Possible environmental hazards include chemical agents; physical agents such as altitude, temperature, and radiation; and personal habits such as smoking,

alcohol consumption, use of drugs (both therapeutic and nontherapeutic), and eating patterns

(164).

Industrial exposures that may interfere with fertility are presented in table 4-1. Because possibly

toxic agents vary in importance and in how much

is known about them, only a few substances are

selectively discussed here. Many more agents are

known to be associated with poor reproductive

outcomes (e.g., teratogenicity, growth retardation)

than with infertility (12), but this may be because

the connection between toxic exposures and infertility has not been studied as carefully as other

reproductive outcomes (117).

Glycol ethers, a chemical species found in a wide

variety of products, including paints, stains, varnishes, and solvents, are the best studied of reproductive toxicants (72). This important and

widely used class of solvents is embryotoxic and

teratogenic (causing defects in formation) in male

and female animals, and it produces testicular atrophy and infertility in male animals; studies have

confirmed that glycol ethers can cause oligosper -

mia, azoospermia, and decreased sperm count per

ejaculate in human males as well (165,181).

In utero exposure to DES is associated with abnormal reproductive development in males and

females when they mature. Development of vagiTable 4-1 .—Industrial Exposures That May Affect Reproductive Health

Metals Chemicals Undefined industrial exposures

Antimony Agricultural chemicals: Agricultural work

Arsenic Carbaryl Laboratory work

Boron Dibromochlorpropane (DBCP) Oil, chemical, and atomic work

Cadmium DDT Pulp and paper work

Chromium compounds Kepone (Chlordecone) Textile work

Lead 2,4,5-T Dioxin (TCDD) and Agent Orange

Manganese 2,4-D

Mercury Anesthetic agents

Epichlorohydrin

Ethylene dibromide (EDB)

Ethylene oxide (EtO)

Formaldehyde

Organic solvents:

Carbon disulfide

Dinitrotoluene and toluene diamine

Styrene

Benzene

Carbon tetrachloride

Trichiorethylene

Polyhalogenated biphenyls:

Polybrominated biphenyls (PBB)

Polychlorinated biphenyls (PCB)

Chemicals in rubber manufacturing:

1,3-Butadiene

Chloroprene

Ethylene thiourea

Vinyl chloride

Hormone s

SOURCE: U.S. Congress, Office of Technology Assessment, Reproductive Health Hazards in the Workp/ace,OTA-BA-266 (Washington, DC: U.S. Government Printing

Office, 1985); D.D Baird and A.J. Wilcox, “Effects of Occupational Exposures on the Fertility of Couples, ” Occupational Medicine: State of the Art Reviews

1:361-374, 1986
.

70 . Infertility: Medical and Social Choices

nal cancer in daughters of DES users, although

rare, is significantly more common than among

nonexposed women, and exposed women are

known to have a higher proportion of reproductive tract anomalies resulting in infertility (117)$

Reports suggest that males exposed to DES commonly have abnormal spermatozoa and potentially

diminished fertility (156).

The effects of physical agents on fertility are

outlined in table 4-2.

Certain medications and substances used for

self-intoxication can also interfere with fertility.

Most prominent among these agents are cigarette

smoking (discussed in next section) and chronic

and acute alcohol consumption. Chronic alcohol

abuse is consistently associated with abnormalities of spermatogenesis and presumed subfecun -

dity in males. Although alcohol consumption impairs fertility in laboratory animals through a

Table 4-2.—Summary of Effects of

Physical Forces on Fertility

Condition Comment

Atmospheric pressure

Low (high altitude)

High (scuba diving)

Electric and magnetic

fields (many sources)

Gravity and acceleration

Hyperthermia

Hypothermia

Ionizing radiation

Noise

Optical radiation

(UV, visible, infrared,

laser)

Radio-microwave

radiation

Ultrasound

Vibration

Lower human birth rate

No data

Possible increase in

congenital malformations

No adverse effects noted

Reversible damage to spermatogenesis

No adverse effects noted

Dose-dependent effects at

high but nonlethal doses;

reduce to “as low a s

reasonably achievable”

Conflicting results

No adverse effect noted

Subjective complaints with

video displays

No adverse effects in

absence of measurable

heating

Not adequately studied

Little data

SOURCE: American Medical Association Council on Scientific Affairs, “Effects

of Physical Forces on the Reproductive Cycle, ” Journal of the American Medical Association 251 :247-250, 19S4; H.B. Holmes, Risks of lnferfillfy Dhgrrosis and Treatment, prepared for the Office of Technology

Assessment, U.S. Congress, Washington, DC, August 19S7; S. Nordstrom, E. Birke, and L. Gustavsson, “Reproductive Hazards Among

Workers at High Voltage Substations,” Bioelectromagnetlcs 4:91-101,

19s3.

variety of mechanisms, human infertility from

“moderate” nonhabitual alcohol consumption is

not apparent (123).

Marijuana use has also been implicated in reproductive impairment, although studies present

conflicting results. Decreased hormone levels in

men and women, ovulatory disorders in women,

and decreased sperm counts in men have been

associated with infertility in some studies. The development of tolerance to the drug may account

for some of the conflicting data (153).

Smoking

Experimental evidence in animals indicates that

cigarette smoking has adverse effects on reproduction. In humans, evidence suggests that smoking has a deleterious effect on menstrual cyclicity, oocyte production, and tubal function (136).

Variously designed epidemiological studies from

different countries confirm an association between smoking and infertility and menstrual abnormalities in women (11,74,123,160). Other

studies have noted the adverse effects of smoking on tubal function (157). A recent study noted

significant association between cigarette smoking

and primary infertility resulting from cervical factors and tubal disease (128). No association between smoking and ovulatory factors was found

in this study. Finally, smoking can shorten the reproductive lifespan by decreasing the age of menopause in a dose-related way (89).

In males, some studies have found that smoking or nicotine consumption is associated with decreased sperm motility and count, altered sperm

morphology, and altered hormonal levels (179,

182). Experimental findings suggest that these alterations are caused by changes in hypothalamic

pituitary axis function and possibly by impaired

motility of cilia in the genital tract (110). One study

found that smokers with testicular varicoceles had

a tenfold increase in incidence of oligospermia

over nonsmokers with varicoceles, and a fivefold

increase in incidence of oligospermia over smokers

without varicoceles (94). Other studies have found

no significant effect of cigarette smoke on sperm

density, motility, or morphology (171).
Ch. 4—Factors Contributing to Infertility ● 7 1

Congress has recognized the harmful effects of

smoking on the reproductive system. In 1985, new

warning statements were required (Public Law

98-474) on the packages and advertising of all cigarette brands sold in the United States (177). Two

of these statements call specific attention to the

reproductive hazards caused by smoking:

SURGEON GENERAL’S WARNING: Smoking

by Pregnant Women May Result in Fetal Injury, Premature Birth, and Low Birth Weight.

SURGEON GENERAL’S WARNING: Smoking

Causes Lung Cancer, Heart Disease, Emphysema, and May Complicate Pregnancy.

Spinal Cord Injury

The outlook for fertility in paraplegic men after spinal cord injury is poor; the outlook for paraplegic women is often better. Paralyzed men often

(but not always) suffer from impotence because

of neurological deficits in the spinal cord. Problems resulting from spinal cord injury include inability to achieve an adequate erection, inability

to ejaculate normally, infection resulting from

prolonged or intermittent catheterization, and decreased sperm quality. This topic is discussed in

detail in chapter 10.

GENETIC AND CHROMOSOMAL ABNORMALITIES

Genetic and chromosomal abnormalities can affect fertility in several ways. Most significantly,

abnormalities in human embryos can lead to early

fetal loss, and genetic diseases (e.g., cystic fibrosis) that are not serious enough to cause embryonic

death can impair reproductive function in adults.

Many of the factors contributing to infertility mentioned elsewhere in this chapter may have genetic

components,

Substantial pregnancy loss occurs between implantation and the time pregnancy is usually recognized (173)) some portion of which may be

caused by chromosomal abnormalities of early embryos. Abnormalities can affect the chromosomal

health of a human embryo in five ways:

●

●

●

●

The sperm can have a chromosomal abnormality. One study found that approximately

9 percent of human sperm are abnormal

(107).

The oocyte can be abnormal. A study of infertile women undergoing clomiphene stimulation found that nearly 50 percent of the

oocytes recovered were abnormal (188). Chromosomal abnormalities of human oocytes are

known to increase as a woman ages. (The

women described in this study maybe representative of all women of their age group

(mean age 30.8), but they are probably not

representative of women of all ages.)

The early embryo can fail to divide (35).

The early embryo can drop or fail to incorporate one or more chromosomes, resulting

in an incomplete set of chromosomes (141).

● There can be double sperm penetration, leading to triploidy (141).

Chromosomal abnormalities of human embryos

are thus a sum of these problems. Limited data

suggest that from 23 to 50 percent of human embryos may have chromosomal abnormalities

(4,129,167).

Chromosomal abnormalities that do not cause

early fetal loss can also impair the reproductive

functioning of an adult. The spectrum of chromosomal abnormalities associated with infertility is more complex than originally supposed (151).

Mutations or deletions of sex-determining chromosomal regions have been linked with infertility (95). Women with XO, XY, and other abnormalities are subfecund or sterile. A region of the

long arm of the X chromosome appears essential

for normal ovarian function; deletion of this region is associated with premature ovarian failure

(51,96). Furthermore, the genetic makeup of an

individual may predispose that person toward certain diseases, such as cancer or endometriosis.

A number of Mendelian traits, most of which

are extremely rare, are associated with infertility (151). In Caucasians, the most common of these

is cystic fibrosis, with an incidence of I in 1,600

to 1 in 2,000 individuals (142). With contemporary

multisystem supportive care, half of all cystic fibrosis patients survive to age 19. This trend is expected to continue, allowing many more patients
72 . Infertility: Medical and Social Choices

to survive into reproductive age groups. Puberty nary disease of any origin can restrict sexual peris commonly delayed in cystic fibrosis patients and formance, most couples in which one partner has

the degree of delay correlates primarily with cystic fibrosis can have sexual relationships (99).

severity of illness and height-weight ratios (142). In earlier decades, most affected individuals died

In males with cystic fibrosis, abnormalities of the before reaching reproductive potential.

vas deferens are common (100). Although pulmoCANCER

Cancer can affect fertility in three ways. As with

many diseases, the very presence of cancer in the

body is known to affect semen quality (122) and

is likely to affect the female reproductive process as well. The tumor itself can affect fertility

if there is direct gonadal involvement. Finally,

treatment of cancer—surgery and therapy (radiation and chemotherapy )-can also reduce fertility (see table 4-3).

Obviously, fertility will be impaired if there is

direct damage of female or male genital tract structures required for procreation. Cervical, uterine

or endometrial, ovarian, and testicular neoplasia

are not uncommon. (Neoplasia refers to the progressive multiplication of cells under conditions

that cause the cessation of multiplication of normal cells.) Cancer of the cervix, of the uterus, and

to a lesser extent ovarian cancer are associated

with certain risk factors involving lifestyle, possible carcinogenic exposures, and inherited predispositions (14). Infertility caused by hormone deficiency can be a risk factor for uterine cancer (134).

Cervical and, to a lesser extent, vaginal and vulTable 4-3.—Reproductive Consequences of

Cancer and Cancer Therapy

Cancer or therapy Consequences

Tumor Direct gonadal involvement

Surgery Removal of gonad

Neurogenic dysfunction

Failure of emission

Retrograde ejaculation

Loss of orgasm

Therapy Germ cell depletion

Clinical hypogonadism

Mutagenic changes in germ cell

Teratogenic effects on fetus

Seminal transmission of drug

SOURCE: R.J. Sherins, “Reproductlve Hazards of Radiotherapy and Chemotherapy in Adult Males, ” paper presented at the International Conference

on Reproduction and Human Cancer, Bethesda, MD, May 12, 1987.

var cancer have been associated with increased

numbers of sexual partners and the increased

occurrence of sexually transmitted disease. Development of endometrial cancer is associated

with a history of sustained high-fat diet and

prolonged periods of anovulation or relative infertility. For testicular cancer, undescended testes,

prior history of mumps orchitis, an inguinal hernia in childhood, and previous testicular cancer

in the other testis have been identified as risk factors, but in the majority of cases no predisposing

factors are evident (19).

Therapeutic removal of genital tract structures

will obviously lead to infertility if not sterility. Surgical procedures involving areas such as the prostate may also result in infertility; prostate surgery

often leads to impotence in males. Modification

of surgical procedures has drastically reduced the

problems associated with male cancer surgery

(147), but a recent study found a 20-percent fertility deficit in men treated with surgery for childhood cancer. Women treated with surgery in

childhood or adolescence had almost no fertility

deficit (24).

Transient or permanent gonadal damage and

dysfunction may also occur during cancer therapy with radiation and chemotherapy. The National Cancer Institute has developed a device to

prevent testicular damage in male patients undergoing radiation therapy (see figure 4-l). Research

suggests that the impacts of various treatments

vary by age, sex, type of cancer, type of drug,

total drug or radiation dose, duration of treatment,

use of single v. multiple agents or combined modalities, and length of time since cessation of treatment (91)144,148).

Germ cells have a normal mutation rate of

approximately 12.5 percent (50). Cancer therapy
Ch. 4—Factors Contributing to Infertility c 73

causes an increase in the mutation rate, which

decreases quickly with cessation of treatment but

remains higher than normal for about 10 years.

In men, nearly all cytotoxic agents used in cancer

therapy produce at least a temporary reduction

in sperm counts. However, even after 2 to 3 years

of total azoospermia, sperm production can gradually return to normal levels (114). One study

reports that for all forms of therapy combined,

the fertility of male cancer survivors is decreased

significantly while the fertility of female cancer

survivors is not. Radiation therapy is the exception; it affected men and women similarly (24).

Newer regimens for treatment of testicular cancer affect spermatogenesis less than earlier ones,

since they use less toxic drugs and do not last as

long (18).

Various effects of cytotoxic drugs and radiation

on the ovary have been described. These include

ovarian fibrosis, follicular destruction, reduced

estradiol levels (estradiol is a form of estrogen),

increased follicle-stimulating and luteinizing hormone levels, amenorrhea, and premature menopause (probably the most frequent effect) (10).

ovarian failure in these circumstances is agerelated, with older women being predisposed to

sterility at lower dose regimens (144).

Overall, Hodgkin’s disease and male genital cancer appear to cause the greatest decrease in fertility (24,1 12). Precise information on thresholds

of gonadal vulnerability and ability to recover depends on the drug, dosage, or amount of radiation used. The influence of pubertal status remains

controversial (91,144).

Figure 4.1 .—Testicular Shield

The National Cancer Institute has developed a shield designed to protect the testes from scatter radiation during

cancer therapy. The shield is recommended for patients

receiving radiation treatment to the lower abdomen, pelvis,

and thigh. It is constructed of lead and coated with plastic.

SOURCE: T.J. Kinsella, Deputy Chief, Radiation Oncology Branch, Clinlcal On.

cology Program, Division of Cancer Treatment, National Cancer Insti.

tute, personal communication, June 25, 1987

IATROGENIC FACTORS

Iatrogenic factors contributing to infertility are

those produced inadvertently by physicians or by

treatment by them. Procedures listed in table 4-4

can lead to infertility, especially when not performed properly. The most common of these is

tubal occlusion resulting from contraceptive

sterilization. Obviously the intent of tubal sterilization is tubal occlusion, but for the small percentage of women who want the sterilization

reversed, a poorly done procedure can mean later

undesired infertility.

Surgical procedures can impair a woman’s fertility primarily by producing fallopian tube or

ovarian adhesions (as well as by causing infection,

as discussed previously). Much information links

appendicitis, appendectomy, overuse of dilation

and curettage (the procedure used to remove remaining placental material after pregnancy or

spontaneous abortion), and other pelvic operations

with tubal-based infertility (35,1 18,163).
74 . /nferfj/ity: Medical and Social Choices

Table 4-4.–latrogenic Causes of Infertility

Procedure Finding

Tubal sterilization . . . . . . . .

Vasectomy . . . . . . . . . . . . . .

Misdiagnosed incomplete

abortion . . . . . . . . . . . . . . .

Ovarian wedge resection .,

Ovarian cystectomy . . . . . .

IUD insertion or retained

IUD . . . . . . . . . . . . . . . . . . .

Appendectomy. . . . . . . . . . .

Uterine suspension . . . . . . .

Cesarean section . . . . . . . .

Hysterosalpingogram . . . . .

In utero exposure

to DES. . . . . . . . . . . . . . . .

Infant hernia repair . . . . . . .

Dilation and curettage . . . .

Tubal occlusion

Blockage of vas deferens

Tubal occlusion or

adhesions

Tube-ovarian adhesions

Tube-ovarian adhesions

Tubal occlusion or

adhesions

Tube-ovarian adhesions

Partial tubal obstruction

Tube-ovarian adhesions

Tubal occlusion

Hypoplastic uterus

Poor cervical mucus

Increased susceptibility to

adhesions following

trauma such as D&C

Blockage of vas deferens

Scarring and Asherman’s

syndrome

SOURCE: Adapted from W.R. Keye, “Avoiding Iatrogenic Infertility,” Contemporary Obstetrics/Gynecology 19:185, 1982.

MISCELLANEOUS FACTORS

Sexual dysfunction may contribute to infertility in as many as 5 percent of infertile couples

(139). In the male, these conditions usually fall into

one of three categories; impotence, which can

have psychological or organic causes; premature

ejaculation, which, if severe, causes failure of

sperm transmission to the female reproductive

tract; and retrograde ejaculation, where semen

is propelled into the bladder rather than out

through the penis. Sexual dysfunction in the female can also affect reproduction, although negative consequences of these disorders on fertility

are not as common.

It is possible that immunological factors maybe

associated with otherwise unexplained infertility

(106,109). Three such potential factors are antibodies to sperm (from the male or the female),

cellular immunity to sperm, and antibodies to the

oocyte zona pellucida (105). A number of studies

in humans have demonstrated impairment of fertility with sperm antibodies. Since normally fertile men and women frequently possess such antibodies, it has been suggested that they play a

role in destroying aging sperm (41), Development

of such antibodies is not understood. It is presumed that women develop antibodies to sperm

or seminal plasma antigens during intercourse.

Details of the specific stimuli and time course in

developing such antibodies remain unstudied. The

roles of cellular immunity and antibodies to the

zona pellucida in infertility are not as well established. Despite enthusiasm for greater recogni-
Ch. 4—Factors Contributing to Infertility “ 75

tion of immunologic infertility, controversy surrounding the subject makes it an unsettled area

(55,108).

Macrophages can occur in elevated numbers

during menstruation, possibly due to the release

of chemotactic or irritating substances from retrograde menstruation or infection (68). Macrophages

are thought to destroy male and female gametes

and play roles in adhesion formation (112).

Inflammatory bowel disease—ulcerative colitis

(recurrent ulceration of the colon) and Crohn’s

disease (regional inflammation of the ileum)–

occur most frequently in reproductive-age individuals, with approximately equal frequency between the sexes (62,88)168), Ulcerative colitis does

not appear to impair fertility (168), on the other

UNEXPLAINED

In approximately 3 to 20 percent of infertile couples, no clinically apparent cause of infertility is

demonstrable using standard techniques (34,127,

159). Although couples cannot be placed in this

category until a thorough investigation has been

performed by an infertility specialist, couples with

unexplained infertility may actually suffer from

subclinical expression of acknowledged causes of

infertility that could be revealed by further testing or continued observations. Laparoscopy performed on 50 women whose couple evaluations

were normal revealed that 28 (56 percent) demonstrated either previously unsuspected peritubal

adhesions or endometriosis (187). Of those who

had abnormal findings, 16 received appropriate

hand, a preponderance of reports suggest that

Crohn’s disease is associated with diminished fertility; mechanisms are not well established.

Another miscellaneous cause of subfecundity

is cervical incompetency (52). If the cervix is not

strong enough to support the added weight as a

pregnancy progresses, it will dilate prematurely

and spontaneous abortion can occur.

premature menopause, defined as the cessation

of menses prior to age 40) has been estimated to

occur in 1 to 3 percent of American women. Furthermore, estimates state that approximately 10

percent of women with amenorrhea have premature menopause, meaning that in total at least

130,000 women in the United States suffer from

this problem (6).

INFERTILITY

treatment and 50 percent became pregnant within

a year of treatment, versus 10 percent in the

women who had no abnormalities (187). Other

candidates for causes of unexplained infertility

include numerous immunological abnormalities

(127), luteal phase cysts, poor progesterone surge,

abnormal sperm-mucus penetration, abnormal

sperm-egg penetration (75), and factors known

to prevent the sperm from penetrating the egg

(58) (as demonstrated by a sperm penetration test).

Reports disagree on the prognosis for couples

with unexplained infertility. Some claim these couples have a higher probability of conceiving than

the general infertile population (15); others claim

lower (90).

SUMMARY AND CONCLUSIONS

The factors contributing to infertility are often

multiple and the boundaries between them are

not clear. Accepting this limitation, certain general statements can be made.

In women, the main contributors to infertility

are hormonal disturbances, blocked or scarred

fallopian tubes, and endometriosis. Hormonal disturbances can arise from a number of different

sources, and they can result in abnormal or nonexistent ovulation. Blocked fallopian tubes result

most often from infection by pelvic inflammatory

disease (often caused by sexually transmitted diseases) and inhibit or prevent transport of the egg

and sperm. Endometriosis is characterized by the

presence of cells of the uterine lining outside of

the uterus and may interfere with nearly every

phase of the reproductive cycle.
76 . Infertility: Medical and Social Choices

In men, most cases of infertility result from abnormal or too few sperm, although sometimes the

transmission of sperm is a problem. A number

of factors, including testicular varicoceles, enviCHAPTER 4

1. Adamson, D., MD, Palo Alto, CA, personal communication, Sept. 13, 1987.

2. Alausa, O., and Osoba, A. O., “The Role of Sexually Transmitted Disease in Male Infertility in

Tropical Africa,” Nigerian A4edical Journal 6:32-

33, 1978.

3. American College of obstetricians and Gynecologists, Chknnydkd Infections (Washington, DC:

1987).

4. Angell, R. R., Aitken, R. J., van Look, F. A., et al.,

“Chromosome Abnormalities in Human Embryos

After In Vitro Fertilization) ’’Alature 303:336-338,

1983.

5. Aral, S.0., Mosher, W.D., and Cates, W., “Self6

7.

Reported Pelvic Inflammatory Disease in the U. S.:

A Common Occurrence,” American Journal of

Public Health 75:1216-1218, 1985.

Asch, R, H., Balmaceda, T. O., Borrero, C., et al.,

“Gamete Intra Fallopian Transfer (GIFT) and

Oocyte Donation—A Novel Treatment for Infertility in Premature Ovarian Failure)” Gynecological Endocrinoio~, pp. 99-106, 1987.

Atrash, H. K., Hughes, J. M., and Hogue, C., “Ectopic Pregnancy in the United States, 1970-1983)”

Morbidity and Mortality Weekly Report: CDC Surveillance Summaries 35:29 -37ss, 1986,

8. Awojobi, O. A., and Lawani, J,, “Aetiologic Factors

of Male Infertility in Ibadan, Nigeria)” African

Journal of Medical Science 12:91-94, 1983.

9. Bachrach, C. A., and Mosher, W. D., “Use of Contraception in the United States, 1982)” nchs: advancedata 102:1-8, 1984.

10. Bagshawe, K. D., “Reproductive Hazards of Radio

11

and Chemotherapy in Adult Females, ” paper presented at the International Conference on Reproduction and Human Cancer, Bethesda, MD, May

12, 1987.

Baird, D.D., and Wilcox, A. J., “Cigarette Smoking

Associated With Delayed Conception,” Journal of

the American Medical Association 253:2979-2983,

1985.

12. Baird, D. D,, and Wilcox, A. J., “Effects of Occupa -

tional Exposures on the Fertility of Couples,” Occupational Medicine: State of the Art Reviews

1:361-374, 1986.

ronmental hazards, drug abuse, and cancer, have

been implicated in male infertility, although much

less is known about factors leading to male infertility than about those leading to female infertility.

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Weinstein, L., Morris, M.B., Dotters, D., et al., “Ectopic Pregnancy—A New Surgical Epidemic)” Obstetrics and Gynecology 61:698-701, 1983.

Weisberg, E., “Smoking and Reproductive Health,”

Clinical Reproduction and Fertility 3:175-186,

1985.

Weisberg, E., and Fraser, 1, S., “Fertility Following Reversal of Male and Female Sterilization, ”

Contraception 26:361-371, 1982.

Welch, L, S., Schrader, S. M., Turner, T. W., et al.,

“Effects of Exposure to Ethylene Glycol Ethers on

Shipyard Painters, I: Male Reproduction)’) Journal of Industrial Medicine, in press.

182. Wentz, A.C., “Cigarette Smoking and Infertility,”

Fertility and Sterility 46:365-367, 1986.

183. Westrom, L., “Effect of Acute Pelvic Inflammatory Disease on Fertility,” American Journal of

obstetrics and Gynecology 121:707, 1975.

184. Westrom, L., Bengtsson, L. P., and M~rdh, P-A.,

“The Risk of Pelvic Inflammatory Disease in Women

Using Intrauterine Contraceptive Devices as Compared to Nonusers,” Lancet, July 31, 1976, pp.

221-224.

185. Westrom, L., “Incidence, Prevalence, and Trends

186,

187.

188.

189.

of Acute Pelvic Inflammatory Disease and Its Consequences in Industrialized Countries, ” American

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886, 1980.

Wheeler, G.D., Wall, S. R., Belcastro, A. N., et al.,

“Reduced Serum Testosterone and Prolactin

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American Medical Association 252:514-516, 1984.

Wood, G. P., “Laparoscopic Examination of the

Normal Infertile Woman, ” Obstetrics and Gynecology 62:642-643, 1983.

Wramsby, H., Fredga, K., and Liedholm, P., “Chromosome Analysis of Human Oocytes Recovered

From Preovulatory Follicles in Stimulated Cycles,”

New England Journal of Medicine 316:121-124,

1987.

Zoldag, L., “Stress und Fortpflanzungsstorungen

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Wochenschrift 90:152-156, 1983.

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Wochenscrift 90:184-187, 1983.
Chapter 5

Prevention of Infertility
CONTENTS

Page

Prevention Strategies . . . . . . . . . . . . .

Primary Prevention . . . . . . . . . . . . .

Secondary Prevention . . . . . . . . . . .

Sexually Transmitted Diseases . . . . .

Maternal Age . . . . . . . . . . . . . . . . . . .

Iatrogenic Infertility. . . . . . . . . . . . . .

Education . . . . . . . . . . . . . . . . . . . . . .

Research Needs.. . . . . . . . . . . . . . . . .

A Strategy for Prevention . . . . . . . . .

Summary and Conclusions . . . . . . . .

Chapter 5 References. . . . . . . . . . . . .

Figure No.

5-1. Testicular Self-Examination . . . .

Table No.

5-l. Prevention of Infertility . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

,..,. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

,... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Figure

85

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87

87

88

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Page

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Table

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Chapter 5

Prevention of Infertility

More is known about treating infertility (see ch.

7) than preventing it. Nevertheless, prevention

strategies are desirable because they can avert

the emotional and economic costs associated with

infertility treatment, as well as preempt some infertility that would be wholly untreatable.

The most preventable type of infertility is that

caused by sexually transmitted diseases (STDS).

An estimated 20 percent of infertility in the United

States results from STDS (4), while in some regions

of the developing world the figure is up to 80 percent (25). It is noteworthy that changes in sexual

behavior, attitudes about discussion of sex, and

health education wrought by the epidemic of acquired immunodeficiency syndrome (AIDS) could

have the salutary effect of preventing some infertility due to STDS. But the majority of cases

of infertility are not due to these diseases but instead to factors that are difficult, if not impossible, to prevent (see ch. 4).

PREVENTION STRATEGIES

Primary prevention strategies are those aimed

at avoiding a disease process entirely. This can

be accomplished by health promotion activities,

specific medical methods of protection, or diagnosis and treatment of infection or other ills

among transmitters. Secondary prevention aims

at reducing morbidity once an infection or a disease has already been acquired, and restricting

its spread through the population. Infertility—a

clinical condition often treated by medical or surgical means, and in some instances secondary to

an underlying disease—is notably difficult to prevent, although it is the target of prevention strategies at both levels.

Primary Prevention

Little solid evidence can be cited of any useful

means of primary prevention of male infertility.

This follows logically from the finding that a principal factor leading to infertility in men is idiopathic oligospermia—i.e., sperm count reduction

of unknown origin (see ch. 4). With the cause

usually not known, primary prevention of infertility in the male becomes little more than guesswork (23).

On the other hand, enhanced awareness of the

male reproductive organs is easily achieved among

men and may occasionally lead to early detection

of threats to fertility. Self-examination of the testes,

and of the male genitalia in general, is a technique

that deserves far more attention than it has traditionally received (see figure 5-l). Testicular selfexamination is useful for detecting physical abnormalities and diseases, such as cancer of the

testis, epididymal cysts, and STDS, Testicular cancer, which almost always occurs in only one testis, is highly curable when treated promptly. If

a testicular tumor has begun to metastasize, surgical removal of the testis is usually accompanied

by a dissection of the local lymph nodes to assess

the extent of tumor spread. A major complication

of such surgery is absence of ejaculation because

of damage or removal of nerve fibers that run

interspersed with the lymph channels (15,22).

Among women, the three main factors leading

to infertility are tubal obstruction, endometriosis, and disorders of ovulation (see ch. 4). The principal means of avoiding tubal obstruction is primary prevention of STDS (discussed later in this

chapter). Endometriosis can often be kept in check

by oral contraceptives or drug therapy, but specific prevention strategies for this disease are unknown. Disorders of ovulation are probably the

easiest to treat but they, too, are not clearly amenable to primary prevention (23).

With tubal ligation now the main means of contraception among women in the United States, and

with vasectomy popular among men, obviously

sterilization procedures must be undertaken carefully in order to prevent infertility that is later

85
86 ● Infertility: Medical and Social Choices

Figure 5-1 .—Testicular Self-Examination

SOURCE Adapted from U.S. Department of Health and Human Services,

Public Health Service, National Institutes of Health, Testicular

Se/f-Exarnirration, NIH Pub, No, 85-2836 (Bethesda, MD 1985),

unwanted. A host of other factors are weakly

linked with infertility (see ch. 4). Table 5- I reviews

a range of primary and secondary preventive

methods that might derive from these various contributing factors.

Freezing sperm for use at a later date can be

thought of as a means of primary prevention of

infertility that is subsequently caused by events

either expected (e.g., radiation therapy for canTable 5.1 .—Prevention of Infertility

Factors predisposing individuals toward infertility and

preventive steps available

Sexually transmitted diseases (STDS) and pelvic inflammatory disease (PID)

●

●

●

●

●

●

●

Careful selection of possible sexual partners. Health education to

discourage unprotected sexual encounters. Monogamy. Forthright

inquiry and check of sexual partners for risks of STDS,

Contraception by means of condoms. Use condoms routinely with

new sex partner. Media campaign to encourage condom use,

Periodic screening for STDS, If sexually active; STDS in both males

and females are commonly asymptomatic.

Changes in societal attitudes about STDS to lessen stigma of diagnostic examination for them.

Recognize findings of STDS and seek medical care. Ensure that

correct treatment is given for yourself and partner, with followup,

Media campaign to encourage men and women with genital discharge to be checked for STDS.

Rapid, adequate management of PID to reduce risk of sequelae,

Pelvic infections after birth, abortion, surgery, or invasive diagnostic testing:

● Ensure that optimally safe birth and surgical services are available,

● Use prophylactic antibiotics In high-risk situations to prevent infection.

Exercise, poor nutrition, and stress:

c Recognize that regular strenuous exercise (i. e., exceeding 60

minutes daily), rapid weight loss, low body fat, and stress may

cause decreased fertility. Women are at higher risk than men,

Smoking, environmental toxins, and drugs:

● Smoking, as well as other substance abuse, reduces reproductive

potential and should be avoided, Environmental exposures are inadequately studied, but appear more common in males, Semen analysis can be performed.

Endometriosis:

● If strong family history for endometriosis exists, consider oral contraception and possible specific endometriosis suppression. Oral

contraceptives may suppress endometriosis even in those not at

high risk.

● Early diagnosis and treatment in symptomatic women, Conservative surgical approaches.

Cryptorchidism and varicocole:

● Undescended, especially intra-abdominal, testes should be treated as promptly as possible. Benefits of surveillance and treatment

of varicocele are controversial.

Chemotherapy and radiation:

● Risks of gonadal damage must be considered and, if appropriate,

gamete collection or protection of the gonads should be performed,

Intercurrent illnesses:

● Many acute and chronic diseases cause anovulation or decreased

spermatogenesis. Prevention of these effects is by treatment of the

primary disease.

Inadequate knowledge of reproduction:

● Ensure that information on reproduction is available from parents,

schools, clergy, and other sources.

Inadequate medical treatment:

● Couples with difficulty conceiving should educate themselves about

fertility and seek specialized care before infertility is prolonged.

Lack of perspective about reproduction:

● Discuss family life with parents, peers, and professionals. Formulate life plan that allows adequate time for reproductive aoals.

SOURCE Office of Technology Assessment, 1988

cer) or unanticipated. In fact, as reproductive technology crosses new frontiers (see ch. 15), primary

prevention of infertility may acquire an even fuller
Ch. 5—Prevention of Infertility . 87

meaning. Cryopreservation of embryos-or ultimately oocytes-may give young women or young

couples some assurance of avoiding infertility by

being able to conceive months or years in the future despite intervening events that compromise

their fertility.

Secondary Prevention

Once a symptom that foreshadows infertility

occurs, a few steps can be taken to attempt to

preserve fertility. As with primary prevention,

secondary prevention focuses largely on STDS.

Examples of such approaches include prompt recognition of signs of urethritis, vaginal infection,

pelvic inflammatory disease (PID), epididymitis,

or orchitis, followed by prompt evaluation by a

caregiver, diagnosis, and effective treatment. Locating cases of STDS and sexual contacts of infected individuals is also an important means of

secondary prevention since it allows for early diagnosis and treatment of individuals infected but

not yet irretrievably affected by chlamydia or

gonorrhea. In the case of endometriosis, it should

be treated at the earliest possible opportunity–

either medically or surgically—to provide the

greatest likelihood of averting subsequent infertility.

SEXUALLY TRANSMITTED DISEASES

Infertility due to infectious disease—found in

an estimated 20 percent of infertile couples in the

United States–is distinguished by its preventability. Sexually transmitted diseases, principally

gonorrhea and chlamydia, are important factors

leading to infertility (see ch. 4). The specific risk

is tubal occlusion secondary to the infection (25).

The risk increases with the number of infections,

the duration and severity of each infection, and

any delay in instituting treatment; each of these

components is a target for preventive efforts. (For

a detailed review of the prevention of STDS, see

19)20.)

Public health initiatives aimed at preventing

STDS and infertility include efforts in the following

●

●

●

●

●

areas (3,6):

health education of patients and public health

professionals;

disease definition, including long-term sequelae of STDS;

optimal treatment and improved clinical

service;

partner tracing and patient counseling; and

research, including on the social, psychologic,

and biologic aspects of STDS.

In addition, research increasingly focuses on behavioral aspects of STD acquisition and prevention. Principles of primary prevention for sexually active individuals include: reducing the

number of sexual partners; avoiding persons

known to have many sexual partners; using mechanical barriers (i.e., condom, diaphragm, or contraceptive sponge) or chemical barriers (i.e., sper1s

Photo credit: Library of Congress

Slogan promoting prevention of venereal disease
88 . Infertility: Medical and Social Choices

micide); periodic screening for STDS; and prompt

medical care if symptoms develop (2,5,7,16,19).

According to the Centers for Disease Control

(CDC), STD control for the balance of the 1980s

and into the next decade will focus on the primary prevention of all sexually transmitted infections, especially the persistent viral infections for

which no therapies or vaccines exist (14). This emphasis is a new one, as historically the focus has

been on secondary prevention efforts. If current

primary prevention efforts are successful, an overall reduction in STDS will result. This would not

affect those already afflicted with one of these

diseases and associated infertility, but it may mean

that infertility caused by STDS may ultimately

decline.

A crucial step was taken in 1987 toward a vaccine against chlamydia, as researchers identified

previously unknown details about the bacteria’s

outer coat. These findings should permit the synthesis of large quantities of the outer coat protein, a necessary step in developing a vaccine

against chlamydia (18).

MATERNAL AGE

The calculus of infertility includes the age of

the prospective mother. Female fertility decreases

somewhat before age 35 and significantly more

after age 35; in contrast, a decline in male fertility has not been linked to increasing age (see ch.

3). To avoid the decline in fertility related to age,

some suggest that women should devote the third

decade of life to childbearing and the fourth to

career development rather than the other way

around, as they are increasingly doing (8). Couples with access to child care or parental leave

from employment may not be faced with so stark

a choice.

Although no such social prescription fits all couples in all circumstances seeking to conceive, the

biology of female fertility dictates that a couple

maximize the number of months or years devoted

to attempts at conception. Stated simply: The more

months, the better; and the earlier the attempts,

the better. A woman’s reproductive lifespan is circumscribed, and whenever the decision to procreate is taken, the chances of success generally depend on the number of months during which

conception is attempted. For some individuals, the

equation is complicated by balancing the biological advantages of attempting conception early in

their reproductive careers against the social disadvantages of entering the employment career

market later in life.

IATROGENIC INFERTILITY

Surgical procedures can inadvertently impair

a woman’s fertility primarily by producing fallopian tube or ovarian adhesions (see ch. 4). Education and sensitization of practicing physicians

about the risks to future fertility posed by abdominal surgery are the primary means of preventing

iatrogenic infertility. Such education can stress,

for example, the aggressive initial treatment of

young patients with pelvic inflammatory disease,

the conservative treatment that avoids pelvic surgery in young women, and the conservative surgical treatment of ovarian cysts (21).

The most common form of iatrogenic infertility occurs when a woman undergoes a tubal liga -

tlon and then seeks reversal. If the ligation was

not carefully done in a fashion that conserved the

fallopian tubes (e.g., if it was done with large and

destructive cauterizing burns on each tube), the

physician attempting to reverse the procedure is

unlikely to be successful (23). One method of tubal

ligation makes use of clips on the severed ends

of the tubes—obviating the need for cautery—

and offers the best probability for reversal.

Among men, iatrogenic infertility can also occur when sterilization—vasectomy—is done in too

aggressive a fashion. Removal of too much of the

vas deferens, for example, makes microsurgical

reattachment exceedingly difficult. Another, hid-
Ch. 5—Prevention of Infertility ● 89

den cause of male infertility stems from surgical

repair of a hernia during infancy. Surgical closure

of the hernia can inadvertently include the vas

deferens, permanently blocking sperm transport

from one or both testes.

Additional prevention strategies aimed at physicians include avoiding overprescription or incorrect prescription of fertility drugs that cause

hyperstimulation and bursting of the ovaries, and

avoiding repeated microsurgery that leads to excessive scarring of the fallopian tubes (9). Also,

hysterectomy ought not be automatically accompanied by ovariectomy, as is sometimes the practice, when the option of egg retrieval for surrogate

gestation is available. Finally, new medicines and

surgical interventions must be evaluated for side

effects on both female and male fertility.

EDUCATION

Effective advocacy of preventing infertility involves developing sophisticated and focused health

education techniques appropriate for a pluralistic society. The twin targets of such educational

efforts are medical care providers and individuals

contemplating sexual activity. The imperatives of

AIDS education and behavior modification will

likely push frontiers of health-related education

far further and faster than previously anticipated.

Medical care providers need specific undergraduate medical and postgraduate training to improve recognition and therapy of diseases that

threaten fertility. Greater general recognition, for

example, that Chlamydia trachomatis causes severe reproductive tract damage is an immediate

goal that, if accomplished, would lead to earlier

detection and treatment of these infections in men

and women.

One of the national health objectives of the U.S.

Public Health Service (PHS) states that by 1990,

at least 95 percent of U.S. health care providers

seeing patients with suspected cases of STDS

should be capable of diagnosing and treating all

currently recognized STDS (24). A 1986 review

of progress toward this goal found that training

for health care professionals in the treatment of

STDS had improved in recent years, but still falls

short of the necessary quality and scope (14).

Since 1979, PHS has emphasized four approaches to improving the training of clinicians

treating STD patients. First, 10 STD Prevention/Training Centers were established to improve

the diagnostic, therapeutic, and patient management skills of midcareer clinicians directly involved with STD patients. Second, PHS has funded

the development and pilot testing of STD curricula in six medical schools. A 1986 survey found

that STD training had increased in these schools

to an average of 10 hours per student. The same

survey showed that 44 percent of medical schools

had no clinical curriculum on STDS. Third, PHS

has funded an increasing number of STD Research

Training Centers to encourage young scientists

to pursue an academic career in STD research.

Fourth, PHS has funded the development of an

instructional package for clinicians who do not

frequently see STD patients in their practices. Despite these efforts, the achievement of the 1990

PHS objective is in doubt (14).

A second PHS objective states that by 1990 every

junior and senior high school student in the United

States should be receiving accurate, timely education about sexually transmitted diseases (24).

No systematic measures of this objective are available. In 1983, a Gallup poll found that only onethird of high school respondents considered themselves “very informed” and almost half considered

themselves “somewhat informed” about STDS. The

Centers for Disease Control has since placed increased emphasis on behavioral knowledge and

attitudes related to biological facts. CDC actively

promotes adoption of STD education for junior

high and high school students, principally through

State STD units. Increased attention to schoolbased education as a way to prevent AIDS should

improve knowledge, attitudes, and behaviors affecting other STDS as well (14).

It is important to note that the influence that

information and education can have on sexual behavior is limited (l). Individuals at greatest risk,
90 Infertility: Medical and Social Choices

for example, for PID maybe resistant to conventionally given cautions. In one study, women with

PID were more likely to take health risks, believe

in luck, be more socially alienated, endure symptoms longer, and have coitus with a greater number of partners (12).

RESEARCH NEEDS

Developing and implementing effective and safe

preventive strategies depends on thorough understanding of the problem. At present, vast gaps

in knowledge impede further progress in preventing infertility. Immediate needs for research and

further understanding include (11):

●

●

●

●

●

Fuller realization and broadened inquiries

into all aspects of reproduction, including

sexuality. Reluctance to scrutinize such basic

human characteristics and behaviors as these

retards and distorts the ability to deal with

the realities of reproduction as individuals and

as a society.

More complete epidemiological definition

and analysis of decreased fertility. Present

knowledge derives from relatively small, geographically and ethnically limited surveys and

case reviews. Development of methodologic

techniques and uniform terminology will be

crucial for measuring all aspects of infertility and communicating the results.

Fuller understanding of social and economic aspects of infertility for young

adults, women, men, families, and society

at large. Integration of careers and reproduction remains poorly studied in U.S. populations.

Inquiries into both normal and abnormal

male and female reproductive physiology.

Rudimentary questions remain unanswered:

How does aging reduce fertility? How do body

mass and composition, as well as exercise and

stress, influence reproductive ability? Solutions to these and other questions could offer means to prevent these causes of infertility.

Specific disease-oriented basic and clinical research, which can lead to dramatic

advances in prevention. Development of

●

●

vaccines against various infectious diseases

has been crucial to their control. Yet vaccine

development for STDS, including Neisseria

gonorrhoeae and C. trachomatis, is difficult

because of incomplete understanding of the

molecular biology and virulence of each

organism and the means to induce a protective response in human hosts. With time and

sustained supported effort, these difficulties

can likely be overcome. In the meantime, new

approaches to STD avoidance, detection, and

treatment can be evaluated. Male responses

to genital tract infections, for example, remain

virtually unstudied with modern methods.

Similarly, little is known about the pathogenesis or prevention of endometriosis. This common disorder remains a disease of hypotheses.

Better understanding of how to communicate most effectively health-related information to general populations and

selected groups. Such information has generally trickled down as news from various

media or is dispensed piecemeal by care

providers, parents, and friends. Initial attempts at using dynamic mass communication techniques for STD education are promising (10). The exigencies of dealing with AIDS

will greatly expand and refine effective use

of mass communication for motivating healthrelated behavior.

Development of reversible methods of

sterilization and long-term contraception.

Contraception and conception—two sides of

the same coin—are inextricably linked. Longterm contraceptives that are reliable and safe

and do not place future fertility at risk are

an important goal of research into preventing infertility.
Ch. 5—Prevent/on of Infertility . 9 1

A STRATEGY FOR PREVENTION

Any strategy for preventing infertility must possess certain characteristics to be effective. Such

a plan must:

●

●

●

●

be simple and understandable so it could be

disseminated to the general population;

be cost-effective-i .e., it should save more resources than it expends;

respect individual privacy and not disrupt individuals’ lives or their relationships; and

offer an opportunity to measure its effect,

so that results can be assessed.

In 1987, OTA convened a meeting of experts

in Seattle, WA, to design a plan for preventing

infertility that meets these four criteria (17,23).

The strategy is based on people of reproductive

age testing themselves to ascertain whether they

have developed or acquired any risk factors for

infertility. This type of preconceptional health

questionnaire was recently used with a favorable response by women attending family planning

clinics in North Carolina (13). Its primary purpose

is not to identify people who are already infertile; rather, it seeks to identify men and women

who may have a condition or lifestyle that could

render them infertile in the future.

People in at least seven settings might be predisposed to completing a self-administered questionnaire concerning their reproductive potential.

Each setting is one where relatively young people interact with the health care system. They are:

SUMMARY AND

With the personal, familial, and societal losses

caused by infertility inestimable and the economic

costs so great, it is clear that infertility is better

prevented than treated. Yet the former is more

difficult. Only an estimated 20 percent of infertility—that caused by sexually transmitted diseases

—is clearly amenable to prevention strategies. In

those instances, curative medicine equals prevention of sexually transmitted diseases. Otherwise,

●

●

●

●

●

●

●

individuals entering military service,

women seeing their obstetrical/gynecologists

for annual examinations,

individuals attending family planning clinics,

college students consulting the student health

service,

patients being seen in oncology clinics at risk

of loss of their fertility,

individuals having annual physical examinations, and

individuals attending STD clinics.

A self-administered questionnaire can obtain information about an individual’s nutritional status

and social, family, medical, drug, and reproductive histories, while providing useful information

keyed to the respondent’s answers. Examples of

specific questions and the related information that

could be provided to the respondent appear in

appendix B.

Implementation of this strategy for prevention

has the potential to educate people exposed to the

questionnaire, identify persons currently at risk

who have not yet become infertile, identify persons who are already infertile, identify nonreproductive disease processes, and reduce iatro -

genic infertility by enhancing patient awareness.

On the other hand, such a questionnaire carries

potential problems, including risking inappropriate responses by health care providers and causing respondents alarm, anxiety, guilt, regret, or

apathy as their reproductive potential is described.

CONCLUSIONS

the majority of cases of infertility are difficult,

if not impossible, to prevent.

Prevention of male infertility is an enigma and

will likely remain so as long as most male infertility is caused by reduced sperm count of unknown

origin and little research addresses this question.

Among women, tubal obstruction, endometriosis, and disorders of ovulation are the principal
92 ● Infertility: Medical and Social Choices

factors leading to infertility. Some tubal obstruction is preventable by avoiding sexually transmitted diseases, but specific prevention strategies

for endometriosis and anovulation are largely

unknown.

The biology of female fertility makes maternal

age, especially beyond age 35, a factor in infertility. Although no social prescription fits all couples seeking to conceive, couples enhance their

chances of success by maximizing the number of

months or years devoted to attempts at conception, and doing so before maternal age becomes

a significant factor.

Education of individuals contemplating sexual

activity and of medical care providers about reproductive health and sexually transmitted diseases plays an important role in reducing threats

to fertility. Gaps in their knowledge and even

broader gaps in scientific understanding of normal and abnormal male and female reproductive

physiology impede further progress in preventing infertility.

CHAPTER 5 REFERENCES

1!

2,

3.

4,

5.

6.

7.

8.

9.

10.

11.

12.

Aral, S.0., Cates, W., Jr., and Jenkins, W .C., “Genital Herpes: Does Knowledge Lead to Action?” American Journal of Public Health 75:69-71, 1985.

Cates, W., Jr., “Sexually Transmitted Organisms and

Infertility: The Proof of the Pudding,” Sexually

Transmitted Diseases 11:113-116, 1984.

Cates, W., Jr., ‘(Priorities for Sexually Transmitted

Diseases in the Late 1980s and Beyond,” Sexuah’y

Transmitted Diseases 13:114-117, 1986.

Cates, W., Jr., Director, Division of Sexually Transmitted Diseases, Centers for Disease Control, Atlanta, GA, personal communication, Apr. 28, 1987.

Cates, W., Jr., “Tubal Infertility: An Ounce of (More

Specific) Prevention, ’’Journal of the American Medical Association 257:2480, 1987.

Cates, W., Jr., Parra, W.C., and Brown, S.T., “Control of Sexually Transmitted Disease: View From

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Cramer, D. W., Goldman, M.B., Schiff, I., et al., “The

Relationship of Tubal Infertility to Barrier Method

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DeCherney, A. H., and Berkowitz, G. S., “Female

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Laborite, R. N., “Evaluation of an Advertising Program on Sexually Transmitted Diseases,” Sexuah’y

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14

15

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20.

Acute Salpingitis,” paper presented at 22nd Annual

Meeting, Association of Planned Parenthood Professionals, San Antonio, TX, Nov. 12, 1984.

Moos, M. K., and Cefalo, R. C,, “Preconceptional

Health Promotion: A Focus for Obstetric Health

Care)” American Journal of Perinatology 4;63-67,

1987.

Morbidity and Mortality Weekly Report, “Progress

Toward Achieving the National 1990 Objectives for

Sexually Transmitted Diseases,” Morbidity and

Mortality Weekly Report 36:173-176, 1987.

Nijman, J. M., Schraffordt Koops, H., Oldhoff, J., et

al., “Sexual Function After Bilateral Retroperitoneal

Lymph Node Dissection for Nonseminomatous Testicular Cancer, ’’Archives of Andrology 18:255-267,

1987.

Rosenberg, M.J., Rojanapithayakorn, W., Feldblum,

P.J., et al., “Effect of the Contraceptive Sponge on

Chlamydial Infection, Gonorrhea, and Candidiasis,”

Journal of the American Medical Association

257:2308-2312, 1987.

Soules, M. R., “A Report on a Proposed Method to

Prevent Infertility: Self-Identification of Risk for Infertility)” prepared for the Office of Technology

Assessment, U.S. Congress, Washington, DC, September 1987.

Stephens, R. S., Sanchez -Pescador, R., Wagar, E. A.,

et al., “Diversity of Chlamydia trachomatis Major

Outer Membrane Protein Genes,” JournaZ of Bacteriology 169:3879-3885, 1987.

Stone, K. M., Grimes, D. A., and Magder, L. S., “Personal Protection Against Sexually Transmitted Diseases, ” American Journal of Obstetrics and Gynecology 155:180-188, 1986.

Stone, K. M., Grimes, D. A., and Magder, L. S., “Primary Prevention of Sexually Transmitted Diseases:

A Primer for Clinicians)” Journal of the American
Ch. 5—Prevention of Infertility ● 9 3

Medical Association 255:1763-1766, 1986.

21, Stone, S. C., Director, Division of Reproductive Endocrinolo~v and Infertility, Department of Obstetrics and Gynecology, University of California

Irvine Medical Center, Orange, CA, personal communication, June 1987.

22. Swanson, J. M., and Forrest, K. A., Men’s Reproductive Health (New York, NY: Springer Publishing Co.,

1984).

23, U.S. Congress, Office of Technology Assessment,

Prevention of In fertilitwv Symposium, transcript of

a workshop, Seattle, WA, June 19, 1987.

24. U.S. Department of Health and Human Services,

Public Health Service, Promoting Heahh/’Preventing Disease: Objectives for the Nation (Washington, DC: U.S. Government Printing Office, 1980).

25. World Health Organization, “Infections, Pregnancies, and Infertility: Perspectives on Prevention, ”

Fertilit.v and Sterility 47:964-968, 1987.
— .. —

Chapter 6

Diagnosis of Infertility
— . —

CONTENTS

History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Page

. . . . . . . . . . . . . . . . 98

. . . . . . . . . . . . . . . . 100

. . . . . . . . . . . . . . . . 100

. . . . . . . . . . . . . . . . 100

. . . . . . . . . . . . . . . . 100

. . . . . . . . . . . . . . . . 102

. . . . . . . . . . . . . . . . 107

. . . . . . . . . . . . . . . . 110

. . . . . . . . . . 112

. . . . . . . . . . . . . . . . 112

Physical Examination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Male . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Female . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Technologies for Evaluation of Reproductive Status . . . . . . . . . . . .

Diagnostics: Female Infertility . . . . . . . . . . . . . .

Diagnostics: Male Infertility . . . . . . . . . . . . . . . .

Risks of Diagnostic Procedures . . . . . . . . . . . . .

Summary and Conclusions . . . . . . . . . . . . . . . . . .

Chapter p references.+.. . . . . . . . . . . . . . . . . . . .

 . . . . . . . . .

. . . . . . . . . . . . . . .

. . . . . . . . . . .

 . . . . . . . . .

. . . . . . . . . . . . . . .

Boxes

Support Network for

Box

6-A. Resolve, A Nationwide

Page

. . . . . . . . . . . . . . . . 98

. . . . . . . . . . . . . . . . 101

Infertile Couples

6-B. Undergoing Diagnostic Procedures for Infertility . . . . . . . . . . .

Figures

Charts. ......, . . . . . . . . . . . . . . . . . .

Page

. . . . . . . . . . . . . . . . 102

. . . . . . . . . . . . . . . . 104

. . . . . . . . . . . . . . . . 106

. . . . . . . . . . . . . . . . 109

Body Temperature

Evaluation Tests . . . . . . . . . . . . . . . . . . . . . . . . .

6-1.

6-2.

6-3.

6-4.

Cervical Mucus

Laparoscope in

Vasogram . . . .

Use for Laser Surgery . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Table

Table No.

6-1. Counseling Opportunities . . . . . . . . . . . . . . . . ... ... . . ... 99

7’
Chapter 6

Diagnosis of Infertility

Determining that there is a need for infertility

treatment is often a difficult and somewhat arbitrary decision. Some professionals suggest that

after 6 months of carefully timed unprotected intercourse or, more commonly, after a year of random attempts at conception, a couple seek some

form of infertility evaluation (8)33).

Although a growing number of physicians are

specially trained in infertility treatment, most such

treatment is still carried out by the female partner’s gynecologist (l). Since most women visit a

gynecologist more frequently than their male partners seek medical treatment, the gynecologist usually serves as the first professional an infertile couple encounters in their attempt to conceive. As

much as 80 percent of basic infertility treatment

occurs with the personal gynecologist, In addition, the male partner may be referred to a urologist for basic infertility evaluation.

In cases of persistent infertility, however, patients increasingly are seeking out treatments by

primary care physicians who specialize in infertility services, such as gynecologists and urologists

who are often part of a group practice or infertility clinic. These are usually identified by one of

the

●

●

●

following means:

referral by personal gynecologist or urologist to an associate in a group practice who

is an infertility specialist;

referral by gynecologist, urologist, or personal physician to the nearest medical school,

large medical center, infertility clinic, or group

practice;

referral to a particular physician or clinic by

organizations like Resolve (see box 6-A), a

national infertile-couple support group that

●

maintains a referral service in its local chapters; or

other methods, such as referral by other infertile couples, national or local medical societies or groups, advertisements, or media

coverage of babies born from new reproductive technologies.

Since infertility problems can involve both men

and women, infertility is best diagnosed and

treated with a team approach, spanning several

specialties in medicine such as gynecology, urology, andrology, endocrinology, and reproductive

tract microsurgery. Many medical schools, large

medical centers, and group practices have infertility treatment programs that employ, or have a

close consulting relationship with, a variety of

specialists. Because of the psychological aspects

of undergoing treatment and accepting the results

of these diagnostic procedures, some infertility

programs make psychologists or counselors available to the patients (see table 6-l). Comprehensive infertility practices usually include:

● a gynecologist who specializes in reproductive endocrinology (hormonal control of reproduction) or reproductive tract surgery,

● a urologist or andrologist who specializes in

male infertility conditions or reproductive

tract surgery, and

● a genetic and psychological counselor.

Although the presence of these specialists does

not guarantee the success of an infertility treatment program, and much successful infertility

diagnosis and treatment is administered by personal gynecologists, the more complex the factors

contributing to a couple’s infertility are, the

greater the chance they will benefit from a broad

range of experts.

97
—

98 ● Infertility: Medical and Social Choices

`PATIENT HISTORY

A complete health history taken from both part- Information obtained in this critical initial stage

ners of an infertile couple is probably the single

most important diagnostic tool the caregiver can

employ. A complete patient history includes information about each partner’s education, employment, personality, stimulant and substance use,

medications and treatments, nutrition and diet,

exercise, immunizations, medical history, surgical history, family history, psychological history,

and sexual history.

of the examination often provides important insights into the causes of a fertility problem. Clues

derived from the details of an individual’s personal,

familial, and occupational background and the

couple’s sexual interaction can preclude the need

for laboratory tests or complement their results.

Questions, for example, about coital frequency

and technique (e.g., use of vaginal lubricants) may

indicate that these variables are the source of a
Ch. 6—Diagnosis

Table 6.1 .—Counseling Opportunities

of Infertility 99

Mechanism of

psychological support Advantages Disadvantages

Infertility clinic:

Infertility clinic staff No extra cost

Clinic staff familiar with in-house

procedures, may be able to be

sensitive to likely emotional

reactions

Infertility clinic consultant

Professional counselor on staff at

infertility clinic for orientation and

counseling when requested

Professional counselor on staff at

infertility clinic for orientation and

regular contact with all patients

to monitor emotional coping with

diagnosis and treatment

Community settings:

Counselors in community

Community support group

Telephone hot line

Counselors in private practice

Religious leader

Counseling professional available

when cases of extreme emotional

distress are noted

Preventive approach that includes

orientation to clinic procedures,

possible emotional impact of

diagnosis, and referral to

appropriate support groups or

community services

Preventive approach includes

orientation to clinic, possible

emotional impact of diagnosis

and treatment, short-term

counseling, referrals to

community services, and offer of

a clinic support group

Counselor can work cooperatively

with other members of the

medical team

Sliding fee scales

Located in patient’s community

Low or no cost

Reduces feelings of isolation

Offers privacy and anonymity

Wait less lengthy than at

community counseling agencies

Patient chooses specific counselor

No cost

Can address spiritual issues

May be distant from patient’s home,

thereby presenting logistical

difficulties

Patient may not wish psychological

information in records

Expressions of emotional needs

usually limited to specific clinic

procedures

Professional alerted only after the

patient is clearly overwhelmed,

thereby being more reactive than

preventive in counseling response

Emphasis is on initial visit with

patient, but the responsibility for

future or ongoing contact rests

with the patient

May be perceived as intrusive, or

unnecessary; patients may resent

efforts to make counseling

mandatory

Waiting lists at many agencies

Few counselors have in-depth

knowledge about infertility

individual needs may be submerged

to group priorities

Counselors not likely to be

knowledgeable about infertility

Costs may be high, although

insurance may cover part or all

Affiliation with religious institution

may be necessary

May be doctrinal objections to

treatment chosen

Few clergy knowledgeable about

infertility

SOURCE Office of Technology Assessment, 1988

couple’s inability to conceive. It is important, for whether either partner has successfully reproinstance, for the caregiver to ascertain whether duced with the present or any previous mate.

the couple has experienced any form of sexual

dysfunction (e.g., male impotence or erectile dys - The sexual history, like any other part of the

function), whether the couple engages in inter- health history, is taken to produce information

course coincident with the woman’s ovulation, and that may bear on the couple’s fertility problem
100 . /fertility: Medical and Social Choices

(12). When a sexually transmitted disease is sus- that partners may have exhibited. The informapected, patients must often describe sexual prefer- tion contained in a comprehensive sexual history

ence, numbers and regularity of sexual partners, may quickly pinpoint the source of fertility

and any symptoms of sexually transmitted disease problems.

PHYSICAL EXAMINATION

Physical examination seeks evidence of physiological or anatomical bases for infertility. Standard health parameters (e.g., height, weight) and

cardiovascular and necrologic function (e.g., blood

pressure, strength of pulse in lower extremities,

reflexes, pelvic sensation) are measured and particular attention is paid to the genitals and any

anatomical abnormalities.

Male

The physical exam verifies the presence and

structural adequacy of the various components

of the genital tract (e.g., vas deferens, prostate,

epididymis). Particular structural abnormalities

associated with impaired fertility are sought (e.g.,

hernia, varicocele (varicose veins associated with

the testes), or hypospadias (opening of the penis

on the underside)). In addition, the size and volume of the testes are measured, as testicular atrophy is an indication of reduced sperm supply.

Female

Although the gonads are not external in the female as they are in the male, secondary sex characteristics (i.e., breast development, hair and fat

distribution) are observable and provide an important indication of hormonal secretion and response. Excessive facial or body hair, for instance,

may be the result of an excess of male hormones

in a female.

A thorough pelvic examination, including palpation of structures throughout the genital tract,

may identify infection, tumors, adhesions, or other

abnormalities contributing to reproductive difficulties. Considerable information about internal

pelvic structures can be obtained by means of palpation. An experienced physician can feel the size

and shape of the uterus (which may have no bearing on fertility potential) and can check for the

presence of any leiomyoma tumors (also known

as fibroids), Leiomyomas, common in women over

age 35, can sometimes interfere with implantation of the embryo or in rare instances cause miscarriage.

The pelvis is palpated for adhesions, rubbery

bands of scar tissue that remain from previous

infections or surgery. Adhesions that encapsulate

the uterus, tubes, or ovaries can compromise the

function of these organs. Small endometrial

growths that are enough to cause infertility cannot, however, always be detected on manual exam.

And there is no way to tell from a pelvic exam

if the oviducts are open or closed. Overall, if the

pelvic exam is normal, the probability of physical

obstruction to pregnancy is reduced.

TECHNOLOGIES FOR EVALUATION OF REPRODUCTIVE STATUS

The evaluation of the infertile couple is a com - once an isolated abnormality is discovered, furplex, time-consuming process. Since some infer- ther diagnostic evaluation may not be pursued.

tility can be attributed to idiopathic (unknown) This can be misleading if the infertility has more

causes, the diagnostic process can result in much than one contributing factor.

frustration for both the physician and the patients.

Most procedures are designed to evaluate the In addition, a single determination of specific

function of a single physiological or anatomical variables in the diagnostic evaluation can be mis -

aspect of reproductive function. In some cases, leading, since many of the physiological parame -
—-.

Ch. 6—Diagnosis of Infertility . 101

ters assessed by these procedures, such as semen ● basal body temperature charts and other

analysis and the postcoital test, can vary consider- menstrual cycle mapping,

ably over time. ● cervical mucus evaluation,

● hormone assays ,

A standard infertility workup (see box 6-B) may ● post-coital test,

differ considerably from physician to physician,

● immunologic evaluation,

but the following procedures are most commonly ● endometrial biopsy,

followed: ● hysterosalpingogram,

● laparoscopy,

● couple’s history and physical exam, ● hysteroscopy, and

● semen analysis , ● hamster-egg penetration assay,

Box 6-B.—Undergoing Diagnostic Procedures for Infertility

Undergoing diagnostic procedures can often be unpleasant. Women are likely to feel probed and manipulated, and repeated trips to the physician’s office may begin to affect personal and professional life. Men

may need to supply several semen samples. Masturbation in a physician’s office may feel ridiculous or

embarrassing. Men may find the process of having sperm counted and scored disconcerting. In addition,

men may suffer from a great deal of helplessness and guilt for being the one having a much less invasive

diagnostic process.

A post-coital test involves visiting the physician within a few hours of timed intercourse so that the

woman’s cervical mucus can be examined to determine how sperm interact with the vaginal and cervical

environment of the woman. The demands of the pending doctor’s appointment may make sex unpleasant

for either partner. The man must achieve erection and ejaculation on schedule, and the surrounding tension may result in temporary impotence. The same reaction may occur when a couple has charted the

woman’s basal body temperature to determine ovulation. Once again partners may feel pressured to have

intercourse on a schedule unrelated to sexual desires. This problem presents itself as a midcycle pattern

of sexual dysfunction. Both partners may dislike having to reveal the intimate details of their sex lives,

particularly at a time when that has been disrupted and distorted by the needs of the diagnostic workup.

If a couple are told that their infertility is caused by a problem for which there is no treatment, their

psychological response almost universally resembles that of mourning a death. A couple learning that there

is a treatment are likely to feel relief and hope. However, these feelings may not be based on an accurate

perception by the couple of what lies ahead. In addition, the couple may also feel apprehensive of the

cost, the inconvenience, the discomfort, and the risks associated with many treatments. If their infertility

is due to repeated miscarriages, rather than an inability to conceive, they may dread the prospect of risking

the loss of more pregnancies.

The couple who receive a diagnosis of unexplained infertility enter a psychological limbo. For some,

the diagnosis of idiopathic infertility begins a series of new visits to infertility specialists; for others, it begins

mourning, denial, anger, and grief, without final acceptance. The couple may feel out of control, and with

medical professionals also baffled as to the cause of their infertility, the couple enter what is often a lengthy

period of intermittent mourning, and efforts to “try again. ”

Secondary infertility (the inability to conceive after having at least one biological child) engenders surprise, followed by frustration, as a couple once in control of reproduction find that fertility now eludes

them. When such couples express sadness about their inability to conceive another child, their pain is often

discounted by others as they are reminded that they are, in fact, already parents. Couples with secondary

infertility may find themselves overly preoccupied with the child they have, as all their hopes rest on his

or her accomplishments and good health.

SOIIR(’E. office of I echnolog} Assessment 1988
—

102 ● Infertility: Medical and Social Choices

Diagnostic* Female Infertility

There are essentially three types of diagnostic

technologies to evaluate infertility in women: overthe-counter products, laboratory-based methods,

and physician- and hospital-based methods and

procedures. In addition to the well-known advances made in laboratory- and physician-based

infertility treatment technologies, the market for

patient-use products and devices distributed

mostly over the counter has grown rapidly. These

products increasingly allow informed infertile patients to use on their own some basic infertility

diagnostics and treatment methods.

Not all the procedures described here would

routinely be used in each diagnostic workup. If

patient history, for example, indicated multiple

episodes of a sexually transmitted disease, then

investigation for tubal obstruction would be indicated, such as a hysterosalpingogram (an x ray

of the uterus and fallopian tubes).

Basal Body Temperature

The recording of basal body temperature (BBT)

is one of the oldest and most popular methods

for predicting ovulation. This procedure relies on

the characteristic changes in basal (resting) body

temperature during the menstrual cycle (see figure 6-l). These alterations in temperature are a

result of changes in the hormonal output of the

ovaries. During the preovulatory phase (usually

14 days in regular, average cycles) of a menstrual

cycle, when estrogen levels are rising, the BBT

remains at resting level, approximately 98.00 F.

When ovulation occurs, estrogen levels decline

and progesterone levels rise, which causes an upward shift in BBT to 98.40 F or higher, @here may

also be a slight decrease in BBT immediately before the upward shift to 98.4° F. This small decline may coincide with ovulation.)

Since preovulatory temperature values may

vary among women, it is the change in temperature rather than the absolute reading that

is important. The BBT usually remains elevated

throughout the remainder of the cycle, returning to 98.0° F at the onset of the next cycle (38).

By taking body temperatures daily, the menstrual

cycle can often be charted and subsequent ovulations pinpointed to within a 4- to 6-day period.

If BBT does not increase during a cycle, this indiFigure 6-l.—Basal Body Temperature Charts

99°

Anovulation

(no ovulation) 98”

97 ‘

9 9

Luteal phase ~8~

defect

97<’

Typical basal body temperature patterns that indicate normal ovulation (top), ovulatory failure (middle), or ovulation

with Iuteal phase defect (bottom).

SOURCE: J.H. Belllna and J. Wilson, You Can Have A Baby (New York, NY: Crown Publishers, Inc., 19S5),
Ch. 6—Diagnosis of Infertility ● 103

cates that ovulation has probably not taken place

and progesterone levels remain low.

As part of the infertility workup, the BBT has

the greatest value with women who have average length (28 days), regular cycles. Although some

clinicians find the BBT to be an inaccurate indicator that the preovulatory surge of luteinizing hormone (LH) and ovulation have occurred (7), others

find it useful for pinpointing 4 to 6 days during

which ovulation is likely to occur during subsequent cycles (38).

Another way to predict ovulation is the calendar method, which relies on the regularity of a

patient’s cycle to indicate the period of fertility.

After a woman has recorded the duration and days

between her menstrual period over several consecutive cycles, she can get a general idea as to

the timespan surrounding subsequent ovulations.

This method relies heavily on the regularity of

an individual’s cycles, since no other indicators

besides past history are employed to pinpoint ovulation. When used to predict the fertile period of

a cycle for means of birth control, this method

has a fairly high failure rate (8).

Hormone Monitoring

Several ovulation prediction kits are currently

sold over the counter, These kits measure, in a

semiquantitative manner, the midcycle increase

of LH, the hormone that causes ovulation under

normal circumstances. The onset of the midcycle -

LH increase precedes ovulation by an average

of 32 to 36 hours (20). This change in LH secretion is quickly reflected in the urine, making measurement of urinary LH useful in clinical applications to approximate the time of ovulation (24).

Most of these kits employ the enzyme-linked im -

munosorbent assay procedure. Antibodies that

bind LH are immobilized on a small dipstick pad

or forma dry coating at the bottom of a test tube.

These antibodies (either pad or coated test tube)

are incubated with the urine specimen and an additional reagent. When LH is present in the urine,

a specific antibody -LH-reagent complex will form,

When treated with another reagent, this complex

develops a characteristic color indicating the presence of LH in the urine. If LH levels are high, the

color that develops will be intense compared with

Photo credit: Office of Technology Assessment

Home diagnostic tests

a blank or reference indicator. In this manner, a

qualitative prediction about the onset of the LH

surge and the timing of ovulation can be made.

Measurement of another hormone, progesterone, as confirmation of ovulation, is quite routine

in the infertility workup (17). This can be performed on a patient’s blood or urine sample by

laboratory personnel using complicated procedures such as radioimmunoassays to obtain a

quantitative value, or in the physician’s office or

at home with rapid hormone test kits that provide semiquantitative values. Although observation of increased progesterone suggests that ovulation has occurred, failure to detect a rise of this

hormone does not always indicate ovulatory failure but may suggest other hormonal problems

such as luteal phase defect (50). In addition, failure of progesterone to increase to within the

appropriate range may also signal a failure of ovulation. Furthermore, even in some instances where

progesterone is in the ovulatory range, ovulation

is not certain (49).

other hormonal tests may also be performed

to evaluate the function of the other endocrine

systems. These hormones include prolactin, thyroid hormones, adrenal hormones, and gonadotropin (LH and follicle-stimulating hormone

(FSH)).
104 ● Infertility: Medical and Social Choices

Cervical Mucus Evaluation

Another method for ovulation prediction relies

on gross and microscopic examination of cervical mucus. As a result of changing levels of hormones during the cycle, cervical mucus undergoes consistent and dramatic changes in several

of its physical properties. Under the influence of

the high estrogen levels that precede ovulation,

cervical mucus becomes thin, watery, salty, and

stretchy (elastic). These first three characteristics

can be evaluated by what is known as the fern

test (see figure 6-2). When placed on a glass slide

and allowed to dry, cervical mucus dries into a

distinctive fern-like pattern. As ovulation approaches more ferning can be seen.

Likewise, the spinnbarkeit test evaluates the

stretchiness of cervical mucus, which also increases under the influence of high estrogen

levels. A small drop of mucus, obtained close to

ovulation, is placed between two glass slides (or

two fingers). When the slides are separated, the

threading of the mucus that results should stretch

8 to 12 centimeters without breaking (see figure

6-2). If ovulation has already occurred, or there

is ovulatory failure, then the mucus is scanty and

thick.

In addition to these characteristics, cervical mucus should also be examined for the presence of

cells or debris and proper pH (acidity or alkalinity), factors that can also affect fertility. The administration of fertility drugs such as clomiphene, for

ovulation induction, can affect the characteristics

of cervical mucus.

More sophisticated examination of the hormoneinduced changes in the characteristics of these

body fluids can contribute to ovulation prediction.

One recently developed method relies on the documented changes in ion concentration (sodium

and potassium) in saliva and vaginal mucus

throughout the menstrual cycle (35). A handheld

electronic device (CUE Fertility Monitor; Zetek,

Inc., Aurora, CO) employs sensors that measure

the electrical resistance of saliva and vaginal mucus. Because minute changes in the ion concentrations of these body fluids result in alterations

of their electrical resistance, changes in electrical resistance of the saliva and vaginal mucus can

Figure 6=2. —Cervicai Mucus Evacuation Tests

far

B. Closer to ovulation

—spreads a little more

before breaking

C. Just prior to

ovulation—very thin,

watery, and

stretchable

Two simple cervical mucus evaluation tests. Top panel shows

the characteristic fern-like pattern (fern test) that results when

pre-ovulatory cervical mucus dries on a glass slide. Bottom

panel shows the characteristic stretchiness of cervical mucus during the pre-ovulatory period.

SOURCES: L. Speroff, R.H. Glass, and N.G. Kasej C/in)ca/ Gyneco/og/c Endocrinology and /nfertl/My (Baltimore, MD: Williams & Wilkins Co., 1978);

S.J. Silber, How Not To Get Pregnant (New York, NY: Charles Scribners Sons, 1987).

be used to predict ovulation, possibly up to 7 days

in advance (2).

Endometrial Biopsy

Endometrial biopsy involves microscopic examination of a sample of endometrial cells obtained
Ch. 6—Diagnosis of Infertility ● 105

between days 22 and 25 (sometimes as late as day

26 or 27) of the menstrual cycle (assuming a regular, 28-day cycle). In the physician’s office, a long

hollow tube is passed through the cervix into the

uterus and a small amount of tissue is scraped

off the endometrium. By microscopic examination of these cells, the physician can date the endometrial lining in reference to the first day of

the cycle. This dating of endometrial cells is accomplished by observation of the distinctive hormone-induced characteristics. The appearance of

these cells changes daily under the influence of

ovarian hormones (39).

During this stage of a normal menstrual cycle

the endometrium is primed for implantation under the influence of progesterone, with the cells

appearing secretory and spongy. If ovulation has

not occurred or there is a luteal phase defect

caused by inadequate progesterone secretion after ovulation, then the endometrial cells will not

have the typical progesterone-induced appearance. If the characteristics of the endometrial cells

can be dated to the appropriate day of the cycle

(usually within 1 day), then normal ovulation and

progesterone secretion have most likely occurred,

suggesting normal ovulatory function.

Ultrasonography

Use of ultrasound in infertility evaluation and

treatment has become increasingly important.

This technique uses high-frequency sound waves

that are transmitted to one area of the body and

echoed or reflected back by internal organs and

structures. From the resulting patterns of transmission and reflection, detailed outlines of the

female reproductive system can be obtained.

Ultrasound is particularly useful in evaluating development of ovarian follicles during spontaneous or drug-induced cycles (16,34). If development

of one or more follicles is monitored, and the subsequent collapse of these follicles after release of

the ova can be visualized, then there is a good

indication that ovulation has taken place. Ultrasound determination of ovulation is best used in

combination with BBT, cervical mucus, or progesterone measurement. In some instances, ultrasound can be useful for visualization of growths

or abnormalities in ovaries or the uterus. In addition, this technology is used in oocyte retrieval

for in vitro fertilization (IVF).

Hysterosalpingogram

The hysterosalpingogram (HSG) is a radiographic

(x-ray) examination of the female reproductive

tract. Radio-opaque dyes are slowly injected into

the uterus while x rays are taken. As the uterus

fills and the dye moves out into the interior of

the fallopian tubes, the radiographs can pinpoint

areas of occlusion, adhesions, growths, or abnormalities such as fibroids. In most cases of normal,

healthy fallopian tubes, the dye fills the length

of the tube and slowly spills out the far end into

the body cavity (44). Some practitioners report

therapeutic benefits from the use of oil-soluble

rather than water-soluble dyes for HSG (15).

Hysteroscopy

Hysteroscopy provides direct visualization of the

interior of the uterus. The physician can evaluate directly any abnormalities that may be present

in the uterus such as fibroids, polyps, a septum,

or adhesions such as a web of scar tissue covering the uterine opening to the fallopian tubes. During hysteroscopy the uterus is expanded with injection of carbon dioxide gas or a liquid. This aids

in visualization of tissue through the eyepiece of

the hysteroscope, a long, narrow, illuminated instrument that is inserted through the cervix into

the uterus. In addition to direct viewing, surgical

procedures can also be performed by an experienced surgeon through the operating channel of

the hysteroscope. These procedures include biopsies, removal of polyps, septums, scar tissue,

fibroids, and removal of lost intrauterine devices.

Some uterine and tubal abnormalities that do not

appear with HSG or laparoscopy can only be detected by hysteroscopy (32).

Laparoscopy

The laparoscope has become an essential tool

in both the diagnosis and treatment of infertility

(see figure 6-3). Laparoscopy, like hysteroscopy,

allows direct visualization of the female reproductive tract through an illuminated long, narrow instrument. The laparoscope is inserted into the
-— .— — -- .— - — . .- .- . - .- — . - - ——

106 . Infertility: Medical and Social Choices

Figure 6-3.—Laparoscope in Use for Laser Surgery

SOURCE: Martin M, Quigley, Clevaland Clinic, Cleveland, OH.

body cavity (usually through the umbilicus or naval) to view the outside (internal) surface of the

uterus, ovaries, and fallopian tubes. To enhance

the visualization of the peritoneal surface of these

structures and assess patency of the fallopian

tubes, a blue dye is often injected into the uterus

and fallopian tubes, as in the HSG. To detect pelvic endometriosis, pelvic adhesions, and tuboovarian adhesions, the laparoscope is usually necessary. As in the case of the hysteroscope, surgical procedures can be performed through the

operating channel of the laparoscope, including

Iysis of pelvic adhesions and ablation of endometriosis (13,23). In addition to its diagnostic value, the

laparoscope is frequently used to retrieve oocytes

for IVF or gamete intrafallopian transfer.

Post-Coital Test

A number of in vivo and in vitro procedures

evaluate the interaction of sperm, semen, and cervical mucus. The oldest and most widely practiced

of these techniques is the in vivo post-coital test

(also known as the Sims-Huhner test), which can

be performed in a physician’s office. Although this

simple exam is widely used in infertility evaluation, there is lack of standardization and consensus

on how to interpret the results (14).

This method evaluates sperm transport mechanisms within the female reproductive tract by

directly examining under a microscope the interaction of sperm and cervical mucus. It should be

performed as close to ovulation as possible, since

cervical mucus is most conducive to sperm transport at that time. As ovulation approaches, the

couple is asked to abstain from intercourse for

several days prior to the planned test. One or two

days before ovulation, the couple are instructed

to have intercourse 2 to 4 hours before arriving

at the physician’s office (some physicians believe

6, 10, or even 24 hours after intercourse is a better indication of sperm transport). By means of

a catheter, one to three samples of mucus are

taken from different areas along the length of the

cervical canal.

These specimens are evaluated for ferning pattern, spinnbarkeit, pH, cellularity, and debris, and

for the number, motility, and quality of sperm

present in the mucus sample. When examined under a microscope, a count of fewer than five motile sperm per field for mucus taken from the highest level of the cervical canal (internal OS) indicates

an abnormal post-coital test (37). Since inaccurate

timing of this procedure is the most important

cause of an abnormal result, negative post<oital

tests should always be repeated. The presence of

dead or nonmotile sperm can indicate a hostile

cervical mucus or poor semen quality, which

should be followed up by additional testing.

Several in vitro methods are also used to evaluate the quality of sperm-cervical mucus interaction. In a method devised by Kremer (25), cervical mucus collected around the time of ovulation

is drawn up into a capillary tube (thin glass tubing) and the tube placed in a reservoir of the

spouse’s semen, Under normal conditions, the

sperm can be observed penetrating the column

of cervical mucus in one direction only when observed under low power through a microscope.

If the sperm fail to move a set distance over a specified period of time, then subfertility maybe suspected.
Ch. 6–Diagnosis of Infertility ● 1 0 7

A variation on the Kremer method uses a commercially available preparation of small flat glass

tubes filled with bovine cervical mucus (PeneTrak*”, Serono Diagnostics). Because of biochemical similarities between human and bovine cervical mucus, human sperm migrate up the PeneTrak[h! tube in a manner similar to their behavior when exposed to human cervical mucus.

After a given period of time, the tube is examined

under a microscope and the distance the sperm

have penetrated the mucus column is measured.

As with the Kremer method, failure of the sperm

to move a minimal distance over a given period

of time suggests an infertility problem (3,36). HOWever, this test is not a substitute for human mucus in clinical testing (40).

Sperm Antibody Evaluation

Antibodies to sperm maybe present in a signif -

icant portion of infertile couples. The exact extent or importance of these antibodies is unclear.

However, some experts believe that antibodies can

impair fertility by:

● impeding sperm penetration of cervical

mucus,

● decreasing transport and viability of sperm

in the oviducts,

● inhibiting sperm penetration of the ovum

through blocking of possible receptor sites, or

● interfering with the normal postfertilization

development of the fertilized ovum.

Antibodies are most readily diagnosed by examination of the postcoital test for sperm cervical

mucus interaction, gelatin agglutination tests,

sperm immobilization test, or the immunobead

test (4). With improved sensitivity and better detection of minute quantities of sperm antibodies,

diagnosis of immunological factors in infertility

will most likely increase.

Diagnostics: Male Infertility

Since less is known about male than female reproductive physiology, methods to diagnose and

treat male infertility remain underdeveloped. The

lack of comprehensive, standardized population

data on various aspects of male infertility often

results in a poor predictive value of test results.

However, the present state of the art in male infertility diagnostic tests can supply at least some

information about the ability of an individual to

impregnate a female partner. Until additional research and data analysis are conducted, the diagnosis and treatment of male infertility will remain

difficult.

Semen Analysis

The best diagnostic methods available to evaluate male infertility rely on the examination of a

number of basic characteristics of sperm and seminal fluid (18). These parameters include the volume, pH, and viscosity of seminal fluid and the

quantity, morphology, and motility of sperm in

the sample. Basic sperm counts have been performed for many years as an index of male fertility, but recently developed tests can evaluate more

subtle characteristics of the semen.

Since the evaluation of the semen has traditionally been subjective in nature, there is little standardization of diagnostic procedures. As a consequence, with the exception of total absence of

sperm in the ejaculate, there remains less than

total agreement over what constitutes a minimally

adequate ejaculate necessary to achieve pregnancy

(31,48). Introduction of computerized analysis may

contribute to standardizing evaluation parameters and normal sperm characteristics between

laboratories, and may provide objective criteria

for measurements.

Since semen characteristics are subject to considerable fluctuation, semen analysis should be

performed several times to ensure accurate evaluation of the ejaculate (46,48). The characteristics

that can help in the diagnostic process include the

following:

Appearance: The freshly collected semen sample should be whitish-gray in color. The presence

of a bad odor or yellowish or red color may indicate infection or drug treatment (18).

Volume: Average semen volume ranges from

1.5 to 6 milliliters per ejaculate and varies depending on the period of abstinence between ejaculations. Even though smaller or larger semen

volumes are often associated with infertility, the

abnormal volume may not be the cause of the infertility but rather a symptom of some other condition. On the other hand, low semen volume may

impair transport of sperm and high volume may

dilute sperm density and decrease motility (18,31).
108 ● Infertility: Medical and Social Choices

Ejaculate pH: Large deviations outside the normal pH range (7.2 to 7.8) can indicate inflammatory disorders of the prostate or seminal vesicles

and may compromise fertility (18).

Liquefaction and viscosity: Usually the normal semen sample undergoes a transition from

gel to liquid within 30 minutes of ejaculation. Liquefaction that does not occur or takes longer than

60 minutes may indicate prostatic disease and possibly trapped sperm contributing to infertility (18).

Sperm concentration: The concentration or

count of sperm in the ejaculate is usually determined with the aid of a counting chamber such

as a hemocytometer, a Makler chamber (30), or

an automated device such as a Coulter counter

or computer-assisted videomicrographic system.

The actual number or concentration of sperm necessary to achieve pregnancy is still a matter of

uncertainty. Statistical data and some clinical experience suggest that a sperm density of 20 million per milliliter is the lower limit of normal (29)

but not the lower limit of fertility.

In general, 50 million to 60 million total sperm

are usually necessary for fertilization (22). This

assumes that the other characteristics of the

sperm, such as motility and morphology, are good.

However, men with sperm counts below this value

may have reasonable chances for impregnation

provided other characteristics of the ejaculate are

normal (53). Since sperm density is a function of

total semen volume as well as the number of

sperm present, careful attention should be given

to the natural fluctuation of semen volume and

its infiuence on sperm counts.

Sperm motility Although motility of sperm has

traditionally been a more subjective evaluation

than sperm number, many investigators believe

it to be the most important indicator of semen

quality (18,31). In the simple slide technique, a

small sample of the specimen is placed on a slide,

coverslipped, and viewed under the microscope.

The percent of motile sperm in several fields is

determined and the motility itself rated on a + I

to +4 scale. Using this subjective analysis, 60 percent or more motility is considered normal. With

the use of more objective techniques such as videomicrography, this figure may be lower (31).

Computer-assisted semen analysis involves a

video camera and recorder integrated with a

microscope. Images of sperm in the sample are

digitized and sequential images are stored. Most

commercial systems provide data on the percentage of motile sperm, the swimming speed or velocity, the percentage of progressively motile

sperm and their swimming speed, the percentage of rolling sperm, and the percentage of

straight-swimming sperm. Some systems offer information on other sperm parameters, such as

lateral head displacement and linearity of motion.

Overall, computer-assisted analyses provide

more objective information about sperm motility

and swimming patterns. However, the accuracy

of these systems maybe low with samples having

low sperm concentrations or large amounts of debris. At this time only a small number of the objective measures made possible by these systems

has been correlated with infertility parameters

(4). However, as these objective measures become

more widely used and more information is collected, a better understanding of sperm characteristics may be achieved.

Sperm morphology: Morphological evaluation

of human sperm is complicated by the great natural variation in shape and size. This makes it dif -

ficult to predict which forms are associated with

infertility and which are within the normal range.

Normal sperm have symmetrically oval heads with

stout midpieces slightly longer than the heads.

Also present are long, gradually tapering tails, 7

to 15 times longer than the heads. Ratios of these

various parameters appear to be important predictors of fertility (4). Human semen always contains some abnormal or immature sperm forms

but increased percentages of these types can decrease fertility. Analysis of sperm morphology

has not found widespread use in clinical practice.

However, with computer-assisted video micrographic systems, morphological characteristics

may become better diagnostic tools,

Fructose test: Fructose is a sugar produced by

the seminal vesicles and present in the normal

ejaculate. When sperm are present in the semen

sample, fructose is almost always present as well.

However, in cases where no or few sperm can

be observed in the sample, the absence of fructose suggests blocked or missing seminal vesicles

or ejaculatory ducts. The presence of fructose in

a sample with few or no sperm indicates functioning seminal vesicles with possible blockage further down in the epididymis or the vas deferens,

or testes that are not producing sperm. Fructose

is detected in the semen by the addition of chemi -

cal reagents and heat. Color change to orange-red

indicates the presence of fructose (31).

Agglutination and immunological disorders:

Immunological disorders, such as sperm antibodies or bacterial infections, can cause sperm to bind

together, or agglutinate. This condition is observed

microscopically and may be tail to tail, head to

head, mixed, or agglutination with cellular debris
Ch. 6—Diagnosis of Infertility ● 109

(18). The presence of antibodies can also be detected by sperm/cervical mucus interaction characteristics during the post-coital test. The importance of this parameter remains unclear.

Infection screening: As part of the evaluation

of semen, routine cultures are also taken to detect the presence of micro-organisms such as

ureaplasma, chlamydia, and others. The precise

role of these infections in infertility is unclear.

Hamster-Oocyte Penetration Test

The sperm/cervical mucus interaction tests evaluate sperm ability to navigate within the female

reproductive tract. The hamster-oocyte penetration test examines sperm ability to penetrate the

ovum once it has migrated into position. Usually,

after capacitation for 18 to 20 hours, sperm are

incubated with hamster eggs that have had their

outer layer (zona pellucida) removed; normal human sperm usually penetrate these ova (52). If performed properly, there appears to be a correlation between the sperms’ ability to penetrate the

hamster and human oocytes. The reliability and

significance of this testis controversial (10); however, further refinements and standardizations

could make this an important diagnostic procedure for male infertility.

Testicular Biopsy

In men with normal size testes, no sperm in

the ejaculate (azoospermia), and normal FSH, a testicular biopsy may be performed to determine

whether the underlying defect is failure or blockage of the sperm-conducting system or the absence of sperm production in the testes. The

biopsy is performed under local or general anesthesia. A small sample of testicular tissue is removed through an incision in the scrotum. The

tissue is placed in a fixing agent and examined

by a pathologist microscopically (9). The physician examines the specimen to identify the sperm

cells at different stages of development that indicate normal, ongoing production of sperm. The

absence or small number of particular cell types

can help identify the infertility factor.

Radiography and other Methods

Lasography and vesiculography are diagnostic

methods that employ radio~opaque dyes and xray examination of the sperm transport ducts. A

small incision is made in the scrotum and the vas

deferens is exposed. Contrast dye is injected into

the vas deferens or the ejaculatory duct and x rays

are taken from various angles (see figure 6-4). This

approach is particularly useful in pinpointing tubal

obstruction in the male, since it gives an outline

of the sperm transport system (48). Examination

of the blood supply to the testis can also provide

valuable diagnostic information in identifying

varicocele. Venography or injection of contrast

dye into the spermatic vein can verify a varicocele

that may have escaped physical examination. Scrotal thermography, ultrasound, technetium scan,

and Doppler test can also be useful for identification of varicocele and other vascular disorders

of the male reproductive system (11,19).
110 ● Infertility: Medical and Social Choices

Endocrine Evaluation

Since sperm production is critically dependent

on hormones produced by the testes, such as

testosterone, and on hormones produced at other

sites in the body, such as the gonadotropins (LH

and FSH), the hormonal workup is an essential

part of male infertility diagnostic procedures. Basic

endocrinological tests include blood assay for LH,

FSH, and testosterone. other hormones that may

be examined are prolactin, thyroid hormones, estradiol, and adrenocorticoids. In addition, in a few

instances the competence of the pituitary/testicular system is assessed by the luteinizing hormonereleasing hormone (LH-RH, also known as Gn-RH)

test. This involves injecting LH-RH and carefully

monitoring the gonadotropin and testosterone response to this stimulation (26)31).

Sexual Dysfunction

Sexual dysfunction should trigger a psychosexual evaluation by a trained psychologist or psychiatrist in the search for a cause for infertility.

Physical examination of a patient who describes

problems with impotence (erectile dysfunction)

may include an assessment of erectile capacity,

Determining the occurrence of erections during

sleep (nocturnal penile tumescence, NPT) is considered one of the best means for distinguishing

between physiologic and psychogenic causes of

sexual dysfunction. NPT monitoring is best performed in the laboratory, where multiple sleep

Photo credit: DACOMED Corp., Minneapolis, MN

Penile rigidity monitor

characteristics can be recorded. The principle of

the monitoring device is a strain gauge worn

around the penis, which indicates changes in

penile circumference during sleep. Erectile function has also been evaluated using ultrasound

evaluation of the blood supply to the penis during drug-induced erection. (For additional discussion of impotence, see ch. 7.)

Retrograde ejaculation may be suspected when

a patient fails to produce a semen sample or

produces a small ejaculate. Diagnosis of this condition is most easily accomplished by observation

of large numbers of sperm in the urine specimen

taken soon after ejaculation. Full investigation of

the etiology of this disorder may require a complete neurological assessment (18).

Risks of Diagnostic Procedures

Tests and procedures performed in any specialty of medicine have certain known (and unknown) risks associated with them. Some infertility diagnostic and treatment procedures also fall

into this category. Although some of these risks

have been documented in the medical literature,

others remain unknown or unreported.

Most procedures performed as part of an infertility workup have relatively minor risks associated with them. For example, endometrial biopsy is considered a generally safe procedure.

possible side effects of this procedure include pain,

bleeding, and uterine cramping. More serious

complications of this procedure, although uncommon, can result from accidental uterine perforation. In addition, if this biopsy is inadvertently performed during early pregnancy, spontaneous

abortion is possible (21,47).

Hysterosalpingogram is often a painful procedure. In some cases severe pain may require

administration of analgesics, The major risks of

this procedure include the spread of micro-organisms from cervix to upper genital tractor the reactivation of dormant pelvic organ infections. However, infection occurs in only a small percentage

of women after HSG, usually those with a previous history of this condition (21,44,47). Other

possible complications include lung emboli and

respiratory distress, which can have severe consequences. In addition, the risks associated with
Ch. 6—Diagnosis of Infertility . 111

small amounts of radiation exposure to the ovary

are unknown (21).

It is not known if there is risk to the offspring

from HSG inadvertently performed during early

pregnancy. There is concern about radiation exposure of an early embryo; however, the dose of

radiation from HSG is on the order of 1 rad or

less. This amount of radiation appears unlikely

to result in an increase in adverse pregnancy outcome (28). Whether or not HSG can dislodge an

implanted blastocyst is uncertain but this possibility appears unlikely (47). In order to avert any

theoretical risks to the early embryo, HSG is customarily performed prior to the anticipated time

of ovulation.

Laparoscopy is a common procedure for both

diagnosis and treatment of infertility. This procedure carries risks such as anesthesia complications, infection, or tissue damage, similar to those

associated with other surgical procedures. The

most common risk is post-surgical infection. Typical infection rates are two to three per thousand

for laparoscopy. (6,41,42). Of these, most infections are superficial, involving the incisions in the

abdominal wall, although more serious infections

can occur.

Other risks associated with laparoscopy include

injuries to intra-abdominal organs. These are associated in diagnostic procedures with introduction

of instruments through the abdominal waif. In conventional laparoscopy, the initial step in the operation is the establishment of a space around the

reproductive organs by placing two or three liters

of gas (often carbon dioxide or air) into the

peritoneal cavity. This gas lifts the abdominal wall

off the internal organs permitting more space for

insertion of instruments and a clearer view of the

intra-abdominal contents. The placing of the gas

is often accomplished with a long needle, placed

into the abdomen. Misplacement of the needle into

intestinal or blood vessels maybe associated with

severe injury to these organs and the need for

major surgical repair (47).

In laparoscopic procedures where intra-abdom -

inal surgery is also performed, another opportunity for internal organ injury exists—thermal injury to the intestine during cauterization of the

fallopian tubes for sterilization. A final source of

complications during laparoscopy is the gas used

to lift the anterior abdominal wall from the viscera.

Gas-related shoulder discomfort after surgery is

common, but serious complications are rare. Gas

emboli maybe associated with exceptionally large

volumes or pressures of gas or with accidental

injection of gas into a vessel.

Complications of hysteroscopy can include those

attributable to the distending media and those

associated with surgery, such as infection, anesthesia-related complications, or uterine perforation. Carbon dioxide used as the distending medium can cause hypercarbia, acidosis, and cardiac

arrhythmias (43), although a review of 1)500 cases

in which carbon dioxide was used showed no complications and there were no changes in pH, pCO2

,

or electrocardiogram in 40 monitored patients

(27). The insertion of instruments into the uterus

introduces the possibility of perforation of the

uterus. Pelvic infection after hysteroscopy is unusual although the incidence of this complication

appears to increase if surgical procedures are performed (5,51).

Since far fewer diagnostic tests exist to evaluate male infertility problems, the known risks of

male infertility workup are fewer. For example,

there are no known hazards associated with semen analysis, the most common and important

diagnostic procedure for males. However, invasive techniques such as testicular biopsy can result in bleeding, infection, and possibly trauma

to the testis causing transient decrease in function (47). Injection of radiologic contrast material

into the vas deferens in lasography has been used

to visualize portions of the male genital duct system. This procedure carries with it the possibility of injury to the vas or epididymis as well as

exposure to x rays (45).

The degree of risks associated with any of these

diagnostic procedures (as well as all medical procedures) are profoundly influenced by the skill

with which they are performed. Relatively safe

procedures can result in severe complications if

performed by inexperienced and unqualified professionals. On the other hand, physicians with

appropriate skill and training can provide safe and

effective infertility workups, even if complicated
112 ● Infertility: Medical and Social Choices

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SUMMARY AND

Although an individual’s reproductive capacity

can be estimated with several methods, fertility

is a product of the specific interactions of a couple. Evaluation of infertility, therefore, must consider the couple as a unit.

A thorough assessment of fertility extends beyond an evaluation of reproductive organs and

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CONCLUSIONS

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current sophisticated level of diagnostic technology, however, no fertility test can positively predict a woman’s ability to conceive or maintain a

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Rapid Sperm Count and Motility Evaluation,” Fertility and Sterility 33:337-338, 1980.

31. Makler, A., ‘(

Evaluation and Treatment of the Infertile Male,” I?eprmluctive Failure, A.H. DeCherney

(cd.) (New York, NY: Churchill Livingstone, 1986).

32. March, C. M., “Hysteroscopy and Uterine Factor in

Infertility” Infertility Contraception, and Reproductive Endocrinology, D.R. Mishell, Jr., and V. Dava -

jan (eds.), 2d ed. (Oradell, NJ: Medical Economics

Books, 1986).

33. Marrs, R., “Evaluation of the Infertile Female, ’’Reproductive Failure, A.H. DeCherney (cd.) (New

York, NY: Churchill Livingstone, 1986).

34. Marrs, R. P., Vargyas, J. M., and March, C. M., “Correlation of Ultrasonic Measurements in Human

Menopausal Gonadotropin Therapy,” American

Journal of obstetrics and Gynecolo& 145:417-421,

1983.

35. Moghissi, K. S., “Prediction and Detection of Ovulation,” Fertility and Sterility 34:89-98, 1981.

36. Moghissi, K. S., Segal, S., and Meanhold, D., “In Vitro

Sperm Cervical Mucus Penetration: Studies in Hu-
114 . /n fertility: Medical and Social Choices

man and Bovine Cervical Mucus, ” Fertility and

Sterility 37:823-827, 1982.

37. Moran, J., Davajan, V,, and Nakamura, R. M., “Comparison of the Fractional PCT With the SimsHuhner PCT,” International Journal of Fertility

19:93-96, 1974.

38. Newil], R. G., and Katz, M., “The Body Basal Temperature Chart in Artificial Insemination by Donor

Pregnancy Cycles,” Fertility and Sterility 38:431-

438, 1982.

39. Noyes, R. W., Hertig, A.T., and Rock, J., “Dating the

Endometrial Biopsy)” FertiZit&~ and Sterility 1:3-25,

1950.

40. Overstreet, J. W., Professor, Department of Obstetrics and Gynecology, University of California,

Davis, CA, personal communication, Sept. 4, 1987.

41. Penfield, A.J., “How To Prevent Complications of

Open Laparoscopy, ’’Journal of Reproductive A4edicine 30:660-666, 1985.

42. Phillips, J., Hulka, B., Keith, D., et al., “Laparoscopic

43.

44.

45.

Procedures: The American Association of Gyneco -

logic Laparoscopists’ Membership Survey of 1975,”

Journal of Reproductive Medicine 18:227-232,

1977.

Quinones, R.G., “Hysteroscopy: Choosing Distending Media, ” International Journal of Fertility 29:129-

132, 1984.

Richmond, J. A., “Hysterosalpingography,” Infertility, Contraception and Reproductive Endocrinology, D.R. Mishell, Jr., and V. Davajan (eds.), 2d ed.

(Oradell, NJ: Medical Economics Books, 1986).

Ross, L. S., “Diagnosis and Treatment of Infertile

Men: A Clinical Perspective)” Journal of UrologV

130:847-855, 1983.

46. Schwartz, D., Laplanche, A., Jouannet, P., et al.,

“Within Subject Variability of Human Semen in Regard to Sperm Count, Volume, Total Number of

Spermatozoa, and Length of Abstinence)” Journal

of Repxwduction and Fertility 57:391-395, 1979.

47. Scialh, A. R., “Risks of Infertility Diagnosis and Treatment,” prepared for the Office of Technology

Assessment, U.S. Congress, Washington, DC, June

1987.

48. Sherins, R.J., and Howards, S. S., “Male Infertility)”

49

Campbell’s Urology, P.C. Walsh, R.E. Gitts, A~D.

Perlmutter, et al. (eds.), 5th ed. (Philadelphia, PA:

W.B. Saunders Co., 1985).

Steingold, K., Director, IVF Program, Department

of Obstetrics and Gynecology, Medical College of

Virginia, Richmond, VA, personal communication,

Sept. 16, 1987.

50. Stillman, R.J., “Ovulation Induction) ’’Reproductive

Failure, A.H. DeCherney (cd.) (New York, NY: Churchill Livingstone, 1986),

51. Taylor, P.J., and Hamou, J. E., “Hysteroscopy,” Journal of Reproductive Medicine 28:359-389, 1983.

52. Yanagimachi, R,J., Yanagimachi, H., and Rogers,

B.J., “The Use of Zona Free Animal Ova as a Test

System for the Assessment of Fertilizing Capacity

of Human Spermatozoa, ” Biology of Reproduction

15:471-476, 1976.

53. Zukerman, Z., Rodriguez-Rigau, L. J., Smith, K. D.,

et al., “Frequency Distribution of Sperm Counts in

Fertile and Infertile Males,” Fertility and Sterility

28:1310-1313, 1977.
chapter 7

Treatment of Infertility
CONTENTS

Medical Treatments

Female Infertility .

Male Infertility . . .

Surgical Treatments

Female Infertility .

Male Infertility. . .

Page

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 125

Artificial Insemination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........126

Intracervical . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...............126

Intrauterine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...............127

Direct Intraperitoneal Insemination . . . . . . . . . . . . . . . . . . . . . ...............127

Sperm Preparation . . . . . . . .

Cryopreservation . . . . . . . . . . .

Gametes . . . . . . . . . . . . . . . . .

Embryos . . . . . . . . . . . . . . . . .

Risks of Infertility Treatments

Drug Treatments . . . . . . . . . .

Surgery. . . . . . . . . . . . . . . . . .

Artificial Insemination . . . . .

In Vitro Fertilization . . . . . . .

Knowing When To Stop . . . . .

Summary and Conclusions . . .

Chapter 7 References. . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .‘ 128

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

Box No.

7-A. Psychological

Figure No.

Box

Page

Effects of Undergoing Treatment . . . . . . . . . . . . . . . . . . . . .. ..118

Figures

Page

7-1. Portable Infusion Pump . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ..119

7-2. Uhrasonogram of Developing Follicles . . . . . . . . . . . . . . . . . . . . . ...........123

7-3. Multicellular Embryo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ....124

7-4, Device Used for Artificial Insemination . . . . . . . . . . . . . . . . . . . . . ..........126
Chapter 7

Treatment of Infertility

Sophisticated new technologies, such as in vitro as drug therapy and reproductive-tract microsur -

fertilization (IVF) and gamete intrafallopian trans- gery and laser surgery. Although noncoital reprofer (GIFT), have recently been developed for the ductive technologies have received much attentreatment of infertility. In addition to these new tion, the more traditional approaches currently

reproductive technologies, great progress has account for the overwhelming majority of inferbeen made in the treatment of infertility with tility treatments.

traditional medical and surgical approaches, such

MEDICAL TREATMENTS

In this section, all nonsurgical procedures and

practices are considered medical treatments. Artificial insemination and cryopreservation are considered separately.

Female Infertility

Medical treatments for female infertility administered by a health care provider can range from

advice that assists a couple in pinpointing the time

of ovulation to complex regimens of fertility drugs.

As described in chapter 6, the initial patient history and physical examination are important tools

in identifying possible infertility problems or suspected factors contributing to it. Evaluating and

maintaining good general health and nutrition can

contribute significantly to reproductive function,

Yet even in the case of robust general and psychological health, a fully functioning reproductive system may be lacking. As is true with all diagnostic procedures, infertility treatments can be

a source of considerable anxiety about pain and

outcome; the psychological well-being of the couple is a principal factor to consider during treatment (see box 7-A).

Ovulation Induction

Female infertility is often related to problems

with the complex biological events surrounding

ovulation. Disorders of ovulation include conditions such as amenorrhea (absence of menstruation), Oligomenorrhea (scanty or infrequent menstruation, usually cycles longer than 35 days), or

luteal phase defects (LPD) (failure of the endometrial lining of the uterus to develop properly

after ovulation). The complete absence or irregu -

larity of the menstrual cycle is the most obvious

indicator of ovulatory dysfunction. In this case,

further testing is needed to determine the exact

site of the ovulatory problem—hypothalamus, pituitary, ovary, or elsewhere. Only when the origin of the dysfunction has been identified can

appropriate treatment be administered.

It is not unusual, however, even in the presence

of apparently normal and regular menstrual

periods, for there to be underlying ovulatory failure, Ovulatory dysfunction without menstrual irregularity becomes apparent only after examination of basal body temperature (BBT) charts, serum

progesterone levels, and endometrial biopsies. Although a number of therapeutic agents treat ovulatory dysfunction, the most commonly used are

compounds known as fertility drugs. These include clomiphene citrate, human gonadotropins

(human menopausal gonadotropin, follicle-stimulating hormone, human chorionic gonadotropin),

gonadotropin releasing hormone, bromocriptine,

glucocorticoids, and progesterone. The etiology

of the dysfunction determines which treatment

to use.

Clomiphene Citrate.—The most commonly

prescribed fertility drug is clomiphene citrate (CC).

Clomiphene is a nonsteroidal estrogen-like compound that binds to estrogen receptors in the body.

Although its mode of action in inducing ovulation

remains unclear, it most likely blocks the actions

of the natural estrogens in the hypothalamus (36).

117
118 ● Infertility: Medical and Social Choices

BOX 7-A. —Psychological Effects of Undergoing Treatment

The emotional effects of medical and surgical treatments for infertility are often a problem, particularly

for women. Clomiphene citrate, for example, may prolong the menstrual cycle and thus falsely increase

the hope of a pregnancy. Other drugs cause weight gain, nausea, acne, hot flashes, and mood swings.

Some fertility drugs create a risk of multiple conceptions. Although many couples welcome twins after

a period of infertility, the increased risk of miscarriage, birth defects, low birth weight, and complications

during delivery are worrisome, and some couples hesitate at the thought of raising several children at once.

Many people find themselves nervous about surgery, fearing both the procedure and their future efforts to achieve pregnancy once the procedure is over. Those who take time away from work for surgery

and recovery will need to decide whom to tell and how much to tell about the reason for the surgery,

and how to manage lost income as well as expenses not covered by insurance.

A couple using artificial insemination must adjust to achieving pregnancy noncoitally. The clinical atmosphere surrounding the insemination can be unsettling, and the man must produce a semen specimen while

the woman waits. It is not uncommon for the male to be temporarily impotent. The woman is often concerned that she may not be ovulating on the day of the insemination, despite efforts to use home ovulation

test kits accurately. Since about 50 percent of infertility clinics do not do inseminations on weekends, some

couples feel frustrated that they have missed a potential insemination because of the rigidity of the clinic’s

schedule.

Couples using IVF must accept its relatively low success rate and high cost; tolerate the medication

prescribed for the woman; be able to travel to the clinic; bear the expense of lost work time, travel, and

hotel stays; endure the anxiety of waiting to see whether fertilization occurs; and wait two anxious weeks

to see if pregnancy ensues.

Some couples using artificial insemination by donor are put off by the thought of the woman carrying

another man’s baby. Together, they must decide whether they will tell others about the insemination. They

may wonder whether their love for a child conceived with donor sperm will be any different than that

for a child conceived in traditional fashion.

Couples hiring surrogate mothers are still so few that little has been written about their experiences.

Nevertheless, all the problems experienced with artificial insemination by donor are likely to be present

in analogous form. In addition, during the 9 months of pregnancy the couple will probably worry about

whether the baby will ever really be turned over to them. Even if this happens, they may well worry whether

complications will arise later, should the baby’s biological mother ever regret her participation.

Infertile couples may also have difficulty making major decisions or changes in their lives. Job changes

may not take place because the medical insurance is needed or a pregnancy is expected at any time. A

new house may not be bought or a vacation may be skipped because of the expense and uncertainty of

infertility. A couple’s life can become controlled by infertility treatment.

WIJRCE. Office of ‘1’echnolo&v Assessment, 1988

It may also affect the function of the pituitary and Gonadotropin.—In more severe cases of ovuovaries (35,66,75). The end result ‘is increased

gonadotropin secretion and stimulation of the

ovary. Clomiphene’s use is primarily indicated for

patients with oligomenorrhea caused by mild dysfunction of the hypothalamus or pituitary or by

other conditions (66). To induce ovulation, this

drug is usually given on the fifth day after the

onset of menses and continued through day nine.

With this regimen, ovulation is expected between

days 14 to 18 of the cycle.

latory dysfunction resulting from pituitary or

hypothalamic shutdown, human gonadotropins

can be administered to stimulate the ovary directly

(36). This can be accomplished with either human

menopausal gonadotropin (hMG) or human follicle-stimulating hormone (hFSH). These potent

stimulators of ovarian function are extracted from

the urine of menopausal women. They are usually used if an individual fails to respond to clomi -

phene citrate or other compounds.
-.

Ch. 7—Treatment of Inferti/ity ● 119

Administration regimens for gonadotropins can

vary considerably depending on the nature of the

ovulatory dysfunction, the other medications being given concurrently, and the preference of the

individual clinician. Because these hormones bypass the endogenous gonadotropin control system and act directly on the ovary, careful monitoring of their potent effects on the ovary must

accompany their administration. This is accomplished by daily measurements of the amount of

estrogen produced by the ovary under the influence of these compounds, and by monitoring the

growth of ovarian follicles with ultrasound (52).

As the ovarian follicles containing the ova (eggs)

develop under the influence of these two hormones, ultrasound (and estrogen measurement)

allows the physician to determine if the follicles

are large and mature enough for ova release.

The actual release of the ovum is brought about

by injection of an additional hormone, human

chorionic gonadotropin (hCG), which is similar to

luteinizing hormone (LH). The high hCG levels resulting from the injection mimic the actions of the

natural LH ovulatory surge, causing rupture of

the follicle and release of the ovum.

Gonadotropin Releasing Hormone.—In cases

of severe hypothalamic dysfunction with intact

pituitary and ovarian function, induction of ovulation with gonadotropin releasing hormone (GnRH) has been successful (76). Gn-RH is the hormone released from the hypothalamus that in turn

causes the secretion of gonadotropins from the

pituitary gland. In cases of hypothalamic dysfunction, Gn-RH release is impaired or absent. With

the use of a portable infusion pump, Gn-RH can

be administered in such a way that it mimics the

natural release pattern (see figure 7-1), This promotes secretion of gonadotropins from the pituitary, follicle development, and subsequent natural ovulation. Although officially only available for

ovulation induction in clinical trials at present,

this approach of mimicking endogenous hormone

patterns may become more widely used upon approval by the Food and Drug Administration.

Bromocriptine. –Bromocriptine is commonly

used in cases of infertility associated with oversecretion of prolactin. Prolactin, a hormone responsible for normal milk production, can also

Figure 7.1 .—Portable Infusion Pump

Infusion pump is worn continuously and delivers gonadotropin releasing hormone intermittently either subcutaneously or intravenously.

SOURCE: Ferring Laboratories, Inc., Suffern, NY, 1988

disrupt regular ovulatory function. In women with

hyperprolactinemia (high levels of prolactin, often

caused by a hormone secreting tumor) or transient elevations of prolactin, daily administration

of bromocriptine can lower blood prolactin levels.

Bromocriptine is a synthetic compound that interferes with the pituitary’s ability to secrete

prolactin. Ovulation usual]y returns after 6 to 12

weeks of daily treatment (66).

Glucocorticoids. -Ovulatory dysfunction is

often present in patients with adrenal disorders.

Treatment of the adrenal condition with synthetic

glucocorticoids (one class of hormones naturally

produced by the adrenal glands) alone or in combination with other drugs can result in resumption of ovulatory cycles (17). This treatment can

also be effective for the amenorrhea associated

with polycystic ovaries (24).

Progesterone. —Luteal phase defect can also be

treated with drugs, depending on the etiology,

Treatment with progesterone, the hormone normally secreted in large quantities by the ovary

after ovulation, can be an effective treatment for

this condition (47).

Other Drug Therapies

Endometriosis can be treated with a variety of

pharmaceutical agents. Even in severe cases, drug
.

120 “ Infertility: Medical and Social Choices

therapy is usually recommended prior to surgical intervention. Although many of these medical treatments prove effective in combating the

symptoms of this disorder, the efficacy of these

treatments for endometriosis-associated infertility remains uncertain (33,53). In addition, the precise role endometriosis plays as a mechanism for

infertility remains unclear (53).

The most popular drug treatment for endometriosis is danazol, a synthetic derivative of testosterone. This compound acts to suppress normal

gonadotropin secretion and thereby cyclic ovarian hormone production, and has a direct effect

on the endometrium (5). The end result of these

multiple actions is to produce a hormonal state,

similar to that of chronic anovulation, that causes

regression of endometriosis tissues (25). Danazol

taken daily for periods of 4 to 6 months or longer

is the usual course of treatment. After this time,

evidence of endometriosis is often reassessed by

laparoscopy.

Other drug therapies include progestogens, estrogens, Gn-RH blockers, or combinations of these

compounds.

Uterine and Cervical Infections

Infections of the male and female reproductive

tract have been increasingly recognized as a major contributory factor of infertility. Although infectious organisms such as gonorrhea have long

been associated with severe reproductive tract

disorders, micro-organisms such as chlamydia and

mycoplasma are now also associated with reproductive-tract infections that lead to infertility.

These infections are associated with pelvic inflammatory disease and cervical or uterine factors in

infertility.

Treatment of chlamydia, gonorrhea, and mycoplasma is usually accomplished with a 7- to 10-

day regimen of antibiotics such as tetracycline,

erythromycin, or doxycycline. Adequacy of treatment must be verified by followup laboratory cultures 3 to 6 weeks after treatment (59).

Immunological Disorders

The role of antibodies to sperm and semen in

the etiology of infertility has received increased

attention. A number of studies have shown an increased incidence of sperm antibodies in both the

male and female partners of infertile couples compared with normal fertile couples (60). These antibodies are most likely responsible for abnormal

sperm and cervical mucus interactions that inhibit

or prevent fertilization from taking place.

A number of treatments for this condition have

been used. When the antibodies to the sperm appear in the female partner only, condom therapy

may be beneficial. Use of condoms for 6 months

has been reported to reduce the quantity of sperm

antibodies in the female (31), This may lead to normal sperm-mucus interaction when use of a condom is discontinued during subsequent fertile

periods. However, this practice is no longer widely

used. Glucocorticoid therapy is also effective in

Photo credit: Repro-M& Systems, Inc., Middletown, NY

Water-cooled scrotal jacket.
Ch. 7—Treatment of Infertilify . 121

suppressing the production of these antibodies

in both the male and female. It has been reported

that once antibody levels have been reduced, pregnancy rates increase (37). In addition to the above

procedures, which act to reduce the production

of sperm antibodies, intrauterine insemination

with the husband’s washed sperm, donor insemination, IVF, or gamete intrafallopian transfer may

be appropriate.

Sexual Dysfunction

Several sexual dysfunction conditions are associated with infertility in the female. The most common is vaginismus, a condition in which penile

entry into the vagina is impossible or extremely

difficult because of an involuntary contraction of

the muscles around the outer third of the vagina.

This condition can be caused by past sexual assault, previous traumatic pelvic examinations,

anxiety, painful intercourse due to chronic vaginitis or lubrication disorders, or other psychological and organic problems. If an organic cause can

be treated or ruled out, and the condition continues, then treatment for this disorder usually

entails simple, passive dilatation of the vagina with

associated desensitization techniques. This treatment is effective in nearly all patients, allowing

normal intercourse to commence or resume (23).

Male Infertility

Medical treatment for male infertility is not as

extensive as treatment for female infertility. Although a number of characteristics of semen and

sperm can be assessed by semen analysis, the

treatment of abnormalities remains elusive.

Environmental Factors

Environmental factors appear to be closely associated with some forms of male infertility. Excessive heat to the testes and exposure to toxic chemicals (e.g., in the workplace) have been associated

with reduced sperm production and viability (72).

Routine cooling of the scrotum, as with a watercooled scrotal jacket, may increase sperm quality

(78).

Hormone Therapy

Hormone therapy in male infertility is most beneficial in cases of gonadotropin deficiency. Human

menopausal gonadotropin administered in combination with human chorionic gonadotropin for

periods of up to 6 months can be an effective treatment for some types of azoospermia. Clomiphene

citrate and tamoxifen can stimulate natural gonadotropin secretion, thereby increasing stimulation of the testes and subsequent spermatogenesis. Long-term treatment with gonadotropin

releasing hormone delivered by portable infusion

pumps has been reported to induce spermatogenesis in patients with hypothalamic deficiencies (73).

Testolactone, a drug that reduces the production of estrogen, has also been used for treatment

of male infertility, although its efficacy in such

treatment has been challenged (14). Numerous

other kinds of drugs have been administered in

cases of male infertility, including testosterone (low

and high doses), corticosteroids, triiodothyronine,

kinin-releasing agents, anti-prostaglandins, and

vitamins C and E (45). Overall, the efficacy of drug

and hormonal therapy in the majority of male infertility patients remains unclear.

Reproductive Tract Infections

Although infections of the reproductive tract

are less common in the male than in the female,

a patient’s semen should be cultured in the laboratory to screen for the presence of a wide range

of micro~organisms. Infections such as gonorrhea,

chlamydia, mycoplasma, and others can be treated

with appropriate antibiotics, depending on the patient’s medication sensitivity. Prostatitis (inflammation of the prostate gland) can also be treated

with antibiotic regimens for periods as long as

several months.

Sexual Dysfunction

Sexual dysfunction as a contributing factor of

infertility may be present in as many as 5 percent

of infertile couples (56). Male patients with organic

impotence may respond to hormone therapy, surgery to restore blood flow to the penis, or drug

therapy that directly induces erections. In addition, erection and ejaculation may be induced by

electrical or vibratory stimulation such as used

76-580 - 88 - 5 ; QL ~
122 . Infertility: Medical and Social Choices

in spinal cord injury patients (see box 1O-A in ch. apy and behavior modification. Retrograde ejacu10). Psychogenic impotence and premature ejacu- lation can be treated with drugs or surgery

lation can be treated successfully with psychother- depending on the etiology of the condition.

SURGICAL TREATMENTS

Female Infertility

Many different surgical procedures are used in

the treatment of various disorders of the female

reproductive tract. Only the procedures most commonly and widely used in the treatment of infertility are discussed here. These procedures can

be roughly divided into two categories, traditional

surgery (macrosurgical) and microsurgery. Traditional reproductive surgery techniques usually refer to surgery on large, easily visualized structures; microsurgical techniques entail fine, delicate

surgical procedures performed with the aid of a

microscope or other magnifying apparatus. Although some conditions may indicate the use of

one approach over the other, there is often overlap

between these approaches for any given treatment.

All these procedures are performed under general anesthetic and, with the exception of the use

of the laparoscope, involve laparotomy. Laparotomy involves a larger incision in the abdominal

wall than laparoscopy, to allow direct visualization of the reproductive structures.

Traditional Surgery

Infection, previous surgery, peritonitis, and

pregnancy complications can all lead to adhesions,

occlusion, and scarring of the female reproductive tract.

Adhesions are abnormal fibrous connections

made between structures of the female reproductive tract that are not otherwise joined. These

often occur in the ovary or fallopian tubes after

inflammation or damage. This condition can impair fertility by severely restricting the movement

of the fallopian tubes, thereby hindering ovum

pickup from the ovary and transport toward the

uterus. Removal of adhesions (adhesiolysis) is accomplished by electrocautery devices, dissection,

or lasers, In the case of lasers, this maybe accomplished via the laparoscope, although this approach is not common. Once adhesions are removed, tubal and ovarian motility can be greatly

improved (64).

Pelvic inflammatory disease can often lead to

a narrowing or occlusion of the distal end (closest

to the ovary) of a fallopian tube—the ampulla and

fimbria. A salpingostomy attempts to recreate the

normal fallopian tube opening and fimbria function when complete occlusion has occurred. A fimbrioplasty corrects partial restriction, occlusions,

or adhesions of the finger-like appendages of the

fimbria so that normal movement can resume.

These procedures are usually performed without

magnification, although the microsurgical approach is likely to improve success. In addition,

the carbon dioxide laser may be of some use in

these procedures (46,62).

A surgical approach may also be warranted in

cases of endometriosis that either do not respond

to drugs or are severe. Endometrial tissue (implants) throughout the abdominal cavity can be

removed by excision or cauterization. Recent attempts have employed the laser to vaporize implants. Again, as with distal tubal surgery, microsurgical techniques may greatly improve removal

of endometrial tissue that may otherwise go undetected (53).

Microsurgery

The development of new and better microsurgical techniques in recent years has greatly improved the success of tubal surgery. The most

common tubal microsurgical procedures involve

excision and repair of scarring or damage at various points along the fallopian tubes. This is critical to ensure proper ovum transport down the

fallopian tubes and passage of sperm in the opposite direction,

Scarring to the inside of the fallopian tube is

most difficult to treat successfully since this condition usually involves not only narrowing or occlusion of the tube but also damage to the mil-
Ch. 7—Treatment of Infertility ● 123

lions of cilia lining the tract. Extensive damage

to these cilia, which help propel the ovum toward

the uterus, severely impairs ovum transport.

With the aid of a microscope, fine surgical instruments, and much practice, a skilled microsurgeon can locate and excise the damaged portion

of the tube. The two ends of the tubes are cleared

of any material and then the inside of the tube

(lumen) is rejoined and sutured together. Special

care must be taken for proper alignment of the

ends of the tube. Using this basic approach, various sections of the fallopian tubes can be repaired.

Because the diameter of the tubes varies at different locations, however, removal of large lengths

can make joining a larger diameter section to a

much smaller diameter section technically difficult. In addition, depending on the extent and location of damage or scarring, the difficulty and success rate varies. Overall, the greater the length

of fallopian tube left, the higher the rate of success at attaining pregnancy (63).

Success rates for these procedures depend

largely on the skill and training of the individual

surgeons. The overall success rate for this treatment of infertility should continue to improve as

more surgeons become proficient at reproductive

microsurgical techniques.

In Vitro Fertilization

In vitro fertilization is a highly sophisticated infertility treatment that involves obtaining mature

oocytes through surgical procedures such as laparoscopy or through nonsurgical procedures such

as ultrasound-guided oocyte retrieval. These mature oocytes are produced by natural ovulatory

cycles, or, more commonly, by ovulation induction with fertility drugs such as clomiphene citrate, human menopausal gonadotropin, gonadotropin releasing hormone, and others.

Protocols for ovulation induction vary among

IVF practitioners. Development of follicles under

the influence of fertility drug stimulation is usually monitored by ultrasound imagery (see figure

7-2) and blood estrogen levels. Eggs are collected

by aspiration of the fluid inside the follicles via

laparoscopy or nonsurgically with ultrasoundguided aspiration techniques. Once the oocytes

are collected, their maturity is assessed microscopFigure 7-2. -Ultrasonogram of Developing Follicles

Ultrasound is routinely used to monitor the growth and development of follicles under the influence of fertility drug

stimulation. The black areas represent f Iuid-filled follicles that

contain the maturing oocyte. The size of a follicle can be estimated from sonogram.

SOURCE: IVF Program, Medical College of Virginia, Richmond, VA, 1987.

ically, and fertilization of mature eggs is attempted

with washed sperm. If available, at least 50,000

motile sperm per oocyte are added to the culture

dish to achieve fertilization. The sperm and oocytes are incubated for about 18 hours. Oocytes

are then examined to see if fertilization has

occurred (evidenced by the presence of pronuclei).

The fertilized oocytes then cleave, usually within

35 hours after insemination, and the resulting embryos are transferred back to the uterine cavity

at the 2-to 16~ell stage (see figure 7-3). After transfer, progesterone or hCG administration maybe

given to supplement the natural luteal phase hormonal environment. If implantation occurs, small

increases in hCG can be measured within a few

days.

IVF treatment is indicated in a number of disorders including tubal disease unresponsive to

therapy, endometriosis, cervical mucus abnormalities, oligospermia, idiopathic infertility, and any

combination of these disorders. The success rate

for IVF varies considerably among programs (see

chs. 8 and 15).

Gamete Intrafallopian Transfer

Gamete intrafallopian transfer is an infertility

treatment method that directly transfers sperm
124 ● Infertility: Medical and Social Choices

Figure 7-3.—Multicellular Embryo

Human embryo developing in vitro before transfer to female

reproductive tract or cryopreservation.

SOURCE: @Reprinted with permission. A.A. Acosta and J.E. Garcia, “Extracorporeal Fertilization and Embryo Transfer,” /nfert///ty: Diagnosis and

Management, J. Aiman (cd.) (New York, NY: Springer Verlag, 19S4).

and oocytes into the fallopian tubes. As a consequence, fertilization can take place within the fallopian tubes. This technique relies on both medical and surgical procedures (3).

Development of follicles is accomplished by the

administration of either clomiphene citrate or human menopausal gonadotropin or both. Thirtysix hours before GIFT is to take place, hCG is

administered to the patient to precipitate ovulation of the mature follicles. The oocytes are collected by aspiration of the developed follicles

through laparoscopy. Approximately 2.5 hours before the procedure, a semen sample is collected,

prepared by washing and swim-up techniques,

and treated with antibiotics. After evaluation of

both the sperm and oocytes, one or two oocytes

are loaded into a catheter. Next an air bubble is

introduced into the catheter, followed by 100,000

motile sperm, The catheter is then threaded

through the operating channel of the laparoscope

into the end of the fallopian tubes for a short distance (1.5 centimeters). The contents of the catheter are gently emptied into the fallopian tube and,

if possible, the procedure is repeated for the other

fallopian tube. Subsequently the patient usually

receives daily progesterone treatment for up to

8 weeks.

In some instances of male infertility, when small

numbers of sperm are available, a variation of this

procedure may be employed. Oocytes retrieved

after ovulation induction may be fertilized in the

laboratory as with IVF. The resulting embryo(s),

however, are placed in the fallopian tubes rather

than directly in the uterus.

Treatment with gamete intrafallopian transfer

may be indicated in infertility related to a number of factors including endometriosis, premature

ovarian failure, unexplained infertility, poor oocyte

pickup by the fimbria due to adhesions, and oligospermia (3)32). Recent reports of success with

GIFT are described in chapter 15.

Tubal Ovum Transfer

A less common technique with some similarities to IVF and gamete intrafallopian transfer is

the tubal ovum transfer method (also known as

low tubal ovum transfer). This approach uses similar ovulation induction and oocyte retrieval protocols as IVF and gamete intrafallopian transfer.

However, the oocytes are transferred past a

blocked or damaged section of the fallopian tube,

to an area closer to the uterus. The couple then

engages in intercourse or artificial insemination

is performed. In this manner, the oocytes overcome the barrier created by disease or damage

to the fallopian tubes and fertilization can occur

within the female reproductive tract.

Embryo Lavage and Transfer

Embryo lavage (also known as ovum transfer,

uterine lavage, or flushing) involves the retrieval

of a fertilized ovum from the uterus by means
Ch. 7—Treatment ot Infertility ● 125

of a specially designed catheter. After carefully

monitoring a menstrual cycle to determine the

point of ovulation, artificial insemination is performed on a fertile donor woman. Several days

later a specially designed catheter is inserted into

the female reproductive tract and the fertilized

ovum is literally flushed out and retrieved. The

ovum is then transferred to a waiting recipient

whose cycle has been synchronized in such a way

that the uterine lining is prepared for implantation (lO)ll).

Male Infertility

Repair of Varicocele

Varicocele is the presence of a dilated varicose

vein in the testes. This condition occurs in between

10 and 20 percent of all men and approximately

20 to 40 percent of infertile men. Varicoceles are

most often found in the left testis, probably because of the anatomical differences between the

blood supply to left and right testes. In some cases,

however, there may be a right testis varicocele (55).

The mechanism by which a varicocele depresses

male fertility remains unclear but it has been suggested that the increased scrotal blood flow may

raise scrotal temperature and adversely affect

spermatogenesis. Regardless of the exact mechanism, repair of varicoceles can increase the quality and quantity of the ejaculate. The surgical procedure is relatively simple. Usually, under general

anesthetic, a small incision is made in the groin,

the spermatic cord is located, and the spermatic

vein is isolated from the spermatic artery and vas

deferens. The varicose spermatic vein is tied off

above the varicosity, taking care not to include

or damage the artery or vas deferens. Ahernative approaches to this procedure include insertion of a small balloon to occlude the vein or injection of substances that will block the veins. In

some cases the varicocele may reappear due to

either recollateralization or failure to ligate all

branches of this vein during prior surgery (55).

Improvement in semen quality after this procedure can take 3 months or longer. Reports of

the effectiveness of this procedure vary widely

(22,61). of the individuals who do show improved

semen analysis, a smaller percentage have partners who eventually become pregnant. Although

this procedure remains one of the oldest and simplest treatments for male infertility at the moment,

its efficacy for improving male fertility remains

controversial.

Microsurgery

A number of other conditions contribute to infertility in the male that can be effectively treated

with surgery. Only the most frequently performed

procedures are discussed here. These conditions

result in blockage of sperm transport through the

delicate ducts of the male reproductive tract.

These obstructions can arise in the epididymis,

vas deferens, or ejaculatory ducts for a variety

of reasons, including inadvertent damage during

previous surgery or vasectomy, infections, or failure to develop as a result of a birth defect.

Reconnection or reanastomosis of the vas deferens (also known as vasovasostomy or vasectomy

reversal) is a delicate operation that must be performed by a skilled microsurgeon. Portions of the

vas deferens are cut away until two clean ends

are obtained. To ensure that all obstruction of the

duct has been removed, small samples of fluid are

taken from the testicular end of the vas and examined for sperm. This procedure is continued

until the presence of large numbers of sperm confirm no further occlusion between the testis and

the vas deferens. The two ends are then carefully

aligned and sutured together. The success of this

procedure is greatly influenced by the skill of the

surgeon (62).

The other location in the male reproductive tract

where blockage or occlusion is likely to occur is

the epididymis. Blockage here most often is a result of infection and inflammatory reaction. Because the epididymis is such an extensive duct

(approximately a 20-foot-long coiled tube), pinpointing the location of the obstruction can be

difficult. However, by carefully excising portions

of the epididymis until sperm are observed, the

occlusion can be eliminated. Once sperm are present, the end of the vas deferens is connected to

the patent epididymal duct (62).
126 ● Infertility: Medical and Social Choices

ARTIFICIAL

Artificial insemination is one of the oldest forms

of infertility treatment, having been performed

in the nineteenth century. Even though more sophisticated infertility treatment techniques have

been developed since these early reports, artificial insemination continues to be one of the simplest and most successful infertility procedures.

The practice of artificial insemination is usually

classified as using the husband’s sperm for insemination or using donor sperm. In each case the

sperm can be placed either within the cervical

canal or directly into the uterus. In addition, an

approach that places sperm directly into the body

cavity (peritoneum) has been successful in treating infertility. All inseminations are performed

around the time of either drug-induced or natural ovulation.

Intracervical

Intracervical insemination involves placing

sperm in or near the cervical canal of the female

reproductive tract by means of a syringe or catheter (see figure 7-4). Protocols vary among pracINSEMINATION

titioners but multiple inseminations during each

fertile period are usually performed to increase

the likelihood of conception.

The optimum time for insemination is the period

just prior to or during ovulation, before basal body

temperature rises. Cervical mucus is most receptive to sperm at this time. Approximately 48 hours

before the expected BBT rise, sperm are collected

from the husband or donor by masturbation into

a clean, sterile container. In some cases, sperm

are collected after the couple has had intercourse

using a condom. In these instances, the condom

should be void of lubricants and spermicides. The

collected semen is allowed to liquefy and a semen

analysis performed. Usually, within 1 to 2 hours

after collection, part of the semen sample is loaded

into a syringe with a flexible tip and placed in the

cervix. The remaining sperm are placed in a special cervical cup that fits over the cervix. This cup

remains in place for 6 to 8 hours to retain the

sperm within the cervical canal and is then removed by the patient. Similar procedures are employed when frozen donor sperm are used. Intracervical insemination with the husband’s sperm

Figure 7=4. —Device Used for Artificial insemination

Artificial insemination is usually performed with a syringe similar to the device shown.

SOURCE: Zygotek Systems, Inc., Springfield, MA, 19S8.
Ch. 7—Treatment of Infertiolity c 127

is usually indicated in cases where the male fails

to deposit sperm in the female reproductive tract.

Intrauterine

Intrauterine insemination differs from intracervical by the location of sperm deposition in the

female reproductive tract. In instances where cervical mucus is hostile to sperm, it is often advantageous to bypass the cervix and place sperm

directly in the uterine cavity. Washed sperm are

used with intrauterine insemination,

Direct Intraperitoneal Insemination

One technique for infertility treatment involves

the same methods of ovarian stimulation and

sperm preparation as IVF and gamete intrafallopian transfer. However, 35 hours after hCG is

administered to precipitate ovulation, a sample

containing at least 6 million sperm is injected

directly into the body cavity between the uterus

and the rectum. It appears that at least 500,000

motile sperm are needed for fertilization to occur with this method, If ultrasound shows that

the follicles have not ruptured 24 hours after the

first insemination, then the sperm injection is

repeated. In the initial reports based on a small

sample, this relatively simple technique produced

a pregnancy rate of 14 percent per treatment cycle

(26).

Sperm Preparation

Sperm Washing

Sperm washing is performed to separate viable

sperm from the other components of the semen

such as prostaglandins, antibodies, and possibly

micro-organisms. This can also work to concentrate the viable sperm into a smaller volume for

insemination. The basic approach involves diluting the semen sample with various tissue culture

media containing albumin or serum, which somehow helps maintain sperm motility. This mixture

is then centrifuged at low speed to separate out

sperm (2). The concentrated sperm are resuspended in appropriate solutions for artificial insemination, IVF, or gamete intrafallopian transfer.

Swim-up Techniques

The swim-up technique is employed to concentrate only the highly motile sperm in the semen

sample. This is usually accomplished by layering

a solution containing proteins (albumin) or other

substances over the semen or washed sperm sample. During a short time the most motile sperm

in the sample will literally ‘(swim up” into the top

layer, leaving behind most of the abnormal and

nonmotile sperm. Motility of the sample used for

insemination can be increased severalfold, thereby

increasing the likelihood of successful fertilization (2),

Drug Treatment

Disorders of motility may sometimes be improved by addition of chemicals such as caffeine,

arginine, or kinins to the semen sample, but the

efficacy and safety of these procedures is unclear

(7). Other drug treatments of the ejaculate most

notably include treatment of the sample with antibiotics to eliminate possible bacterial infection (2).

CRYOPRESERVATION

Gametes

Sperm

Spallanzani’s 1776 report of sperm survival after freezing in snow was the first step to modern

cryopreservation of sperm in both humans and

animals (41). It was only after the discovery that

glycerol, acting as a cryoprotectant, was effective

in preserving sperm’s survivability during freezing that successful insemination of women with

previously frozen and thawed sperm was accomplished (9). Since then many laboratories have successfully frozen sperm to be used in subsequent

insemination. Large-scale operations of semen collection and cryopreservation have become a major part of the animal husbandry industry. For

humans, sperm banks and programs now exist

around the world from which donor sperm can

be purchased for insemination.
128 ● Infertility: Medical and Social Choices

Techniques for sperm cryopreservation differ

among laboratories. Most facilities now use cryo -

protecting agents such as glycerol, and they freeze

sperm in straws or ampoules in liquid nitrogen

(41). Although some loss of sperm or sperm motility during freezing is expected, this can vary

greatly depending on characteristics of original

sample, freezing technique, and cryoprotectant.

Oocytes

Three births have been recorded in Australia

and West Germany from oocytes that were frozen and thawed. Freezing oocytes is not widely

practiced, however, in IVF programs at present.

Although the technique is similar to freezing

sperm and embryos, different characteristics of

the unfertilized oocyte make it extremely susceptible to cryopreservation damage (71). Much additional work is needed before oocyte freezing

is a viable procedure in infertility treatment.

Embryos

Cryopreservation of embryos is increasingly

practiced in IVF programs around the world. This

approach presents several advantages. If multiple eggs are retrieved and fertilized during an IVF

cycle, then any embryos not transferred during

that cycle would be available for transfer during

subsequent cycles without additional fertility drug

stimulation and egg retrieval. Another aspect of

cryopreservation of embryos is the ability to reduce the risk of multiple pregnancies by transferring only one embryo at a time. However, this

transfer protocol reduces the chances of pregnancy as well.

The techniques for freezing embryos differ in

several respects among laboratories. The major

differences involve the substance used to protect

the embryo from damage by freezing (the cryoprotectant), and the stage at which the embryo

should be frozen to ensure maximum survivability upon thawing (7 I). In addition, the length of

time the embryos remain frozen also varies. One

recent study suggests freezing embryos at the

earlier, l-cell to 4-cell stages is optimal (70)71). Conflicting reports make it unclear whether the length

of time an embryo is frozen is a factor on postthawing success (70)71).

RISKS OF INFERTILITY TREATMENTS

As in most areas of medical practice, there are

potential risks associated with certain procedures

used in infertility treatment. These risks can generally be divided into several categories: risks involved with drug treatments; risks associated with

surgical procedures; and risks of pregnancy complications including miscarriage, ectopic pregnancy, and multiple gestations. Risks of some of

the most commonly used treatments are discussed

in this section.

Drug Treatments

Female

Risks related to ovulation induction with various fertility drugs have been widely investigated.

Clomiphene citrate can result in subadequate cervical mucus, impaired tubal motility, abnormal

sperm transport, and Iuteal phase defect (58), Although some reports have suggested that CC may

contribute to an increased incidence of early pregnancy loss (2.5 times more likely than in spontaneously conceived gestations) (29), other reports

have found no such increase (1,42).

Treatment with CC may increase the risk of ectopic pregnancy (16). This increased risk may be

due to alterations in tubal motility, to a higher incidence of damaged tubes in infertile women (who

tend to get placed on drugs such as CC), or to the

increased number of ova released after ovulation

induction, raising the number of opportunities for

a tubal implantation (15).

Multiple gestation is another risk of CC and other

drugs used to induce ovulation, increasing the risk

of pregnancy complications including prematurity,

gestational diabetes mellitus, toxemia, and placental abnormalities. The incidence of multiple gestations after CC use has been reported to range from

8 to 13 percent (58).

Other risks of CC treatment include hyperstimulation of the ovary (ovarian enlargement), moler
Ch. 7—Treatment of Inferti/ity . 129

intrauterine pregnancies, vitamin Blz deficiency,

and possible premature aging of the ovary from

repeated stimulations (38).

A number of the risks described for CC use may

also be applicable to ovulation induction with human menopausal gonadotropins. As reported for

CC, hMG treatment maybe associated with luteal

phase defect (21). Risk for ovarian hyperstimula -

tion syndrome (OHSS) is more prominent with

hMG than CC administration (20). Severe OHSS

can include ovarian enlargement (which may be

massive), abdominal distension, increased blood

viscosity, and coagulation abnormalities, leading

to thromboembolism and death (49)57). OHSS is

largely the result of excessive hMG administration and can usually be avoided by careful monitoring of blood estrogen levels. OHSS appears to

be associated with the administration of hCG (57);

if estrogen levels become too high, therefore, hCG

can be withheld.

Ectopic pregnancy rates of 2.7 percent (30) and

3.1 percent (48) have been reported in hMGinduced pregnancies, similar to the incidence with

CC administration. Multiple pregnancies are more

commonly encountered after hMG therapy than

after CC. The incidence of twin and higher order

pregnancies has been reported to range from 11

percent to 42 percent of hMG-induced gestations

(58),

Other drugs used in infertility treatments carry

risks of side effects as well. Many individuals taking bromocriptine for hyperprolactinemia experience side effects such as nausea, hypotension, hair

loss, and headache (19). More serious complications of therapy have occasionally been reported,

including pleuropulmonary fibrosis, which occurs

with some regularity in patients on bromocriptine for extended periods of time, as in the treatment of Parkinsonism (58). Psychosis has been reported to have been induced by bromocriptine

(69), ostensibly due to effects on central neurotransmitters. Of particular concern are reports

of stroke and myocardial infarction in young,

apparently healthy women on moderate doses of

bromocriptine. It is believed that these complications may be due to an increase in coagulability

of blood (18).

As with other drugs used to induce ovulation,

gonadotropin releasing hormone carries some

risks. Hyperstimulation of the ovary has been reported using Gn-RH. However, this risk appears

to be less likely than with CC or hMG ovulation

induction (58).

The hormone that has become most widely used

in the suppression of endometriosis is danazol.

Most women taking this drug experience bloating and weight gain (12). Additional possible side

effects include muscle cramps, flattening of the

breasts, hot flushes, oily skin, depression, acne,

and hirsutism (12). Other infrequent complications

that have been reported include thrombocytopenia, hepatotoxicity, hepatitis, and hepatocellular

carcinoma (58).

There is no evidence that danazol therapy can

cause persistent reproductive toxicity after the

drug is stopped; however, inadvertent administration of danazol during pregnancy can cause

masculinization of female fetuses (40).

Male

A number of different agents that are used to

induce ovulation have also been used in an attempt

to optimize semen quality in infertile or subfertile men. These include androgens, CC, hCG, hMG,

Gn-RH, glucocorticoids, and a variety of other

agents.

The rationale for giving androgens is to temporarily suppress the activity of the testes, Subsequent withdrawal of the androgens then might

be accompanied by a rebound increase in spermatogenesis. Androgens administered to some

men may suppress sperm production altogether

with no subsequent rebound. It is unclear, however, if this is a complication of the drug treatment or of the primary testicular disorder for

which the therapy was given (58).

The use of CC in oligospermic men is based on

the anti~estrogenic activity of this drug. There have

been occasional reports of serious adverse effects

of this therapy, including a case of pulmonary embolism (13) and two cases of testicular germ cc]]

tumors after therapy (51). The occurrence of such

isolated cases may be coincidental and cannot be

interpreted as indicating a risk of the therapy. It

is considered unlikely that CC poses a significant

health risk for men (58).
130 ● Infertility: Medical and Social Choices

Glucocorticoids have been used in men to reduce the development or activity of sperm antibodies. Glucocorticoids, given chronically, maybe

associated with adrenal suppression, osteoporosis, impaired glucose tolerance, psychosis, and

other complications. Men receiving glucocorticoids for sperm antibodies develop such complications as readily as any other patient (54).

Side effects and potential complications of bromocriptine, used to treat male infertility, are similar for men and women.

Surgery

Female

The complications of general anesthesia, including drug reactions, cardiac depression, hypotension, aspiration, and death, do not appear to be

different for infertility surgery than for surgery

in general. Surgical complications such as injury

to bowel, excessive blood loss, and infection are

possible with any intra-abdominal operation (58).

Because surgery may cause scar tissue of its

own, much effort has gone into developing procedures to prevent postoperative pelvic adhesions.

However, adhesions and scarring remain potential consequences of reproductive tract surgery.

The complication of tubal surgery of greatest

concern is ectopic pregnancy. A number of investigators have reported ectopic pregnancy rates

after tubal surgery ranging from 4 to 38 percent

(58).

Use of lasers at laparotomy for tubal reconstructive surgery may be associated with complications

specific to the laser, such as inadvertent reflection of the laser beam resulting in damage to other

tissues or in the starting of fires in the surgical

drapes. The incidence of documented injury from

laser surgery in the abdomen has been reported

to be less than 0.5 percent (18).

Laser laparoscopy is an acceptably safe tool for

the treatment of endometriosis, although intraabdominal bleeding may require the use of traditional cautery for control. Based on the limited

number of reports available, serious complications

do not appear to occur more often than in laparoscopies in general (58).

Male

The major risk of male genital tract surgery such

as reversal of vasectomy is operative infection and

bleeding. The major complication of varicocele ligation is postoperative hydrocele, a collection of

fluid in the scrotum. The fluid collection maybe

due to inadvertent destruction of lymphatic drainage vessels during the procedure (68).

Testicular atrophy was also at one time a complication of varicocele ligation, occurring in as

many as 14 percent of cases. Improvements in

surgical technique appear to have eliminated this

complication (28).

Artificial Insemination

The major risk of artificial insemination by

donor is transmission of disease from the donor

to the recipient, including chlamydia, gonorrhea,

cytomegalovirus (a potential cause of fetal illness),

hepatitis B virus, and human immunodeficiency

virus (38)58). The risk appears to be less after intra -

cervical insemination than after intrauterine insemination (67).

In Vitro Fertilization

IVF can involve a number of procedures that

each have risks and possible complications. Ovulation induction for IVF often involves several fertility drugs (CC, hMG, Gn-RH, hCG) used in combination and carries the risks described previously.

Many IVF cycles demonstrate features of luteal

phase deficiency (8,27). It has been proposed that

aspiration of the follicle to obtain the ovum may

damage the follicle or may remove too many

granulosa cells, which impairs subsequent luteal

phase function. Experience with human IVF cycles suggests that the agents used to hyperstimu -

late the ovary are more likely than aspiration to

be responsible for luteal dysfunction (74).

Several oocyte retrieval methods employing

ultrasound-guided aspiration have been developed

(44). Since the aspirating needle may traverse the

bladder, blood in urine is seen with regularity after

this procedure (38,58). It is likely that ultrasoundguided aspiration of follicles will replace laparoscopy in many programs due to comparable re -
Ch. 7—Treatment of Infertility . 131

suits and lower cost, fewer discomforts, and less

risk with the nonoperative approach (34).

obtaining multiple oocytes leads to the possibility that more embryos will be generated than

can be transferred in a given IVF cycle. The cryo -

preservation of excess embryos for use in future

cycles is being considered an important option

in more and more programs. Thawing of frozen

embryos often fails to yield viable embryos. Longterm effects to individuals born after embryo

cryopreservation remain to be fully investigated.

As the number of embryos transferred per cycle increases, so does the incidence of multiple

gestations. Several complications attributable to

the embryo transfer procedure have been reported. The catheter used to introduce the embryos into the uterus may result in trauma to the

endometrium (50). The transferred embryos may

implant in the fallopian tube. The first IVF pregnancy was, in fact, a tubal pregnancy (65). Some

programs report an ectopic pregnancy rate of 2

to 3 percent (39); however, a review of the experience of a number of programs reported that

10 percent of IVF pregnancies are extrauterine

(6). The placement of the catheter high in the

uterus may predispose to ectopic pregnancies. One

study reported a 17-percent ectopic rate with high

placement as opposed to a 2-percent ectopic rate

when the catheter was place in the middle of the

cavity (77).

The miscarriage rate for infertility patients is

generally higher than that for the normal population. Although rates as high as one in three have

been reported for some infertility patients, determination of these risks remains a complex undertaking (see ch. 15).

Preterm delivery is more common in pregnancies after IVF than in spontaneous pregnancies

(4,43). This is partly due to the high incidence of

multiple gestations, although an increased prematurity rate is also seen in births of one infant.

KNOWING WHEN

When you absolutely cannot have children, it’s

called sterility. When it seems to be taking an awfully long time but you still hope, it’s called infertility.

Infertility is worse.

Katherine Bouton

Ms., April 1987

Current estimates indicate that even appropriate therapy will assist only 50 percent of infertile

couples to achieve a pregnancy. Couples often ask

how to know when to quit trying medical treatments. Their uncertainty is complicated by prevalent social assumptions that anything is possible

if one works hard enough, that “where there is

a will there is a way.” In addition, the lack of information about idiopathic infertility in particular contributes to the fear of stopping too soon

and perhaps omitting what would have been a

successful treatment.

Medical indications for stopping treatment are

not yet well developed because:

● selected reproductive technologies have only

recently proliferated and instances of over-

●

●

TO STOP

use have not been well documented;

the current high costs of diagnosing and treating infertility cause many couples to exhaust

their personal resources well before they

have exhausted available treatments; and

existing services for infertile couples may not

help the couple to know when the stress associated with continued diagnosis and treatment

is excessive.

Infertile couples who can afford to continue

treatment may assume that infertility specialists

will tell them when to stop, but in their desire

to help infertile couples to conceive, physicians

may not often enough pause to consider if a particular couple should stop trying.

It may be helpful for infertile couples to ask

themselves:

●

●

●

IS further treatment worth the pain, expense,

and disruption?

Is adoption or childfree living becoming an

acceptable option?

Is treatment costing so much that other goals

are sacrificed?
132 ● Infertility: Medical and Social Choices

● If it is not yet time to stop, when will it be? make this decision, but knowing when to stop will

New information about infertility and overuse continue to be an individual matter for every infertile person and couple. of certain reproductive technologies may help to

SUMMARY AND CONCLUSIONS

A variety of traditional and more recently developed medical and surgical treatments for infertility exist. Treatments often involve both

members of a couple, each of whom may have

a condition that causes subfertility. Medical treatment can range from instruction of the couple

in the relatively simple methods of pinpointing

ovulation to more complex treatments involving

ovulation induction with fertility drugs followed

by artificial insemination. Surgical treatments also

span a wide spectrum of complexity, from ligation of testicular veins for varicocele repair to delicate microsurgical repair of reproductive tract

structures in males and females.

As is true for the diagnostic procedures described in chapter 6, far fewer procedures exist

for the treatment of male infertility than for female infertility. This underscores the lack of basic

knowledge about male reproductive physiology

and the paucity of approaches to treat dysfunctions of this system.

Although sophisticated noncoital reproductive

technologies such as IVF or gamete intrafallopian

transfer offer some hope to some infertile couples who could not otherwise be successfully

treated, improvements of more traditional infertility treatments such as ovulation induction, traditional surgery and microsurgery, and artificial insemination continue to make these treatments the

most widespread and successful approaches. It

is also important to note that even complex and

sophisticated treatment of one partner will be of

no benefit if the other partner suffers from undiagnosed infertility. Therefore, as with diagnostic

technologies, the couple as a unit is properly considered as the infertility patient.

Even as infertility treatments become more sophisticated and complex, basic knowledge of the

male and female reproductive process remains

lacking. Further research stands as a prerequisite in order for dramatic improvements in infertility treatment to occur.

CHAPTER 7 REFERENCES

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Ch. 7—Treatmenf of /nferti/ity ● 1 3 5

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Chapter 8

Infertility Services and Costs
CONTENTS

Page

Infertility Treatment Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. 139

Costs and Effectiveness of Infertility Services . . . . . . . . . . . . . . . . . . . . . . .......144

costs . . . . . . . . . .. .. .. .. .. .. .. .. .. . $ . . . . . . . . . . . . . .......144

Affordability. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ......................144

Access to Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...145

Effectiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...146

Aggregate U.S. Expenditures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...............146

Non-IVF Expenditures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ......146

IVF Expenditures. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .........147

Total Expenditures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ......147

Third-Party Reimbursement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...147

Recent Developments in Insurance.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......149

Future Developments . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ....152

The Cost of Insurance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ......155

Public Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...156

Federal Employee Health Benefits Program. . . . . . . . . . . . . . . . . . . . . . . .......156

IVF/Infertility Centers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....157

General Operating Characteristics. . . . . . . . . . . . . . . . . . . . . . . ...............157

Type of Services offered . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..............157

Funding Sources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...........158

Demand for Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......158

Opening Up New Centers. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .159

Future Trends . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............160

Summary and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..............160

Chapter p references. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...............162

Box

Box No. Page

8-A.Integrating Psychological and Medical Treatment. . . . . . . . . . . . . . . . . . . . . ..159

Figures

Figure No. Page

8-1.Infertility Health Care Dollar: Household Expenditures . .................148

8-2. Typical Language Describing Health Care Benefits Related to IVF and

Artificial Insemination. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..............154

8-3. Distribution of IVF/Infertility Centers in the United States . ..............158

Tables

Table No. Page

8-l. Estimated Costs of Infertility Services, 1986 . ..........................141

8-2. Scenarios of Infertility Diagnosis and Treatment . ......................142

8-3. Summary of Infertility Diagnosis and Treatment Scenarios . . . . . ..........143

8-4 .Affordability Analysis for Insured Couples . ...........................145

8-5. infertility Expenditures in 1980, by Source of Payment . . . . . . . . . .........147

8-6. infertility Expenditures in 1980, by Type of Service . ...................148

8-7. Status of Insurance Coverage for Infertility. . ..........................152
Infertility Services and

Chapter 8

costs

This chapter examines the current state of infertility-related services from the perspectives of

costs, affordability, and insurance coverage. For

the purposes of this report, infertility-related services, referred to as infertility treatment, include

medical and surgical diagnostics and treatments

that attempt to directly overcome diseases and

disorders that cause infertility as well as technological procedures and practices that attempt to

circumvent infertility conditions.

As infertility-related services are adapted and

refined, and as infertility treatment centers increase in number, questions arise about the costs

of the services, the recipients of treatment, and

the effectiveness of the services. This chapter considers:

●

●

How much do various infertility treatments

and technologies cost for typical courses of

treatment? For atypical treatments?

What are the total infertility -treatment-related

expenditures in the United States? How is the

infertility health care dollar spent? How is the

cost burden distributed among individual,

public, and private payers?

How effective are different infertility treatments? Do certain types of infertility treatments have better success records than others

and, if so, are these success rates correlated

with identifiable factors?

How widespread is access to infertility treatment for various types of infertile couples?

Does access depend on income, geographic

location, or other factors?

The number of new infertility cases per year

is unknown, but has been estimated to be between

111,200 and 161,240 (6,7). The number of patients

receiving treatment for infertility is estimated at

between 200,000 and 300,000 per year, for the

following disorders:

● ovulatory disorders, 120,000 patients;

● endometriosis, 30,000 patients;

● tubal disorders, 20,000 to 40,000 patients; and

● seminal factors, 20,000 to 45,000 patients.

In addition to these estimates, the National Survey of Family Growth estimates that about 1 million couples use some form of infertility services

annually (15,18).

INFERTILITY TREATMENT SCENARIOS

In most cases, infertile couples first seek medical assistance so that they can have a baby genetically related to each of them. Should these attempts fail, they may consider methods by which

they can have a baby that is the genetic product

of at least one member of the couple (i.e., artificial insemination by donor, embryo donation,

ovum donation, or surrogate motherhood), or they

may consider adoption. In comparing the costs

and availability of assistance for infertile couples,

it is important to keep in mind the widening range

of alternatives that infertile couples face.

This discussion focuses on infertile married couples, primarily on the women. Although men and

women are equally likely to be infertile, male infertility does not account for an equal proportion

of the costs spent on infertility because there are

relatively few diagnostic and treatment services

for men.

In treating infertility, the more tailored the protocol is to the patient, the more likely the chance

of success. Some specialists, for example, treat

endometriosis with surgery, with drugs, or with

both; the choice of therapy, the length of time,

and the drug dosage prescribed depends on the

woman’s history and reactions as well as on the

severity of the disease. Many patient-specific decisions may be made over the course of treatment;

the results of each test and the success of each

treatment indicate the next steps to be taken. Because of the varieties of sources and types of infertility, it is often difficult to determine whether

139
140 ● Infertility: Medical and Social Choices

standard treatment protocols exist, how much

each treatment costs, and what the effectiveness

is expected to be.

In addition, as in any advancing medical arena,

infertility specialists disagree as to the proper

course of action in many cases. Some physicians

investigate mechanical problems such as blocked

or scarred fallopian tubes as part of the routine

workup; others wait until ovulatory problems are

cleared up before determining the status of the

tubes (4).

Finally, there are tradeoffs to be made in cost,

convenience, and surgical invasiveness. For example, most infertility workups do not routinely

include a sperm penetration (hamster~oocyte) test

because of its $3OO price tag and the uncertainty

of its importance. Nevertheless, hindsight can

sometimes show that the test would have been

appropriate and would have saved thousands of

dollars and numerous invasive procedures.

More often, cost savings can be gained by grouping procedures together. For example, if a hysteroscopy, hysterosalpingogram, and laparoscopy

are all performed at the same time, the cost to

the patient will likely be lower than if the hysterosalpingogram is done earlier, in an outpatient

setting. Furthermore, an early hysterosalpingogram may indicate no need to proceed with surgical diagnostics. Practices vary among specialists.

To examine the typical costs and procedures

faced by an infertile couple, a series of hypothetical scenarios were developed to reflect the course

of diagnosis and treatment of common infertility

problems (4)12). The scenarios proceed from simple procedures to more complex techniques. A

detailed description of the types and cost of possible procedures involved is presented in table 8-1.

Table 8-2 summarizes the procedures and costs

for each scenario.

Stage I Scenario—lnitial Diagnosis and Treatment. Couple seeks treatment for infertility. Full

patient histories and physicals are performed; routine tests are done to check hormone levels and

sperm quantity and motility. Counseling may be

offered to determine whether behavioral changes

may be helpful and to inform the couple of options and prognoses.

Assume, for purposes of the scenario, that the

problem is oligomenorrhea (scanty or infrequent

menstruation), a problem found in about 20 percent of infertile women and roughly applicable

to women suffering ovulatory problems in general. The treatment prescribed in this stylized version of infertility services is the use of fertility

drugs, first with clomiphene citrate, then (assuming that clomiphene citrate is ineffective) with

menotropins (human menopausal gonadotropins).

Stage I diagnosis and treatment is estimated to

require about 6 to 9 months to complete, yielding

a pregnancy rate of about so percent. Thus, if

100 infertile women were to begin this course of

treatment, so pregnancies would be expected at

the end of Stage I. Total costs of Stage I for the

couple are $3,668.

Stage II Scenario-Comprehensive Infertility

Evaluation for Persistent Infertility. This scenario

includes the full range of diagnostic tests for nonovulatory causes of infertility, including investigation of infections, hysteroscopy, and cervical

mucus tests. Some of the tests may have therapeutic value as well, and thus represent both diagnostic and treatment services. This is especially

true for laparoscopy; where feasible and necessary, surgery for endometriosis or adhesions can

be performed at the same time a diagnostic

laparoscopy is done.

Stage II is likely to require about 1 year to complete, although for many couples less time is required for a diagnosis. This more comprehensive

evaluation is likely to pinpoint fertility problems

that are less obvious than oligomenorrhea, such

as endometriosis, adhesions, sperm antibodies, lu -

teal phase defects, and others. Once diagnosed,

these conditions would receive appropriate treatments. It is estimated that Stage II would have a

30-percent success rate, and would cost $2,055.

If the 70 couples who did not conceive after Stage

I continued on to Stage II, at the end of 18 to 21

months (end of Stage II), out of the original 100

infertile women, there would be a total of 51 pregnancies (i.e., 30 plus 0.3 times 70) . The total cost

of only diagnostics from both Stages I and II is

$2,905 (7,11).

Stage III Scenario—Tubal Surgery. The assumption in the Stage III Scenario is that the Stage
Ch. 8—Infertility Services and Costs ● 141

Table 8.1.– Estimated Costs of Infertility Services, 1986°

Service Median survey cost Survey range of costs Other estimates

Diagnostic services:

Patient history and full physical. . . . . . . . . . . . . . .

Infection screen . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sonography (per exam) . . . . . . . . . . . . . . . . . . . . . .

Hormone tests (per test) . . . . . . . . . . . . . . . . . . . . .

Pelvic exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cervical mucus:

Postcoital test . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Mucus penetration . . . . . . . . . . . . . . . . . . . . . . . .

Hysterosalpingogram . . . . . . . . . . . . . . . . . . . . . . . .

Endometrial biopsy . . . . . . . . . . . . . . . . . . . . . . . . . .

Hysteroscopy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Laparoscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Semen analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sperm antibody test . . . . . . . . . . . . . . . . . . . . . . . . .

Hamster-oocyte test . . . . . . . . . . . . . . . . . . . . . . . . .

Infertility counseling . . . . . . . . . . . . . . . . . . . . . . . .

Treatment services:

Medical treatment:

Clomiphene citrate . . . . . . . . . . . . . . . . . . . . . . . .

HMG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

HCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Danazol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Bromocriptine . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Tubal reversals . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Reversal of vasectomies . . . . . . . . . . . . . . . . . . . . .

Tubal surgery forbid... . . . . . . . . . . . . . . . . . . . . .

Repair of varicocele . . . . . . . . . . . . . . . . . . . . . . . . .

Laser laparoscopy. . . . . . . . . . . . . . . . . . . . . . . . . . .

Endometriosis-ablation . . . . . . . . . . . . . . . . . . . . . .

In vitro fertilization . . . . . . . . . . . . . . . . . . . . . . . . . .

Frozen embryo transfer . . . . . . . . . . . . . . . . . . . . . .

Gamete intrafallopian transfer (GIFT) . . . . . . . . . .

Artificial insemination

Husband’s sperm . . . . . . . . . . . . . . . . . . . . . . . . .

intracervical . . . . . . . . . . . . . . . . . . . . . . . . . . . .

intrauterine, washed sperm. . . . . . . . . . . . . . .

Donor sperm . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

fresh . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

frozen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$120

$ 4 0

$100

$ 5 0

$ 4 0

$40

$40

$150

$ 8 5

$400

$800

$45

$75

$275

$ 75’

$ 30 per month

$ 28 per ampule

$588 per month

$20 per 5,000 units

$160 per month

$ 90 per Rx

$2,oooh

$2,000h

N/A

$1,200

$1,200

$4,688

$500

$3,500

$ 5 3

$ 8 5

$80

$100

$50-415

$18-138

$40-186

$25-85

$18-75

$25-100

$25-200

$50-1,500

$50-350

$130-1,100

$400-2,500

$15-108

$35-300

$35-390

$38-135

$16-75

$24-38

$200-1,500

$10-45

$120-200

$30-450

$1,300-5,000

$1,000-2,500

$750-3,800

N/A

$485-3,000

$400-5,000

$775-6,200

$220-1,800

$2,500-6,000

$30-105

$40-200

$35-150

$40-350

$ 60b

$ 40’

$ 25b

$100-300C

$150b

$100-300C

$loob

$650-900 cd

$25-70, c$15b

$300C

$300C

$20/month bc

$40-42bc

$420-504’

$120, g

$135b

$3,000-6,000’

$2,000-2,500 C

$4,000-6,000’

$35-90’

$35-90, c$25b

donor fee . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . $50-100’

aMedlan ‘O~t~ ~ePOfled bY lvF ‘enters ~~”ta’t’d in a November 1988 OTA survey, Figures reported are generallyon a pertest or per procedure basis, for the first

in aseries, where aseries inapplicable. Forexample, one form of artificial insemination is reportedat amedian costof $53. Typically, the$53 would reflect the initial

artificial insemination; subsequent attempts(up to, say, three times permonthfor6 months) might belowerin cost. Similarly, only the cost per hormone test is given,

although a battery of tests is usually done. Examples of actual costs to patients for a given protocol are provided in the scenarios developed in the next section

bG, CoopeL ’’The Magnitude and consequences of lnfert~ityinthe unit’dstat’s;’pr’par’d for Resolve, inc. February 1985, and G. Cooper, ”An Analysis of the Costs

of lnferfility Treatments,M American Jouma/ of Pub/lc Hea/th 76:1016-1019, 1988,

cD, Harris, “what it Costs to Fight Infertility/’ ~Ofr8y, December 1~.

dHospital Laparoscopy runs between $l,escrand$l,~(c~ or around $1,500 (b)

ecounseling charges are often included in charges for full history and physical.

fDrug chargeS only; excludes physician charges.

gJ.H. Bellina and J. Wilson, You Car? Have aBaby (New York, NY: Crown Publishers, lncv 1985)

hphysician fee50nly; excludes hospital charges, cooper, lg~(b), estimates$s,m forail SIJrQiCd procedures.

SOURCE: Office of Technology Assessment, 1986.
142 ● Infertility: Medical and Social Choices

Table 8-2.—Scenarios of Infertility Diagnosis and Treatment

Infertility service cost

Stage I Scenario-Oligomenorrhea

Diagnostics

Patient history and physical . . . . . . . . . . . . . . . . . . . . .

Hormone tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Pelvic exam . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Semen analysis. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Counseling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fertility Drug Treatment

Clomiphene citrate

Drug costs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Blood tests . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Physician visits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

HMG (l month)

Drug costs, 5-10 days . . . . . . . . . . . . . . . . . . . . . . . . . .

Blood test run each day . . . . . . . . . . . . . . . . . . . . . . . .

Ultrasound . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

HCG . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

physician visits... . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$120X2

$50 per test, battery of 3 run 3X 1 month . . . .

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5 days per month

$40X3

$40x2

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

x4 months . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

$28 per ampule X 3 per day X 7 days

$40X7

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Drug treatment total. . . . . . . . . . . . . . . . . . . . . . .

Total, Stage l Scenario (6-9 months) . . . . . . . . . . .

Stage ii Scenario-Complete infertility Evacuation

Screening for infections . . . . . . . . . . . . . . . . . . . . . . . .

Sonography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cervical mucus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Endometrial biopsy . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Hysterosalpingogram . . . . . . . . . . . . . . . . . . . . . . . . . . .

Hysteroscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Laparoscopy (outpatient) (including laser) . . . . . . . . .

Total, Stage II Scenario (12 months) . . . . . . . . . . .

Stage III Scenario-Tubal Surgery

Tubal surgery (for PID)

Physician costs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Hospital charges (anesthesia, operating room,

hospital stay)... . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Laparoscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fertility drug treatment (see Stage l Scenario) . . . . .

Total, Stage III Scenario (18 months) . . . . . . . . . . .

Stage iV Scenario-in Vitro Fertilization

History and physical, counseling . . . . . . . . . . . . . . . .

Drugs (chemical stimulation) . . . . . . . . . . . . . . . . . . . .

Clomiphene citrate

HMG

HCG

Ultrasound assessment of follicular growth . . . . . . .

Hormone blood tests . . . . . . . . . . . . . . . . . . . . . . . . . . .

Laparoscopy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Physician fees

Anesthesia

Operating Room

Embryology and embryo transfer. . . . . . . . . . . . . . . . .

Laboratory

Physician

Hospital room . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Followup, routine tests... . . . . . . . . . . . . . . . . . . . . . .

$ 240

$ 450

$ 40

$ 45

$ 75

$ 850

$ 30

$ 120

$ 100 $ 80

$ 330

$1,330

$ 588

$ 350

$ 250

$ 20

$ 280

$1,488

$2,818

$3,668

$ 40

$ 100

$ 80

$ 85

$ 150

$ 400

$1,200

$2,055

$2,000

$1,500

$ 800

$2,818

$7,118

$ 150

$ 638

$ 500

$ 425

$1,500

$1,100

$ 250

$ 125

$4,688

x 2.0 cycles

Total, Stage IV Scenario (6 months) . . . . . . . . . . . . $9,376

SOURCE: Offlce of Technology Assessment, 1988.
Ch, 8—infertility Services and Costs 143

II evaluation indicates blocked or damaged tubes.

Tubal surgery is then performed on the woman

to repair or open blocked or damaged tubes. In

the absence of pregnancy following surgery,

another laparoscopy may be done and fertility

drug treatment may be started again.

Stage III is estimated to last about 18 months

and to result in a 30-percent pregnancy rate. If

the 49 couples who had not conceived after Stage

II had all proceeded to Stage III, about 15 would

become pregnant, bringing the total of pregnancies to 66. Total cost of the Stage III scenario is

estimated at $7,118. Total cost for all three

scenarios is $12,841.

Stage IV Scenario–In Vitro Fertilization (IVF).

When pregnancy does not result after tubal surgery, IVF may be considered. Only one-third to

one-half of the women who make it to this stage

are likely to be suited to IVF. If one-third of the

remaining 34 couples undertake IVF, and assuming a pregnancy rate in expert hands of 25 percent for IVF, an additional three pregnancies

would result among the 11 couples. Total cost of

Stage IV, assuming an average of two IVF cycles

per couple, is estimated at $9,376 over 6 months.

This estimate assumes retrieval of eggs is done

by laparoscopy rather than with ultrasound, and

that embryos are not frozen. Total cost for a couple undergoing all four stages is $22,217.

All four scenarios thus yield a total of 69 pregnancies out of 100 original infertile women. With

a 25-percent miscarriage rate, the number of

women having successfully completed pregnancies resulting from these scenarios would be about

50.

Although these scenarios are a hypothetical version of the individualized treatment actually

offered to patients, they represent most of the

procedures commonly used in infertility treatment. Table 8-3 summarizes the scenarios, the

associated investments of cost and time, and the

resulting expected pregnancy rates.

Significant changes even in these stylized scenarios can be expected over the next several years

as technological advances occur. Some of these

developments are foreseeable, and some are already being applied in a few centers but have not

yet taken hold industry-wide. Embryo freezing,

for example, allows IVF to be tried a second, and

possibly a third, time without requiring additional

ovulation induction and oocyte-retrieval. As embryo freezing develops and becomes more successful, the costs of subsequent treatment cycles

could drop by half. In addition, ultrasound rather

than laparoscopy is gaining wider use for oocyte

retrieval, potentially cutting costs by an additional

30 percent. The diffusion of new technology will

take time, however. For example, IVF centers that

have invested in developing skills and purchasing equipment used in laparoscopic surgery will

not necessarily dispense with that procedure in

favor of ultrasound retrieval of eggs.

The most significant change likely to occur may

be the frequency with which tubal surgery is

Table 8-3.—Summary of Infertility Diagnosis and Treatment Scenarios

Pregnancy Number o f

Scenario Time cost rate pregnancies

100 couples begin

(after 12 months of unprotected intercourse)

Stage l—Simple diagnosis and treatment

of oligomenorrhea . . . . . . . . . . . . . . . . . . . . . . 6-9 months $3,668 300/0 30

70 couples continue

Stage 11—Compiete infertility evaluation. . . . . 12 months $2,055 300/0 21

49 couples continue

Stage Ill—Tubal surgery. . . . . . . . . . . . . . . . . . . 18 months $ 7,118 30% 15

One-third of remaining 34 couples (11)

are suited to continue

Stage IV—in vitro fertilization . . . . . . . . . . . . . . 6 months $9,376 250/o 3

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . at least 4.5 years $22,217 690/o 69

SOURCE: Office of Technology Assessment, 1988.
144 . Infertility: Medical and Social Choices

bypassed in favor of IVF, gamete intrafallopian

transfer (GIFT), or for a similar type of technology. To date, in most cases, IVF has been considered a last resort treatment, turned to after tubal

surgery has been performed with unsuccessful

results or for idiopathic infertility. There are,

however, growing indications that IVF is now considered earlier on in the process—in effect collapsing Stages III and IV into a single stage. For

COSTS AND EFFECTIVENESS

Data included in this section were collected by

OTA from IVF/infertility centers, published infertility cost information, and other sources.

costs

Diagnostic and treatment procedures tend to

be slightly more expensive at nonprofit centers.

This is most obvious for IVF, where charges may

be $1,000 greater than at for-profit centers. However, this may reflect the relatively more difficult

cases that are treated by larger, longer-established,

nonprofit IVF centers, or merely higher fees (some

of which may support IVF research projects).

The median charges reported to OTA by infertility centers surveyed (see table 8-1) may or may

not reflect typical charges for procedures commonly provided by individual gynecologists and

urologists who are not infertility specialists or are

not associated with an IVF program. (Other data

sources, giving figures generally in the same range,

are also noted on table 8-l.)

In interpreting the cost data in table 8-1, it is

important to recognize that infertility treatment

includes an ever-widening array of approaches.

The experience of the medical community with

regard to proper use and resulting success of this

array are far from universal. Although about 20

to 30 of these procedures are commonly used by

most infertility specialists, differences exist in

methods of application, timing, and experience.

These differences are reflected in both costs and

pregnancy rates. Thus, on some of the procedures

a wide range of costs are reported, and medians

are used rather than means.

example, should oocyte cryopreservation techniques improve, it may be routine to collect

oocytes during diagnostic laparoscopies and store

them for possible IVF or GIFT procedures at a later

time. This approach further reduces both the cost

of infertility treatment and the time involved,

which is often of critical importance to couples

nearing the end of their childbearing years.

OF INFERTILITY SERVICES

Affordability

A couple proceeding through the four scenarios

outlined earlier do not move automatically

through each stage. Even at this highly stylized

level of analysis, the process is dynamic. At each

stage, some couples are successful in achieving

pregnancy, while others are unsuccessful and continue on. Still other couples are unsuccessful and

drop out, whether for reasons of cost and affordability, the strain on relationships and careers, advancing age, the attractiveness of other options

such as adoption or surrogate motherhood, or

another reason, As the couple proceeds through

these stages of treatment, the chances of pregnancy recede, and the costs escalate.

To what extent are these costs affordable, both

for infertile couples and for society? On an individual level, the substantial costs of the four

scenarios are beyond the reach of low-income couples and represent a sizable investment for middleincome couples. Table 8-4 provides the basis for

assessing the affordability of each scenario for

married couples in the United States. For married couples with before-tax incomes under

$20,000, the out-f-pocket costs per stage range

from 6 to 62 percent of annual income. For married couples with before-tax incomes ranging from

$20,000 to $35,000, infertility expenditures represent between 2 and 23 percent of annual income. Finally, for the remaining married couples,

those with incomes over $35,000, costs represent

between 1 and 12 percent of annual income. Alternative assumptions about the levels of income and

insurance coverage of typical infertile couples

would alter the results. These figures apply only
Ch. 8—Infertility Services and Costs ● 145

Table 8-4.—Affordability Analysis for Insured Couples

Percent of annual household income

Scenario Low-income Middle-income High-income

Stage 1: 11 4 2

Diagnosis and fertility drug treatment

Total Cost: . . . . . . . . . . . . . . . $3,668

Cost to Couple:. . . . . . . . . . . $1,100

Stage II: 6 2 1

Complete Evaluation

Total Cost: . . . . . . . . . . . . . . . $2,055

Cost to Couple:. . . . . . . . . . . $ 617

Stage Ill: 21 8 4

Tubal Surgery

Total Cost: . . . . . . . . . . . . . . . $7,118

Cost to Couple:. . . . . . . . . . . $2,135

Stage IV: 62 23 12

In Vitro Fertilization

Total Cost: . . . . . . . . . . . . . . . $9,376

Cost to Couple:. . . . . . . . . . . $6,188

Assumptions:

Income profiles of infertile married couples:

● Low-income group Median income: $10,000 Range: $0-19,999

● Middle-income group Median income: $27,500 Range: $20,000-34,999

● High-income group Median income: $50,000 Range: $35,000 plus

—Insurance coverage:

● Assume all couples have health insurance coverage.

s Assume two-thirds to three-quarters of non-IVF infertility expenditures are reimbursed (i.e., costs to couples = 70 per.

cent of total costs).

● Assume 66 percent of IVF costs are covered, at rate of 66 percent (i.e., 44 percent of IVF charges are covered by insurance).

SOURCE: Office of Technology Assessment, 1966.

to couples who have health insurance. They

underestimate the burden of infertility costs on

low- to middle-income couples, many of whom

remain uninsured or underinsured.

Are the costs of pregnancies using the current

range of infertility treatment services more than

society is willing to pay? A recent analysis shows

that such costs are roughly in line with average

costs of adoption ($3,000 to $10,000) and of surrogacy ($20)000 to $45)000) (21).

Access to Services

In general, a higher proportion of white women

(15 percent) than black women (10 percent) report using infertility services, particularly for

women over age 24. Women who had ever been

married, who had higher incomes, and who had

higher educational levels reported greater use of

infertility services than women never married or

with low incomes or low levels of education

(15,17). Women with primary infertility tend to

seek services more than women with secondary

infertility (13).

There is evidence that, at least in the 1976-82

period, infertility services were not reaching a considerable number of infertile couples. For example, as of 1982, about 200,000 married women

with primary infertility had never sought infertility services although they wanted a baby (13).

Another 550,000 married women with secondary infertility had never sought services. This lat -

ter group of women, compared with those who

have sought services, tended to be of lower socioeconomic status, to have less education, and to

never have worked (13,18).

With regard to financial barriers to treatment,

among the private physicians surveyed by the Alan

Guttmacher Institute (AGI) (l), 21 percent reported

that they accept Medicaid patients; only 6 percent

varied their fees for low-income patients. Among

19 specialized infertility centers, AGI reported that

about half accept Medicaid reimbursement and

16 percent reduce their fees for low-income patients, The AGI study concluded that in general,

people with adequate financial resources, either
146 ● Infertility: Medical and Social Choices

their own or insurance with infertility coverage,

have no more difficulty obtaining infertility services than they do most other types of medical care.

However, infertility services are less available to

low-income couples, and low-income women face

serious financial obstacles to obtaining specialized

or complex infertility services.

Effectiveness

Interpreting effectiveness data in the field of

infertility treatment is difficult and controversial.

First, and most basically, it can be hard to determine what particular service may have been responsible for a pregnancy. Infertile couples seeking treatments are often told that their chances

of success are about 50 percent. Various studies

report that 21 to 62 percent of pregnancies of

treated and untreated infertile couples appeared

to be independent of treatment (5). An in-depth

followup study of 1,145 infertile couples found

that 41 percent of treated couples had pregnancies, while 35 percent of untreated couples became pregnant (5). One IVF clinic, for example,

reported that five women became pregnant while

on the waiting list for IVF, When a number of

infertility approaches have been used over a relatively short period, it becomes virtually impossible to isolate the procedure that worked, if indeed

any procedures were responsible for a subsequent

pregnancy.

Effectiveness or success rate data for more traditional infertility treatments have not been as controversial as those for IVF and related approaches,

in part, perhaps, because the traditional treatments have not been as closely scrutinized. Alternatively, greater emphasis on success rate and

effectiveness data for IVF and related procedures

may stem from the current lack of third-party

reimbursement for them and the need to establish the procedures as acceptable, nonexperimental medical treatments. Rapid introduction and dissemination of these technologies may also be a

contributing factor.

In evaluating the likely success of any particular procedure, there are difficulties in using most

effectiveness measures (see chs. 9 and 15). One

that is used is numbers of babies, but that figure

may include multiple births, which do not reflect,

in a sense, the desired outcome of a baby for each

couple seeking one. Another measure commonly

used is numbers of pregnancies, but definitions

of pregnancy vary. A pregnancy may be defined

as clinical, preclinical, chemical, viable, or live

birth. Some IVF programs report pregnancy rates

per patient, per treatment cycle, per laparoscopy,

or per embryo transfer (19).

Neither babies born nor pregnancies achieved

represent a full measure of effectiveness of infertility treatment. The object of infertility treatment is a safe pregnancy resulting in the live birth

of a healthy baby. To the extent that certain infertility services result in increased health risks,

either to the woman or to the baby, these risks

diminish the “effectiveness” of the procedure. IVF

pregnancies, for example, are about two to four

times as likely as normal conception to result in

an ectopic pregnancy (8,14,21). Other risks include

the daily intake of hormones, anesthesia during

egg retrieval, stress to the uterus, spontaneous

abortion, and multiple pregnancies.

Finally, interpreting success rates on a centerby-center basis is difficult. Some IVF/infertility

clinics are research centers; others offer only IVF,

in a standard, almost production-line approach.

IVF clinics associated with university medical

schools and hospitals tend to receive the most difficult cases and claim that their success rates

would be higher if they had a group of patients

with infertility problems of varying severity. Overall, however, it is worth noting that technologies

and experience take substantial time to diffuse

industry-wide.

AGGREGATE U.S. EXPENDITURES

Non-IVF Expenditures

Estimates of the total cost of treating infertility

in the United States allow measurement of the

amount of societal resources currently devoted

to this problem. One report concluded that most

couples spend little or nothing for infertility problems although a few spend an extraordinary
Ch. 8—infertility Services and Costs ● 147

amount. As a rough estimate the report assumes

an average expenditure of $2OO per couple who

seek help, yielding a total of $200 million for 1982.

Even if the correct figure were twice as high, the

overall estimate for reproduction-related health

expenditures would increase by only 1 percent (9).

Another estimate placed aggregate infertility expenditures between $340 million and $460 million in 1984, based on a survey of service prices

and a construction of the cost of a typical set of

infertility treatment procedures (6,7). The cost of

each scenario was then multiplied by an estimate

of the number of people who used the service,

as derived from several sources.

Data derived from an analysis of a national

population-based survey, the National Medical Care

Utilization and Expenditure Survey (NMCUES),

and from the International Classification of Diseases Code yield an estimate of U.S. expenditures

of between $345 million and $676 million, with

$480 million as the intermediate estimate (21).’

Using the intermediate estimate, table 8-5 reports

this sum by type of medical service and source

IThis analysis employed a version of NMCUES made available by

the National Institute on Aging and software developed at ICF Incorporated. The authors identified diseases related to infertility and

the expenditures for those conditions. To estimate the percentage

of expenditures on each disease that can be considered infertilityrelated, they consulted several additional infertility specialists (4, 12)

who provided estimates of the percentage of treatments where concern for infertility was a primary factor in determining treatment,

or where it was extremely to quite likely that a patient with the

disease would be treated for infertility. They then applied these percentages to NMCUES data on expenditures for each disease.

of payment. Table 8-6 breaks down this figure

into percentage terms of how these expenditures

were distributed by type of service and source

of payment. Hospital expenditures, for example,

amounted to $297 million, representing 62 percent of total infertility expenditures. The other

major category of services was expenditures on

doctors, accounting for $151 million in 1980, or

31 percent of total infertility expenditures. Close

to half that amount ($70 million) was spent on doctors’ charges of over $300 per visit.

Table 8-6 also shows how a couple’s dollar spent

on infertility was divided among services. For

every household dollar spent on infertility in 1980,

more than half (55 percent) went for physician

services. Over a third (36 percent) went to hospitals (mostly for inpatient services), and less than

9 percent was spent on drugs (see figure 8-l).

The picture for expenditures by private insurance companies complements that for households,

Private insurers spent 69 percent of their budget

on hospital care and 26 percent on physician care.

Two-thirds of the expenditures on physicians were

for services that cost more than $3oo.

The category of “all other sources” includes the

amounts paid for infertility services by various

government programs, philanthropy, and company clinics. whereas these payment sources play

a considerable role in national health care expenditures, they account for less than 10 percent of

infertility expenditures, with nearly three-quarters

of that amount spent on services provided in hospital outpatient facilities. As indicated in a survey

Table 8-5.-infertility Expenditures in 1980, by Source of Payment (in millions)a

Type of service Total charges Households Private insurance All other sources

Hospital. . . . . . . . . . . . . . . . . . . . . . . . . $296.9 $36.7 $232.8 $27.4

c Emergency room . . . . . . . . . . . . . . . 1.6 0.6 1.0 0.0

● Outpatient. . . . . . . . . . . . . . . . . . . . . 65.0 5.4 39.9 27.4

● Inpatient . . . . . . . . . . . . . . . . . . . . . . 230.3 30.7 191.9 0.0

Physician service cost . . . . . . . . . . . . 150.6 56.7 87.3 6.6

● $0-100 . . . . . . . . . . . . . . . . . . . . . . . . 43.0 27.3 12.4 3.3

● $101-300 . . . . . . . . . . . . . . . . . . . . . . 37.1 20.1 16.7 0.3

● $301 + . . . . . . . . . . . . . . . . . . . . . . . . 70.5 9.3 58.2 3.0

Other professional. . . . . . . . . . . . . . . . 2.6 0.3 1.2 1.1

Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . 25.5 8.8 15.6 1.1

Other . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.0 0.4 1.5 2.1

Total. . . . . . . . . . . . . . . . . . . . . . . . . . $479.6 $102.9 $338.4 $38.3

aFor ~er~on~ aged 15 t. 44; ~~timate~ e~~lude health care expenditures by the institutional and noflcivilian pOplJl@lOrlS and all expenditures for rlorlprescriptiofl drugs,

SOURCE: Office of Technology Assessment, 1988.
148 ● Infertility: Medical and Social Choices

Table 8-6.–infertility Expenditures in 1980, by Type of Service (in percentages)

Type of service Total charges Households Private insurance All other sources

Hospital. . . . . . . . . . . . . . . . . . . . . . . . . 62.0 35.7 68.8 71.5

Physician . . . . . . . . . . . . . . . . . . . . . . . 31.4 55.1 25.8 17.2

Other professional. . . . . . . . . . . . . . . . 0.5 0.3 0.4 2.9

Drug. . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.3 8.5 4.6 2.9

Other health . . . . . . . . . . . . . . . . . . . . . 0.8 0.4 0,4 5.5

Total. . . . . . . . . . . . . . . . . . . . . . . . . . 100.0 100.0 100.0 100.0

aFor persons aged 15 to 44; estimates exclude health care expenditures by the institutional and noncivilian populations and all expenditures for nonprescription drugs.

SOURCE: Office of Technology Assessment, 19SS.

Figure 8=l.— Infertility Health Care Dollar:

Household Expenditures

Physician (55.1 0/0)

-, ‘ =’i’ -),’ , Other professionals (0.4°/0)

1’

1 ~ Other (0.3°/0)

r

Drugs (8.5°/0)

Hospital (35.7°/0)

How the infertility y health care dollar spent by households was

divided among professionals, hospitals, drugs, and other sewices in 1980. Developed from National Medical Care Utilization and Expenditure Survey.

SOURCE: Office of Technology Assessment, 19S8

of private physicians conducted by the Alan Guttmacher Institute (l), the primary sources of funds

in infertility treatment are patient fees and private insurance.

IVF Expenditures

Data about the cost and number of IVF procedures in 1986 were collected from OTA’S survey

of centers, published estimates, personal communications, and other sources (21)23), OTA estimates

that the average cost of IVF was between $4,000

and $6,000 (median $4,688; see table 8-1), OTA

estimates that approximately 14)

000 completed

IVF cycles were performed in 1987 in the United

States. (One estimate places the number of IVF

cycles at 21,000 (24).) At a median cost of $4,688

per cycle, this represents a total expenditure on

IVF of $66 million in 1987.

Total Expenditures

OTA estimates the total 1987 expenditures on

infertility as the sum of the non-IVF and IVF expenditures. To reach a figure for the former, the

estimate of 1980 non-IVF expenditures is inflated

by 10 percent each year to reflect changes in the

cost of medical care and in the incidence of infertility diagnosis and treatment. This raises the 1980

estimate of $480 million to about $935 million in

1987. Together with IVF expenditures of $66 million, total infertility expenditures in 1987 are therefore estimated at $1.0 billion.

This approach assumes that the treatment of

infertility has not changed ‘(structurally” (e.g., in

the relative expenditures on hospital services v.

doctors) since 1980. It also assumes that IVF does

not replace previous treatments, but represents

a new, suppkrnental cost.

THIRD-PARTY REIMBURSEMENT

Conventional infertility treatment services may this coverage is specific to each insurance plan,

be covered by insurance, as long as they can be varying among underwriters, group policy purassociated with medical conditions or diseases re- chasers, and geographic location (10). Of total U.S.

quiring diagnosis and/or treatment and not solely non-IVF infertility expenditures (estimated in the

related to infertility and fertilization. However, previous section as $480 million in 1980), private
Ch. 8—infertility Services and Costs ● 149

insurance paid 70 percent and individuals paid

22 percent out-of-pocket, with the remainder paid

by other sources.

While individuals paid 12 percent of hospital

costs related to infertility, they paid 38 percent

of physician charges. As would be expected, individuals paid a larger share (64 percent) of physician charges under $101 than of charges over $300

(13 percent).

In 1986, some 2.3 million organizations in the

United States had health care plans, and 176,424

of these (8 percent) were reportedly self-funded

(10,16). There are currently no comprehensive

data available that detail the number of these thirdparty plans providing infertility coverage or the

extent of this coverage. However, several general

comments can be made about the provisions of

these programs that can be applied to infertility

coverage.

Examination of third-party reimbursement for

infertility services must take into account that the

technology applied to these services and to medical treatment in general is changing rapidly, as

is the structure of third-party reimbursement, and

that both of these trends can evoke a variety of

responses. In the case of technology, for example, IVF, which was initially introduced to the

United States in 1981, is still considered by many

third-party payers to be “experimental” and therefore not insurable. At the same time, however,

some carriers provide largely routine coverage

for IVF, a rather remarkable development in such

a short time (22).

With respect to the structure of third-party

reimbursement, there has been a dramatic shift

away from traditional group health insurance

(Blue Cross/Blue Shield) and commercial insurance )) which accounted for roughly 95 percent

of the total as recently as 1980; some forecasts

indicate that these traditional insurance plans may

account for as little as 5 percent by 1990. Much

of the shift is to health maintenance organizations

(HMOS) and to preferred provider organizations,

which did not even exist in 1980. As much as 25

percent of the total by 1990 maybe under ‘(managed care” plans, also a creature of the 1980s.

In general, most of these health care plans offer benefits that are a standard package of hospital, surgical, and medical services, with or without major medical or comprehensive provisions.

Once these basic provisions are met, the insurer

will normally be willing to tailor provisions to the

tastes of the buyer. This tailoring may apply, for

example, to combinations of deductibles and copayments, specific exclusions, and special additions to normal coverage. The most important variable here is typically the availability of premium

dollars, since most group plans are experiencerated.

Given the fact that cost containment has been

the dominant theme of both health insurers and

employers during the 1980s, there is reason to

believe that many group health plans may have

chosen to restrict coverage for certain “fringe”

services, of which infertility treatment is an example. Since many people still have a variety of

moral and ethical concerns in reference to some

infertility services, restrictions based on the source

of eggs and semen (i.e., spouse versus donors) will

undoubtedly continue to appear in some plans for

years ahead.

Recent Developments in Insurance

Delaware

In Delaware, a statewide program was instituted

by its Blue Cross/Blue Shield Association in response to a nearly successful attempt to have coverage mandated by the State. Since January 1,

1987, employees of the State of Delaware have

been covered for IVF and employees of midsize

firms (3OO to 500 employees) have been offered

coverage as a rider (21). Large employers have

the option to purchase IVF coverage as their contracts are renewed throughout the year,

Delaware Blue Cross/Blue Shield does not require patients to undergo a minimum waiting

period, although all other means, with the exception of tubal surgery, must be tried by the patient.

The actuaries anticipate that some of the IVF costs

will be offset by a reduction in the use of tubal

surgery. Although no restrictions apply to the

number of cycles a person may attempt or the

cost per cycle, a lifetime maximum of $25)000 will

be paid; for artificial insemination, the lifetime limit

is $600, although either donor or spousal sperm

will be covered.
150 ● /fertility: Medical and Social Choices

Surgical procedures, including tubal reconstruction, are covered if medically necessary, but not

simply to reverse previous contraceptive sterilization. Delaware Blue Cross/Blue Shield routinely

covers surgical sterilization without medical necessity, on request (10). Company actuaries estimate that 90 to 95 percent of costs per cycle will

be reimbursed by the insurance plan. The cost

of insurance is about $0.60/person/month.

Maryland

In Maryland, the State has mandated coverage

of infertility treatments. However, this mandate

does not require coverage for artificial insemination, a treatment that normally precedes IVF, but

Blue Cross/Blue Shield added this to its policy to

assure that this less costly procedure would be

attempted before IVF (10). Aside from the mandated IVF benefit, the standard Blue Cross/Blue

Shield contracts in Maryland cover all other infertility services on the same basis as other medical procedures. If the group contract provides for

diagnostic services (which 90 percent of their contracts do) or drug coverage (75 percent of basic

contracts and 95 percent of major medical contracts do), they are covered in the same manner

for infertility services as for any other. Similarly,

the same rules apply for deductibles (usually $100

t. $200), coinsurance on major medical (normally

80 percent), and out-of-pocket limits on major medical expenses. About half the policies have such

a limit, usually in the $2,500 range (10).

Attempts by the insurance industry in Maryland to limit coverage to five IVF cycles were

defeated, and in 1985 insurance plans were required to offer benefits for IVF at the same level

as benefits for other pregnancy related procedures [Maryland Insurance Code Sees. 354DD,

470WW, 477EE, 1987]. This coverage extends to

the insured and the insured’s spouse. At the same

time, some important restrictions on coverage

were put in place:

●

●

The couple seeking IVF treatment must be

using their own gametes.

The person seeking IVF treatment must have

been seeking infertility treatment for at least

5 years, or the infertility must be associated

with one or more of the following conditions:

●

●

●

endometriosis, exposure to diethylstilbestrol,

or blockage or surgical removal of one or both

fallopian tubes (it is not clear whether reversal of voluntary sterilization would be covered); however, IVF benefits for couples with

male-factor only infertility are not covered.

The person seeking IVF treatment must have

exhausted all non-IVF treatments covered under the insurance plan.

Only outpatient services are covered.

The IVF procedures must be performed at

a facility that conforms to the American College of Obstetricians and Gynecologists

(ACOG) guidelines for IVF clinics or the American Fertility Society’s (AFS) minimal standards for IVF programs.

Although the State mandated coverage by all

insurance carriers, not everyone in Maryland is,

in fact, covered. Since the State has no jurisdiction over Federal or municipal employees, the legislation does not apply to them. Consequently, neither Federal employees working or residing in

Maryland nor employees of the City of Bahimore

are covered, Furthermore, the mandate does not

apply to groups that are self-insured. Many, if not

most, organizations with 500 or more employees

have Administrative Services Only contractual arrangements with an insurance carrier, whereby

the insurer provides only administrative services

and the benefits are self -insured. As a result, most

employees of large organizations in Maryland may

not be covered for IVF. In addition, Maryland’s

mandate to provide insurance coverage for IVF

does not apply to its Medicaid program. The current cost charged by Blue Cross/Blue Shield in

Maryland averages $1.06/household/month, and

the company anticipates that 75 to 80 percent of

IVF expenses will be reimbursed by the plan.

Hawaii

Hawaii’s legislation (Act 332, 1987), effective

June 26, 1987, states that all individual and group

health insurance plans that provide pregnancyrelated benefits must provide, in addition to any

other benefits for treating infertility, a one-timeonly benefit for the outpatient expenses resulting from IVF for the insured or the insured’s

spouse. The one-time~only benefit is considered
one IVF cycle. Restrictions on eligibility do not differ from those in Maryland except that abnormal

male factor contributing to the infertility is also

considered an indication for IVF treatment.

Texas

In Texas, legislation effective September 1, 1987

(Act HB 843, 1987), requires that all insurers or

administrators of group health insurance policies,

self-insured plans, and all health maintenance

organizations must offer benefits for IVF in all

plans that have maternity benefits. The policyholder does not have to accept these benefits. The

benefits must be provided to the same extent as

benefits provided for other pregnancy-related

procedures under the policy. Only an insurer affiliated with a bona fide religious denomination

that objects to IVF for moral reasons is exempt

from the requirement to offer coverage for IVF.

The restrictions on eligibility in Texas, like those

in Hawaii, state that oligospermia is also an indication for treatment.

Arkansas

Arkansas legislation in 1987 (Act 779, 1987)

directed the Insurance Commissioner to issue regulations setting benefit levels for IVF coverage.

The regulations, effective December 31, 1987 [Regulation No. 1 (Nov. 18, 1987) pursuant to Act 779

(1987)], require that insurance policies offering

maternity benefits offer IVF benefits as well, at

the same level as those for maternity. Restrictions

are basically the same as those in Hawaii except

that the couple need only have a 2-year history

of unexplained infertility, and a woman who has

been voluntarily sterilized is explicitly ineligible.

Cryopreservation is specifically included as an IVF

procedure. The IVF must be performed in a Statelicensed or certified facility, with the Department

of Health in charge of licensing and certifying.

However, if no such facility is licensed or certified in Arkansas or no such licensing program is

operational, then coverage shall be extended for

any procedures performed at a facility that conforms to the ACOG guidelines for IVF clinics or

to the AFS minimal standards for programs of IVF.

Finally, a lifetime maximum benefit is set at

$15,000, which may also include other infertility

treatments.

—

Ch. 8—Infertility Services and Costs ● 151

Massachusetts

Legislation in Massachusetts is more extensive

than in the other States. In 1987, the Commonwealth of Massachusetts enacted legislation requiring that insurance plans covering pregnancyrelated benefits provide coverage for medically

necessary expenses of diagnosis and treatment

of infertility to the same extent that benefits are

provided for other pregnancy-related procedures

(Act H 3721, 1987). Infertility was defined as “the

condition of a presumably healthy individual who

is unable to conceive or produce a conception during a period of one year. ” The resulting regulation on infertility benefits promulgated by the Division of Insurance outlined these benefits in more

detail [211 C.M.R. 37.01 to 37.11, pursuant to Mass.

Gen. Law chs. 175 and 176 (1987)]. Both the legislation and the regulations went into effect January 6, 1988.

Under the new regulations, insurers must provide benefits for all nonexperimental infertility

procedures. These include, but are not limited to,

artificial insemination, IVF, and other procedures

recognized as generally accepted or nonexperimental by the AFS, ACOG, or another infertility

expert recognized as such by the Commissioner

of Insurance. Gamete intrafallopian transfer is considered experimental, and surrogacy, reversal of

voluntary sterilization, and procuring donor eggs

or sperm are specifically excluded. The insurers

may establish reasonable eligibility requirements

that must be available to the insured and the Commissioner upon request. The regulations suggest

that standards or guidelines developed by AFS or

ACOG may serve as eligibility requirements.

Private Insurers

The Prudential medical insurance programs recognize infertility as an illness, and routinely cover

virtually all related services, including artificial

insemination (restricted to only husband and wife,

no donors or surrogates) and IVF, so long as the

services conform to ACOG standards and are determined to be medically necessary. Drugs, such

as clomiphene citrate and human menopausal

gonadotropin, are covered, dependent on the plan

(i.e., whether drugs are covered for other purposes). Deductibles, copayments, and out-of-
152 ● /fertility: Medical and Social Choices

pocket limits are the same for IVF as for all other

covered services (10).

A number of insurance company representatives contacted specifically noted, however, that

even under plans where no IVF or other infertility coverage exists or is intended, many if not most

individual procedures can individually “slip by the

screens.” If claims for services are submitted by

a physician as “medically necessary” and the word

“infertility” does not specifically appear, coverage

is more likely to result (10).

Future Developments

Future developments for third-party reimbursements are difficult to predict because of the changing structure of the health care delivery systems

as well as the rapid development of innovative

technologies. However, some general trends may

be predicted:

●

●

●

●

Greater movement by all types of insurers

toward requiring preauthorization for an increasing number of services, second opinions

for elective surgery, and a variety of other

controls that do not deny coverage, but that

tend to control utilization. Although many of

these techniques originated in the context of

“managed care” situations, they are now being adopted in virtually all settings.

Lifetime limits and limited cycles of treatment

in a given time period applied to some infertility treatments, and selective coinsurance

applied to others.

A growing proportion of infertility services

being performed on an ambulatory basis,

driven in that direction both by the pressure

generated by these selective insurance provisions and, quite independently, by rapid

changes in medical technology (10). As some

of the more expensive infertility treatments

grow in acceptance (because they are better

known, clinically proven, and no longer experimental) and demand (because they will

increasingly be covered), more infertile couples will be shielded by out-of-pocket limits.

An increased number of States mandating infertility coverage (see table 8-7) (10,2 o).

The demand for health services, both in the

United States and around the world, has always

Table 8-7.–Status of Insurance Coverage for Infertility

Legislation Legislative No legislation

.State/jurisdiiction exists activity on infertility

Alabama . . . . . . . . . . . . .

Alaska . . . . . . . . . . . . . . .

Arizona . . . . . . . . . . . . . .

Arkansas. . . . . . . . . . . . .

California . . . . . . . . . . . .

Colorado . . . . . . . . . . . . .

Connecticut . . . . . . . . . .

Delaware. . . . . . . . . . . . .

District of Columbia . . .

Florida. . . . . . . . . . . . . . .

Georgia . . . . . . . . . . . . . .

Hawaii . . . . . . . . . . . . . . .

Idaho . . . . . . . . . . . . . . . .

Illinois . . . . . . . . . . . . . . .

Indiana . . . . . . . . . . . . . .

lowa. . . . . . . . . . . . . . . . .

Kansas . . . . . . . . . . . . . .

Kentucky. . . . . . . . . . . . .

Louisiana . . . . . . . . . . . .

Maine . . . . . . . . . . . . . . .

Maryland . . . . . . . . . . . . .

Massachusetts . . . . . . .

Michigan. . . . . . . . . . . . .

Minnesota. . . . . . . . . . . .

Mississippi . . . . . . . . . . .

Missouri . . . . . . . . . . . . .

Montana . . . . . . . . . . . . .

Nebraska . . . . . . . . . . . .

Nevada . . . . . . . . . . . . . .

New Hampshire. . . . . . .

New Jersey . . . . . . . . . .

New Mexico . . . . . . . . . .

New York . . . . . . . . . . . .

North Carolina . . . . . . . .

North Dakota . . . . . . . . .

Ohio . . . . . . . . . . . . . . . . .

Oklahoma . . . . . . . . . . . .

Oregon . . . . . . . . . . . . . .

Pennsylvania . . . . . . . . .

Puerto Rico . . . . . . . . . .

Rhode Island . . . . . . . . .

South Carolina. . . . . . . .

South Dakota. . . . . . . . .

Tennessee . . . . . . . . . . .

Texas. . . . . . . . . . . . . . . .

Utah. . . . . . . . . . . . . . . . .

Vermont . . . . . . . . . . . . .

Virginia . . . . . . . . . . . . . .

Washington . . . . . . . . . .

West Virginia . . . . . . . . .

Wisconsin. . . . . . . . . . . .

Wyoming. . . . . . . . . . . . .

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

x

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

x

. . . . . . . . .

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. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

x

x

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x

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. . . . . . . . . x

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x . . . . . . . . . . . .

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x . . . . . . . . . . . .

x . . . . . . . . . . . .

. . . . . . . . . x

. . . . . . . . . x

. . . . . . . . . X

a

. . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . x

. . . . . . . . . x

. . . . . . . . . x

. . . . . . . . . x

. . . . . . . . . x

. . . . . . . . . x

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. . . . . . . . . x

. . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . x

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. . . . . . . . . x

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. . . . . . . . . x

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. . . . . . . . . x

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. . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . x

. . . . . . . . . x

. . . . . . . . . x

x . . . . . . . . . . . .

. . . . . . . . . x

x . . . . . . . . . . . .

. . . . . . . . . x

aHowever, the G@rgia insurance department routinelv reauires ~1 insurance carriers to cover infeti-ility treatment except for experimental procedures, and IVF

is currently considered experimental (R. Terry, Chief Deputy Commissioner,

Regulatory Law Division, Office of Commissioner of Insurance, Atlanta, GA, personal communication, September 1987),

SOURCE: Office of Technology Assessment, 1988.

been significantly influenced by the level of thirdparty reimbursement. Thus, assuming that most

infertility services are eligible for at least some

level of coverage, and that the overall level of reimbursement improves, demand can be expected to

increase. When this will occur is difficult to predict. There is generally a timelag between the in-
Ch. 8—Infertility Services and Costs . 153

production of new coverage and the increase in

demand. This is explained by the learning curve

of consumers and providers of care, who do not

immediately perceive the change and therefore

require some time before altering their behavior.

Another factor that may contribute to an increase

in demand is improvement in expected results (i.e.,

technology. This maybe a particularly important

factor in relation to infertility services.

With the advent of IVF, gamete intrafallopian

transfer, and other new reproductive technologies, the issue of insurance coverage has become

more controversial and more influential in determining what types of treatment are sought and

provided.

A major concern of insurers is to protect themselves from covering risks where the likelihood

of the event occurring can be influenced by the

insured party. This concern is generally referred

to as moral hazard. Insurers who underwrite such

risks could be subject to adverse selection. In their

quest for a “fair bet,” insurers will often pass up

an insurable risk when they think they cannot

at reasonable cost protect themselves from adverse selection. Insurance markets can fail altogether if insurers think they are buying a risk

but are in fact buying a certainty.

Even if they can arrange a fair risk, insurers

do not want the amount at which they are at risk

to be extremely large. Furthermore, they prefer

to insure events where the likelihood of the event

occurring is known rather than uncertain. Finally,

health insurers try to avoid covering procedures

that have not met with general approval and that

may be difficult to sell to policyholders. Examples

include costly experimental procedures the efficacy of which has not yet been proved and procedures for which a societal consensus has not

yet developed.

Coverage of IVF procedures poses several problems for insurers. First, IVF belongs to a class of

risks where the purchasers of insurance may have

better information than the insurer at the time

of purchase regarding the likelihood that they will

need the procedure. Using the same reasoning,

insurers resisted coverage of pregnancy for a long

time. They considered having a child to be a

choice, not an unforeseen event, and believed that

couples wishing to have a child should, therefore,

simply save for that event, Unless all insurers provided pregnancy benefits (or IVF benefits), an insurer might fear that persons knowing in advance

that they wanted children or needed IVF would

sign up for that company’s insurance.

In addition, the potentially high cost of IVF combined with a perception of low success makes it

difficult to sell premium increases to policyholders.

That IVF is perceived to be a procedure of uncertain benefit to a few at the expense of many has

served to further deter insurers from entering

this market.

When insurers do undertake to insure events

where adverse selection is likely, where the possible losses are high or the risks not well known,

or where it may be difficult to sell the need for

the procedure to large employer/employee groups,

they try to institute mechanisms to protect themselves. When this is not yet reasonably possible

and, for reasons of social policy, it is desirable to

protect certain individuals, then the risks are often

borne by society as a whole through social insurance schemes (e.g., Medicare and Medicaid).

The majority of health insurance plans and

health maintenance organizations exclude specific

coverage for IVF (22). Typical is the language used

by Blue Cross/Blue Shield in its coverage of Federal employees under the Federal Employee Health

Benefits Program (FEHBP) (see figure 8-2). These

programs state that they exclude from coverage

artificial insemination by donor, IVF, and reversals of sterilization (10)21).

However, even though the majority of providers

exclude IVF, this coverage may be increasing. A

recent survey conducted by the Health Insurance

Association of America of its 20 largest companies plus a random sample of 80 other members

produced rather surprising results (22). While

large companies were more likely than small companies to provide IVF benefits, there was little

difference between coverage in group versus individual policies. On a weighted basis, an estimated

41 percent of those covered under group policies

and 40 percent of those covered by individual policies currently have coverage for at least most of

the services associated with IVF, though a variety of restrictions exist, particularly with respect

76-580 - 88 - 6 : QL 3
154 . Infertility: Medical and Social Choices

Figure 8-2.-Typical Language Describing Health Care Benefits Related to IVF and Artificial Insemination

We don’t provide benefits for cervices or supplies that

are:

> Related to sex transformations or sexual dysfunctions or inadequacies.

F For or related to artificial insemination or in-vitro

fertilization.

_ Related to ahortions except when the life of the

mother would he endangered if the fetus were carried to term.

Your Standard Option

benefits explained in

easy-to-understand

language

v

SOURCE: Office of Technology Assessment, 1968.
Ch. 8—/Infertility Services and Costs c 155

to the source of egg and sperm. These figures are

based on a question that referred to ‘(typical”

group and individual policies.

In a followup question, virtually all of the large

and none of the small insurers who did not provide for IVF in their most typical policy did make

the option available under other policies upon request for the benefit by the policyholder. The most

common reason for not covering IVF under both

group and individual contracts was that “it is not

the treatment of an illness.” The next most common reason given was that “it is still an experimental treatment. ” Claims evaluation is done on

a case-by-case basis, with no standard practice

identified by most carriers (10).

Despite the continued exclusion of IVF from coverage by a majority of insurers, OTA estimates

that for the current patient population, insurance

coverage is actually considerable for many aspects

of the IVF workup and treatment procedures. If

insurance claims for each of the individual diagnostic and treatment components of IVF are submitted separately, then the cost of the components

may be reimbursed. One center reported that

laparoscopies performed as part of an IVF procedure were covered by insurance at a reimbursement level that averaged 70 percent (21).

THE COST OF INSURANCE

earlier, the extra cost of IVF cov -

estimated by actuaries at Blue

As mentioned

erage has been

Cross/Blue Shield to range from $1 .06/household/

month in Maryland to $0.60/person/month in Delaware. It is important to recognize that these are

short-term estimates. They have not been developed using estimates and projections of the incidence and prevalence of infertility or an estimate

of the likely demand for IVF. They are based on

the number of IVF services currently available and

upon the assumption that every one of the currently available services will be used.

For example, actuaries for Maryland Blue Cross/

Blue Shield surveyed the IVF clinics in and near

Maryland and found that the potential treatment

capacity for these clinics in 1985 was 800 women

per year, and that the average cost per patient

would be $12,800 based on three treatment cy -

cles per patient, with varying degrees of success.

The total cost for all 800 women treated in or near

Maryland would therefore be about $10.2 million;

it was assumed that Blue Cross/Blue Shield of

Maryland would be responsible for about half the

amount, or $5.1 million. They then assumed that

capacity would grow by 33 percent in 1986, so

that the estimated total cost to them in 1986 would

be 1.33 times $5.1 million, or about $7 million.

Distributing this sum over the 550,000 households

that would be insured for this coverage yielded

the rate of $1.06/household/month (21).

Where the demand for services is unknown, the

supply of services is well known, and demand is

thought to greatly exceed supply, near-term estimates based upon supply alone are reasonable

and quite accurate. The estimation by Maryland

Blue Cross/Blue Shield actuaries was done in June

1985. As of December 1, 1986, about 300 patients

had applied for reimbursements of IVF expenses.

Given the lag both in starting the program and

in reporting by patients, it appears that the estimate of patient utilization was accurate. Unknown

at this point is whether the estimates of the number of treatments per patient or the cost per treatment were close. Finally, Blue Cross/Blue Shield

built into its rates a margin of error of at least

20 percent. They estimate that, after deductibles

and coinsurance, they will only reimburse about

80 percent of charges.

Estimates of long-term or equilibrium costs of

IVF coverage will have to be based on experience

with the need and demand for services, and especially with the effect insurance will have on such

demand. This will require a close look at the incidence of infertility, especially the kind for which

IVF is a preferred procedure; at the cost structure of the industry that underlies the supply

price; at the availability and demand for substitute procedures; and at the effect of insurance

on the demand for IVF and non-IVF services.
756 ● Infertility: Medical and Social Choices

Public programs

Coverage for infertility services by Medicaid

varies among State programs. In the Federal Medicaid program many infertility services can be covered under the “family planning services” category. Many State programs will pay for drugs,

counseling, and surgical procedures, including

sterilization reversals if deemed medically necessary.

At present, no Federal Government programs

cover IVF procedures, Furthermore, no Government health facility, such as those operated by

the Department of Defense or the Veterans’ Administration, has been identified that provides IVF

services. However, just as the commercial insurance industry appears to be paying for some portion of the IVF expense even when its policies explicitly exclude such procedures, Government

reimbursement programs may be paying for some

of these benefits as well.

Although the Federal Medicaid program does

not restrict State provision of IVF procedures

(10,2 I), OTA has not identified any State program

that has paid out IVF benefits. However, the District of Columbia, which appears to have the most

liberal medical coverage in the country, may be

an exception. It reported that it covers all types

of infertility services. Though it had not received

any requests for IVF, if they do come, it would

“probably pay them” (10).

As with private insurers, it is likely that some

IVF component services are inadvertently paid by

most Medicaid plans. This “leakage” is far less likely

to occur under HMOS and “managed care” plans.

For the unwitting reimbursement of IVF charges

by insurance carriers to occur, however, patients

must have sufficient resources to pay the clinic

and await reimbursement. This is a possibility for

persons covered by private insurance and the Civilian Health and Medical Program of the Uniformed Services, but Medicaid beneficiaries are

unlikely to have such resources. Therefore, it is

unlikely that most Medicaid programs cover IVF

benefits directly, although there may be partial

coverage of various components of the IVF workup, such as ovulation induction or laparoscopy.

Federal Employee Health

Benefits Program

The approximately 3 million current civilian employees of the Federal Government are covered

by 435 different health plans nationwide. Although some smaller local health plans may provide IVF coverage, the U .S. Government Office of

the Actuary could not readily identify any (21).

As mentioned, the large nationwide plans serving Federal employees, such as Aetna and Blue

Cross/Blue Shield, specifically exclude IVF, reversals of sterilization, and artificial insemination (21).

Despite these specific exclusions, these plans may

be providing some reimbursement for IVF components, as described earlier. HMOS, on the other

hand, are more able to control patient utilization

of infertility services and are therefore less likely

to reimburse IVF-related charges.

The cost of extending insurance coverage for

IVF to Federal civilian employees can be roughly

estimated, There are about 690)000 female employees of the Federal Government between the

ages of 15 and 44, and 1,2 million male employees aged 20 to 49. Some 52 percent of females

between 15 and 44 are married (21), If this percentage holds for Federal employees as well, then

about 360,000 female employees are married. If

half the male Federal employees are married to

women between 15 and 44, then there are 600,000

women between 15 and 44 married to male Federal employees, Altogether, that yields 960,000

couples with female partners between the ages

of 15 and 44 potentially eligible for Federal insurance coverage (assuming for the sake of these

rough estimates that Federal employees are not

married to each other).

Assuming that 8.5 percent of married women

between 15 and 44 were part of an infertile couple, and applying that rate to women covered by

Federal plans, then 81,600 of these couples would

be infertile. on average, approximately 31 percent of infertile couples seek infertility treatment

(13). This would suggest that about 25,000 infertile couples who are eligible for Federal employees insurance coverage seek infertility treatment.

OTA estimates that at the present level of prac-
Ch. 8—infertility Services and Costs ● 157

tice, only about 11 percent of those who seek in- 8-1), with on average two treatment cycles per

fertility treatment actually undergo IVF proce- patient, the current cost per patient is between

dures. Thus the current number of female Federal $8,000 and $12,000. For the 2,783 women covemployees who would undergo IVF is 2)783. ered by FEHBP, the total expenditure for IVF

If the average cost of IVF treatments is between would ‘be $22 million to $33 ‘million.

$4,000 and $6,000 per treatment cycle (see table

IVF/INFERTILITY CENTERS

This section provides a more detailed profile of

IVF/infertility centers, focusing on their operations

and the characteristics of the market in which

they operate (21). Profile characteristics discussed

include the organizational status of the clinics

(nonprofit or for-profit), their size and age, funding sources, types of services offered, demand for

services, barriers to entry, and future trends. In

general, IVF/infertility facilities are well distributed geographically and evenly split between

profit and nonprofit operations (see app. A). Most

offer a variety of infertility services and are not

limited to IVF.

General Operating Characteristics

OTA has identified 169 IVF/infertility centers

in the United States as of early 1988. Most of these

are listed with the American Fertility Society as

offering IVF (2). However, it is estimated that only

80 to 90 of these centers are established facilities

with particularly active programs (14). IVF/infertility centers are located in 41 States, the District

of Columbia, and Puerto Rico; only five States have

10 or more centers (California with 22, Florida

with 10, New York with 11, Ohio with 10, and

Texas with 14).

Although the centers are fairly well distributed

around the country, it should be noted that even

on a State-by-State basis, infertile couples seeking services in nine States must travel elsewhere

for treatment (see figure 8-3).

Most, though not an overwhelming majority, of

IVF/infertility centers in the United States are nonprofit, The predominant organizational arrangement is a nonprofit infertility center that is part

of a nonprofit university or hospital. The remaining centers include independent, for-profit outfits and for-profit centers affiliated with a nonprofit institution (such as hospitals or universities).

Most IVF/infertility centers are relatively small,

rarely exceeding 20 staff. Typically, the staff includes:

. one or two physicians specializing in reproductive endocrinology,

● one doctorate-level scientist (reproductive biologist),

● two to four registered nurses,

● one to six technicians, and

● one psychologist or counselor (see box 8-A).

Type of Services Offered

These centers generally offered a variety of services in addition to IVF, including microsurgery.

A growing number also offer alternative reproductive technologies such as gamete intrafallopian

transfer and tubal ovum transfer. Yet a small but

increasing number offer only IVF.

Some IVF/infertility centers have restrictive policies as to the types of patients they will serve.

These policies include not serving individuals without partners, treating only married couples, age

restrictions (no services to those under ages 17

to 20 or over ages 39 to 50)) and restrictions on

treatments of homosexuals. No pattern of restrictions related to the organizational status of the

clinics appears present.

Most centers offer a variety of the well-established infertility diagnostic and treatment services. The only major exception is male microsurgery and artificial insemination. As expected, many

IVF clinics appear to be much more oriented

toward female microsurgery and treatment than

treatment of male infertility.
-— —.—. . .— - . .

158 “ Infertility: Medical and Social Choices

Figure 8-3.—Distribution of IVF/infertility Centers

in the United States

I I J

SOURCE: Office of Technology Assessment, 1988.

A second item of interest is that many facilities

do not yet offer the latest techniques and advances

in infertility treatment (such as embryo freezing,

laser laparoscopy, or even frozen donor sperm

for artificial insemination). The lag time for diffusion of new technology appears to be on the order of at least 2 years.

Funding Sources

Patient fees account for the largest source of

funds for the IVF clinics, in general making up

80 to 100 percent of revenues. Aside from a small

number of IVF/infertility clinic that treat many

Medicaid patients, most programs receive less than

10 percent of total funding from Medicaid funds.

other sources of funding for IVF centers include -

university subsidies and private research grants.

Demand for Services

The majority of IVF programs in the United

States have a waiting list of patients. Although the

older, more established programs can have waiting lists as long as 1 to 2 years, this is not the case

with the smaller, recently started programs.

IVF/infertility centers receive a small amount

of referrals from hospitals. A major source of patients for most IVF clinics is referrals from physicians. But referrals from other patients or selfreferrals by patients appear to be equally, if not

more, important for IVF clinics,

As the demand for infertility services has grown,

some couples with diagnosed or suspected infertility problems may place themselves on one or

more IVF center waiting lists even before other
Ch. 8—lnfertility Services and Costs c 159

Box S-A. —Integrating Psychological and Medical Treatment

Many couples surveyed at infertility clinics say they wished they had been offered psychological counseling during their treatment. Issues identified by infertile people as a potential focus for counseling include problems in the marital relationship, sexual dissatisfaction, crisis reactions, anxiety surrounding efforts

to achieve a pregnancy, and alternative solutions to involuntary childlessness.

There are at least four ways that infertility clinics try to meet the psychological needs of their patients.

Most common is to rely upon professional medical staff to be sensitive to the emotional stress of infertility

diagnosis and treatment. Others use a consultant on a case-by-case basis. The consultant is alerted by medical staff when an individual or a couple exhibits emotional distress, particularly if their anxiety is interfering with the successful outcome of treatment.

Some clinics have a professional counselor on their staff. Usually this person’s responsibilities involve

meeting with each individual or couple on their first visit to orient them to the clinic services. At this time

the professional also may make an effort to alert patients to the potential emotional strains of the diagnosis

and treatment experience. Community resources are often mentioned at this time, particularly any nearby

support groups of infertile people who meet on a regular basis.

Still other clinics have adopted a preventive mental health approach, in which each individual meets

with the counseling professional on the first visit, both as a way of learning what to expect from the clinic,

to explore his or her present emotional state, and to help develop acceptance of the stress infertility and

its treatment can cause. The professional then offers ways to cope with the emotional distress for clinic

patients, including regular visits with all patients, short-term counseling for particularly stressful times,

referrals to community professionals for long-term counseling, and an invitation to join a support group

of infertile patients conducted by the professional in the clinic. The professional may make daily visits

to the surgical ward of the hospital, both to discuss patient apprehensions prior to surgery and to offer

support and advocacy during a hospital stay.

Some infertile people may choose to decline these various offers of psychological counseling. Clinicbased counseling may be inconvenient if the patients live far from the site or visit it infrequently. Some

may be reluctant to place in clinic records any information that may influence judgments about their acceptability as candidates for medical or surgical treatments, or for noncoital techniques for achieving pregnancy. Others may find the clinic staff insensitive, or feel that even well-meant offers of counseling are

nonetheless unnecessary or intrusive. They may not care for this type of professional counseling, and prefer

to seek help from family, friends, support groups, or outside professional counselors.

SOI” H(’F. of fwx of ‘I echnnlo~v Aw>ssment 1988

non-IVF infertility treatments have been at- in infertility services for years and want to include

tempted. The extent of this practice is unknown.

Despite the waiting lists, there also appears to be

a growing amount of competition among IVF

centers located in large metropolitan areas or

among programs within the same general geographical area. Competition may increase as the

number and efficacy of the infertility treatments

improve.

Opening Up New Centers

To what extent is it difficult for infertility clinics

to expand into the market for IVF services? Most

IVF clinics begin as adjuncts to departments of

obstetrics and gynecology that have been involved

this new technology. Although IVF requires a good

deal of specialty equipment and labor, much of

each is generally available in most hospitals. As

a result, IVF clinics can often begin operation without equipment and labor specifically dedicated to

IVF, as indicated by the wide range in the number of IVF cycles conducted around the country.

Although the large, well-known clinics operate at

the level of 800 to 1,000 treatment cycles per year,

some programs perform fewer than 50.

The coexistence of clinics doing 50 and 800 cycles per year indicates the ease with which a viable clinic can be organized and run from an existing medical facility. The major items of equipment

required for ovum preparation and embryo trans -
160 . Infertility: Medical and Social Choices

fer include an incubator, high-purity water system, autoclave, and low temperature freezer to

freeze embryos. The cost of purchasing this equipment has been estimated as in the neighborhood

of $40,000 to $60,000 (21), although the actual cost

may be as high as $100,000 (14).

The remainder of equipment needed, such as

microscopes, video camera and monitor for the

laparoscope, and all the hospital and surgical

equipment, is generally priced internally so that

little of the cost is passed on to the IVF facility.

In addition, the services of technicians and an embryologist can generally be found in the hospital,

so these specialty labor costs can also be priced

at the margin, Finally, an expanding obstetrics/

gynecology facility will not have to incur the expense of waiting and examining rooms. Thus if

demand increases substantially due to wider insurance coverage of IVF, enhanced effectiveness

of IVF, or a change in the public’s perception of

the cost and effectiveness of IVF, supply can be

expected to increase to meet the new demand

without necessarily encountering bottlenecks.

Future Trends

New developments in infertility diagnosis and

treatment have the potential to revolutionize the

way services are demanded and offered. A number of trends in particular could significantly affect the estimates developed in this section.

Charges for IVF and other infertility treatments

can be expected to continue to increase in the next

few years. In addition to the rise in fees associated with increases in all health care, some increases will result from the raising of fees as individual programs become more established and

accomplished with the various techniques. Neither competition among facilities nor increased

success rates for procedures such as GIFT and

SUMMARY AND

Over the last decade infertility services have

grown in scope and sophistication. The demand

for infertility services has increased as well, to

a point where between 300,000 and 1 million couIVF are likely to reduce infertility costs drastically

in the near future.

The majority of IVF/infertility centers will continue to introduce new procedures to their practices in the near future. In particular, many centers

intend to expand into embryo freezing, the cryo -

preservation of oocytes, and the use of donor

oocytes and embryos in IVF for women unable

to produce eggs. Other techniques that are offered

at some clinics but that have not yet been disseminated throughout the industry include laser laparoscopy, GIFT, intrauterine insemination, surrogate pregnancies, artificial insemination with

frozen donor semen, artificial insemination with

sex selection, and ultrasound-guided vaginal oocyte

retrieval.

Other areas of likely expansion for IVF/infertility centers include andrologic diagnosis and treatment, immunologic studies, embryo transfer, estrogen replacement therapy, gamete manipulation,

hormone evaluation and treatment correlation,

and possible changes in the fertility drug stimulation regime for IVF and GIFT.

Most IVF/infertility centers agree that changes

in third-party reimbursement policy would affect

the number of patients seeking infertility services, Expanded insurance coverage of IVF and

GIFT services could have a significant impact on

the demand for these services. Couples who cannot currently afford IVF or GIFT, or who cannot

afford more than one cycle, would be able to undergo the procedures. This expanded group would

include both couples who are now “doing nothing” in the absence of IVF as well as women who

are currently undergoing tubal surgery in lieu of

IVF or GIFT. Making IVF or GIFT insurance-reimbursable could in some instances replace low-yield

surgical procedures that are currently reimbursed.

CONCLUSIONS

pies in the United States seek infertility treatment

services annually. Overall, doctors report that half

the infertile couples who seek treatment are able

to have a baby.
Ch. 8—Infertility\ Services and Costs ● 161

An examination of U.S. expenditures on infertility treatment produced the following key

findings:

● Access to infertility treatment. For the initial

medical consultation on an infertility problem, couples are most likely to seek the advice of their gynecologist, general practitioner,

or urologist. Most gynecologists and urologists can provide at least basic infertility diagnostic and treatment services. For problems

serious enough for referral to an infertility

specialist, access to specialized care is likely

to be reduced. Sophisticated infertility care

is generally located in urban areas. Procedures for more difficult infertility cases are

more likely to be available at universities and

medical centers,

Access to highly specialized infertility treatment, in addition to being geographically determined, is also a function of cost and insurance coverage for many procedures. In

general, people with adequate financial resources, either their own or insurance with

infertility coverage, have no more difficulty

obtaining infertility services than they do

most other types of medical care; however,

infertility services are less available to lowincome couples, and low-income women face

serious financial obstacles to obtaining specialized or complex infertility services.

● Choices of reproductive services. Infertility

treatment represents only one of a number

of options for achieving parenthood. Other

options that are weighed by infertile couples

side by side with medical treatment include

adoption, embyro transfer or donation, and

surrogacy. For couples with serious infertility problems, the choice of treatment maybe

made several times and at several points over

an extended period of time. In estimating the

cost of infertility services, OTA hypothesizes

four scenarios typical of female infertility

diagnosis and treatment. Medical costs for

each of the four stylized scenarios range from

$2,055 to $9,376. Viewed together as a fourstage, worst-case treatment process, a couple

starting out would have a 69-percent chance

of achieving pregnancy (approximately 50

●

●

●

●

percent chance of a live birth), at a cost of

more than $22)

000.

Costs of infertility services to couples. Costs

to individual couples receiving infertility treatment vary widely, depending on the severity

of the infertility problem. Typically, a full diagnostic workup can cost $2,500 to $3,000, although many couples do not need to make

such an extensive outlay. In addition to medical costs, couples often incur considerable

expenses on travel, lost time from work, and

hotel accommodations.

Total expenditures on infertility services. Extrapolating from data from the National Medical Care Utilization and Expenditure Survey

of 1980, infertility expenditures in 1987 were

estimated to total $1,0 billion. Of that amount,

about $66 million was spent on IVF, The remainder was spent on non-IVF infertility diagnosis and treatment.

Coverage by third-party reimbursers. private

health insurance is estimated to cover about

70 percent of infertility expenditures. Couples pay out-of-pocket about 20 percent of

the cost of infertility diagnosis and treatment,

while other sources such as Medicaid account

for another 8 percent. For IVF-related treatment, although the majority of health insurance plans have specifically excluded coverage from their policies, there appears to be

a significant amount of reimbursement for

the various components of IVF treatment,

such as laparoscopy.

Insurance perspective on IVF. IVF is considered to be an expensive item for insurance

companies, both because individual components are expensive, and because there is no

defined upper limit on the number of times

IVF can be undertaken. Insurance companies

have therefore been reluctant to underwrite

such a large potential liability without placing restrictions on the number of procedures

covered. OTA estimates an average of two

IVF cycles per patient, suggesting that unlimited IVF cycles per patient are not currently occurring. This figure may increase,

however, if more insurance coverage becomes available.
162 ● Infertility: Medical and Social Choices

CHAPTER 8 REFERENCES

1. Alan Guttmacher Institute, Infertility Services in

the United States: Need, Accessibility and Utilization (New York, NY: 1985).

2. American Fertility Society, List of IVF infertility

Centers (Birmingham, AL: 1987).

3. Bellina, J. H., and Wilson, J., You Can Have A Baby

(New York, NY: Crown Publishers, Inc., 1985).

4. Bustillo, M., Genetics and IVF Institute, Fairfax, VA,

personal communication, November 1986.

5. Collins, J. A., Wrixon, W., Janes, L. B,, et al.,

“Treatment-Independent Pregnancy Among Infertile Couples,” New England Journal of Medicine

309:1201-1206, 1983.

6. Cooper, G., “The Magnitude and Consequences of

Infertility in the United States,” prepared for Resolve, Inc., February 1985.

7. Cooper, G., “An Analysis of the Costs of Infertility

Treatment,” American Journal of Public Health

76:1018-1019, 1986.

8. The Economist, “Making Babies Is Hard To Do,” p.

9<

10,

11,

12,

13.

105, NOV. 15, 1986.

Fuchs, V., and Perreault, L., “Expenditures for

Reproduction-Related Health Care,” Journal of the

American Medical Association 255:76-81, 1986.

Hall, C., and Raphaelson, A., “Economic Considerations for Infertility,” prepared for Office of Technology Assessment, US. Congress, Washington,

DC, August 1987.

Harris, D., ‘(What It Costs to Fight Infertility, ”

Money, December 1984.

Haseltine, F., National Institute of Child Health Development, Bethesda, MD, personal communication, November 1986.

Hirsch, M. B., and Mosher, W,D., “Characteristics

of Infertile Women in the United States and Their

Use of Infertility Services,” Fertility and Sterility

47:618-625, 1987.

14. Hodgen, G., Scientific Director, Jones Institute for

Reproductive Medicine, Norfolk, VA, personal communication, October 1987.

15. Horn, M. C., and Mosher, W.D., “Use of Services for

Family Planning and Infertility, United States,

1982,” nchs: advancedata 103:1-8, 1984.

16. McDonnell, P., “Self-Insured Health Plans,” Health

Care Financing Review 8(2):1-15, 1987.

17. Mosher, W .D., and Pratt, W .F., “Fecundity and Infertility in the United States, 1965 -82,’’ nchs:advancedata 104:1-8, 1985.

18. Orr, M.T., and Forrest, J.D., “The Availability of

Reproductive Health Services from U.S. Private

Physicians)” F’andy P]am”ng Perspectives 17:63-69,

1985.

19. Russell, J.B., and DeCherney, A.H., “Helping Patients

Choose an IVF Program,” Contemporary Obstetrics

and Gynecology 30:145-149, 1987.

20. Terry, R., Chief Deputy Commissioner, Regulatory

Laws Division, Office of Commissioner of Insurance, Atlanta, GA, personal communication, September 1987.

21. Thorne, E., and Langner, G,, “Expenditures on In22

23

24

fertility Treatment,” prepared for Office of Technology Assessment, U.S. Congress, Washington,

DC, January 1987.

Toth, C., Washington, D., and Davis, O,, “Reimbursement for In Vitro Fertilization: A Survey of

HIAA Companies,” Research and Statistical Bulletin (Washington, DC: Health Insurance Association

of America, 1987).

Wiggans, T., President, Serono Laboratories, Randolph, MA, personal communication, 1987.

Wiggans, T., President, Serono Laboratories, Randolph, MA, personal communication, Mar. 1, 1988.
chapter 9

Quality Assurance in

Research and Clinical Care
CONTENTS

Page

The Role of Professional Societies in Assuring Quality . . . . . . . . . . . . . . . . . .. ...166

Distinguishing Therapeutic From Experimental Treatments . ................,168

Screening Donor Sperm for Sexually Transmitted Diseases . .........,.......169

Nonregulatory Protection of Patients and Research Subjects ...,, . ...........170

State Authority To Regulate Infertility Treatment and Research . .............172

Licensing Health Care Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......172

Licensing Health Care Facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . ............,174

Health Planning and Certificate of Need . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..174

Medical Malpractice Litigation .,.... . . . . . . . . . . . . . . . . . . . . . . .............175

Regulating Research on Embryos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..176

Criminal statutes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...176

Federal Authority To Regulate Infertility Treatment and Research . . . ., .......176

Taxing and Spending Authority. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...177

Authority Over Interstate Commerce . . . . . . . . . . . . . . . . . . . . . ..............180

Patenting Power . . . . . . . . . . . . . . . . . . . . ..., . . . . . . . . . . . . . . . . . . . . . .......183

Summary and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...183

Chapter 9 References. . . . . . . . . . . . . . . . . . . . . . . .........................184

Boxes

Box No. Page

9-A. Questions To Ask Before Beginning IVF Treatment .,, . ............,....168

9-B. How IVF Success Rates Can Be Reported . . . . . . . . . . . . . . . . . . . . . . .......182

Figure

Figure No. Page

9-1. In Vitro Fertilization Clinic Advertisement. . . . . . . . . . . . . . . . . . . . . . . . . 166
Chapter 9

Quality Assurance in

Research and Clinical Care

This chapter concentrates on the role that can

be played by medical societies, State governments,

and the Federal Government to assure high quality in the provision of four particular reproductive techniques: in vitro fertilization (IVF), artificial insemination by donor, embryo transfer, and

gamete intrafallopian transfer (GIFT). Surrogate

motherhood raises discrete questions related to

the relinquishment of parental rights by women

who are gestational mothers, and is considered

in more depth in chapter 14.

Quality assurance includes protecting individuals from being offered experimental treatments

under the guise of therapy and from the inappropriately enthusiastic use of procedures not yet

shown to be safe and effective. In addition, some

procedures are accepted medical practice for certain indications but not for others. For example,

IVF was originally offered only to women with

damaged fallopian tubes, but has more recently

come to be used for other types of infertility, including male factor infertility. As indications for

use expand, it becomes increasingly important for

patients to understand the realistic likelihood of

success. Differences in success rates among cIinics

cannot yet be fully explained, and some clinics

have yet to achieve a live birth following IVF.

Another concern in this area is that IVF requires

the creation of extracorporeal embryos that may

then be donated, sold, frozen, or used in research.

Restrictions on these dispositions of embryos are

not intended to assure high quality medical care

per se, but rather are an attempt to limit the abuses

that could arise as a corollary to creating extracorporeal embryos.

Finally, the use of donated semen poses the risk

of disease transmission. Concern over reports of

hepatitis B transmission in the United States and

human immunodeficiency virus (HIV) transmission in Australia following donor insemination has

led to activity in State legislatures (see ch. 13), the

Department of Health and Human Services (DHHS),

and various professional societies.

Professional societies influence the research and

treatment protocols of medical practitioners. Some,

such as the American College of Obstetricians and

Gynecologists (ACOG), the American Fertility Society (AFS), and the American Association of Tissue Banks (AATB), have issued reports and guidelines on use of donor eggs and sperm, treatment

of extracorporeal embryos, and the general assurance of high-quality medical treatment of infertility.

The American Fertility Society, for example, has

set up a voluntary registry of IVF and GIFT programs and a special interest group for those who

meet certain minimum criteria for staffing and

success in achieving pregnancy. Although membership in the special interest group does not confer accreditation, that term has been used by at

least one program to help identify itself as meeting certain standards of practice (see figure 9-1).

In addition, all registry members are asked to report on their techniques and success rates, so that

the efficacy of various IVF and GIFT protocols can

be evaluated.

The first part of this chapter discusses the structure of professional medical societies and their

potential for providing practitioner education, for

setting a standard of care that protects individuals from experimental procedures offered in the

guise of therapeutic treatment, for assuring adequate staffing and laboratory facilities for clinics

offering such treatments, and for developing a

consensus among researchers and practitioners

concerning the handling of extracorporeal embryos and the involvement of third parties in conceiving or bearing a child for another person.

Federal authority can facilitate nonregulatory

efforts to assure high quality infertility treatment.

Governmental authority can also be brought to

bear on these issues with respect to establishing

standards of medical practice; approving protocols

for research with humans; protecting the extracorporeal human embryo; regulating donor

screening and confidentiality; regulating commerce

165
I&j ● infertility: Medical and Social Choices

Figure 9-1.- In Vitro Fertilization Clinic Advertisement

Position Available

IVF Laboratory

New Yor k Medical Center: Immediate opportunities to join the laboratory

of established AFS accredited program involved in

In Vitro Fertilization, GIFT, and Gamete Cryopreservation, Previous experience in gamete culture

and manipulation, or in tissue culture and genetics

would be an advantage. Master’s or Bachelor’s degree

SOURCE: Biology of Reproduction, April 1987.

in sperm, eggs, and embryos; and attaching conditions to the delivery of medical services paid for

by Government programs or to research financed

by Government agencies.

States have actively legislated in areas concerning artificial insemination by donor (see ch. 13),

and a number of States have regulations related

to fetal research (see app. C). But few have specific statutes on IVF, and no legislation exists on

gamete intrafallopian transfer. Since the oversight

of medical practice is primarily a State function,

regulating these particular technologies will almost

always fall primarily to individual States.

required. Responsibilities would variously include

management and clinical service related to the Laboratory, activities such as mouse embryo culture etc.,

and involvement in research related to the program.

Interested candidates should forward a resume

with references

The Federal Government has over the last 14

years formed four commissions that have made

recommendations on, among other topics, noncoital reproductive techniques: the National Commission for the Protection of Human Subjects of

Biomedical and Behavioral Research; the Ethics

Advisory Board of the Department of Health, Education, and Welfare; the President’s Commission

for the Study of Ethical Problems in Medicine and

Biomedical and Behavioral Research; and the Congressional Biomedical Ethics Board. The Federal

powers to implement the suggestions of these advisory panels are explored near the end of this

chapter.

THE ROLE OF PROFESSIONAL SOCIETIES IN ASSURING QUALITY

Membership in a professional medical society

is purely voluntary, as is the members’ adherence

to the organization’s medical standards. Physicians

are licensed by the State. A medical license not

only permits them to practice medicine, but forbids all those without a license from competing

by making the practice of medicine without a

license a criminal offense. This State license is the

only one required to practice medicine or any of

its specialties; neither failure to belong to a specialty organization nor failure to maintain such

a membership in any way limits a physician’s legal ability to practice a medical specialty. Nonetheless, intellectual and economic incentives in the

1930s and 1940s led to the development of certification procedures for specialties, to hospitalbased specialty training programs, and finally to

the growth in voluntary professional societies of

specialists (59).

Professional organizations can set informal standards for clinical care, make their members undergo

continuing professional education to maintain active membership status, and require periodic examination and reexamination. A professional organization can also survey its members and gather

data on new techniques. Taking part in such

studies, however, is purely voluntary on the part

of the membership.

In the field of infertility care, one of the most

influential medical societies is the American College of obstetricians and Gynecologists. Members,

designated as “fellows,” must be licensed physicians certified in obstetrics and gynecology, ACOG’s

first national Constitution and Bylaws, adopted

in 1951, listed among its purposes:

● to establish and maintain the highest possible standards for obstetric and gynecologic
Ch. 9—Quality Assurance in Research and Clinical Care ● 167

●

●

●

education,

to perpetuate the history and best traditions

of obstetrics and gynecology practice and

ethics,

to maintain the dignity and efficiency of obstetric and gynecologic practice in its relationship to public welfare, and

to promote publications and encourage contributions to medical and scientific literature

pertaining to obstetrics and gynecology (46).

Pursuant to its professional purposes, ACOG has

periodically issued statements on the professional

and ethical issues raised by use of medically assisted

reproduction (3). For example, in 1984 its Committee on Gynecologic Practice classified IVF as

a “clinically applicable procedure” (i.e., clinically

effective for general or limited use) and then listed

personnel and facilities requirements for an IVF

program (5). In 1986 its Committee on Ethics issued a statement acknowledging the ethical issues

posed by the creation of extracorporeal embryos

(4). Statements such as these do not bind a society’s

members to a particular practice, but do serve

to develop some consensus among practitioners.

Similarly, the American Association of Tissue

Banks issued a statement in 1984 setting forth the

qualifications and training needed to serve as director of a tissue bank, including a sperm bank

(2). Further, its Reproductive Council listed a variety of conditions that ought to be sufficient to

exclude a person from eligibility as a sperm donor,

and proposed a series of examinations that ought

to be undertaken to detect those conditions.

Another influential group in this field is the

American Fertility Society, open not only to obstetricians and gynecologists, but also to urologists, reproductive endocrinologists, researchers,

“and others interested. ” Its purposes are similar

to those of ACOG, and include “extending knowledge of all aspects of fertility and problems of infertility in man and animals.”

The AFS Ethics Committee published a report

in 1986 that summarized prior AFS efforts with

respect to noncoital reproductive techniques (6)

and made recommendations for additional action

(7). The report noted, for example, the AFS guidelines for minimum staffing, counseling, institutional review, and medical services of an IVF program. These guidelines, and those of ACOG, have

been adopted into State law in Louisiana (Act No.

964, 1986), an example of the interaction possible between medical societies and State legislatures. AFS has also initiated a hands-on training

program for handling gametes and embryos. Such

programs help introduce practitioners to techniques often never seen in medical school or during residency. Of course, short training courses

are not equivalent to subspecialty training (12).

AFS recommended in its 1986 Ethics Committee report that IVF clinics develop standard practices for collecting information on pregnancy and

live birth rates, for followup on the participants

and any resulting children, for genetic screening

of gamete donors, and for equipment maintenance. The report stressed the importance of fully

April 25-29,1988

Animal Science Building

1675 observatory Drive, Room 256

Madison, Wisconsin

SPONSORED BY:

The American Fertility Society

Society for Assisted Reproductive Technology

Department of Meat and Animal Science,

University of Wisconsin, Madison Campus

CHAIRPERSONS:

Neil First, Ph.D.

Alan H. DeChemey, M.D.

Source: American Fertility Society

Announcement of Professional Training Cours e
168 ● Infertility: Medical and Social Choices

informing potential patients of the success rate American Fertility Society, are open to anyone

and experience of the particular clinic they are who expresses an interest in the area; membervisiting, of the availability of alternative therapies ship does not necessarily indicate special experor methods to form a family, of the costs they tise. Patients choosing a doctor should inquire

can anticipate, and of the financial or social sup- about a physician’s past experience with the inport they can expect to receive (see box 9-A). fertility treatments and certifications in subspecialties, and not rely only on the physician’s memProfessional society membership can confuse bership in a society or attendance at a short,

patients. Numerous ‘organizations, such as the continuing medical-education course (12).

Box 9-A.—Questions To Ask Before Beginning IVF Treatment

Before beginning IVF treatment at a particular clinic, patients might want to ask a number of questions,

including:

● What is the center’s pregnancy rate and how is it calculated? Does the clinic measure success by achieving chemically detectable pregnancies, those confirmed by ultrasound, or live births? What is the most

meaningful success rate for this particular IVF attempt, based upon the patient’s history of responding

to stimulation, transfer, and pregnancy? What is the success rate for patients with similar histories?

● Does the clinic implant all fertilized eggs or only those that appear capable of normal development?

Does it limit the number of implanted fertilized eggs to minimize risks associated with multiple births?

Can the clinic freeze extra embryos for subsequent attempts? What has been the clinic’s rate of loss

for those embryos?

● Does the clinic offer psychological counseling or have a regular means of referral for those patients

who seek help? Is it coordinated with the medical workup and transfer attempts, to anticipate difficulties

or disappointments?

● Is the program community-based or a referral center? Referral centers are beginning to train local physicians to handle preliminary workups and ovulation inductions, so that the patients need travel to the

main center fewer times.

● Does the clinic offer assistance in obtaining the highest possible insurance reimbursement for the patient? What has been the reimbursement experience of other patients with similar insurance plans? Does

the clinic offer a sliding fee scale for patients with low incomes?

SOURCE: Office of Technology Assessment, 1988.

DISTINGUISHING THERAPEUTIC FROM

EXPERIMENTAL TREATMENTS

One difficult problem in assuring high-quality

infertility treatment is that of correctly characterizing a new kind of service, such as IVF, as experimental or therapeutic. The classification has

implications for whether fees may be charged,

for insurance coverage, and for determining the

amount of information that must be made available before a person can be considered to have

made an informed choice to undergo the procedure. And any classification of IVF as “experimental” further complicates ethical questions concerning the appropriateness of experimenting

with human embryos (16).

As noted earlier, ACOG classifies IVF as a “clinically applicable procedure ’’—i.e., no longer purely

experimental (5). Similarly, a 1986 AFS position

paper stated: “IVF is no longer considered to be

an experimental procedure” (7). The AFS Ethics

Committee, however, did not explicitly find IVF
Ch. 9—Quality Assurance in Research and Clinical Care c 769

to be nonexperimental. Although it found the procedure to be ethical medical practice, it concluded

that “when a procedure hike IVF] is being done

for the first time by a practitioner or for the first

time at a particular facility, that procedure should

be viewed as experimental,” adding “there is merit

to the position that charges should be reduced

until the clinic has established itself with a reasonable success rate” (7). This line of reasoning

could be troublesome, as it is unclear whether

it is the number of times a procedure has been

done or the success with which it is used that determines its experimental status. Further, even

an experienced practitioner might encounter reduced success upon changing laboratories or laboratory personnel.

Some might argue that a procedure is either experimental or it is not, depending on whether it

is a deviation from standard medical practice for

the purpose of testing a hypothesis or obtaining

new knowledge. The fact that a particular person or facility is performing it for the first time

does not necessarily change the nature of the procedure itself. The AFS executive board in 1986

passed a resolution calling on insurance companies to reimburse for IVF, as it is no longer an

experimental procedure. Institutional Review

Boards (IRBs) across the country have also struggled with this issue, some concluding that IVF is

research and others that it is innovative or accepted clinical practice.

Federal regulations define “research” (rather

than “experimentation”) as “a systematic investigation designed to develop or contribute to generalizable knowledge” [45 CFR 46.102(e)], thus focusing on the intent of the individual performing the

research. In general, before such an activity is conducted on a human subject, there must be successful animal work, a reasonable hypothesis, IRB

review, and informed consent from the research

subject.

Some commentators have suggested that there

is no clear line between experimentation and therapy (as indeed the preceding definitions suggest),

and have argued for a continuum that includes

a third category of interventions between research

and therapy, often designated “innovative therapy.” The AFS also suggested new terminology

for such categories, proposing ‘(clinical experiment” for an innovative procedure with little or

no historical record of success, and “clinical trial”

for the systematic effort to improve the effectiveness of an existing procedure (7).

In a similar vein, the Blue Cross/Blue Shield Association’s Technology Evaluation and Coverage (TEC)

Program groups procedures, for the purpose of

coverage, as experimental (largely confined to animal or laboratory research), investigative (limited

human applications but lacking wide recognition

as proven safe and effective), and standard (widely

accepted as clinically effective, but may need to

be qualified as standard only under certain specified conditions) (33).

The Food and Drug Administration (FDA), on

the other hand, has not adopted these distinctions,

and a drug is either “investigational” (research)

or proven “safe and effective” (i.e., therapeutic).

IRBs have authority to review and approve all “research” and to decide whether or not a proposed

use is ‘(research. ” Rulings by individual medical

societies, insurance companies, or governmental

agencies are not conclusive. Indeed, such rulings

may often be in conflict, as they currently are in

the area of heart and liver transplantation and

IVF (see, e.g., 45 CFR 46).

SCREENING DONOR SPERM FOR SEXUALLY TRANSMITTED DISEASE

Professional societies can also continue to work passed can sperm be shown to be almost incapato minimize the risks associated with procedures ble of transmitting the human immunodeficiency

that have long been accepted as therapeutic. One virus. This is because current laboratory tests for

example can be drawn from the debate over the exposure to the virus areas yet sufficiently crude

use of fresh and frozen sperm for artificial in- that they require 3 or more months for the consemination by donor. Only by freezing sperm and centration of antibodies to become high enough

testing the donor after 3 or more months have to be detected. AFS guidelines in place through
170 ● Infertility: Medical and Social Choices

1987 did not suggest that physicians abandon the

use of fresh sperm, and suggested instead that

they carefully screen donors to exclude any whose

exposures in the months just prior to the donation might have left them infected. OTA’S national

survey found that physician awareness of AFS

standards was tantamount to their adoption (63).

As long as there was no evidence that this practice had failed to screen out all infected donors,

its possible inadequacies were theoretical only,

and widespread physician preference for possibly more efficacious fresh sperm was accepted.

Just such evidence came out of Australia, where

four of eight women became seropositive after

insemination with sperm from a seropositive

donor (50). In 1987 there were reports that at least

one U.S. sperm bank found that a donor serocon -

verted (i.e., tested positive for HIV after having

tested negative at the time of donation) during

the time that his sperm where quarantined (55,

58)70). Another U.S. sperm bank, despite adherence to the 1987 AFS standards for fresh-sperm

donors, subsequently found the donor to be infected and capable of having transmitted the virus at the time of donation (56,70).

In 1988, new AFS standards were developed.

They stated that in light of the inability to ensure

that sperm are incapable of transmitting HIV without freezing the sperm and retesting the donor,

the use of fresh sperm is unwarranted (50). These

new AFS standards are identical to those adopted

in 1988 by the FDA, in conjunction with the Centers for Disease Control (CDC), and ACOG is expected to follow suit (70).

Source: ZyGen Laboratory

Advertisement by Sperm Vendor

Some physicians express concern that exclusive

reliance on frozen sperm, which is widely perceived to be less efficacious (63), will result in a

population of women who fail to achieve pregnancy at all when using donor insemination (56,

70). Another concern is that physician education

will stress careful screening of donors for HIV,

while failing to stress the importance of improving

screening practices for more prevalent infectious

diseases, such as hepatitis (56), that are also known

to have been transmitted by donor insemination

in the United States (64). A final concern is that

formal regulation by a State or the Federal Government may prevent physicians from returning

to the use of fresh sperm should convenient and

economical HIV antigen tests become available,

making reliable donor screening possible at the

time of donation.

NONREGULATORY PROTECTION OF PATIENTS

AND RESEARCH SUBJECTS

Short of regulating infertility treatment and research, the Federal Government could work to

facilitate greater data collection and self-regulation. This can be done by authorizing additional

Federal efforts for epidemiological studies of infertility (see chs. 1 and 3) and by encouraging the

use of governmental, professional society, and insurance industry resources to hold consensus conferences and to recommend protocols for highquality care. For example, consensus conferences

could evaluate data on patients and recommend

a protocol that lists the best indications for the

use of IVF as opposed to GIFT. Conferences and

reports could also help define a “successful” program, distinguish experimental from investigative

techniques or applications of standard techniques,
Ch. 9—Quality Assurance in Research and Clinical Care ● 171

and make more uniform the minimum level of

staffing for a program.

Concern over costly and possibly premature applications of medical innovations led to the 1977

creation of the National Institutes of Health (NIH)

Consensus Development Program (49,62,66). Its

purpose is to develop consensus on the clinical

significance of new findings and the financial, ethical, and social impacts of a procedure’s development and use. To that end, an Office of Medical

Applications of Research coordinates consensus

conferences and other activities with the NIH Bureaus, Institutes, and Divisions, and guides the appointment of expert advisory panels to review and

make recommendations on medical innovations

and their applications. Denmark, Israel, the

Netherlands, Norway, Sweden, and the United

Kingdom have used similar mechanisms to review

medical developments (33).

Despite criticisms that the NIH consensus advisory panels have at times been biased, worked

from insufficient data, or made unsupported recommendations (1,34,38,48), over 60 consensus

conferences have been convened in the last decade, with noticeable effects on the practice of

medicine in several areas, including indications

for breast cancer screening by mammography,

surgical protocols for treatment of breast cancer,

and extension of Medicare and private third-party

insurance coverage for liver transplantation. Little or no effect has been demonstrated, in contrast, on the practice of cervical cancer screening or rate of cesarean delivery (49), areas that

were also the subject of such conferences.

One important consideration in whether an NIH

consensus conference is appropriate is whether

the questions concerning the medical technology

are primarily scientific and clinical, or primarily

ethical or economic. The conferences are more

effective when they focus on the former. They

are also most useful when professional consensus

has not yet begun to build.

A 1987 study funded by NIH to assess the effectiveness of its consensus conference program

found that all too often the conference lagged behind other professional educational activities, and

so was not itself responsible for any demonstrable improvement in clinical practice. The study

also demonstrated that simple dissemination of

information concerning the best practice of a technique or use of a device would be insufficient unless coupled with an educational program directed

at altering physician practice (39).

In addition, one Federal agency is dedicated to

technology assessment of clinical medicine—the

Office of Health Technology Assessment (OHTA)

of the National Center for Health Services Research and Health Care Technology Assessment,

under the Office of the Assistant Secretary for

Health. Although much of its work is in response

to requests from the Health Care Financing Administration for medical guidance prior to decisions

concerning Medicare coverage, OHTA can review

other technologies as well (48 FR 2444). OHTA

reports focus mainly on safety, efficacy, and indications for use, but at times cover cost-benefit

analyses too.

Although infertility treatments are of interest

to only a small number of Medicare-eligible patients, the Prospective Payment Assessment Commission (ProPAC) could be useful in forging agreement concerning the experimental or clinical

status of procedures such as IVF. It was established by the Social Security Amendments of 1983

(public Law 98-21) as an independent, legislativebranch commission to advise and assist Congress

and the Secretary of Health and Human Services

to maintain and update the Medicare prospective

payment system. ProPAC is required to collect and

assess information on safety, efficacy, and costeffectiveness of medical technologies in order to

identify medically appropriate patterns of health

resources use. Its findings influence the development of the diagnosis-related groups now used

as the basis for Medicare reimbursement to hospitals.

Among professional societies, the American Medical Association (AMA) has a diagnostic and therapeutic technology assessment program, under

the aegis of the AMA Council on Scientific Affairs.

The program uses panels of experts to examine

and report on the safety, effectiveness, and indications for emerging or new medical technologies.

The American College of Physicians’ Clinical Efficacy Assessment Project uses expert opinion and

group judgment to provide up-to-date informa-
—

172 ● lnfertility: Medical and Social Choices

tion and guidelines for a variety of medical and

surgical procedures, with an emphasis on safety,

efficacy, and cost. Procedures that have been

evaluated by the program include biofeedback for

hypertension and ambulatory cardiac catheterization (26).

The University of California—San Francisco is

the home of the Institute for Health Policy Studies,

a multidisciplinary research institute that studies

efficacy and cost-effectiveness of both standard

and new medical technologies. Its advice is often

requested by Congress and Federal agencies such

as the Federal Trade Commission (FTC) and the

Department of Health and Human Services. The

Institute of Medicine, an organization chartered

in 1970 by the National Academy of Sciences, also

has an active technology assessment group, and

responds to many congressional requests for

studies of the efficacy and costs of particular medical and surgical treatments.

Among industrial groups, the Blue Cross/Blue

Shield Association has two influential programs

that affect the degree to which certain medical

procedures are recognized as necessary, safe, effective, and covered by insurance. The Medical

Necessities Program focuses on identifying procedures that are not effective or not strictly necessary. The Technology Evaluation and Coverage

Program develops medical policies for the Association’s Uniform Medical Policy Manual, which

is provided to all local plans. Although the manual is largely advisory, its use is required by certain national-account corporate plans that cover

residents of the several States. As indicated earlier,

TEC is mainly concerned with categorizing medical technologies as experimental, investigative, or

standard (33). other private, third-party payer

groups with technology assessment programs include Kaiser Permanence, a California-based health

maintenance organization with almost 2 million

members .

STATE AUTHORITY TO REGULATE

INFERTILITY TREATMENT AND RESEARCH

“Police power” is not a term referring to municipal police as much as it is a technical term that

has come to refer to all the powers of government to protect the health, safety, and morals of

its citizens (17,71). All the traditional powers of

government, including police powers, are retained

by the States, even if parallel areas of Federal authority have developed. Thus, almost all criminal

laws are State laws, almost all public health measures are State measures, all licensing of medical

personnel and facilities is based on State law, and

almost all tort law is State-based.

Accordingly, the States have the authority to

regulate noncoital reproductive techniques directly in a variety of ways. All these are limited

by the provisions of the U.S. Constitution regarding the rights of individual citizens, but the State’s

inherent powers to protect patients, research subjects, and perhaps even embryos are broad and

provide many potential avenues for regulation.

Those with the most relevance to noncoital reproductive techniques are licensing of health care

personnel and facilities, certificate-of-need laws,

medical malpractice litigation, restrictions on the

sale of embryos, and criminal statutes.

Licensing Health Care Personnel

IVF, embryo transfer, and GIFT are medical procedures requiring the skill of a licensed physician.

This means that the State can and does limit the

performance of these techniques to licensed physicians, and that any nonphysician performing

them is practicing medicine without a license—a

crime in all States. Some States have enacted statutes declaring that artificial insemination by donor

is the practice of medicine, in order to limit or

regularize its use. Others have passed artificial

insemination laws designed to ensure the legitimacy of the resulting child (see ch. 13) but that

refer only to inseminations performed by a physician, thus creating the possibility that the statutes’ terms will not fully apply when artificial

insemination by donor is performed without a

physician’s supervision (see discussion of case of

Jhordan C. in ch. 13).
Ch. 9—Quality Assurance in Research and Clinical Care ● 173

The medical justification for restricting performance of donor insemination to physicians is that

they are better able to screen donors to ensure

that no infectious or genetic disease is passed to

the recipient or child. Other justifications include

the facilitation of screening for nonmedical conditions, such as welfare dependency, marital status,

or sexual orientation. It can be argued, however,

that artificial insemination should not necessarily

be considered the practice of medicine (36). It is

easily performed by a nonphysician, requires no

elaborate equipment, and may be used to overcome a social condition—lack of a male partner—

rather than a medical condition. Further, physician screening against infectious and genetic disease would not be available for coital reproduction, and thus some might argue is not necessarily

an appropriate subject of State law with respect

to artificial insemination performed by the recipient herself.

Medical licensing protects both the public, who

may be incapable of informed comparison shopping and evaluation of quality, and the profession,

which otherwise might suffer from undue or unfair competition. This limitation of services to

licensed physicians has at times created considerable controversy in the area of childbirth, notably concerning patients’ desires to use midwives,

but fewer problems regarding noncoital reproductive techniques. One problem, however, has

been the inability of singles and homosexuals to

locate physicians who find it ethically acceptable

to assist them with IVF or artificial insemination

by donor.

ACOG’s 1986 Ethics Committee statement acknowledged a trend in the United States to recognize that unmarried persons can provide excellent care for their children, and called on

physicians to handle requests for infertility services from these people based on the probable welfare of the child and in such a way as to avoid

arbitrariness. It went on to state, however, that

physicians ought to be free to acceptor reject patient requests if these considerations are kept in

mind (4). T O the extent that physicians continue

to have qualms about the appropriateness of helping singles or homosexuals to have children, as

demonstrated in OTA’S national survey of artificial insemination practice (63), and as long as phy -

sicians are the only persons entitled to offer these

services, this problem of access will persist among

unmarried and homosexual women.

Medical licenses are general licenses—i.e., once

an individual graduates from an approved medical school, passes a standard examination, and

does an internship or residency, he or she can

be licensed to practice medicine. The practice of

medicine is broadly defined, and includes diagnosis, treatment, prescription, surgery, and other

specific activities as the statute or the State’s board

of medicine may decree.

Specialty Boards, through which a physician

may become board-certified in a specialty following more years of specialty training and passing

another exam (e.g., Obstetrics and Gynecology),

are private certifying agencies. No State requires

that a person be a board-certified obstetrician-gynecologist or a member of a private professional

organization in order to provide services related

to any noncoital reproductive technique. A State

could, however, specify (either by statute or regulation) particular qualifications necessary for providing a specialized service, such as infertility treatment. Thus far, only Louisiana has done this, and

only with respect to IVF.

On the other hand, it seems likely that at least

some State licensing boards will follow the lead

of the Massachusetts Board of Registration in

Medicine and require its licensees to follow certain nationally recognized standards in defined

specialties, such as anesthesiology. The Louisiana

law fits this pattern, as it accepts compliance with

the training and staffing guidelines of ACOG or

AFS as sufficient to meet State law. The Federation of State Medical Boards of the United States

publishes compilations of the activities of State

licensing and discipline boards, so that States may

compare their provisions with those of others (22).

Licensing also provides State governments with

the right to intervene (at the request of a patient,

another physician, or any third party) to review

an individual physician’s practice and to discipline

the physician, by sanctions ranging from simple

censure to license revocation, for failure to follow proper standards in the delivery or advertisement of medical services (22,27). Physicians

who are incompetent or have been negligent on
174 . Infertility: Medical and Social Choices

more than one occasion, for example, could have

their licenses revoked (22,27). Although such disciplinary actions have historically been rare, many

States are trying to improve the operations of their

medical licensing agencies and to strengthen the

policing function of these agencies. This mechanism is after the fact, but it might deter some unqualified physicians from claiming to be experts

in infertility treatment.

Licensing Health Care Facilities

Following World War II and the passage of the

Hill Burton Act of 1946 (which made hospital licensure a prerequisite to receiving Federal funds),

States that did not have mandatory licensing for

hospitals proceeded to adopt statutes requiring

such Iicensure and setting forth certain minimum

standards, mainly for construction (30).

Currently all 50 States and the District of Columbia require that hospitals be licensed, although

the scope of the laws varies considerably (71).

Traditionally, these statutes have focused on minimum safety standards concerning construction,

fire, and equipment, rather than on the quality

of services delivered at the facility. Nonetheless,

the States do have the authority to regulate service provision. Most, however, rely on a private

organization, the Joint Commission on Accreditation of Healthcare Organizations (JCAHO). In

addition, DHHS has in practical effect delegated

to JCAHO much of its own authority to certify

facilities for Medicare reimbursement.

About half the States also license medical laboratories, and a majority regulate the qualification of laboratory personnel (53). Clear authority

exists to adopt regulations governing medical laboratories. States could, for example, adopt laboratory licensing regulations aimed specifically at

infertility clinics or free-standing IVF, artificial insemination, embryo transfer, or GIFT programs.

On the other hand, one general exception to laboratory licensure relates to a physician’s private

office. States do not generally license private doctors’ office procedures; they license physicians.

Therefore, to the extent that a physician can offer infertility treatment in an office setting, it

would be unlikely that facility Iicensing schemes

would apply directly to the activity, although certainly it could influence office practice (23).

Health Planning and

Certificate of Need

In the early 1970s, the Federal Government

established two separate hospital capital expenditure programs intended to control the cost of

medical care: the Section 1122 program authorized under the Social Security Act Amendments

of 1972 (Public Law 92-603) and the certificateof-need (CON) program established by the National

Health Planning and Resource Development Act

of 1974 (Public Law 93-641). The Section 1122 program provided for voluntary agreements between

State governors and the Secretary of HHS, such

that any hospital failing to obtain State approval

of a capital expenditure would not be eligible for

Medicare reimbursement of that capital expenditure. The 1974 legislation created a mandatory

national system of State and local health planning

agencies to conduct reviews of capital expenditures for construction and major equipment purchases, and to perform other review and monitoring tasks that would help reduce medical costs

(57).

Some States have used their CON programs to

control the introduction of expensive new medical technologies, such as heart transplants. The

CON mechanism could be used for large clinics

or hospitals offering IVF, embryo transfer, or

GIFT, in order to ensure adequate laboratory facilities and equipment, and to determine patient

need in light of the efficacy of the procedure, before extensive funds are committed. At least two

university clinics and one private clinic have had

to comply with CON procedures before establishing IVF facilities (7). But CON procedures are generally not applicable to small office practices, although some exception is made if the services are

reviewable were they offered by a hospital or if

they go beyond those generally offered in a physician’s office (7,31). Further, Federal funding for

CON and Section 1122 programs dropped to zero

in fiscal year 1987, and the 1974 legislation was

repealed in January 1987. By late 1987, only 40

States maintained either a CON or a Section 1122

program, and many States do not structure their

programs to apply to nonhospital facilities (69).

of those that do, many do not review expenditures of less than $1 million, which makes their

applicability to even hospital-based IVF programs

somewhat doubtful.
Ch. 9—Quality Assurance in Research and Clinical Care ● 175

Medical Malpractice Litigation

Tort law is a nonregulatory means for social

control of risks to health and safety (10). Permitting individuals to sue those who have wronged

them through negligence serves as a mechanism

for financial and emotional compensation, and for

quality control. Of these three, the one most relevant to noncoital reproductive techniques is quality control. Theoretically, by making people responsible for their actions, individuals have a n

incentive to act responsibly. In practice, medical

malpractice litigation suffers from numerous short -

comings, including the fact that it focuses on past

errors rather than future improvements. Nevertheless, it has had a profound effect on the practice of medicine and infertility treatment. For example, concerns over malpractice liability have

altered the way physicians balance the risk of multiple births against the goal of initiating conception when fertility drugs are used to stimulate

ovulation.

The medical profession largely sets its own practice standards. Accordingly, to prove medical malpractice by an infertility specialist, another infertility specialist generally must testify that what

the practitioner did was not “good and accepted

medical care” for the specialty, and thus amounted

to a breach of the practitioner’s duty to the patient. Otherwise, the plaintiff patient would need

to show that the accepted medical practice in this

field is itself so poor that it constitutes negligence

toward the patient,

The major issue in this context is how suc h

standards of practice are set in the treatment of

infertility, particularly when treatment involves

noncoital reproduction, The standard of care i n

medicine is generally defined by “standard medical practice”-i.e., what reasonably prudent physicians customarily do. The problem is that, at least

with IVF, embryo transfer, and GIFT, these procedures are so new that no “standard” of practice exists yet, and practices actually vary widely.

In addition, negligence litigation as an alternative

to regulation is probably “unsuitable for deterring systems failure in cases where the system

is new and is introduced into the marketplace

without the realization that it is having a significant harmful effect on health, safety or the environment” (10).

ACOG and AFS have made an effort to identify

good medical practice in the area of noncoital reproduction. As indicated earlier, both organizations develop and publish guidelines for practice,

to be used for practicing and teaching their specialties. It is made clear, however, that these guidelines are voluntary. As ACOG states in the introduction to its published standards:

It is important, particularly to those agencies

or individuals who may consult this manual in preparing codes and regulations governing the delivery of obstetric-gynecologic health care, to recognize that the standards set down here are

presented as recommendations and general guidelines rather than as a body of rigid rules. They

are intended to be adapted to many different situations, taking into account the needs and resources particular to the locality, the institution

or type of practice. Variation and innovation

which demonstrably improve the quality of patient care are to be encouraged rather than restricted (5).

These guidelines can play a central but not determinative role in malpractice litigation. The general rule in medical malpractice litigation is that

the physician must demonstrate that his or her

practice conformed with that of the “reasonably

prudent physician” (or specialist, if the defendant

is a specialist) under the same or similar circumstances. Nonconformity is evidence of negligence.

Conformity is evidence of due care, but is not an

absolute defense to an assertion of negligence.

Conformity to professional custom or guidelines

is just one circumstance considered when assessing whether an act was negligent.

One reason compliance with such professional

guidelines is not determinative is that a court may

find that an entire profession or specialty has

lagged behind in adopting rules required by the

standard of reasonable prudence. Defendants

have tried unsuccessfully to use adherence to customary standards as a conclusive defense. Over

50 years ago, Justice Holmes noted:

In most cases reasonable prudence is in fact

common prudence; but strictly it is never its measure; a whole calling may have unduly lagged in

the adoption of new and available devices. It never

may set its own tests, however persuasive be its

usages, Courts must in the end say what is required; there are precautions so imperative that

even their universal disregard will not excuse

their omission (60).
176 ● Infertility: Medical and Social Choices

Even compliance with a Federal or State statute may not be sufficient to defend fully against

a claim of negligence:

While compliance with a statutory standard is

evidence of due care, it is not conclusive on the

issue. Such a standard is no more than a minimum, and it does not necessarily preclude a finding that the actor was negligent in failing to take

additional precautions (52).

Overall, while compliance with professional or

Federal guidelines is evidence of due care, physicians must continually improve their own safety

practices to be free of all charges of negligent care.

Regulating Research on Embryos

States specifically addressing IVF research, with

the exception of Louisiana, have focused on monitoring and recordkeeping, rather than on limiting research. (See ch. 13 and app. C for summary

of State IVF statutes.) Some fetal research statutes, however, are sufficiently ambiguous that

they might apply to IVF research or at least have

some chilling effect on embryo research within

the affected State. (See ch. 13, table 13-2, and app.

C for discussion of applicability of fetal research

statutes to IVF treatment.)

The laws of Arizona, Massachusetts, Michigan,

North Dakota, Ohio, and Rhode Island extend to

research with “embryos, ” and in Kentucky, Louisiana, Missouri, Oklahoma, and Pennsylvania they

apply by functional definition to any product of

conception (7). Furthermore, in Maine, Massachusetts, Michigan, North Dakota, Rhode Island, and

Utah the fetal research statutes are not limited

to postabortion products of conception or research in connection with abortion.

Even where statutes are restricted to the products of an abortion, it is still somewhat unclear

whether ova fertilized in utero by artificial insemination and then flushed from the uterus prior to

implantation would be covered, and thus numerous statutes might possibly be applied to research

applications.1 The applicability, however, of all

these fetal research statutes is in question in light

of the 1986 case Margaret S. v. Edwards, which

struck down for vagueness a Louisiana ban on

experimentation with fetuses obtained from induced abortions (see chs. 12 and 13) (42).

Criminal Statutes

States have the authority to declare criminal,

within constitutional limitations, activities dangerous to the public health, safety, welfare, or even

morals. Some States, as indicated, make it a criminal offense for a nonlicensed person to offer artificial insemination by donor or outlaw certain

types of fetal research. The statutes in Florida and

Louisiana prohibiting the purchase and sale of human embryos are based on consideration of the

fetus or embryo, as well as larger considerations

of public morality and respect for the products

of human conception, Criminal homicide statutes

are grounded in concerns for public safety, however, and rarely apply to the destruction of embryos in vitro. Few States have extended homicide laws to include unborn children without

indicating that they are referring to unborn children in utero (9). Further, in at least two States

with embryo protection statutes (Massachusetts

and Illinois), district attorneys have agreed not

to seek to prosecute any physician engaged in IVF,

whether therapeutic or research, so long as the

physician agrees to attempt to implant all the embryos created by the process (see ch. 13).

*These include statutes in Arizona, Florida, Indiana, Lousiana,

Maine, Massachusetts, Michigan, Missouri, Montana, Nebraska, North

Dakota, Ohio, Oklahoma, Pennsylvania, Rhode Island, Utah, Wyoming. See app. C for summaries of State fetal research statutes’ applicability to embryo research.

FEDERAL AUTHORITY TO REGULATE

INFERTILITY TREATMENT AND RESEARCH

In theory, the Federal Government can only ex - personnel and defining family relationships are

ercise those powers specifically granted to it in State laws, as described in the preceding section.

the U.S. Constitution. None of those powers relates directly to medical care or to human repro- Yet the Federal Government is not powerless

duction, so all the laws on licensing health care in this area. With respect to health care in gen-
Ch. 9—Quality Assurance in Research and Clinical Care . 177

era], and to noncoital reproductive techniques in

particular, Congress can influence the development of medical techniques forcefully in areas

where it has indirect authority to get involved.

First, it can encourage nonregulatory efforts by

governmental agencies, professional societies, research institutes, and industrial groups, in order

to influence the clinical practice of new infertility therapies, a topic discussed at the end of this

chapter. Second, the Federal Government has extensive regulatory powers over health care under its taxing and spending power and under the

interstate commerce clause.

Taxing and Spending Authority

Article I, Section 8 of the U.S. Constitution states

that “Congress shall have Power to lay and collect Taxes.” This is a direct authority, and Congress may tax individuals whom it may not otherwise regulate independently. This same section

also provides that Congress may spend money “for

the common Defense and general Welfare of the

United States.” It is through the use of conditional

appropriations —i.e., attaching strings to grants

of money—that Congress derives its power to regulate through spending (61).

One question is whether the ‘(general welfare”

clause grants Congress authority to do whatever

is in the “general welfare” of the country, or

whether it is restricted to spending money. Attempts to limit the use of Federal funds to noncoercive purchases have proved ineffective, and

it is generally recognized that Congress itself can

decide how to spend Federal monies, limited only

by the Bill of Rights and the Constitution’s implicit

protections of State sovereignty (29,61). There is

no longer any question that:

. . . the Federal Government, unless barred by

some controlling constitutional prohibition, may

impose the terms and conditions upon which its

money allotments to the states shall be disbursed,

and that any state law or regulation inconsistent

with such Federal terms and conditions is to that

extent invalid (37).

The State must, of course, comply with the Federal conditions only if it wants to receive the Federal funds (28).

Research on Human Subjects

The most important area in which Congress has

used its spending power to adopt regulations related to noncoital reproductive techniques has

been in the area of research on human subjects.

Current Federal regulations on research with

human subjects have evolved from a combination

of circumstances involving the military, the executive branch, and Congress. The key document

in this brief history is the Nuremberg Code, developed by U.S. judges sitting in judgment of Nazi

physicians under U.S. military authority following World War 11 (20). That document sets forth

basic rules still in use today. It was adopted by

the United Nations and the U.S. Army, but not

formally used to help determine DHHS policy until the mid-1960s, when the Department’s first

regulations on research with humans were promulgated.

Following a series of public scandals involving

unethical research, including the Tuskegee syphilis study (65) and the Jewish Chronic Disease Hospital case (32), Congress passed the National Research Award Act of 1974 (Public Law 93-348),

establishing the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to study medical research settings and to recommend regulatory standards. The

Commission was established within the Department of Health, Education, and Welfare (now

DHHS). The Commission’s activities led to the adoption of a number of regulations concerning federally funded research with human subjects.

The regulations provide that institutions receiving Federal funds (the only ones bound by the regulations) can voluntarily agree to have all of the

research done on their premises or by their employees and faculty members subject to the Federal guidelines. Most institutions have agreed to

be bound by Federal regulations, and have evidenced this agreement in the form of a “general

assurance” given to DHHS (40).

The regulations provide that all federally funded

research, except that which is specifically exempted,

shall be reviewed by a local review group called

an Institutional Review Board to ensure that risks

to subjects are minimized, that risks are reasonable in relation to anticipated benefits, that selec -
178 ● Infertility: Medical and Social Choices

tion of subjects is equitable, and that informed

consent is obtained and properly documented.

During the National Commission’s 4-year tenure it issued a number of reports, which led to

DHHS adoption of a series of specific regulations

applying to research “involving fetuses, pregnant

women, and in vitro fertilization” (45 CFR 46.201-

46.211). The National Commission limited its definition of ‘(fetus” to a product of conception from

the time of implantation, so research on extracorporeal embryos was not covered.

Because research on embryos and fetuses was

seen as so difficult and divisive, the Commission

recommended the establishment of an Ethics Advisory Board (EAB) within DHHS to continue to examine this area, render advice to the Secretary,

and review specific proposals to fund IVF research. These recommendations were all adopted

as regulations.

One commentator proposed that DHHS promulgate guidelines for the EAB to follow in considering proposals. These guidelines would contain

minimum qualifications for IVF experimenters,

standardize the laboratory conditions that must

exist, develop safety standards for conducting human IVF experimentation, and establish when an

IVF conceptus may be destroyed (8). The American Medical Association suggested establishing

international and interprofessional groups to

study the ethical, medical, and legal issues associated with IVF (35). The Ethics Advisory Board concluded that IVF and embryo transfer research

could be acceptable from an ethical standpoint

if certain stringent criteria were met (44 FR 35033)

(67).

The provision that had the most profound effect on keeping the Federal Government out of

funding, and thereby reviewing, IVF research was:

No application or proposal involving human in

vitro fertilization may be funded by the Department or any component thereof until the application or proposal has been reviewed by the Ethical Advisory Board and the Board has rendered

advice as to its acceptability from an ethical standpoint [45 CFR 46.204 (D)].

In 1974, a researcher was told that his request

for a $375,ooo grant from the National Institutes

of Health would be reviewed by the EAB. The

grant application proposed to remove approximately 450 eggs from women undergoing surgery;

the eggs would then be fertilized, with subsequent

microbiopsy of the fertilized eggs. Thus, the embryos were not intended to mature to a live birth.

The EAB approved the project provided that the

fertilized eggs not be sustained beyond the stage

normally associated with the completion of implantation, or no more than 2 weeks after fertilization. The application was never approved by

the Secretary of Health, Education, and Welfare

(41), however, and in 1980 the Ethics Advisory

Board ceased to exist. Although the Secretary of

HHS has the authority to waive the criteria for

ethically acceptable IVF research, in part by reconvening the EAB to approve the waiver, this has

never been done. Nor has a new EAB ever been

appointed. The result has been an unofficial

moratorium on all Federal funding and oversight

of IVF research.

In 1980, pursuant to Public Law 95-622, a new

Federal commission was created for 3 years by

Congress—the President’s Commission for the

Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. It endorsed the

conclusions of the EAB on IVF, but completed no

further analysis on noncoital reproductive techniques (51).

The regulations on research with human subjects have also been adopted, with a few modifications, by the FDA (51 FR 20203-20208), and will

likely soon be adopted by other Federal agencies

involved with such research. These regulations

could be important for the responsible development and early use of noncoital reproductive techniques, since they provide a principled framework

within which to assess their risk/benefit ratio, to

protect participants, and to ensure informed

consent.

Although these regulations were employed in

the initial tests of GIFT in Texas and of embryo

transfer in California (13), they have generally not

been used recently for IVF, on the basis that IVF

is not a clinical experiment but rather a clinical

practice, albeit with a developing procedure. However, no uniform protocol for IVF exists. Further,

the technique never went through a formal or
Ch. 9—Quality Assurance in Research and Clinical Care ● 179

regulatory research stage in the United States to

demonstrate either safety or efficacy, in large part

due to the lack of Federal direction and Federal

funding.

In 1985 Congress authorized a 12-member, bipartisan Biomedical Ethics Board consisting of six

senators and six representatives (Public Law 99-

158). Pursuant to the statute, the Board was named

in 1986, and in 1987 began appointing a 14-member Advisory Committee composed of citizens with

interest or expertise in biomedical ethics. The

Board is directed to conduct studies in the area

of ethics and health care, including studies on two

specific topics:

the nature, advisability, and biomedical and

ethical implications of exercising any waiver

of the standard of risk that is applied to all

human research subjects, as defined in 45 CFR

46. 102(g), when considering the conduct or

support of research involving human fetuses

(to be completed no later than May 20, 1988);

and

research and developments in human genetic

engineering (to be completed no later than

18 months after the appointment of the Advisory Committee).

To date, the Board and its Advisory Committee

have not begun to function,

During the 36 months allotted for study of fetal

research protocols, the 1985 legislation repeals

the Secretary of HHS’S prior authority to call for

a waiver of the CFR regulations governing the degree of risk to which a fetus may be subject in

the course of research. Although this has been

perceived by some researchers as a formalization

of the moratorium on funding for IVF research,

in fact it has little effect on embryo research. The

CFR regulations set forth limits on the risks to

which a fetus may be subjected during research,

but “fetus” is carefully defined to mean “the product of conception from the time of implantation

. . . until . . . expulsion or extraction” [45 CFR

46.203(b)]. This definition would exclude eggs fertilized either in vitro or in vivo if they are never

implanted in a uterus.

Thus, the 1985 law does not affect the ability

of the Secretary to waive the limitations on IVF

research, limitations that were recommended by

the EAB although never adopted into regulation.

EAB approval is still required for DHHS funding

of IVF research. Only a request by the Secretary

of HHS to waive EAB review, coupled with a reconstitution of the EAB so that it might agree to waive

its right to review, can permit funding of IVF research without Ethics Advisory Board review.

The effect of this moratorium on Federal funding of IVF research has been to eliminate the most

direct line of authority by which the Federal Government can influence the development of both

embryo research and infertility treatment so as

to avoid unacceptable practices or inappropriate

uses. It has also dramatically affected the financial ability of American researchers to pursue improvements in IVF and the development of new

infertility treatments, possibly affecting in turn

the development of new contraceptives based on

improved understanding of the process of fertilization.

Models of Financing

Other countries that offer IVF seem to have done

better at monitoring it than the United States has,

probably because IVF is covered by their nationally financed health insurance plans. Through this

financing power, the services are generally restricted to State-licensed clinics, and uniform

guidelines for their provision can be developed

and enforced. Although it seems unlikely that the

United States will soon directly fund infertility

services that include artificial insemination by

donor, IVF, embryo transfer, and GIFT, it is useful to consider the range of regulatory authority

that such funding would permit.

Direct funding would give the Federal Government the authority to determine a wide variety

of requirements for the delivery of a safe and highquality service. One model of this is DHHS’S 1987

“Medicare Program Criteria for Medicare Coverage of Heart Transplants” (52 FR 10935). Among

other things, it provides that to be eligible for Medicare reimbursement for heart transplantation, the

facility must develop adequate patient selection

criteria and patient management plans and protocols, and must have a sufficient commitment

of resources, sufficient clinical expertise in related
180 ● Infertility: Medical and Social Choices

areas, adequate data maintenance, and reasonable laboratory facilities.

Most innovative, however, is the requirement

that the facility have a demonstrated experience

and survival rate before any procedures will be

reimbursed, Tying reimbursement to actual performance could have a powerful influence on the

quality of services made available to the public.

Specifically, proposed regulations would require

a facility to have performed a minimum number

of heart transplants, with specified actuarial survival rates (52 FR 10935).

The use of appropriate success standards in IVF

(standards that, of course, private insurance companies could adopt) would reduce the number of

facilities eligible for reimbursement under any

scheme, since some of the estimated 169 IVF and

GIFT programs in this country have yet to record

a birth. It should be noted, however, that such

a scheme might affect the willingness of clinics

to accept patients of advanced age or who have

a particularly difficult prognosis, as their less successful outcomes might affect possibilities for

reimbursement despite the fact that the medical

care was of acceptable quality.

Aside from direct Federal funding, five States

have mandated that private insurance companies

cover IVF (see ch. 8). Private insurance companies are free to set their own reimbursement or

coverage policies by contract. Most cover generally accepted medical procedures, but not experimental procedures. Since there is no universal

definition of “experimental,” coverage often varies.

When a new procedure is moving from the experimental to the realm of the generally accepted

practice, there is likely to be a timelag during

which individual insurance companies will be

making the coverage decision (47).

Indirect Financing

The Federal Government also has the power to

condition the receipt of Federal funds by a State

(instead of by a health care provider) on the State’s

taking a specific regulatory action, such as in regard to noncoital reproductive techniques. This

is true even when the connection between the

State program and infertility is quite attenuated.

For example, when Congress enacted the Child

Abuse Amendments of 1984 (Public Law 98-457)

in partial response to the controversy over medical care for severely or terminally ill newborns,

it specifically required States accepting funds under this act to adopt certain regulations and procedures on child abuse and neglect.

Congress could equally mandate that States receiving such funds develop specific policies with

regard to monitoring noncoital reproductive techniques, under the theory that these techniques

require more monitoring than others because they

are designed to produce children, and that the

best interests of these children require that such

services be of the highest quality. This would be

true even without any inference that children conceived or born by use of reproductive techniques

such as IVF or surrogate motherhood are at all

harmed.

Similarly, the Federal Government has the authority to condition funding of Aid to Families with

Dependent Children programs or family planning

agencies on adoption of stated standards relating

to infertility services if these were also offered

by such agencies. An analogous example is the

Federal requirement regarding consent to sterilization.

Authority Over Interstate Commerce

The second major area over which Congress has

wide authority to regulate noncoital reproductive

techniques is through the commerce clause of Article I, Section 8, which provides the authority “To

regulate Commerce with foreign Nations, and

among the several States, and with the Indian

Tribes .“

Congressional authority to pass laws relating

in any reasonable manner to interstate commerce

is “such broad power that judicial review of the

affirmative authorization for congressional action

is largely a formality” (61). Most judicial review

focuses instead on the intent of Congress to interpret the reach and scope of the legislation. For

example, “unless Congress conveys its purpose

clearly, it will not be deemed to have significantly

changed the Federal-State balance” (68).
Ch. 9—Quality Assurance in Research and Clinical Care c 181

Monitoring the Use of Noncoital

Reproductive Techniques

The Centers for Disease Control (CDC) may ask

State departments of health to monitor artificial

insemination by donor or other uses of third-party

gametes for the presence of human immunodeficiency virus or antibodies, or for the presence

of other communicable diseases. CDC is not a regulatory agency and has no direct authority to regulate individual physicians or State health departments. It is under the authority of the Secretary

of HHS and acts under the Secretary’s general statutory authority. For example, under the Public

Health Services Act (42 U.S.C. 201 et seq.), the Secretary has general authority to enact regulations

to prevent the spread of diseases across State or

national borders. The Secretary has used this authority to limit the travel and transportation of

individuals with specific communicable diseases.

In 1988, the CDC used its authority to issue

guidelines for donor insemination, so that the risk

of HIV transmission could be reduced (64). While

not mandatory, these guidelines do set an unofficial standard of the minimum quality of care expected from physicians. The CDC may also ask

for cooperation from local health departments

(which do have direct “police power” regulatory

authority to demand cooperation) for assistance

in collecting data relevant to communicable diseases, and this request is likely to be complied with

if it is reasonable (43).

Antitrust and Information Disclosure

In response to the “trusts” developed by the railroads in the late 19th century, Congress passed

the Sherman Antitrust Act in 1890 (which forbade

“conspiracy in restraint of trade or commerce, ”

and made the exercise of monopoly power a felony)

and, in 1914, the Clayton Act and the Federal

Trade Commission Act. The Clayton Act declared

illegal four specific practices (price discrimination,

tying or exclusive dealings contracts, corporate

mergers among competitors, and interlocking directorates among competitors). The Federal Trade

Commission Act created an independent Federal

administrative agency with the power to study

(and later to take enforcement action against) ‘(unfair methods of competition” and ‘(unfair or deceptive acts” (21).

The antitrust laws have only recently been used

against medical practitioners (11). Some groups,

for example, charged that obstetricians in a certain area had conspired to fix prices for abortions

and other services to try to eliminate these services from the marketplace (24). It is unlikely that

the Antitrust Division of the Justice Department

(or private individuals or corporations) will find

any occasion to attack concerted action in infertility services, since these are generally run as

small businesses rather than as large-scale operations. Yet the Federal Trade Commission could

become involved in examining potential “unfair

practices.”

One of the practices FTC has found unfair is

a seller’s refusal to disclose information about various aspects of products (18). Examples include the

failure to disclose the efficiency rating ((’R value”)

of home insulation, the octane level in gasoline,

or the drop-out and placement rates of vocational

schools (18).

Analogously, FTC could find it an unfair practice for infertility clinics not to disclose their pregnancy or live-birth rates, or any other piece of

information that consumers need to decide whether

to attempt a pregnancy by noncoital reproduction, or whether to make the attempt at a particular clinic. Misleading advertisement of success

rates could also be subject to FTC scrutiny and

regulation (54). The difficulty of choosing a single method by which to calculate and advertise

success rates for IVF (19)44)45), however, points

up how hard it is to determine that a particular

figure is misleading (see box 9-B),

Regulation of Products

The commerce power, of course, also provides

specific authority to regulate articles of commerce

that pass between two or more States. This authority has been used most specifically in the

health care field by the establishment of FDA,

which is authorized to regulate drugs and medical devices and to prohibit trade of such products in interstate commerce until they have been

demonstrated safe and effective. Although this authority is extremely broad, it is of limited value

with respect to noncoital reproductive techniques,

since they generally do not involve the use of new

drugs or medical devices, but rather of new (or
182 . Infertility: Medical and Social Choices

Box 9-B.—How IVF Success Rates Can Be Reported

The reporting of IVF data is limited only by one’s imagination

in contriving some new yardstick of performance, short of a normal liveborn child (44).

In early 1988,41 U.S. IVF clinics reported, as a group, their success rates for 1985 and 1986 (45). These

clinics represent about one-fourth of all IVF programs active in the United States and are generally the

most successful. This first combined report of IVF clinics characterized the average 1986 IVF success rate

as 16.9 percent (clinical pregnancy per embryo transfer cycle). (“Clinical pregnancy” denotes positive fetal

heart documented by ultrasound.) This figure is one of several ways to calculate IVF success rates and

may be misleadingly optimistic for some patients. It may also be inadequate to reflect success rates for

procedures using frozen embryos obtained in earlier stimulation cycles.

It is important to note that regardless of how averages are expressed, they can be misleading for an

individual patient. Patients who are older, who have a history of repeated miscarriages, or who have other

special risk factors have smaller chances for success. Conversely, some candidates for IVF are much more

likely than average to have a successful pregnancy.

Assuming an IVF candidate has passed a battery of tests determining her general appropriateness for

the procedure, she’s ready to start her first ovarian stimulation cycle. On average, 6 of 10 women are

successful at stimulation and fertilization, leading to an embryo-transfer attempt. Following embryo transfer, the chance of becoming clinically pregnant is about 1 in 6 (16.9 percent), the figure highlighted in

the report of the success rate of the 41 clinics. However, a woman still faces the risk—about a l-in-3 chance—

that her pregnancy is ectopic, or that it will end in a miscarriage or stillbirth. Therefore, her chance of

walking out with a baby after one embryo transfer cycle is about 1 in 9 (l0.7 percent). Calculated per

stimulation cycle, a woman’s chance of taking home a baby is about 1 in 16 (6.3 percent). She also has

a 1 in 1,000 chance of winding up in the hospital due to hyperstimulation from the drugs.

On average, each patient at the 41 IVF clinics undertook 1.6 stimulation cycles, so the 1 in 16 chance

of taking home a baby following one stimulation cycle can also be quoted as an overall 1 in 10 (10 percent) chance of taking home a baby after undertaking an average course of IVF treatment.

Every couple is unique, and the chances of success may vary from the averages quoted here or by

an IVF clinic. A particular patient’s or clinic’s past success with stimulation, egg retrieval, and fertilization

may make one or another type of reported success rate more useful. Couples undertaking medically assisted

conception should keep in mind that miscarriage rates are high for all pregnancies, IVF-induced or not,

and that they may have to undergo many attempts before a successful pregnancy is achieved. With IVF,

the odds per stimulation cycle, and even per embryo transfer, of taking home a baby are low.

Percentages mean nothing. I know, like every woman who waits

in an IVF clinic, that anything less than 100% is a failure (19).

SOURCE: Office of Technology Assessment, 1988.

old) physical manipulations or surgical proce- laboratories engaged in interstate commerce (42

dures. Unlike drugs and devices, surgical procedures and medical manipulations are not regulated by any governmental agency. Physicians are

simply held to the standard of the “reasonably prudent physician” in developing and using such techniques.

The Federal Government has also used the commerce authority to require licensing of medical

U.S.C. 263). It could require Federal licensure of

infertility clinics that solicit patients from out of

State, although this would be more like regulating medical practice than regulating laboratory

quality. On the other hand, tissue banks and other

suppliers of screened gametes or even of embryos

could probably be regulated in the same fashion

as that used for medical laboratories or blood

banks. Federal regulation to assure the safety of
Ch. 9—Quality Assurance in Research and Clinical Care . 183

semen sold by sperm banks was viewed as unreasonable by only a minority of sperm banks and

individual physicians surveyed in 1987 (63).

Patenting Power

The Constitution also gives Congress the explicit

authority to set up a system of patents and copyrights. Historically, while drugs and medical devices have been routinely patented, it is exceedingly rare for physicians to attempt to patent

surgical or medical procedures. Examples of when

they have done so include a “method and apparatus for direct electrical injection of gold ions into

tissue such as bone, ” “ cranial insertion of surgical needle utilizing computer-assisted tomography,” a “method for maintaining the reduction of

a sliding esophageal hiatal hernia)” and a “surgical method of fixation of artificial eye lenses. ”

Nevertheless, one venture capital corporation

interested in providing embryo lavage and transfer services nationwide did apply for a patent on

the process of lavage and fertilized ovum retrieval.

That application is pending, along with four other

related patent requests for the devices used (25).

Although interest in the procedure has waned due

to its low success rate relative to alternative procedures (14,15), the company has nonetheless begun to open offices around the United States and

in Italy (25).

The U.S. Patent Office can no doubt issue process patents if it so chooses. The real debate over

the embryo lavage and transfer patent is whether

it should have been applied for in the first place,

and, if it is granted, how it could be enforced. One

argument in favor of allowing the patent is that

its holder can enforce high medical standards by

training and monitoring those who purchase

licenses to use the patented procedure. Balanced

against this is the tendency of a patent holder to

keep unfavorable results secret, so that unbiased

groups may not have an opportunity to confirm

or deny claims made for the process; the inhibition by the patent of the generalized training of

medical professionals; and the general inhibition

against sharing scientific knowledge. Human reproduction also does not easily lend itself to patent

infringement enforcement methods, and patent -

ing new reproductive technologies remains problematic (7).

SUMMARY AND CONCLUSIONS

Professional societies such as the American Association of Tissue Banks, the American College of

obstetricians and Gynecologists, and the American

Fertility Society have made efforts to regularize

the practice of medically assisted conception by

offering guidelines on gamete and participant

screening, physician training, and clinic staffing.

The Federal Government, too, has been active with

regard to donor insemination. These efforts, however, may be insufficient. First, as compliance is

entirely voluntary, public health hazards—e.g.,

human immunodeficiency virus transmission by

fresh semen—may persist in medical practice, with

only the threat of malpractice litigation to act as

a check. Perhaps more important, many of the

questions surrounding noncoital reproduction,

such as recordkeeping or screening of participants

who intend to raise the child or contribute to its

conception, are really questions of public policy

as much as of medical practice. As such, the influence of infertile couples, potential gamete

donors or surrogates, social workers, attorneys,

business people, and government officials on the

development of regulations is appropriate.

The regulation of noncoital reproductive techniques has traditionally been primarily a matter

for individual States. Just as they have regulated

adoption, custody, marriage, medical licensing, and

medical practice, States will bear the responsibility for regulating the noncoital reproductive techniques insofar as they are medical procedures performed by physicians. In this regard, regulations

in the area of quality control and monitoring,

safety, recordkeeping, inspection and licensing,

consent, and requirements for donor screening

are all well within traditional State activities and

regulation, In extreme cases, such as banning the

sale of human embryos or experimenting with human embryos, statutes would have to be carefully
184 ● Infertility: Medical and Social Choices

drawn to avoid being struck down for vagueness,

as well as based on a reasonable State policy designed to protect the common good.

Federal activity in noncoital reproductive techniques, on the other hand, has been largely restricted to setting up and financing national commissions and groups of various kinds to study the

scientific, legal, and ethical issues involved and

to make recommendations on the actions of private and governmental organizations. The Federal

Government could, however, become involved in

other areas it traditionally enters, such as regulating interstate commerce, forbidding the sale

of human organs, regulating false and deceptive

advertising, and promulgating special rules for

publicly supported human research. It could also

facilitate nonregulatory efforts to establish more

uniform protocols for selecting patients, choosing therapies, and defining successful outcomes.

Finally, it could continue its efforts to minimize

the risks associated with even the most standard

therapies.

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9. Andrews, L. B., “The Legal Status of the Embryo,”

Lowyola Law Review 32:357-409, 1986.

10. Baram, M. S., Alternatives to Regulation (Lexington,

MA: Lexington Books, 1982).

11. Barnes, E. G., “The Federal Trade Commission’s

12

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VA, personal communication, May 31, 1987.

Bustil]o, M., Buster, J. E., Cohen, S. W., et al., “Nonsurgical Ovum Transfer as a Treatment in Infertile Women: Preliminary Experience, ” Journal of

the American Medical Association 251:1171-1 173,

1984.

Caplan, A., “The New Technologies in Reproduction: New Ethical Problems,” unpublished manuscript,

1987.

Christoffel, T., Health and the Law (New York, NY:

The Free Press, 1982).

Craswell, R., ‘(The Identification of Unfair Acts and

Practices by the Federal Trade Commission,” Wisconsin Law Review 1981:107-153, 1981.

Davis, G., “The Private Pain of Infertility, ” New

York Times Magazine, pp. 106-121, Dec. 6, 1987.

Faden, R. R., and Beauchamp, T. L., A History and

Theory of Informed Consent (New York, NY: Oxford University Press, 1986).

Farabi, S. B., “Advertising Restrictions on Health

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City Law Review 50:82-98, 1981.

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States, Exchange: Section 3, Phuvsician Licensing

Boards and Phuvsician Discipline (Washington, DC:

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Feegel, J. R., Legal Aspects of Laboratory Medicine

(Boston, MA: Little, Brown & Co., 1973).

Feminist Women’s Health Center v. Mohammad,

536 F.2d 530 (5th Cir. 1978)

Fertility Genetics & Research, Inc., Annual Report

(Chicago, IL: 1986).
Ch. 9—Quality Assurance in Research and Clinical Care ● 185

26. Goodman, C. S., “A Practical Guide to Technology

Assessment,” Business and Health 4(10):14-19, 1987.

27. Grad, F. P., and Marti, N., PhuYsicians’ Licensure and

Discipline (Dobbs Ferry, NY: Oceana Press, 1979).

28. Harrisburg Hospital v. Thornburgh, 616 F. Supp.

699 (D.C. Pa. 1985).

29. Havering v. DatJis, 301 U.S. 619 (1937).

30. Havighurst, C.C. (cd.), Regulating Health Facilities

Construction (Washington, DC: American Enterprise Institute, 1974).

31. Hellman, D.J., “Status Report-Health Planning and

Capital Expenditure Regulation, ” Health Law \’igil

8:1-3, 1985.

32. Huvman v. Jewish Chronic Disease Hospital, 15 N.Y.

2d 317, 206 N.E. 2d 338 (1965).

33. Institute of Medicine, Assessing Medical Technologies (Washington, DC: National Academy Press,

1985).

34. Jones, S. E., “Adjuvant Chemotherapy for Breast

Cancer,” Journal of the American Medical Association 245:1527-1528, 1981.

35. Journal of the American Medical Association,

“Genetic Engineering in Man: Ethical Considerations,” Journal of the American Medical Association 220:721-722, 1972.

36. Kass, L. R., Toward A More Natural Science: Biologv and Human Affairs (New York, NY: The Free

Press, 1985).

37. King v. Smith, 392 U.S. 309 (1968).

38. Kolata, G., “Heart Panel’s Conclusions Questioned,”

Science 227:40-41, 1985.

39. Kosecoff, J., Kanouse, D. E., Rogers, W. H., et al.,

“Effects of the National Institutes of Health Consensus Development Program on Physician Practice, ” Journal of the American Medical Association

258:2708-2713, 1987.

40. Levine, R., Ethics and Regulation of Clinical Research, 2d ed. (Baltimore, MD: Urban & Schwarzenberg, 1986).

41. Lorio, K., “In Vitro Fertilization and Embryo Transfer: Fertile Areas for Litigation,” South Western

Law Journal 33:973-978, 1982.

42. Margaret S. v. Edwards, 794 F. 2d 994 (5th Cir.

1986).

43. Matthews, G.W., and Neslund, V. S., “The Initial Impact of AIDS on Public Health Law in the United

States, 1986, ’’Journal of the American Medical Association 257:344-352, 1987.

44. McDonough, P. G., “Comment ,“ Fertility and Sterility 48:899, 1987.

45. Medical Research International and the American

Fertility Society Special Interest Group, “In vitro

Fertilization/Embryo Transfer in the United States:

1985 and 1986 Resuhs From the National IVF/ET

Registry,” Fertility and Sterility 49:212-215, 1988.

46. Mengert, W., History of the American College of

Obstetricians and Gynecologists, 1950-1970

(Chicago, IL: American College of Obstetricians and

Gynecologists, 1971).

47. Michael v. Metropolitan Life Insurance Co., 631 F.

SUPP. 451 (W.D.N.C. 1986).

48. Oliver, M. F., “Consensus or Nonsensus Conferences

on Coronary Heart Disease, ” Lancet, May 11, 198.5,

pp. 1087-1089.

49. Perry, S., “The NIH Consensus Development Program: A Decade Later,” New England Journal of

Medicine 317:485-488, 1987.

50. Petersen, E., Alexander, N.J., and Moghissi, K. S.,

‘

( A.I.D. and AIDS—Too Close for Comfort, ” Fertility and Sterilit-y 49:209-210, 1988.

51. President’s Commission for the Study of Ethical

Problems in Medicine and Biomedical and Behavioral Research, Screening and Counseling for

Genetic Conditions (Washington, DC: U.S. Go\rernment Printing Office, 1983).

52. Presser, W., and Keeton, W., The Lattr of Torts,

5th ed. (St. Paul, MN: West Publishing, 1984).

53. Schaeffer, M. (cd.), Federal Legislation and the Clinical Laboratory (Boston, MA: G.K. Hall Medical Publishers, 1981).

54. Schuman, G., “False Advertising: A Discussion of

a Competitor’s Rights and Remedies, ” Loyola University Law Journal 15:1-31, 1983.

55. Shapiro, S., Director, Gynecology & Endocrinology Laboratory, University of Wisconsin Center for

Health Sciences, personal communication, A’okr. 27,

1987.

56. Shlaff, W., The Johns Hopkins Uni\rersity School

of Medicine, personal communication, Jan. 5, 1988.

57. Simpson, J.B., “State Certificate of Need Programs:

The Current Status, ” American Journal of Public

Health 75:1225-1229, 1985.

58. Sims, C., Director, Southern California Cryobank,

personal communication, November 1987.

59. Starr, P., The Social Transformation of American

Medicine (New York, NY: Basic Books, 1982).

60. The T.J. Hooper, 60 F. 2d 737 (2nd. Cir. 1932).

61. Tribe, L., American Constitutional La\v (Mineola,

NY: Foundation Press, 1978).

62. U.S. Congress, Office of Technology Assessment,

Development of Medical Technology: Opportunities for Assessment, OTA-H-34 (Springfield, L’A: National Technical Information Seririce, 1976).

63. U.S. Congress, Office of Technology Assessment,

“Artificial Insemination: Medical and Social Issues—

Background Paper, ” forthcoming.

64. U.S. Department of Health and Human Ser~~ices,

Ptiblic Health Service, Centers for Disease Control,

76-580 - 88 - 7 : QL 3
186 ● Infertility: Medical and Social Choices

“Semen Banking, Organ and Tissue Transplantation, and HIV Antibody Testing, ” Morbidity and

Mortality Weekly Report 37(4):57-63, 1988.

65. U.S. Department of Health, Education, and Welfare, Tuskegee Syphilis Study Ad Hoc Advisory

Panel, Final Report (Washington, DC: U.S. Government Printing Office, 1973).

66. U.S. Department of Health, Education, and Welfare, Report of the President b Biomedical Research

Panel, Publication No. 0S-76-500 (Washington, DC:

U.S. Government Printing Office, 1976).

67. U.S. Department of Health, Education, and Welfare, Ethics Advisory Board, Report and Conclusions: HEW Support of Research Involving Human

In Vitro Fertilization and Embryo Transfer (Washington, DC: U.S. Government Printing Office, 1979).

68. United States v. Bass, 404 U.S. 336 (1971).

69. Warner, D. A., Status of State Capital Expenditure

Regulation (Chicago, IL: Department of Health

Planning and Capital Finance, Office of Health Care

Financing and Data Analysis, American Hospital

Association, 1987).

70. Weixel, J., U.S. Food and Drug Administration, personal communication, Oct. 19, 1987.

71. Wing, K. R., The Law and the Public’s Health, 2d

ed. (Ann Arbor, MI: Health Administration Press,

1985).
chapter 10

Reproductive Health

of Veterans
CONTENTS

Page

Population of Veterans . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...189

Male . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..189

Female . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .............190

Factors Contributing to Infertility . . . . . . . . . . . . . . . . . . . . . . . . . . .............190

General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...............190

Special Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .191

Infertility Treatment by the Veterans’ Administration. . . . . . . . . . . . . . . . . . . . . . .192

Veterans’ Eligibility for Health Care. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .195

General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .....,..195

Outpatient Care. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...........195

Disabilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,195

Service-Connected Determination . . . ..., . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . .196

Compensation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...196

Costs of Infertility Services . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..............196

Veterans’ Advocacy Groups. . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ., . .197

Additional VA Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . ......198

Summary and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ..,198

Chapter 10 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......199

Box

Box Arc). Page

10-A. Obtaining Semen From the Spinal Cord Injured. , . . . . . . . . . . . . . . . . . . . . .194

Figures

Figure No.

10-l, Population of Veterans With Service-Connected Conditions Rela

Infertility: Comparison With Other Populations . . . . . . . . . . . . .

10-2 Devices Used in Electroejaculation Procedures . . . . . . . . . . . . . .

Tables

Table No.

Page

ed to

. . . . . . . . . 190

. . . . . . . . . 194

Page

10-1 Service-Connected Conditions Related to Infertility. . ...................191

10-2. Infertility-Related Procedures Performed by the Veterans’ Administration .193
Chapter 10

Reproductive Health of Veterans

The largest health care delivery system in the

Nation, the Veterans’ Administration (VA), currently offers only limited treatment for infertility in its 172 medical centers and 227 outpatient

clinics. Discussions both inside and outside the

VA have focused on whether the inability to reproduce is a medical disability that should be

treated by Veterans’ Administration facilities with

available medical technologies.

Are medical treatments for infertility technological luxuries, or are they part of a comprehensive system of health care, in keeping with the

goals and mission of the Veterans’ Administration?

Since infertility treatment often involves the examination and treatment of both partners, should

the VA have authority to administer medical treatment to the nonveteran spouse? This chapter addresses some of the issues related to the reproductive health of veterans.

POPULATION OF VETERANS

There were nearly 28 million veterans living in

the United States and Puerto Rico in 1985. The

group ranges in age from Spanish American War

veterans to some of the most recent veterans of

the Nation’s Volunteer Armed Services (fewer than

500 veterans under 20 years of age). In 1985, the

veteran population declined by 177,000, as many

more veterans died than were separated from the

armed forces. Veteran deaths numbered 413,000

during fiscal year 1985, while net separations from

the armed forces totaled 236,000. The total number of veterans is expected to continue declining

in the absence of any major military personnel

buildup. Approximately two of every five living

veterans are from the World War II era (37 percent), with Vietnam era veterans constituting the

second largest group (about 30 percent).

The median age of veterans in civilian life in

1985 was 52.9 years. This figure is likely to rise

over the next two decades as a large number of

World War II veterans reach 65. Veterans under

the age of 45 constituted 35 percent of the total.

Although the vast majority of veterans are male,

there is a growing population of female veterans.

population. Their median age was 52.9 years, with

approximately 35 percent being under 45 and an

additional 20 percent being in the 45 to 54 age

group. Although male fertility may continue beyond age 54, this age is commonly used as an upper limit after which fertility is no longer a major

concern for the vast majority of men. An estimated

79 percent of male veterans are married (21). If

the incidence of infertility in the general population (8.5 percent of married couples 15 to 44 years

old, see ch. 3) applies to a similar age group in

the veteran population, then at least 627,000 male

veterans between 18 and 44 may be part of an

infertile couple. ]

This estimate makes no distinction between

service~connected and non-service connected conditions that may contribute to the infertility. However, in 1985 approximately 16,000 male veterans

under the age of 55 were on VA records with

known service~connected medical conditions

(rated at greater than O-percent disability) that

could cause infertility (see figure 10-1). The determination of service~connected conditions is discussed later in this chapter.

Male

In 1985, an estimated 26,671)000 male veterans

constituted about 96 percent of the total veteran

IThis figure likely underestimates the number of male veterans

with infertility problems since no data are available on the incidence

of infertility for males 45 to 54 years old. However, if a similar incidence of infertility does exist in the 45- to 54-age group, then an

estimated 985,000 male \’eterans under 55 may be part of an infertile couple.

189
190 Infertility: Medical and Social Choices

Female

The population of women veterans increased

by about 15,000 between 1983 and 1985. Today,

women constitute approximately 10 percent of

active military personnel (21).

The majority of women veterans are comparatively young. In 1985, of the estimated 1,168,000

female veterans, approximately 54 percent were

under 55 years of age. Some 42 percent were under the age of 45. Therefore, there were 490)560

women veterans 17 to 44 years of age (20,21),

roughly the group of women who would most

likely use and benefit from the treatment of infertility. In this group, approximately 70 percent

(343,392) were married.

If the incidence of infertility in the general population is also applicable to the married female

veteran population, then more than 29)000 women

veterans were or are currently having problems

conceiving a child. These figures approximate the

total number of female veterans with possible infertility problems and make no distinction between

service connected and non-service~connected disabilities or conditions. Data recently compiled by

the VA indicate that the number of known female

veterans with service-connected medical conditions that would result in infertility is actually

much smaller: In 1985, between 1)200 and 1)300

female veterans on VA records had a service-connected medical condition (rated above O-percent

disability) that could contribute to infertility.

Figure IO-l.– Population of Veterans With

Service-Connected Conditions Reiated to infertility:

Comparison With Other Populations

Married veterans under age 55

(12,000,000)

\

Veterans with service-connected

Aicahilitiac (~.000)”

Veterans with service-connected

infertility (fewer than 20,000) T

All infertile couples,

veteran and nonveteran

(2,400,000)

SOURCE: Office of Technology Assessment, 1988.

FACTORS CONTRIBUTING TO INFERTILITY

General production of viable sperm) and semen production, and defects in the transmission of sperm from

Historically, infertility was thought to be a dys - the testes to the female reproductive tract.

function of the female reproductive system. Today,

male factors are believed to be the major reason Table 10-1 lists a breakdown of the population

for infertility in 20 to 40 percent of all infertile of male veterans on VA records with service-concouples and to contribute to infertility in another nected medical disabilities that can contribute to

20 percent. Since infertility problems of men have infertility (data from 1985).

not been studied as extensively as those of women, Female factors are believed to account for, or

much less is currently known about the factors

leading to and treatment of infertility in males.

contribute to, 50 percent of all infertility among

couples. These factors are classified in at least

three broad categories: defects in ovum (egg) proMale infertility may be broken down into two duction, tubal defects (transport), and implantabroad categories: defects in spermatogenesis (the tion problems.
Ch. 10—Reproductive Health of Veterans ● 191

Table 10-1 .-Service. Connected Conditions

Related to Infertility

Number of

Condition veterans

Male veterans:

Stricture of the urethra . . . . . . . . . . . . . . . . . . .

Removal of the penis. . . . . . . . . . . . . . . . . . . . .

Deformity of the penis . . . . . . . . . . . . . . . . . . .

Complete atrophy of the testes . . . . . . . . . . . .

Removal of testes . . . . . . . . . . . . . . . . . . . . . . .

Partial or complete removal of prostate . . . . .

Spinal cord injury . . . . . . . . . . . . . . . . . . . . . . . .

Spinal cord disease . . . . . . . . . . . . . . . . . . . . . .

Other. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Female veterans:

Inflammation of the cervix . . . . . . . . . . . . . . . .

Inflammation of the uterus . . . . . . . . . . . . . . . .

Inflammation of the uterine tubes. . . . . . . . . .

Removal of the ovaries . . . . . . . . . . . . . . . . . . .

Atrophy of both ovaries. . . . . . . . . . . . . . . . . . .

Pituitary condition . . . . . . . . . . . . . . . . . . . . . . .

Other. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2,459

68

436

2,414

6,268

2,546

1,660

●

●

15,851

283

65

151

664

6

67

●

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1,236

● Estimates unavailable

SOURCE: US Veterans’ Administration, Department of Medicine and Surgery,

White Paper, /nferti/ify (Washington, DC: 1985).

Table 10-1 lists a breakdown of the population

of female veterans on VA records with a medical

disability that can result in infertility (data from

1985). The incidence of infertility associated with

many of these pathological conditions is most likely

similar in both the veteran and nonveteran populations. However, veterans may suffer from a

subset of these conditions that occur more frequently among veterans or are of special concern

to the VA medical centers.

It must be emphasized that these numbers are

crude estimates of the population of veterans with

service~connected disabilities that could result in

infertility. It is not currently known how many

male and female veterans with these or other

service connected disabilities actually suffer from

infertility.

Special Considerations

Post-Traumatic Stress Disorder

Some veterans of the Vietnam era suffer from

a severe psychological disturbance known as posttraumatic stress disorder (PTSD), which in some

instances can impair procreative ability. This may

be of particular importance to male veterans who

suffer from psychogenic impotence or other sexual dysfunction as a result of PTSD. Although this

form of sexual dysfunction can occasionally occur in otherwise healthy men for a variety of reasons related to stress, anxiety, and emotional disorders, impotence is more notably associated with

physical causes such as normal aging, vascular

disease, drugs, alcoholism, and diabetes. In the

general population, impotence is not considered

a major factor contributing to infertility (see ch.

4), since most of the men affected are over 50 years

old.

Few data are available on the actual incidence

of PTSD-induced sexual dysfunction in veterans.

However, since the VA already has in place special programs to meet the medical and psychological needs of PTSD sufferers (6), adequate treatment of PTSD-induced infertility may already be

available. In addition, as would be true in any infertility medical practice, experts would question

the advisability of providing medical assistance

for procreation to any individuals suffering from

a potentially severe psychological condition such

as PTSD without prior or concurrent treatment

of the psychological disorder.

Agent Orange

Agent Orange is of particular concern to the

Veterans’ Administration and to Vietnam era veterans. The effects of exposure to herbicides such

as Agent Orange on the general and reproductive health of veterans and their offspring have

been the focus of considerable discussion and debate (7). Studies to date have failed to document

definitive adverse reproductive effects in humans

from occupational exposure to Agent Orange or

its components.

Many veterans and veterans’ groups have suggested that exposure to Agent Orange and other

herbicides used in Vietnam has resulted in a variety of deleterious health effects, including birth

defects in offspring and impaired reproductive

function. One study of Vietnam veterans who

were exposed to Agent Orange during shipping,

handling, and loading of herbicides on aircraft;

spray missions; and cleaning of airplanes and

equipment found no significant adverse effects

on fertility (9). In the same study, an excess of

minor birth defects, such as moles, was found
192 . Infertility: Medical and Social Choices

among offspring of exposed personnel compared

with offspring of nonexposed personnel.

A study based on the experiences of parents of

babies born in metropolitan Atlanta from 1968

to 1980 contained no evidence to indicate that Vietnam veterans have been at greater risk than other

men for fathering babies with birth defects, when

all types of serious structural birth defects are

combined (5). The Centers for Disease Control

have been conducting additional studies of the

health effects associated with Agent Orange exposure. It is currently unclear whether these

studies will continue.

Because of the extensive publicity that this topic

has received, many Vietnam veterans still in their

reproductive lifespan remain concerned about the

chance of birth defects in their offspring. Within

this large group, some veterans may be reluctant

to produce offspring because of previous known

or even suspected exposure to Agent Orange. Although the scientific data do not support their

concern, this may not mitigate the worries of individual veterans about possible serious birth

defects of their offspring.

To what extent will the concerns of these veterans affect their procreative desires and ability?

In view of the lack of overwhelming corroborating or contradicting data on possible birth defects

resulting from Agent Orange, alternative reproductive methods such as artificial insemination

by donor or ovum donation could be made available to these veterans. On the other hand, in the

absence of definitive data linking Agent Orange

exposure and reproductive and birth defects, is

providing infertility services on this basis really

warranted? Although the majority of Vietnam veterans have already had children, approximately

15 to 20 years remain in the normal reproductive lifespan of the youngest members of this

group, who may only now be considering having

a child or additional children.

Radiation

Exposure to ionizing radiation can lead to infertility (18). Between 1945 and 1963, the U.S.

Government exploded approximately 235 nuclear

devices in the atmosphere over the American

Southwest and the Pacific Ocean. The Department

of Defense estimates that approximately 222,000

military personnel participated in those tests. A

number of veterans present at the test sites have

reported either sterility or low sperm count to

the National Association of Radiation Survivors,

an organization that compiles data on primary illnesses of participants at nuclear test sites (15).

Most of these veterans are beyond the age at which

infertility is a major concern. However, since the

last atmospheric tests were conducted in 1963 it

is possible that a small population of veterans under 55 have radiation-induced or -aggravated infertility and wish to have children.

INFERTILITY TREATMENT BY THE VETERANS’ ADMINISTRATION

At the moment, most VA medical facilities pro- expertise of the medical staff. In fiscal year 1985,

vide only limited treatments that could be con- VA medical facilities recorded a total of 2,475 medsidered as infertility services. Since the agency ical and surgical procedures that could have been

does not classify infertility as a primary disabil- associated with infertility treatment (see table

ity, the VA is of the opinion that it does not have 10-2).

statutory authorization to perform artificial insemination or in vitro fertilization (IVF) (19). The It is clear from table 10-2 that some procedures

medical treatment that is or can be provided by associated with infertility are being performed in

the VA may involve relatively simple procedures VA medical facilities. According to these data, howsuch as sperm counts, hormone measurements, ever, surgical procedures most commonly assoand drug administration. However, even these ciated with infertility treatment-e.g., repair of

simple procedures can be provided only in con- fallopian tubes and repair of vas deferens and

nection with the treatment of an underlying dis - epididymis—were not performed in any VA mendability. The actual extent of treatment may vary ical facility in fiscal year 1985. In addition, it is

widely from facility to facility, depending on the clear that little, if any, infertility treatment for
Ch. 10—Reprocfucfive Health~ of Veterans ● 193

Table 10-2.—lnfertility-ReIated Procedures Performed

by the Veterans’ Administrationa

Number of

Procedure cases

Male veterans:

Excision of hydrocele . . . . . . . . . . . . . . . . . . . . 230

Excision of varicocele . . . . . . . . . . . . . . . . . . . . 758

Repair of spermatic cord and epididymis . . . 0

Repair of vas deferens and epididymis . . . . . 0

External penile prostheses . . . . . . . . . . . . . . . . 19

Internal penile prostheses . . . . . . . . . . . . . . . . 1,468

Female veterans:

Wedge resection of the ovary . . . . . . . . . . . . . 1

Repair of fallopian tubes. . . . . . . . . . . . . . . . . . 0

Insufflation of fallopian tubes . . . . . . . . . . . . . 0

Artificial insemination . . . . . . . . . . . . . . . . . . . . o

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,476

aThiS list does not account for all medical procedures that are associated with

infertility treatment that may have been administered in VA medical facilities

in 1985. In addition, neither the age of these patients nor their eligibility status

(service-connected or non-service-connected condition) is considered In this

list. Age is particularly important in cases of internal penile prostheses, since

older men are the most likely candidates for this procedure.

SOURCE U S. Veterans’ Administration, Department of Medicine and Surgery,

Pulmonary and Infectious Disease Program, Washington; DC, personal

communication, 1987.

female veterans is currently done in VA facilities.

However, these numbers do not take into account

the medical treatments provided for veterans by

outside health care facilities and by professionals

under contract with the VA. For example, many

VA facilities do not provide in-house gynecological health care for female veterans. These services may be provided by local facilities or gynecologists who are under contract with the VA.

Therefore, it is possible that some infertility services related to gynecological health care are being provided for female veterans in this manner.

Some additional information is available that pertains to treatment of one subpopulation of infertile veterans, spinal cord injury patients. The outlook for fertility in paraplegic men after spinal

cord injury is poor; the outlook for paraplegic

women is often better. These paralyzed men often

(but not always) suffer from impotence because

of neurological deficits in the spinal cord. The impairment in reproductive function depends on the

level of the spinal cord that is damaged and the

severity of the injury. The level of the spinal cord

lesion is important in determining the sexual

sequelae. From a practical standpoint, erections

sufficient for intercourse can be achieved by less

than 25 percent of spinal cord injured males. Likewise, the ability to ejaculate normally is retained

by less than 10 percent of these individuals (3).

Compounding problems of impotence and ejaculatory dysfunction, paraplegics with prolonged intermittent or continuous catheterization-related

prostatitis, epididymitis, and epididymo-orchitis

can frequently develop obstructive lesions of the

reproductive tract and damage to the testes. In

addition, spermatogenesis can be severely impaired in many paraplegics and in most cases is

at least reduced. The reasons for this reduction

in sperm production are unclear, but increased

scrotal temperature and recurring reproductive

tract infections may be contributing factors. However, if there are functional testes with some

ongoing testosterone production and spermatogenesis, the major problem in procreating reproducing becomes transmission of sperm to the female reproductive tract.

Several VA Spinal Cord Injury Centers (there

are 20 in the United States) have been conducting research and some clinical trials on vibrational

and electrical induction of ejaculation of paraplegics during infertility treatment (see box 10-

A), The West Roxbury (MA) VA Spinal Cord Injury Program is conducting research on the use

of electroejaculation and vibration-induced ejaculation to treat the sexual dysfunction and resulting infertility of paralyzed veterans. Although this

program is in its formative stage, it has been successful in inducing ejaculation in a number of spinal cord injury patients. In addition, the program

is conducting tests of the pharmacological treatment of impotence.

Another program, at the Palo Alto (CA) VA Medical Center, has had some success with electroejaculation of paralyzed veterans as well. The Spinal Cord Injury Center there has reported a live

birth as a result of electroejaculation of a paralyzed veteran, sperm washing, and subsequent

artificial insemination of the veteran’s wife. (The

artificial insemination was performed in collaboration with a private gynecologist, since the V A

is not authorized to perform this procedure.) Pregnancies and live births to wives of paraplegics have

been reported using these and alternative techniques in other, non-VA medical centers (1,2,3).
194 ● Infertility: Medical and Social Choices

Box IO-A.—Obtaining Semen From the Spinal Cord Injured

Although sperm may be decreased in number and quality in paraplegics, there can be sufficient amounts

to achieve pregnancy by normal or medically assisted means. A number of techniques can be used to obtain

semen from spinal cord injury patients, although this area of research is in its infancy.

Intrathecal neostigmine injection has largely been abandoned because of the risks and the report

of at least one death resulting from this procedure. However, this approach for inducing ejaculation, which

uses injection of a pharmacologically active substance into the nervous system, has yielded several pregnancies (3).

Electroejaculation has been used in farm animals for many years and was first applied to paraplegic

men in 1948. This involves electrical stimulation of the nerve complex that controls ejaculation. This stimulation is applied via electrodes placed in the patient’s rectum with a device similar to those shown in figure

IO-2. A number of pregnancies have been reported using this approach (1,3).

Vibratory-induced ejaculation has also been used successfully in spinal cord injury patients, although its applications are more restricted than electroejaculation. Direct application of vibratory stimulation to the penis of paraplegic men can elicit reflex erection and ejaculation. However, depending on the

time since injury and the level and severity of the spinal cord lesion, electroejaculation may be the method

of choice.

In a few patients, radio wave-activated nerve stimulators have been implanted in the abdomen

around the hypogastric plexus, a nerve complex involved in reproductive function. When patients apply

a suitable radio transmitter over the implanted receiver, electrical impulses stimulate ejaculation (3).

Several other approaches have been used to collect semen from spinal cord injury patients. The use

of semen capsules (cannulae implanted into the vas deferens) to collect semen in a reservoir fashion

has been reported (3). Recently, a pregnancy has been reported in a couple with a male partner paraplegic

following direct aspiration of sperm from the vas deferens combined with intrauterine insemination (2).

SOURCE office of “1’echnolo&v Assessment, 1988

Figure 10-2.-Devices Used in Electroejaculation Procedures

Rectal probes manufactured from solid bars of polyvinyl chloride. Unlike hollow probes, these devices have built-in temHollow rectal probes constructed of silicone rubber rein- perature sensors that are connected to a monitor.

forced with nylon mesh. Electrodes (metallic circle) are made

of silver and connected to stimulator.

SOURCES: G.S. Brindley, “Sexual and Reproductive Problems of Paraplegic Men,” Oxford Reviews of Reproductive Biology, vol. 8 (Oxford, U. K.: Clarendon Press, 1986);

and C.J. Bennett, J.W.T. Ayers, J.F Randolph, et al., “Electroejaculation of Paraplegic Males Followed by Pregnancies, ” Fertilifyand Sterility 48:10701072, 1987,
Ch. 10-Reproductive Health of Veterans ● 795

VETERANS’ ELIGIBILITY FOR HEALTH CARE

General

Title 38 U. S. C., Sections 601, 603, 610, 612, and

620, define eligibility of veterans for hospital, nursing home, domiciliary, and medical care by the

VA. As a result of legislation enacted in 1986 (Public Law 99-272), three different categories of eligibility for veterans’ health care now exist.

Veterans in the first category must be provided

hospital care by the VA and maybe provided nursing home care, within the resources Congress appropriates. This group includes service~connected

disabled veterans, veterans exposed to Agent

orange or radiation, former prisoners of war,

pre-World War II veterans, and veterans unable

to pay for medical care. To qualify for care on

grounds of inability to pay, a veteran with no

dependents must have an annual income under

$15,000, or under $18,000 with one dependent.

Veterans receiving pensions or eligible for Medicaid are automatically considered unable to pay

(22).

Veterans in the second category will receive hospitalization and other medical care to the extent

resources and facilities are available. This group

includes veterans seeking medical treatment for

non-service-connected disabilities who do not fall

into any of the groups in the first category and

whose incomes do not exceed the $15)000/$18)000

thresholds. If their incomes are below $20,000 (in

the case of veterans with no dependents), or

$25,000 (with one dependent), the medical care

will be free. If their income is higher, then the

veterans fail into the third category of eligibility.

The third group of veterans is expected to pay

for some of their care, by making copayments or

covering all the cost, including the cost of nursing home and outpatient care. In addition, the VA

now has authority to obtain reimbursement from

a veteran’s health insurance plan for health care

provided in VA facilities. However, both the copayments and any reimbursement from health insurers go directly to the US. Treasury and not

into the VA operating budget. With the enactment

of the copayment policy and reimbursement of

the U.S. Treasury from private health insurance

companies, it might be more feasible to provide

infertility services for infertile veterans. It should

be pointed out that, at this time, most health insurers do not cover infertility services such as IVF.

However, other infertility services such as hormone treatment, laboratory tests, semen analysis, and ovulation monitoring may be covered by

such providers. The costs associated with these

latter procedures constitute a significant portion

of all infertility treatment expenses (see ch. 8).

Outpatient Care

The policies just discussed deal mainly with inpatient health care. The eligibility for outpatient

care is not the same. overall, most veterans are

not eligible for comprehensive outpatient care,

but are generally eligible only for care to obviate

a need for hospitalization (i.e., acute care) or to

continue care begun on an inpatient basis. There

is no requirement, as there is for veterans in the

first category needing hospital care, that outpatient care be furnished to any particular veteran (Title 38 U. S. C., Sec. 612).

In some geographical locations, such as the Sun

Belt States, home to a larger population of older

veterans requiring medical care, availability of

outpatient medical treatment for non-service-con -

nected disabilities is limited. Nevertheless, the VA

currently provides a significant amount of outpatient care for many veterans. This is of particular relevance to infertility services because as various infertility treatment methods become more

sophisticated they may be routinely performed

on an outpatient basis. This trend should be considered when evaluating statute changes.

Disabilities

Title 38 U.S.C., Section 601.1, defines disability

as “a disease, injury, or other physical or mental

defect.” Further classification of various disabilities for purposes of compensation by the VA are

outlined in the Code of Federal Regulations, Title

38, Part 4. Although a number of medical conditions associated with infertility are classified as

disabilities, the resulting infertility is not. It is because of this determination that the VA believes

it does not have the legal authority to provide in-
196 ● Infertility: Medical and Social Choices

fertility treatments such as artificial insemination

or IVF.

Service-Connected Determination

Service-connected determination is given to any

injury or disease incurred or aggregated during

active wartime or peacetime service. Veterans

must have been discharged or separated from the

service under other than dishonorable conditions.

To receive medical care for the condition, it must

be rated as a disability by the VA. This has posed

a problem for veterans who have service-related

conditions that result in impaired fertility, since

infertility per se is not considered a medical disability and therefore does not qualify for compensation. Although infertility is not a compensable disability, the underlying injury or disease

that actually causes the infertility may qualify as

a disability.

The determination of service connection, however, is not always clear. Because of the lack of

data on male reproductive physiology, it can be

extremely difficult to diagnose male infertility as

the reason a couple is unable to conceive, let alone

to determine the factors contributing to this condition. At present, the most common diagnosis for

male factor infertility is idiopathic—i.e., of unknown cause (see chs. 4 and 6).

Although this lack of knowledge about male infertility can make attributing a low sperm count

to a specific service-related event difficult, there

are a few instances that can be more easily identified. For example, infertility or sterility can result from orchitis (testicular inflammation) resulting from mumps (especially in adulthood). If this

infection was contracted while in active military

service and subsequent male infertility is diagnosed (decreased sperm number or motility, or

decreased testosterone production), service-connected designation can be made with confidence,

For an individual with similar symptoms and a

service record of exposure to relatively low levels

of ionizing radiation, on the other hand, the determination is far from clear. Although radiation

in large amounts can clearly impair testicular function and fertility, the effects of low levels are controversial and not well understood (18).

A similar but somewhat less problematic situation exists for service-connected designation of

female infertility. Female infertility problems can

more often be readily ascribed to a particular condition such as blocked or scarred fallopian tubes

resulting from pelvic inflammatory disease. However, here too uncertainty about cause and effect

occurs.

Because of the lack of knowledge about all possible factors contributing to infertility in men and

women, many determinations of service connection will remain problematic. Evaluation of service connection or aggravation is best made on a

case-by-case basis by physicians trained in infertility.

Compensation

Compensation for service-connected disabilities

amounts to monthly financial payments if the rating of the disability, as determined by the local

rating boards, is judged greater than O percent.

In 1987, compensation ranged from $69 per

month for a l0-percent rating to $1,355 per month

for a total (100-percent) disability rating. Adjustments to these figures may be made, depending

on number of dependents and

COSTS OF INFERTILITY SERVICES

As described in detail elsewhere in this assess- eral population can range from

circumstances.

$2)000 to more

ment (see ch. 8), the costs of infertility services than $22,000, depending on the severity of the

vary considerably depending on the factors lead- problem. In 1986 an estimated $1 billion was spent

ing to the infertility and the types of diagnostics on infertility-related services. If the VA were to

and treatments required. OTA estimates that the provide medical treatments to overcome infertilcosts of infertility services for couples in the gen - ity, how much would it cost?
Ch. 10—Reproductive Health of Veterans c 197

The VA has estimated the cost of providing “services to achieve pregnancy in a veteran, or a veteran’s spouse, if necessary to overcome a serviceconnected disability which impairs the veteran’s

procreative ability” to be $580)000 in the first fiscal year and $4.1 million over five fiscal years (8).

However, at least one veterans’ advocacy group

questions the accuracy of these numbers (11).

Although OTA has estimated the costs of infertility services for couples in the general population, any accurate estimate of possible costs to

the VA of providing infertility services will remain

elusive until criteria are established for the following variables:

● What population of veterans would be eligible for infertility services? Those with serviceconnected conditions only? Which serviceconnected conditions would be excluded?

● How many eligible veterans actually would

seek infertility treatments? In 1982, in the general population only about 55 percent of the

identified infertile couples reported they

wanted to have a baby. Only about one-third

of the infertile couple population actually

sought out infertility treatment (see ch. 3).

Would the same percentages hold for infertile veterans?

● What types of infertility services would be

provided? All? Would reproductive technologies such as IVF and gamete intrafallopian

transfer be excluded?

● Would treatments be limited to the veteran

partner of an infertile couple or include the

nonveteran spouse as well? This would not

only change the number of patients undergoing infertility treatment but would also significantly affect the kinds of treatments

available.

● Where would infertility treatments be located?

If the VA elects to provide all infertility treatments in-house, then considerable startup and

maintenance costs would result. On the other

hand, providing services on a contract or onetime grant basis would cost considerably less.

VETERANS’ ADVOCACY GROUPS

The Paralyzed Veterans of America (PVA) is a

national, nonprofit service organization for paralyzed veterans founded in 1946 and chartered by

Congress in 1971. PVA has a membership of approximately 14)

000 and is an advocate for 25)000

paralyzed American veterans, an estimated 175,000

nonveteran paralyzed Americans, and all US.

veterans.

Of particular interest to PVA are veterans with

service connected spinal cord injuries or diseases.

This group, estimated by the VA at approximately

1,660 (though a somewhat higher estimate is suggested by PVA), can suffer from infertility problems due to neurological deficits that result in impotence and low sperm count and motility. The

PVA advocates the amendment of 38 U.S.C. to provide medical care and treatment for secondary

disabilities and functional impairments resulting

from primary disabilities (13). This would presumably cover treatment of infertility with procedures

such as artificial insemination, IVF, and gamete

intrafallopian transfer.

In addition to the issue of infertility treatment,

PVA believes that specific changes in Title 38

should be made to cover not only currently available medical and surgical treatments for infertility, but other emerging technologies as well, as

they become available.

Another veterans’ group that has been an active advocate on this issue is the Vietnam Veterans

of America. This organization recently represented an infertile female veteran in a claim against

the VA. In this case, the female veteran from California petitioned the VA to pay for IVF to overcome her infertility, which was the consequence

of a service-connected medical condition. After

the VA denied this request, a tort claim against

the VA was filed. A cash sum for IVF was awarded

to the woman (17).
—

198 . Infertility: Medical and Social Choices

Amendment of 38 U.S.C. to allow the VA to provide medical services to overcome service-connected disabilities affecting procreation is also supported by the Veterans of Foreign Wars of the

United States, which feels that such a program

is long overdue (4). Other veterans’ groups supporting such a change include the American Legion and the American Veterans of WWII, Korea,

and Vietnam (AMVETS) (10,14).

ADDITIONAL VA

Several additional considerations are related to

veterans and the VA. First, the VA’s responsibility is unclear in the event of complications from

infertility treatments. Who would be responsible,

for example, if there were a complicated pregnancy following infertility treatments? The VA

currently contracts out care for complicated pregnancies, since normal, uncomplicated pregnancies are not considered disabilities. Since the VA

does not provide in-house obstetric services in

most of its facilities, this issue would have to be

resolved.

In addition, there is the question of responsibility in the event of an offspring with birth defects.

Title 38 U. S. C., Section 351, requires that a medical condition or complication that results from

medical treatment provided by the VA will itself

be treated as a medical disability by the VA and

render the VA fully liable for any medical malpractice claims. This may make the VA responsible for the medical care of the female partner durSUMMARY AND

Nearly 28 million veterans live in the United

States. The overwhelming majority (96 percent)

are male, 55 percent of whom are below the age

of 55. Female veterans are disproportionately

younger than male veterans; 490,560 female veterans are between ages 17 and 44. The number

of male veterans is decreasing, while the number

of female veterans is increasing.

The Veterans’ Administration offers only limited

treatment for infertility in its 172 medical centers

and 227 outpatient clinics. Since infertility treatAlthough many of these groups support amendment of 38 U.S.C. to allow procreative services,

at least one veterans’ group stated that “it was

more concerned with possible erosion of medical benefits for our Nation’s veterans than for the

expansion of experimental medical treatments”

(12).

CONSIDERATIONS

ing and after pregnancy as well as the resulting

offspring. This would be the case only if the VA

medical staff provided treatment within VA facilities. Such liability for birth defects or malpractice is passed on to the contractor in instances

where particular medical treatments are provided

on a fee-for-service basis by non-VA personnel (16).

The potential for liability may be an important

consideration in thinking about enlarging the VA’s

role in providing infertility treatment.

It should also be noted that at least two other

federally sponsored programs currently cover

some infertility services. Both the Civilian Health

and Medical Program of the Uniform Services and

Medicaid currently provide some types of reimbursement for infertility services (see ch. 8).

Other ethical and legal questions concerning the

access and delivery of various infertility treatments are considered elsewhere in this report (see

chs. 9, 11, 12, and 13).

CONCLUSIONS

ment often involves the examination and treatment of both partners, and the VA has authority

to administer medical treatment solely to veterans,

the VA lacks authority to treat a nonveteran

spouse of an infertile couple. Most important, the

VA does not classify infertility as a primary disability, thus severely limiting the treatment available to veterans.

In 1985, about 16,000 male veterans and more

than 1,200 female veterans had known serviceconnected medical conditions that could contrib -
Ch. 10—Reproductive Health ot Veterans Q 199

ute to infertility. Among the men, the conditions

ranged from removal of the testes or prostate to

spinal cord injury. Among the women, the conditions ranged from removal of the ovaries to inflammation of the fallopian tubes or cervix.

Spinal cord injury is of special concern both to

the VA (which supports 20 spinal cord injury

centers) and to veterans’ advocacy groups. The

outlook for fertility after spinal cord injury in paraplegic men (although not women) is often poor.

Erection and ejaculatory dysfunction, compounded

by infections of the reproductive tract, are common. Research at VA spinal cord injury centers

on the use of electroejaculation and vibrationinduced ejaculation is likely to offer hope for fertility to veterans—and ultimately nonveterans—

with spinal cord injuries. Ironically, even when

sperm are obtained through these procedures by

VA physicians, insemination of the veteran’s nonveteran wife cannot be undertaken within the VA.

Although OTA has estimated how much infertility services cost in the general population, estimating similar costs to the VA if it were to provide these services remains problematic until

criteria are established for a number of variables.

These include specification of the eligibility of veterans and/or spouses for infertility services and

types of procedures to be provided. In addition,

other factors such as whether these services

would be provided in-house or contracted to other

facilities will greatly affect estimates. Until these

questions are answered, meaningful cost estimates

will remain elusive.

CHAPTER 10 REFERENCES

1. Bennett, C. J., Ayers, J. W. T., Randolph, J. F., et al.,

“Electroejaculation of Paraplegic Males Followed

by Pregnancies,” Fertility and Sterility 48:1070-

1072, 1987.

2. Bustillo, M., and Rajfer, J., “Pregnancy Following

Insemination With Sperm Aspirated Directly From

Vas Deferens,” Fertility and Sterility 46:144-146,

1986.

3. Brindley, G. S., “Sexual and Reproductive Problems

of Paraplegic Men, ” Oxford Reviews of Reproductive Biologv, vol. 8 (Oxford, U. K.: Clarendon Press,

1986).

4. Cullinan, D. M., Assistant Director, National Legislative Service, Veterans of Foreign Wars of the

United States, Testimony before the Committee on

Veterans’ Affairs, U.S. Senate, May 21, 1987.

5. Erickson, J.D., Mulinare, J., McClain, P. W., et al.,

“Vietnam Veterans’ Risk for Fathering Babies With

Birth Defects,” JournaZ of the American Medical

Association 252:903-912, 1984.

6. Errera, P., M.D., Director, Mental Health and Behavioral Sciences Service, Department of Medicine

and Surgery, Veterans’ Administration, personal

communication, 1986.

7. Gough, M., Dioxin, Agent Orange: The Facts (New

York, NY: Plenum Press, 1986).

8. Gronvall, J. H., Chief Medical Director, Veterans’

Administration, Testimony before the Committee

on Veterans’ Affairs, U.S. Senate, May 21, 1987.

9. Lanthrop, G. D., Wolfe, W. H., and Albanese, R. A.,

Project Ranch Hand II: An Epidemiology Investigation of Health Effects in Air Force Personnel Following Exposure to Herbicides: Baseline Morbidity

Studtiy Results (Brooks Air Force Base, TX: USAF

School of Aerospace Medicine (EK), Aerospace

Medical Division (AFSC), 1984).

10. Lynch, R. E., Director, National Veterans Affairs

and Rehabilitation Commission, The American

Legion, Testimony before the Committee on Veterans’

Affairs, U.S. Senate, May 21, 1987,

11. Mansfield, G. H., Associate Executive Director for

Government Relations, Paralyzed Veterans of America, Testimony before the Subcommittee on Hospitals and Health Care of the Committee on Veterans’

Affairs, U.S. House of Representatives, Sept. 23,

1987.

12. McDonnell, J. A., Director, Military Relations, Air

Force Association, personal communication, 1986.

13. Moran, R., Associate Legislative Director, Paralyzed Veterans of America, Testimony before the

Committee on Veterans’ Affairs, United States

Senate, May 20, 1986.

14. Passamaneck, D.J., National Legislative Director,

American Veterans of WWII, Korea, and Vietnam

(AMVETS), Testimony before the Committee on

Veterans’ Affairs, U.S. Senate, May 21, 1987.

15, Randlett, T. W., Administrative Director, National

Association of Radiation Survivors, personal communication, 1987.

16. Robinson, R., General Counsel Office, Veterans’ Administration, personal communication, 1987.

17. Snyder, K., counsel, Vietnam Veterans of Ameri-
200 ● Infertility: Medical and Social Choices

ca, personal communication, 1986.

18. U.S. Congress, Office of Technology Assessment,

Reproductive Health Hazards in the Workplace,

OTA-BA-266 (Washington, DC: U.S. Government

Printing Office, 1985).

19. U.S. Veterans’ Administration, General Counsel

Office, General Counsel’s Opinion to the Medical

Director, “Authority of the VA to Perform Reverse

Sterilization Procedures and In Vitro Fertilization

Procedures,” 1985.

20. U.S. Veterans’ Administration, Office of Information Management and Statistics, Survey of Female

Veterans (Washington, DC: 1985).

21. U.S. Veterans’ Administration, Administrator of

Veterans’ Affairs, Annual Report 1985 (Washington, DC: 1986).

22. U.S. Veterans’ Administration, Federal Benefi”ts for

Veterans and Dependents (Washington, DC: U.S.

Government Printing Office, 1987).
Chapter 11

Ethical Considerations
CONTENTS

Page

Context of the Ethical Debate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .203

The Right To Reproduce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ....205

Moral Status of the Embryo . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....207

Parenthood and Parent-Child Bonding . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..209

Research Initiatives and the Rights of Patients and Research Subjects . . . . . . . . .2IO

Truth-Telling and Confidentiality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .........211

Intergenerational Responsibilities . . . . . . . . . . . . . . . . . . . . . ...................212

Summary and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...213

Chapter 11 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......214

Box

BOX NO. Page

11-A. Australians Orphan Embryos . . . . . . . . . . . . . . . . . . . . . . . ................209

Figure

Figure No. Page

11-l, Fertilization and Early Stages of Human Embryonic Development . .......208
—

Chapter 11

Ethical Considerations

Ethical issues raised by the use of reproductive

technologies can be examined in a variety of ways.

One method is to study the arguments for and

against the use of such technologies, with special

emphasis on impacts that are unintended, indirect,

and delayed. Another way is to list novel questions raised by the use of reproductive technologies. New ethical questions arise, for example,

when third parties are involved in procreative interactions, when sperm and ova are banked for

indefinite periods of time, and when surplus human embryos are created. A third method is to

list the human values that are generally at stake

in the diagnosis and treatment of infertility.

This chapter analyzes ethical arguments, raises

novel ethical questions, and surveys relevant human values through discussion of six basic themes

that pertain to specific reproductive technologies:

●

●

●

●

●

●

the right to procreate or reproduce,

the moral status of the embryo,

parenthood and parent-child bonding,

research initiatives and the rights of patients

and research subjects,

truth-telling and confidentiality, and

intergenerational responsibilities.

CONTEXT OF THE ETHICAL DEBATE

Professional, public, religious, and personal

opinions infuse ethical debates about the use of

reproductive technologies. The concerns expressed

by health care personnel are important, since

these individuals are among those most intimately

involved in the development and application of

such techniques. Position statements have been

prepared by relevant committees of the American

Medical Association, the American College of Obstetricians and Gynecologists, and the American

Fertility Society (1,2,4).

All these professional groups consider at least

some, if not all, of the existing reproductive technologies to be morally licit, and all advocate their

use in carefully circumscribed situations. Yet all

share certain concerns and maintain that the use

of these techniques requires careful monitoring.

Seen to be especially central are the issues of confidentiality; informed consent; minimization of risk

to the pregnant woman, the fetus, or the future

child; adequate screening of donors; appropriate

handling of embryos; and ongoing evaluation of

data obtained through the use of these techniques.

Public opinion is reflected in the many responses

of public commissions and groups in this country and throughout the world, particularly since

the 1970s (see also apps. D and E). Several themes

emerge from such reports:

●

●

●

●

●

support for artificial insemination by husband, artificial insemination by donor, and

in vitro fertilization (IVF) as treatments for

infertility;

support for ova and sperm donation (with the

exception of the U.S. Ethics Advisory Board,

which barred the use of FederaI funding, and

the French National Ethics Committee);

support for embryo donation (with the exception of the U.S. Ethics Advisory Board, the

French National Ethics Committee, and the

Working Party in South Australia);

the imposition of guidelines and procedural

regulations on the use of these techniques,

such as restrictions on their use to stable couples and to physicians practicing in appropriate facilities, restrictions for donors of gametes, guidelines on the disclosure of

information to protect confidentiality, and

provisions to ensure informed consent and

to clarify the legal status of children born as

a result; and

great controversy surrounding issues of surrogate motherhood (regardless of whether

a fee is paid), the treatment of embryos not

203
—

204 ● Infertility: Medical and Social Choices

transferred, and the use of these techniques

by single women.

Many religious and secular communities emphasize the moral significance of parenthood in a general way, with several variations on this theme.

One variation emphasizes the ways in which

parenthood enriches the life of individual couples;

a second focuses on the importance of parenthood

for the social order. These two approaches are

best viewed as instances of the appeal to consequences or outcomes of actions. A third emphasizes a theological dimension to parenthood, which

is viewed as fulfilling a divine commitment to

procreate or as a way of human participation in

the divine activity of creating and sustaining life.

Religious traditions offer widespread support

for traditional infertility workups and medical and

surgical interventions (see app. F). The Protestant,

Jewish, and Muslim traditions affirm artificial insemination by husband. The Roman Catholic tradition has special reasons for officially opposing

artificial insemination by husband, although some

theologians dissent (8,23). Most religious traditions

find donation of sperm, eggs, or embryos to be

problematic, The Roman Catholic, Orthodox Jewish, Muslim, and some Protestant traditions oppose it, while other Protestant and Conservative

and Reform Jewish traditions allow it. Surrogate

motherhood in any form is generally opposed by

religious traditions. A few religious thinkers, notably biblical theologians (influenced by Old Testament patriarchal accounts about the importance

of preserving male lineage) give guarded approval,

but these are exceptions. It is important to note

that not all members of a particular religious background adhere to the official tradition of their

church.

Arguments about the use of reproductive technologies are generally expressed in terms of rights

and responsibilities. There are two types of moral

rights—liberty rights (negative or noninterference

rights) and welfare rights (positive or correlative

rights). Responsibilities are also described and

sometimes referred to as duties and obligations.

These terms are chosen because contemporary

ethical discussion, whether it is based on intuition, ethical principles, or faith, is often couched

in terms of rights and responsibilities.

A liberty right is defined as a natural right based

on human freedom such that any human adult

capable of choice has the right to forbearance on

the part of all others from the use of coercion

or restraint except to hinder coercion or restraint

itself, and is at liberty to take any action that is

not coercing or restraining or designed to injure

other persons (16). In addition, liberty rights indicate the limits of the plausible authority of

others, including government. Many people would

extend to adolescents, children, and the unborn

liberty rights in the form of a right to life (25).

A liberty right is a kind of free assertion that requires only noninterference on the part of others,

which is why it is characterized as a negative right,

Exercising such a right does not require any positive response from others—only that they do not

interfere. A liberty right does not claim aid from

others in pursuit of a person’s own goal. This is

unrelated to the issue of whether the aid of others

can be paid for or not. The exercise of a liberty

right simply does not require such assistance.

A welfare right is a claim asserted by an individual that requires a corresponding response,

obligation, or duty on the part of others. Welfare

rights depend on a social consensus about the

value of the goal. The right to be educated is a

welfare right because it involves the assistance,

contributions, and resources of others. The United

States, for example, has a system of public as well

as private education. The right to be educated,

particularly at the public expense, is a kind of welfare right because it of necessity involves the talents, energies, and resources of others. It is important to note that the assertion of a welfare right

does not necessarily indicate the presence or need

for what is commonly called a welfare system.

The claims made by infertile individuals or couples may or may not be something for which they

can pay.

The infertile couple or individual must make

decisions and come to terms with the problem

of infertility in the midst of this professional, public, and religious debate about the ethics of reproductive technologies, The personal experience

of infertility diagnosis and treatment may either

reinforce or come into conflict with deeply held

values. In addition, there are special problems in
Ch. 1 l—Ethical Considerations “ 205

establishing a definitive resolution of many of difficult to restrict the informed and free collabothese issues because of the plurality of moral view- ration of various parties in achieving conception.

points. In such circumstances, it becomes more

THE RIGHT TO REPRODUCE

A fundamental aspect of much modern moral

thinking is the significance of free and autonomous choices. The exact definitions of freedom

and autonomy are controversial, but basically considerable moral significance is attached to a person’s freedom to make voluntary, uncoerced

choices based on self-legislated principles and

values. When applied to an evaluation of techniques for preventing and treating infertility, the

result is an emphasis on the moral significance

of couples and individuals freely choosing to act

in accordance with their own values.

A second aspect of modern moral thought is the

recognition of duties, obligations, or responsibilities that may limit or constrain human actions.

The performance of some types of actions is

morally illicit, however valuable the consequences

and however much the people involved want to

perform them. The exact nature of these constraints and the conditions under which they may

be overridden are matters of great controversy,

but the basic idea that they exist and do impose

limitations on choices is relatively straightforward.

In terms of preventing and treating infertility, the

emphasis is on examining whether particular techniques do or do not violate any of these constraints.

The right to reproduce appears to be linked to

freedom and autonomy in the most basic way:

the desire to have children and create a family

is a natural expression of generative urges and

commitments to religious, ethnic, and familial

values that have characterized the human race

from its beginning. At present, the right to reproduce is a natural as well as a necessary aspect of

human existence for at least some human beings

if the species is to continue. The right to reproduce is most often a liberty right in that it demands

only that others not interfere. When infertility

is not a factor, individuals can exercise their right

to reproduce in a way that minimizes claims on

the goods, services, and resources of others.

Even as a liberty right, some argue that it is and

should be constrained by inordinate population

growth. The right does not exist in a vacuum but

is tempered by societal circumstances in which

people live. China, for example, has a policy limiting to one the number of children married couples in most of the country may have. This public

policy is inconsistent with American values and

probably would never be adopted in this country, although some have urged that considerations

of world population growth should influence the

size of American families (21).

The right to reproduce, then, as a liberty right

is not particularly controversial, especially when

it is asserted by a fertile couple or an individual,

When a man or a woman is infertile, however,

this right involves claims on others for responses,

actions, and services. Such claims, even when

those exercising the right have a full ability to pay,

must be balanced against a host of other health

care needs and priorities. Obviously the right to

reproduce can more easily be exercised by those

who can pay for needed medical service or intervention, whether such services ought to be for

sale is an important question, as is the question

of when, if ever, others in society should subsidize or defray the costs of infertility diagnosis and

treatment for those who cannot afford needed

services. The use of tax dollars for infertility treatment services is also problematic to those members of society who think that some or all reproductive technologies are immoral.

Because it is desirable that procreation be

achieved without the direct contributions of third

parties or the services of health care providers,

it would be better if the condition of infertility

did not exist. The reality of infertility makes this

a moot point, and it is the basis of a strong ethical

argument for a heavy emphasis on preventive

measures. For example, based on the ethical principle of respect for persons, it is important that

factors that could contribute to infertility, such
206 ● Infertility: Medical and Social Choices

as a high incidence of sexually transmitted disease resulting in tubal disorders (see ch. 4), be

minimized. When attempts to prevent infertility

are not initiated early or have failed, some assistance is required for individuals or couples to

satisfy their desire to procreate.

When artificial insemination, gamete intrafallopian transfer, sperm and ovum banking, IVF,

or surrogacy are needed, exercising the right to

procreate makes extensive and in some cases

troublesome claims on the interests and resources

of others.

In the cases of drug therapy for ovulatory failure and surgical intervention for mechanical failure, the right to procreate can be exercised by

infertile couples as long as they are able to procure the necessary expertise and pay for it either

directly or through a third party. These technologies are widely available and the provision of

them would not compromise the interests of any

third party. In fact, infertile couples, health care

professionals, and pharmaceutical companies all

appear to benefit when such services are appropriately sought.

With artificial insemination, the ethical considerations become more complex. In the case of insemination with the husband’s sperm, there is

often no compelling objection as long as both partners are fully informed and choose to engage

freely in this practice. In rare cases in which the

husband is deceased, any harms to the child that

might be born associated with not having a living

biological father must be weighed against the

mother’s right to procreate using the stored sperm

of a deceased spouse. This right has indeed been

claimed by a widow for the use of sperm from

her deceased husband (11).

The right to procreate when it involves insemination with a donor’s sperm is least problematic

when it is asserted by the couple because the husband’s desire to see his wife become pregnant has

obviously transcended his thwarted desire to be

the genetic father. The desires of single women

to be artificially inseminated by a donor do not

cause any apparent harm to the donor but are

most often evaluated with some consideration of

the abilities to competently raise a child as a single parent and to the societal consequences of individuals conceiving with the explicit intention of

raising a child alone, notwithstanding a trend

toward single-parent adoption in this country.

Surrogates and donors of sperm and ova are

not necessarily exercising a right to procreate but

are contributing their human biological materials for a variety of motives, ranging from pure

altruism to a desire to make money. Ethical considerations concerning these transactions center

on issues of confidentiality, truth-telling, and the

moral status of contracts.

Do infertile couples have a right to financial assistance if they are unable to pay for the cost of diagnosing and treating infertility? The American

Fertility Society has noted that if techniques of

assisted reproduction are included in the notion

of an adequate level of health care, then it is consistent with the work of the President’s Commission for the Study of Ethical problems in Medicine and Biomedical and Behavioral Research that

all citizens be provided with infertility services

(2,28). A variation of this position is the view that

individuals have a positive right only to a fair share

of what may fulfill true human needs (15). It can

also be said that infertile individuals and couples

are entitled to diagnosis and treatment for infertility if they have had the foresight to select and

supplement insurance coverage in a way that such

services are included (9).

Providing Federal funds either through a possible extension of Medicaid benefits or by means

of a separate enactment is one of the most controversial aspects of complete support of the right

to procreate for all infertile couples. Some Americans view selected reproductive technologies as

immoral. Spending Federal dollars always raises

questions about the allocation of scarce resources.

The principal arguments in such debates are:

● utilitarianism, that resources should be allocated in a way that promotes the greatest

good for the greatest number (24);

● libertarianism, that individuals are entitled

to whatever resources they possess provided

they acquired such resources fairly, that resources may be exchanged commercially or

as gifts, and that inequalities in the distribution of resources maybe unfortunate but they

are not inherently unfair (27);
Ch. n-Ethical Considerations . 207

●

●

maximin, that as a matter of first principle,

individuals are entitled to equal shares of resources and, as a matter of second principle,

inequalities (either excess or scarce resources)

should be distributed to benefit the least advantaged provided there is fair equality of opportunity (29); and

egalitarianism, that resources should always

be distributed equally (26).

The utilitarian argument can be used to support funding for infertility services by demonstrating how such support would contribute to the

greater good. The libertarian argument is largely

consistent with the status quo, in which infertilMORAL STATUS

Human fertilization creates a biological entity

that is commonly regarded as more than and

different from the precursor germ cells of human

sperm and ovum (see figure 11-1). This new entity may develop into a fetus and, eventually, an

infant. A number of human embryos are naturally lost when the embryo does not implant in

the lining of the womb (see ch. 2).

There is no societal consensus about the earliest point, if any, at which a human embryo should

be considered to be a person. At least two important moral or ethical questions are raised about

embryos. First, how should we regard or value

embryos? Second, what actions are morally

acceptable and morally unacceptable with respect

to embryos?

These questions are directly relevant to two of

the reproductive technologies examined in this

report —IVF and embryo banking. In addition, the

freezing of embryos, research using embryos, and

in vitro embryo culture are influenced by the way

in which the embryo is regarded. In the process

of IVF (see ch, 7), it is standard practice to mix

several ova with sperm in order to increase the

likelihood that several fertilizations will take place.

The desired result is the development of embryos.

Although the precise moment of fertilization and

activation of the new genome may be as late as

the four- to eight-cell stage of cell division, ethical

questions do arise when more embryos develop

than are needed for transfer to the womb or when

ity services are available on a limited basis to those

who can pay for them. The maximin position could

be used to justify some special consideration for

infertility services if it could be demonstrated that

such services are generally available and that the

infertile have the special status of a least advantaged group. Finally, an egalitarian argument

about the availability of infertility services would

support only those services it is feasible to provide to everyone in need. Thus, the arguments

about just distribution and the allocation of scarce

resources suggest a variety of ethical responses

on access to and provision of infertility services

for those who cannot currently afford them.

OF THE EMBRYO

embryos are created for purposes other than

transfer, such as research (19).

It has been suggested that decisions about the

use of human embryos can be made depending

on the neurological development of the embryo

at a given point in time (14)33). The Wailer Committee in Victoria, Australia, the Warnock Committee in Great Britain (see app. E), and the 1979

report of the Ethics Advisory Board in the United

States all approve of research involving human

embryos fertilized in vitro, with varying restrictions but with agreement on a time limit of 14

days after fertilization (35).

There are at least three major philosophical positions on the moral status or meaning of the human embryo. The first is that the embryo is no

different from other human biological material

and that it has meaning only in terms of the goals

and aspirations of others regarding its use and

possible maturation. Adherents of this position

point out that a large portion of all human embryos are naturally cast off when implantation

fails to occur and, further, that an intrauterine

device results in the loss of embryos that are even

more developed than those that might be discarded in the course of IVF (10,2 o).

A second position proposes that the embryo,

while not a person and while not necessarily requiring the respect and rights due to fully functioning persons in society, is not an objective prod-
208 ● Infertility: Medical and Social Choices

Figure 11-1 .—Fertilization and Early Stages of Human

Embryonic Development

Pronuclear One-cell Two.cell

Four.cell Eight.cell Slxteemcell

Compaction Morula Early blastocyst

Blastocyst Expanded blastocyst

Hatching blastocyst

SOURCE: Office of Technology Assessment, 1988

uct or thing, and that it serves as a powerful

symbol of respect for life (30)31)34), The embryo,

in this scheme, is a “transient identity” and should

be accorded ‘(transient rights.” These rights are

not derived from the values others place on its

existence, but from the nature of the potentiality

of existence the embryo possesses. Still, while couples have the primary obligation to respect the

life of the conceptus, however early its human

form, respect for that life may itself lead some

to consider abortion on genetic or other grounds,

These grounds are open to some public scrutiny

and control, When the embryo is at risk—during

transfers, freezings, transplants, and future genetic

manipulations—public scrutiny may also include

public controls, It may be inappropriate to sell

such material for research purposes, because that

would violate the inherent transient rights of such

entities (34).

A third position, which is held by the Roman

Catholic church and others, is that the human being must be respected—as a person—from the very

first instant of existence (8). From the time an

ovum is fertilized, a new life is begun that is of

neither the father nor the mother; it is rather the

life of a new human being with an individual

growth. It would never be made human if it were

not human already. “Right from fertilization is begun the adventure of a human life” (32). This position has important implications for any use or

treatment of the human embryo that would be

different from or less than that afforded to a human person.

In practice, the issue of the use of surplus embryos in IVF is sometimes avoided by implanting

all the eggs that are fertilized, increasing the probability of multiple births. One commentator, however, has argued that the deontological (dutybased) problem of the moral status of the embryo

in this case gives way to the teleological (outcomebased) problem of how to care for more than one

newborn (18). In addition, the presence of multiple fetuses in utero is correlated with lower birth

weight per child and greater risks to the mother

and to fetal health.

A recent Australian case demonstrates some of

the problems and issues associated with the moral

and legal status of unimplanted embryos (see box

11-A). From an ethical standpoint, the Rios case

illustrates why it is important to discern the moral

status of the embryo. Aside from the intents of

the parents, who in this case are no longer living,

it is difficult to ascertain what duties and obligations are owed the frozen embryos.

The extent to which a human embryo should

be respected was addressed in 1986 by the American Fertility Society in its recommendations that:

. cryopreservation should be continued only

as long as the normal reproductive span of

the egg donor or as long as the original objective of the storage is in force;
Ch. 11—Ethical Considerations ● 209

Box 11- A .—Australia’s Orphan Embryos

In 1981 Mario and Elsa Rios, of Los Angeles,

CA, participated in the IVF program at the Victoria Medical Center in Melbourne, Australia.

Then age 50 and infertile, Mr. Rios allowed a local, anonymous donor to artificially inseminate

three eggs from Elsa Rios, his 37-year-old wife;

one was transferred and the other two were frozen for possible use in the future. Mrs. Rios subsequently miscarried and chose not to undertake

further transfers at that time. Before she could

return and try to use the other embryos, she and

her husband died in a plane crash in Chile. Because no will was executed by the wealthy Rios,

the California laws of interstate succession seemed

to apply. Thus, Mr. Rios’ son by a previous marriage was thought to be entitled to his father’s

share of the estate and Mrs. Rios’ 65-year-old

mother to her daughter’s share. In December

1987, a California superior court declared Mrs.

Rios’ mother to be sole heir. The medical center

in Melbourne then announced that the embryos

would be thawed and implanted when a suitable

recipient was found, although the survival chances

were rated at 5 percent.

SOURCE: Office of Technology Assessment, 1988, based on G.P. Smith,

“Australia’s Frozen ‘orphan” Embryos: A Medical, Legal and

Ethical Dilemma,” .lournal of Family bw [University of

I,ouis\’ille School of Law) 24:27-41, 198.5-86; and on “E;mbryos \\’ill Be Implanted,” .%’Ew’ k’ork 7’imes, Dec 5, 1987

● transfer of embryos from one generation to

another is unacceptable; and

● formal discussion with the couple should take

Photo credit Martin Qu/g/ey

Cryopreservation of human embryos in liquid nitrogen

storage chamber

place in advance to decide whether excess

embryos can be transferred to other couples,

used for approved research, examined, or discarded (2).

PARENTHOOD AND PARENT-CHILD BONDING

Opinion differs on the extent to which the genetic, gestational, and social functions of parenting can be separated and yet preserve the welfare of parents and children. Some who contend

that new reproductive technologies are ethically

acceptable regard parenthood as a relationship

defined by acts of nurturing as opposed to acts

of conceiving and giving birth. Others, although

recognizing that acts of nurturing and generating life are distinct and that acts of nurturing are

included in the meaning of parenthood, affirm that

acts of generating life are parental in nature (22).

Bonding between a human infant and an aduIt

is a prerequisite to the physical and psychological growth of the child and creates and sustains

the abilities of the parents to nurture the child.

Do parents and children possess a possible welfare right to at least the minimum conditions necessary for human bonding to take place? Now that
210 ● Infertility: Medical and Social Choices

it is possible for a child to have a total of five

“parents”—three types of mothers (genetic, gesta -

tional, and rearing) and two types of fathers (genetic and rearing) —which of these parents has

the right to form a parent-child bond? Now that

it is possible through surrogacy arrangements and

artificial insemination by donor for individuals to

plan to create a single-parent family, does this violate a possible right of the child to bond to more

than one parent? These questions have important

implications for the way in which parent~child

bonding takes place and for possible new variations in the developing identities of some children.

Any one of these variations on the theme of the

moral significance of parenthood and the importance of parent-child bonding has considerable

relevance to an ethical assessment of techniques

for preventing and treating infertility. Depending on a number of factors (e.g., the way in which

a particular variation views parenthood and the

particular treatment used), the importance of the

parent-child bond may lead to a positive ethical

evaluation of techniques for preventing and treating infertility (6).

RESEARCH INITIATIVES AND THE RIGHTS OF

PATIENTS AND RESEARCH SUBJECTS

In the process of diagnosis and treatment for

infertility, individuals or couples may find themselves in the role of research subjects as well as

patients. Typically they start out as patients and

are presumably informed about and give consent

to each step of the diagnostic process. Couples

are asserting a right to be treated for their infertility using medical therapy.

To expand and improve on the scientific basis

of diagnosis and treatment for infertility, information about patients and their problems must

be gathered and recorded in a systematic way.

This is an aspect of medical treatment that can

result in descriptive research about the course

and outcome of medical therapy. As long as patients are informed that facts about them are being collected, in part for research purposes, and

that their anonymity will be preserved, the benefits of this accumulating database seem to outweigh any possible harms or inconveniences to

the infertile couples. These couples are now, in

addition to being patients, also serving as research

subjects although they may always choose to exercise their right to not participate. This pattern

is not substantially different from that conducted

in other areas of human health and disease.

A more troubling research aspect of infertility

diagnosis and treatment (as well as the diagnosis

and treatment of many other conditions) is how

to make appropriate use of new technologies that

have not yet entered the realm of tried and true

medical therapy. Which reproductive technologies, if any, are more experimental than therapeutic? Do infertile couples become research subjects as a result of the experimental nature of the

technologies that may be used in their treatment?

Is there a subtle pressure occasionally present that

the development of new knowledge can sometimes justify placing a human subject at a disproportionate risk or engaging in research with

inadequate informed consent procedures?

All the parties interested in effective infertility

diagnosis and treatment share a concern about

how to distinguish properly among medical therapies, clinical trials, and clinical experiments. A

specific reproductive technology may be used in

a standard way in one instance and in a novel or

experimental way another time. So it is not only

the technologies themselves, but the way in which

they are used, that determines whether a patient

receives care that is more experimental than therapeutic (7).

Clinicians and researchers note that the problem of consistently developing medical therapies

is particularly acute in the treatment of infertility because a de facto moratorium since 1980 on

Federal funding for many forms of research involving fertilization of human egg and sperm has

impeded the development of knowledge about fertility, infertility, and contraception (see ch. 15).
Ch. n-Ethical Considerations 211

Although research initiatives may result in the

steady transition of reproductive technologies

from the domain of experimental to that of standard medical therapy, the rights of patients who

are being treated for infertility to be appropriately informed about the research aspects of their

treatment persist. In the course of diagnosing and

treating infertility, the liberty or noninterference

rights of scientists to pursue research and of physicians to practice medicine are constrained by

the correlative right of infertile couples to be informed about the experimental nature of selected

reproductive technologies.

group. Because of their strong desire to exhaust

all possibly successful avenues of treatment, an

attitude they share with those who are considering participation in research under the pressure

of severe illness, their ability to give free and informed consent is to some extent always compromised. For this reason, it is particularly important that care be taken to carefully inform

infertile couples when new reproductive technologies are suggested as possible methods of treatment. The special vulnerability of this group

makes quality control of reproductive technologies

a vital societal concern (see ch. 9).

Individuals and couples with problems of infertility are an extremely vulnerable population

TRUTH-TELLING AND CONFIDENTIALITY

Infertility prevention, diagnosis, and treatment

are interactive processes in which the infertile

individuals, physicians, and others exchange information, make evaluations, and even offer predictions. All parties to these interactions have a right

to know the truth. At least two moral arguments

for telling the truth can be cited: Truth-telling is

a general requirement for an action to be moral,

and truth-telling generally has the best consequences in the realms of personal interaction (37).

A common counterargument is that the truth

might result in some harm, such as increased personal suffering or a denial of access to a desired

service. Using the language of moral rights mentioned earlier in the chapter, the right to be told

the truth is a claim right involving the full disclosure of otherwise unknown or unavailable information, The liberty right to be left alone, or free

from harm, might be best exercised with or without the truth.

Infertile individuals and couples who seek diagnosis and treatment are not asking merely to be

left alone. In their quest for a solution to their

infertility, truthful information is an important

basis for accurate diagnosis. It is important for

the physician to know, for example, about any

occurrence of sexually transmitted disease in order to make an accurate diagnosis and to devise

an appropriate treatment. It is also important for

the physician to know the extent of previous diagnostic workups and treatment failures.

By the same token, it is important for the patient to know the truth about a specific treatment

and the likelihood of success of a given effort. A

common criterion used in evaluating various IVF

programs is the pregnancy rate achieved by a specific program. There is considerable variation,

however, in the way that this rate is reported.

The variations include reporting in terms of pregnancies per ovarian stimulation cycle, and pregnancies per embryo transfer (see ch. 9). A group

of prominent clinicians has noted that what constitutes pregnancy is confusing to the lay public.

Couples who seek treatment for infertility are

really interested in taking home babies, and a claim

to a high pregnancy rate based on a limited number of chemical pregnancies, for example, is misleading (5). One commentator makes the point that

technically accurate statements that convey misleading messages are no less a violation of the principle of truth-telling because their content happens to be technically true (36).

One area in which physicians have made judgments that truth-telling may not ultimately be of

benefit to the patients they are trying to treat is

in filing insurance claims on behalf of patients.

The great variation in coverage among third-party
212 . Infertility: Medical and Social Choices

payers may lead to physician subterfuge about

the actual services provided and the goals of treatment (see ch. 8). This is a case in which the physician may knowingly compromise his or her own

integrity in order to assist patients in acquiring

reimbursement. Physicians who do this have made

the judgment that the negative consequences of

telling the truth in a way that corresponds to insurance reimbursement categories outweigh the

general moral requirement to tell the truth.

A major feature of the physician-patient relationship is the expectation that the highly charged

personal information pertaining to the diagnosis

and treatment of infertility will be held in confidence, This is true for most of the interactions

that take place between physicians and patients

but is particularly pressing in an area of medical

practice where problems are of such an intimate

nature and strike at the heart of personal and family relationships. The fundamental statement concerning medical confidentiality appears in the Hippocratic oath:

What I may see or hear in the course of the

treatment or even outside of the treatment in regard to the life of men, which on no account one

must spread abroad, I will keep to myself, holding such things to be shameful to be spoken about

(12).

This principle has been reiterated in modern

times by many groups and in numerous codes of

professional ethics. It has been maintained, for

example, that a doctor owes a patient absolute

secrecy on all that has been confided or that the

doctor knows because of the confidence entrusted

in him or her, and that the patient has the right

to expect that all communications and records pertaining to care should be treated as confidential

(3,4).

The use of reproductive technologies can place

a strain on maintaining confidentiality in several

important ways. The use of donor ova or sperm

involves the transfer of relevant information about

the donor although the anonymity of the donor

can be maintained. It may be impossible to treat

the problem of infertility as a problem of the couple if one partner holds the physician to a principle of confidentiality, for example, with respect

to past sexual practices. The maintenance of confidentiality is also linked to the reestablishment

of privacy concerning sexual matters that may

be essential to the well-being of the couple after

the crisis of infertility has been resolved.

INTERGENERATIONAL RESPONSIBILITIES

One important aspect of ethical arguments for

and against specific reproductive technologies is

the significance of considering the consequences

of individual actions and social practices for all

those affected. These individuals can include those

who perform the actions or participate in the practices, or they may be other members of society.

Any evaluation must consider the consequences

of these techniques for the infertile couples, for

their prospective children, and for the rest of society (6).

Some argue that the use of reproductive technologies carries with it the duty of not harming

either the infertile patient or the resulting embryo, fetus, and child. The ethical principle of nonmaleficence has a long tradition in medical ethics

that many trace back to the Hippocratic oath (36).

In addition, others would argue that there is a

strong obligation to circumvent or treat the problem of infertility in ways that do not harm future

generations in general. Does one generation have

obligations to another and, if so, how are these

duties weighed against individual needs and

desires?

These questions are particularly relevant to issues of confidentiality and truth-telling in the context of donor gametes (ova or sperm) and surrogate motherhood. Should a child be told that

his or her rearing parentis not the child’s genetic

and/or gestational parent, and also how he or she

was conceived? Should information about a child’s

biological origin be kept on file? Should a child

who is not living with his or her father or mother

be entitled to at least some information about this

genetic parent? Should a child be entitled to know

the identity of the genetic father or mother and
Ch. 11--Ethical Considerations ● 2 1 3

thus be afforded the opportunity to contact this

parent?

In his book The Philosophy of Right, G.W.F.

Hegel stated:

Children are potentially free and their life directly embodies nothing save potential freedom.

Consequently they are not things and cannot be

the property either of their parents or others (17).

Children are ends in themselves and not merely

the means or objects of the goals of their parents.

If this is true, then it would be unacceptable to

utilize a reproductive technology that would impinge on the freedom or autonomy of children,

One philosopher argues that duties to future generations must be much weaker than duties to contemporaries, for contemporaries are actual persons who can have actual views about what is

important (13). Even so, there is an important argument that it is prudent to support those practices

that are least likely to be harmful to the next generation.

Reproductive technologies also raise intergenerational concerns about the use of resources. Increased funding for infertility research can have

important benefits for humanity but this claim

for the research dollar has to compete with other

research interests. In addition, any general shift

in the reproductive years of the population as a

whole has important economic and demographic

implications for the generations that follow.

SUMMARY AND CONCLUSIONS

For individuals and couples with problems of

infertility, the right to procreate maybe exercised

as a simple liberty right involving the noninterference or forbearance of others or as a welfare

right that makes significant claims on technology

and the expertise and resources of others. The

right to reproduce becomes problematic when it

involves large financial resources extending beyond those available to an infertile individual or

couple. Given the fundamental nature of the desire to procreate, however, it seems desirable that

individuals from a variety of backgrounds have

some access to reproductive technologies.

The right to reproduce becomes more difficult

to justify when it begins to compromise the interests of a third party. There is a strong moral sentiment that the exercise of the right to procreate

by some individuals should not result in the exploitation of women, for example, in surrogate

mother arrangements. Alternatively, some moral

support exists for the view that in a free society

it is possible and should be legal to give the gift

of genetic or gestational surrogacy to an infertile

couple.

A strong ethical argument can be made that resources and support should be devoted to the prev e n

tion of infertilit y in order that the right to

procreate can most often be expressed as a liberty right. Individuals have an interest in avoiding any curtailment of their reproductive capacity when they wish to reproduce. This places a

heavy emphasis on the eradication of factors that

lead to infertility.

The moral status of the human embryo is a subject of considerable debate. Many people have

made judgments about whether the embryo has

the status and meaning of a person. In addition,

cryopreservation of embryos presents legal and

ethical questions about the rights of such entities

and any duties and obligations owed to them. The

unresolved debate about appropriate uses of human embryos and the de facto moratorium on

Federal support for IVF research have impeded

the growth of new knowledge about fertility, infertility, and contraception.

Reproductive technologies make it technically

possible for a child to have a total of five ‘(parents”

—three types of mothers (genetic, gestational, and

rearing) and two types of fathers (genetic and

rearing). These possibilities change the nature of

parenting and may have implications for the ways

in which parent-child bonding takes place. Such

bonding has important psychological benefits for

parents and is essential to the developing personalities of children.

The right to conduct research is a noninterference or liberty right as well as a welfare or cor-
214 ● /fertility: Medical and Social Choices

relative right. The right to pursue research is al- Most religious traditions in the United States:

ways balanced against other societal goods, and ●

the resources to conduct research are always

limited. Infertile patients have a right to know

when their treatment is in the realm of proven

medical therapy or is essentially experimental.

●

Telling the truth and maintaining confidentiality are important aspects of the physician-patient

relationship. The intimate nature of the diagnosis and treatment of infertility and the special features of reproductive technologies that make use ●

of donor ova or sperm complicate simple ethical

imperatives to tell the truth and to hold personal

information in confidence. A strong argument can

be made that individuals have a duty to refrain

from utilizing reproductive technologies in ways

that could possibly harm future generations or ●

make disproportionate claims on the resources

of existing generations.

support the treatment of infertility when such

treatment involves traditional drug therapy

or surgical intervention, and accept the moral

licitness of such treatments;

accept the moral licitness of artificial insemination by husband, have considerable hesitation about artificial insemination by donor,

and show even less support for artificial insemination of single women with donor sperm;

support IVF as long as only spousal gametes

(ova and sperm) are used and as long as no

embryos are wasted, though support lessens

to some degree when there is early embryo

wastage and to a much greater degree when

donor gametes are used; and

oppose surrogate motherhood in both its

genetic and gestational forms.

CHAPTER 11 REFERENCES

1. American College of Obstetricians and Gynecologists, Ethical Issues in Human In Vitro Fertilization

and Embryo Placement (Washington, DC: 1986).

2.

3.

4.

5.

6.

7.

8.

9.

10.

11,

American Fertility Society, Ethics Committee, “Ethical Considerations of the New Reproductive Technologies,” Fertility and Sterility 46:1 S-94S, 1986.

American Hospital Association, “Statement on a Patient’s Bill of Rights,” Hospitals 47:41, 1973.

American Medical Association, Judicial Council,

Opinions and Reports (Chicago, IL: 1968).

Blackwell, R. E,, Carr, B. R., Chang, R. J., et al., “Are

We Exploiting the Infertile Couple?” Fertility and

Sterility 48:735-739, 1987.

Brody, B. A., “Religious and Secular Perspectives

About Infertility Prevention and Treatment,” prepared for the Office of Technology Assessment,

U.S. Congress, Washington, DC, June 1987.

Caplan, A. L., “The New Technologies in Reproduc -

tion—New Ethical Problems,” Annals of the New

York Academy of Sciences, in press, 1988.

Congregation for the Doctrine of the Faith, Instruction on Respect for Human Life in its Ori@”n and

on the Dignity of Procreation (Vatican City: 1987).

Daniels, N., “Am I My Parents’ Keeper?” Midwest

Studies in Philosophy 7:517-520, 1982.

Dickens, B. M., Faculty of Law, University of Toronto,

Toronto, Canada, personal communication, Aug.

28, 1987.

Dionne, E.J., “Paris Widow Wins Suit To Use

12

13.

Sperm; Court Decides Against Sperm Bank in Plea

From Wife of Man Who Died in 1983, ” New York

Times, Aug. 2, 1984.

Edelstein, L., “The Hippocratic Oath: Text, Translation and Interpretation,” Ancient Medicine: Selected Papers of Ludwig EdeZstein, O. Tempkin and

C. Tempkin (eds.) (Baltimore, MD: Johns Hopkins

University Press, 1967).

Engelhardt, H.T., Jr., Center for Ethics, Medicine

and Public Issues, Baylor College of Medicine, Houston, TX, personal communication, June 24, 1987.

14. Flower, M, J., “The Neuromaturation of the Fetus, ”

15

16.

17.

18,

19.

20.

Journal of Medicine and Philosoph.v 10:237-251,

1985.

Fried, C., Right and Wrong (Cambridge, MA: Harvard University Press, 1978).

Hart, H. L. A., “Are There Any Natural Rights?”

Rights, D. Lyons (cd.) (Belmont, CA: Wadsworth

Publishing Co., 1979).

Hegel, G. W. F., The Philosophy of fi”ght, Trans. T.M.

Knox (Oxford, UK: Clarendon Press, 1952).

Jansen, R., “Ethics in Infertility Treatment, ” The

Infertile Couple, R. Pepperell, C. Wood, and B. Hudson (eds. ) (New York, NY: Churchill Livingstone,

in press).

Jones, H. W., and Schrader, C., “The Process of Human Fertilization: Implications for Moral Status, ”

Fertility and Sterility 48:189-192, 1987.

Kuhse, H., and Singer, P., “The Moral Status of the
Ch. 1 l—Ethical Considerations ● 215

Embr~~o, ” Test-Tube Babies, W’. \\’alters and P.

Singer (eds.) (Melbourne, Australia: Oxford Llni\7ersity Press, 1982).

21. Mann, D., “Growrth hleans Doom, ” Science Digest

4:79-81, 1983.

22. h!cCormick, R. A., “Reproductive Technologies:

Ethical Issues, ” Encyclopedia of Bioethics, W.T.

Reich (cd. ) (Ne\\ York, NY: Macmillan/Free Press,

1978).

23. hlcCormick, R. A., ‘fvatican Asks Governments TO

Curb Birth Technology and To Outlaw Surrogates,”

,\’e~%’ York Times, Mar. 11, 1987.

24. Nlill, J. S., Utilitarianism and Other Writings (New

York, NY: The New American Library, Inc., 1962).

25. Moraczewski, A. S., Regional Director, Pope John

XXIII Medical-Moral Research and Education Center, Houston, TX, persona] communication, Aug.

28, 1987.

26. Nielsen, K., “Radical Egalitarian Justice: Justice as

Equal ity, ” Social Theory and Practice 5:209-226,

1979.

27. Nozick, R., Anarchtiv, State and ~~topia (New York,

NY: Basic Books, 1974).

28. President’s Commission for the study of Ethical

Problems in Medicine and Biomedical and Behavioral

Research, Securing Access to Health Care (Washington, DC: U.S. Government Printing Office, 1983).

29, Rawls, J., A Theory of Justice (Cambridge, MA:

Belknap Press of Harvard University Press, 1971).

30. Robertson, J. A., “Embryos, Families and Procreative Liberty: The Lega] Structure of the Ne\\r Reproduction)” Southern California La\Ir Review 59:

971-987, 1986.

31. Robertson, J. A., “Ethical and Legal Issues in Cryopreservation of Human Embryos, ” Fertilit~ and

Sterility 47:371-381, 1987.

32. Sacred Congregation for the Doctrine of the Faith,

Declaration on Procured Abortion 66: 12-13, 1974.

33. Tauer, C. A., “Personhood and Human Embryos and

Fetuses, ” Journal of Medicine and Philosophy 10:

253-266, 1985.

34. Thomasma, D. C., Director, Medical Humanities

Program, Loyola University Stritch School of Nledi -

cine, Chicago, IL, personal communication, hlar.

16, 1987.

35. U.S. Department of Health, Education, and Welfare, Ethics Advisory Board, HEtV Support of Research Involving Human In 1‘itro Fertilization and

Embryo Transfer, May 4, 1979.

36. Veatch, R. M., A Theory of Afedical Ethics (Ne\v

York, NY: Basic Books, 1981).

37. Walters, L., “Ethical Aspects of hledical Confidentiality,” Contemporary Issues in Bioethics, T.

Beauchamp and L. Walters (eds. ) (Belmont, CA:

Wadsworth Publishing Co., 1982).
chapter 12

Constitutional Considerations
CONTENTS

Page

Freedom To Procreate. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......219

Individual Rights and Freedom To Procreate . . . . . . . . . . . . . . . . . . . . . .......220

Family Privacy and Freedom To Procreate . . . . . . . . . . . . . . . . . . . . . . , . . , ., ..221

Restrictions on Freedom in Procreation . . . . . . . . . . . . . . . . . . . . . . . . ..........222

Protecting the Extracorporeal Embryo. . . . . . . . . . . . . . . . . . . . . . ............224

Regulating Surrogacy Arrangements . . . . . . . . . . . . . . . . . . . . . ..............225

Protecting Children Conceived by Noncoital Techniques . ..................226

prohibiting Commercialization of Noncoital Reproduction . ..................228

Summary and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...233

Chapter 12 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .............234
Chapter 12

Constitutional Considerations

The extent to which States can ban or regulate

noncoital reproduction depends on the extent to

which procreation is protected by the U.S. Constitution. A State constitutional guarantee of a right

to privacy or a right to procreate can also affect

the extent to which a State could regulate noncoital reproduction, but a discussion of State constitutions and their propensity for protection in

this area is beyond the scope of this report.

The more zealously procreation is guarded by

constitutional guarantees, the more compelling

and narrowly drawn must be State efforts to reg -

FREEDOM TO

The right to procreate, that is to bear or beget

children, is widely considered one of the rights

implied by the Constitution. It is grounded in both

individual liberty and the integrity of the family

unit, and is viewed as a “fundamental” right, one

that is essential to the notion of liberty or justice.

The Supreme Court has not explicitly considered whether there is a positive right to procreate

—i.e., whether every individual has a right to actually bear or beget a child. It has, however, considered a wide range of related issues, including

the right of the State to interfere with procreative ability by forcible sterilization, the right of

individuals to prevent conception or continued

pregnancy, and the right of individuals to rear children and to form nontraditional family groups.

The State’s ability to interfere with natural reproductive abilities has been considered in two

cases: Buck v.Bell and Skinner v. Oklahoma (4,47).

In the 1927 Buck decision, the Court upheld sterilization of the mentally retarded on the basis of

eugenic considerations. Since 1927, the eugenic

justifications relied on in Buck have been repudiated (9), and the 1942 Skinner decision has become the more durable statement on forced sterilization. Skinner held that the State could not use

sterilization to selectively punish certain classes

of repeat felons. Although the decision focused

largely on the unfairness of applying the punishulate or restrict use of procreative techniques.

Procreative freedom can extend to questions of

who may procreate and how they may procreate

(43).

This chapter examines two aspects of reproductive liberty: the freedom to procreate (i.e., the extent of the right held by married and single, by

heterosexual and homosexual, to conceive, bear,

and raise children) and freedom in procreation

(i.e., freedom to choose noncoital reproductive

techniques, and the limits of legitimate State regulation of that choice).

PROCREATE

ment to some criminals and not others, thereby

violating the 14th Amendment’s equal protection

clause, the Court did discuss the tremendous importance of reproduction. The discussion was important to the Court’s decision to apply a strict

219
220 ● Infertility: Medical and Social Choices

level of scrutiny to any State effort to use interference with procreation as a form of punishment

or deterrence, and to be particularly scrupulous

in reviewing any State effort to arbitrarily destroy

procreative ability:

This case touches a sensitive and important area

of human rights. Oklahoma deprives certain individuals of a right which is basic to the perpetuation of a race—the right to have offspring (emphasis added).

[This legislation] involves one of the basic civil

rights of man. Marriage and procreation are fundamental to the very existence and survival of the

race. . . . There is no redemption for the individual

whom the law touches. He is forever deprived of

a basic liberty (47).

The Skinner decision is notable for its explicit

mention of a “right to have offspring.” Although

procreation is not mentioned explicitly in the Constitution, the Court characterizes it as a basic human right, justifying a strict level of scrutiny for

any State action that would interfere with its exercise. Further, while the grouping of marriage

and procreation in the same breath indicates that

the Court considered the two as intimately related,

it nevertheless recognized a distinct “right” to

procreate and seemed to characterize the right

as one held by the individual, not the couple.

Individual Rights and Freedom

To Procreate

The implication that procreative rights are held

by individuals rather than by married couples is

further supported by other Supreme Court decisions concerning reproductive and familial liberties. In 1965, the Court held in Griswold v. Connecticut that married couples have a right to be

free of State interference in their decision to obtain and use contraceptives, basing its decision

on the concept of marital privacy, a sphere of personal interest largely immune from State regulation (17). In the 1972 decision Eisenstadt v. Baird,

the Court explicitly extended this principle to individuals, when it held that the individual’s right

to obtain and use contraceptives is also protected

by the right to privacy, and that marital privacy

is simply one aspect of a more general right to

privacy. That case featured one of the Court’s

strongest statements in support of an individual’s

liberty to make decisions concerning reproduction:

It is true that in Griswofd the right of privacy

. , . inhered in the marital relationship. Yet the

marital couple is not an independent entity with

a mind and heart of its own, but an association

of two individuals each with a separate intellectual and emotional makeup. If the right to privacy

means anything, it is the right of the individual,

married or single, to be free of unwarranted governmental intrusion into matters so fundamentally affecting a person as the decision whether

to bear or beget a child (12).

Similarly, in cases upholding the right to terminate pregnancy, the Court has made clear that

the right extends to married and unmarried, adult

and minor, even if some narrowly tailored regulation is permitted to protect maternal health or to

ensure informed consent by a minor (2,20,33,45).

These decisions appear, then, to support the idea

that the right to privacy, including the right to

procreate, extends to individuals, married or not.

Certainly, for example, no State could require contraceptive use by unmarried persons in order to

prevent them from procreating. However, as most

of the reproductive liberty cases considered the

right to prevent conception or continued pregnancy, they are not precisely on point and thus

there is still some room for doubt (48).

Permitting unmarried persons to use contraceptives to prevent their unwilling formation of families is consistent with traditional State preferences

for two-parent homes. Acknowledging that unmarried persons have a right to form families is

somewhat different.

Further, Supreme Court decisions have upheld

State authority to regulate sexual activity, including the recent Bowers decision, upholding prohibitions on specific sexual acts; the Bowers decision also stated in dictum that State laws against

sexual activity outside marriage could continue

to be upheld (3). ((’Dictum” is commentary that

is not strictly necessary to the decision on the case

before the court. Judges use it to explain their

reasoning and to draw analogies to other fact situations, and it can provide a clue as to future judicial decisions in related areas of law.)
Ch. 12—Constitutional Considerations 221

Photo credit: Library of Congress

Nontraditional couples may want to use noncoital

reproductive technology.

If the Supreme Court were to approve a prohibition on coitus outside marriage, it would be

somewhat inconsistent with a stance that those

same unmarried persons have a right to achieve

by noncoital means what they may not attempt

by coitus —i.e., to procreate. If the Bowers dictum

is taken at face value, then it would seem unlikely

that the Court would find a constitutional right

for unmarried persons to use noncoital means to

procreate.

Thus, it is still somewhat unclear that the Supreme Court would find that the right to procreate is an aspect of individual rights. There is little

doubt, though, that it exists as an aspect of marital privacy and family autonomy. When procreation is viewed not as an individual right, but rather

as an aspect of family privacy, limits on governmental intervention will be affected by whether

the family group under consideration is constitutionally protected.

Family Privacy and

Freedom To Procreate

Family privacy is an outgrowth of a history of

leaving many decisions concerning marriage,

childbirth, and childrearing relatively free of governmental intervention (7). For some married,

infertile couples, expanding their families will entail the choice to use noncoital reproductive techniques. Nontraditional parents, such as single parents or unmarried heterosexual or homosexual

couples, may need or want to use these techniques

as well. State authority to regulate who may engage in noncoital reproduction may depend in part

on whether the choice to procreate this way is

an aspect of family privacy, and, if so, whether

that privacy extends to all family forms or only

to married couples.

State authority to regulate family structure and

sexual preferences has had a mixed history in the

United States (18). An 1878 decision affirmed that

the State has authority to outlaw polygamy (4o),

and the U.S. courts have never recognized a right

to marry someone of the same sex, despite recognition of a general right to marry (27,29,59). The

Supreme Court has countenanced societal condemnations of “irresponsible liaisons beyond the

bounds of marriage” (58), “illegitimate relationships” (M), and homosexuality (3), and as a result

courts have frequently lacked sympathy for the

equal protection claims of unmarried parents.

on the other hand, nontraditional parents are

slowly becoming more successful in their efforts

to adopt children or to have custody and visitation rights after divorce (24,50). Further, a number of decisions have emphasized that the family

unit need not be defined by specific generations

living together (3o), by genetic relationships (49),

or by marriage (51). In one case, the Court commented that “the Constitution prevents {government] from standardizing its children—and its

adults—by forcing all to live in certain narrowly

defined family patterns” (30).

More recently, the Supreme Court has stated

that the degree to which a relationship deserves

freedom from governmental interference depends

on ‘(where that relationship’s objective characteristics locate it on a spectrum from the most intimate to the most attenuated of personal attachments” (41). This freedom of association logically

extends to nontraditional as well as traditional families. In its Roberts decision, the Court stated:

IBlecause the Bill of Rights is designed to secure

individual liberty, it must afford the formation and

preservation of certain kinds of personal relation-
222 Infertility: Medical and Social Choices

ships a substantial measure of sanctuary from unjustified interference by the State. . . .

IPlersonal bonds have played a critical role in

the culture and traditions of the Nation by cultivating and transmitting shared ideals and beliefs;

they thereby foster diversity and act as critical

buffers between the individual and the power of

the State. Moreover, the constitutional shelter afforded such relationships reflects the realization

that individuals draw much of their emotional enrichment from close ties with others. Protecting

these relationships from unwarranted State interference therefore safeguards the ability independently to define one’s identity that is central

to any concept of ordered liberty. The personal

affiliations that exemplify these considerations,

and that therefore suggest some relevant limitations on the relationships that might be entitled

to this sort of constitutional protection, are those

that attend the creation and sustenance of a family—marriage; childbirth; the raising and education of children; and cohabitation with one’s relatives (citations omitted; emphasis added) (41),

Nontraditional families—whether they consist

of a single parent and child, same-sex parents and

child, or multiple parents due to divorce and joint

custody of child—provide emotional satisfaction

and expression of personal identity in the same

fashion as more traditional marital unions. Logically, then, this reasoning would extend the freedom of association and the freedom to procreate

to any family form. However, the difficulty of reconciling this reasoning with that which continues

to support State authority to prohibit certain forms

of sexual activity among consenting adults makes

it impossible to predict with certainty the Supreme

Court’s likely reaction to an assertion that nontraditional family privacy supports a right to procreate that extends to the use of noncoital reproductive techniques.

RESTRICTIONS ON FREEDOM IN PROCREATION

Given that there is a right to procreate for married couples, and possibly for all individuals, one

commentator argues that married couples have

a right to use any means to procreate, including

noncoital techniques:

The couple’s interest in reproducing is the same,

no matter how conception occurs, for the values

and interests underlying coital reproduction are

equally present. . . . The use of noncoital techniques such as IVF [in vitro fertilization] or artificial insemination to unite egg and husband’s

sperm, made necessary by the couple’s infertility, should then also be protected (44).

Noncoital reproduction need not be used solely

to overcome infertility, however, as donor gametes

might be used to avoid passing on a genetic disorder or to enhance the possibility of obtaining

desirable characteristics, and surrogate mothers

could be hired for convenience or to overcome

the lack of a female partner. The commentator

argues that freedom in procreation extends to use

of noncoital reproductive techniques for any or

all of these purposes:

The right of married persons to use noncoital

and collaborative means of conception to overcome infertility must extend to any purpose. . . ,

Restricting the right . . . to one purpose, such as

relief of infertility, contradicts the meaning of a

right of autonomy. . . .

Procreative autonomy is rooted in the notion

that individuals have a right to choose and live out

the kind of life that they find meaningful and fulfilling. . . . IMlany people . . . consider reproduction meaningful only if the child is in good

health. . . .

The freedom to select offspring characteristics

includes the right to abort fetuses or refuse to

implant embryos with undesired gender or genetic traits. Just as people are now free to pick

mates, they would have the freedom to pick egg,

sperm, or gestational donors to maximize health

or desirable physical features. . . . [TJhis freedom

would [also] provide the right genetically to manipulate egg, sperm, or embryo to provide a child

with a certain genetic makeup (43).

This expansive view of procreative autonomy goes

considerably beyond the mere “right to have offspring, ” as expressed by the Supreme Court in

Skinner, and encompasses the right to plan completely, within technological limits, the means and

results of conception.
Ch. 12—Constitutional Considerations ● 223

Given the present legality of State regulation of

sexual relations among consenting adults and the

doubt concerning whether the right of an unmarried individual to procreate even by coital means

is protected by the Constitution, it maybe premature to discuss these extensions of the basic right

to have offspring. That right, as expressed by noncoital reproduction, already opens up the possibility of competing concerns that are the subject

of legitimate State regulation. The 1988 New Jersey Supreme Court decision concerning surrogacy

stated:

The right of procreation is best understood and

protected if confined to its essentials, and when

dealing with rights concerning the resulting child,

different interests come into play (21).

The fact that a right exists and is classified as of

“fundamental” importance does not act as an absolute bar to State regulation.

Both explicit and implicit individual rights can

be limited by the State, if the rationale is compelling and the methods used are the least restrictive possible. Thus, the right to free speech may

be sacrificed where its exercise causes a clear and

present danger. The classic example is the prohibition on shouting “fire” in a crowded theater. The

freedom of peaceable assembly maybe regulated

by local laws requiring permits to use certain public areas, if the permits are necessary to ensure

public safety and convenience and if they are

granted in a nondiscriminatory fashion. The exercise of the right to privacy, such as choosing

to terminate a pregnancy, maybe left unassisted,

as when governmental programs fail to pay for

the necessary services even when individuals cannot afford them otherwise.

These three areas of State influence-prohibiting, regulating, or failing to assist the exercise of

a right—are permissible under more or less compelling circumstances. However, there is much

room for disagreement concerning what constitutes a compelling circumstance, or whether the

means chosen by the Government are the least

restrictive possible.

As a constitutionally protected aspect of personal privacy, preventing continued pregnancy

can be subject only to minimal Government regulation (6)15,33,52) carefully tailored to accomplish the one legitimate Government purpose—

protecting health—with only minimal interference

with the individual’s rights. It would seem consistent that the Government could not prohibit

the use of medical or surgical treatments to cure

or circumvent infertility, although it could ensure

the quality of the medical care by appropriate regulation (see ch. 9). Therefore, regulation to ensure that infertile individuals are given adequate

information to make an informed choice among

available infertility treatments, to provide offspring with nonidentifying medical and possibly

personal information on their genetic and gestational parents, and to protect gamete recipients

from transmissible infectious disease would seem

both within State power and not unduly burdensome on the exercise of the right to procreate.

At the same time, the Government does not appear to have the obligation to finance the choice

to use noncoital reproduction. At least with respect to abortion, legislation prohibiting Government funding has been upheld (19)28) on the basis that failure to fund abortions does not impinge

on a woman’s right to have an abortion. By failing to fund abortions for poor women, the Court

reasoned, the State places no obstacles in the pregnant woman’s path to an abortion—i.e., the State

did not create the woman’s poverty that prevents

her from obtaining an abortion. This makes the

regulation constitutional as long as it rationally

furthers any legitimate State purpose.

Similarly, governmental policies to give financial support to infertile couples using treatments

that do not require donor gametes, surrogates,

or maintenance of extracorporeal embryos while

not financing other techniques would probably

be justifiable on the basis of State policy to encourage the use of reproductive techniques that

minimize difficult family law questions or questions concerning the appropriate management of

embryos (see chs. 9, 13, and 14).

When treatment of infertility involves third parties other than medical personnel, however, the

question also arises whether protection of their

interests or societal interests could justify interfering with procreative liberty. “A person’s rights

of privacy and self determination are qualified by
224 ● Infertility: Medical and Social Choices

the effect on innocent third persons,” said the New

Jersey Supreme Court decision on surrogacy arrangements (21). Such third parties include gamete

donors and surrogates, and societal interests might

be expressed with respect to management of extracorporeal embryos or the generalized effect of

commercialization of noncoital reproduction.

Protecting the Extracorporeal

Embryo

Some techniques for noncoital reproduction,

such as in vitro fertilization or embryo donation,

involve the creation or maintenance of an extracorporeal embryo. The legal status of such an

embryo, and the protection the State can afford

it against destruction or manipulation, are unclear.

Guidance can be found in the series of decisions,

beginning with Roe v. Wade, that permit a woman

to choose to discontinue a pregnancy. Thus, where

an individual woman’s right to terminate pregnancy is balanced with a possible State interest

in allowing all potential children to be brought

to term, the interests of the woman are superior.

If the decision to become pregnant is similarly

an aspect of the right to privacy and to procreate, then one would expect that the State could

not easily prohibit all use of techniques that necessitate the creation of extracorporeal embryos,

at least for those couples who cannot conceive

by any other means. This is particularly true in

light of the fact that the embryo does not have

the status of a “person” under the 14th Amendment (45) and therefore any interests ascribed to

it are unlikely to outweigh the identifiable interests of living adults seeking to exercise their right

to procreate.

The fact that creation of extracorporeal embryos

is protected for the purpose of infertility therapy

does not necessarily mean, however, that management of these embryos may not be subject to

State regulation. Efforts could be made to regulate certain forms of embryo research, or the discard, transfer, or cryopreservation of embryos

(see chs. 9 and 13).

In the interest of emphasizing the value placed

on embryos, States could try to ban the discard

and destruction of embryos not transferred following IVF. Such a ban would not directly violate

the principles laid down in Roe v. Wade, as absent a rule that an embryo must be reimplanted

in the egg donor’s uterus, the prohibition does

not interfere with her right to make decisions concerning the continuation of pregnancy. It does,

however, arguably violate the parental or property rights of the gamete donors to dispose of their

embryo as they see fit. Further, if the prohibition

on discard were accompanied by a requirement

that the embryos be frozen and offered for transfer to someone who wished to ‘(adopt” them, then

it might violate the gamete donors’ desire to avoid

having unknown genetic offspring.

This latter argument is weakened, however, by

the fact that there are already situations in which

individuals are not allowed to prevent the birth

of unwanted lineal descendants. A man may not

force a woman to have an abortion, even if he

does not desire to have a child, and his desire to

avoid fatherhood will not eliminate his obligation

to support that child if born. Further, a physician

performing a postviability abortion has an obligation to try and save the fetus regardless of the

mother’s desires (8), unless to do so would threaten

the mother’s physical or psychological health (10,

45)55). Although these cases are distinguishable,

it does appear that States might be able to place

some limitations on the destruction of embryos

not transferred following IVF (44).

The constitutionality of State efforts to limit the

use of cryopreservation of embryos is similarly

difficult to assess. Cryopreservation currently results in a loss of a substantial number of embryos

(see ch. 15). State interests in preventing the loss

of embryos could be used to try to justify limitations on the use of the technique. Other rationales that might be suggested include an interest

in preventing the development of embryo banks,

and the desire to avoid complex family relations

created when children are born long after the

deaths of their genetic parents. Further, the procedure is not strictly necessary to achieve procreation, as fresh embryos could be used instead, and

so it may be argued that prohibiting cryopreservation of embryos does not interfere directly with

the right to procreate.
Ch. 12—Constitutional Considerations ● 225

Balanced against these considerations is the fact

that the procedure is used so that further laparoscopies and their attendant risks can be avoided.

This medical justification may be sufficient to justify the increased risk to the embryo’s potential

for future development. Further, State rationales

based upon concern for avoiding the destruction

of embryos must be considered in light of the very

high rate of embryonic loss in natural reproduction (see ch. 2), and the fact that cryopreservation is usually undertaken to facilitate future implantations and births. Thus, the State interest may

arguably be viewed as overly solicitous on the one

hand, and self defeating on the other.

Prohibitions on embryo research, and particularly on the deliberate creation of embryos for

their use in research, might possibly be constitutional, as there is no direct interference in an individual interest in procreation or bodily autonomy. Although prohibitions on research with

embryos might slow or even halt the development

of certain types of infertility treatments, as well

as other medical developments, the State interest

in protecting embryos might be sufficient to justify

this indirect interference with the future expression of the right to procreate. Medical researchers could argue that such a prohibition also interferes with their First Amendment right to

freedom of expression, as it interferes with the

development and dissemination of information

concerning embryonic development. This would

be, however, a novel interpretation of the First

Amendment (42), and it is unclear how courts

would react,

Regulating Surrogacy Arrangements

Prohibiting all forms of surrogacy, including

those involving no compensation beyond direct

expenses, raises the question of interference with

the right to procreate for couples, as opposed to

individuals. Most commonly, surrogacy involves

a man who hires a woman to be artificially inseminated with his sperm and to relinquish the resulting child to him and his wife. The man in this situation is fertile, and can procreate coitally without

surrogacy, albeit outside marriage, His wife will

not procreate even if surrogacy is used, but instead will adopt a child. Thus, limitations on surrogacy would not interfere with the man’s ability

to procreate, nor would it affect his wife’s inability

to procreate. Rather, it interferes with their ability, as a couple, to raise a child genetically related

to at least one of them.

The Michigan appellate court in Doe v. Kelley

characterized surrogacy as an effort to use contract law to further the statutory right to use adoption to change the legal status of a child, rather

than an effort to exercise the right to procreate

per se (11).

The New Jersey Supreme Court endorsed this

line of analysis in its 1988 Baby M decision, concerning a custody dispute between Mary Beth

Whitehead, a surrogate mother, and William

Stern, who had hired her (see box 14-A inch. 14

for further details on this case):

The right to procreate very simply is the right

to have natural children, whether through sexual intercourse or artificial insemination. It is no

more than that. Mr. Stern has not been deprived

of that right. Through artificial insemination of

Mrs. Whitehead, Baby M is his child. The custody,

care, companionship, and nurturing that follow

birth are not parts of the right to procreation; they

are rights that may also be constitutionally protected, but that involve many considerations other

than the right of procreation (21).

This analysis does not fully address exercising the

right to procreate by hiring surrogate gestational

mothers, who bring to term a child to whom they

are not genetically related. In such cases, this form

of surrogacy may be the only means by which

the genetic mother can expect to pass her genes

on to the next generation. Further, prohibiting

women to earn money by selling their ova, when

men are permitted to sell sperm, may violate the

Equal Protection Clause of the 14th Amendment,

even if ova sales could be more closely regulated

in light of the greater medical risks they pose to

donors.

The point made by the Doe v. Kelley and Baby

M courts can be recast as the question of whether

there is a right to obtain custody of a biologically

related child. To the extent that surrogacy ensures

a man (and through gestational surrogacy, possibly his wife) the ability to raise a genetically related child, rather than the ability to procreate,
226 . Infertility: Medical and Social Choices

it is really a technique for obtaining custody. In

the past, no constitutional right to custody has

been identified when there is a dispute between

biological parents (although courts have been constitutionally permitted to give custodial preference

to a biological parent over a nonbiological parent).

There is nothing in our culture or society that

even begins to suggest a fundamental right on the

part of the father to the custody of the child as

part of his right to procreate when opposed by

the claim of the mother to the same child (21),

Thus, prohibitions on surrogacy raise a somewhat

more attenuated consideration of interference

with the right to procreate.

The question of the constitutional right to use

a surrogate mother has been discussed by a few

State courts. Although reversed on appeal, the

Baby M trial court decision considered surrogacy

a constitutionally protected option for a couple

seeking a child:

If it is the reproduction that is protected, then

the means of reproduction are also to be protected. . . . This court holds that the protected

means extends to the use of surrogates. . . . The

third party is essential if the couple is to rear a

genetically related child (emphasis added) (21).

For a married, infertile couple, other State courts

might accept the same reasoning, especially if they

view the right to procreate as encompassing not

only the right to gestate or to pass on genetic heritage, but also as a right to enjoy the fruit of that

procreation and to rear the resulting child.

Should the intended rearing parents be nontraditional or seek a surrogate for reasons other

than infertility or fear of passing on a serious

genetic disorder, courts may be less sympathetic

to the claim of constitutional protection, particularly if the court views freedom to procreate as

an aspect of marital privacy rather than of individual privacy, as discussed earlier in this chapter. For example, where surrogacy is sought by

a single man as a method for forming a family

without the ties of marriage, as has been done

on at least one instance (23), courts might not be

as sympathetic,

Further, protecting the choice to make a surrogacy arrangement and finding that States are

constitutionally required to enforce such agreements are somewhat different propositions. One

commentator argues that enforcement of the

underlying agreement is important to the viability of surrogacy arrangements, and the State has

an obligation to enforce them, lest it unduly interfere with procreative freedom (43).

On the other hand, the unenforceability of pre -

birth adoption agreements has not prevented couples from using the technique for private adoption. Therefore, failure to enforce surrogacy

contracts is not necessarily a direct interference

with the right to procreate or even the privilege

to adopt. In addition, finding that the genetic father has a constitutional right to obtain custody

of his child would be to find that the surrogate

mother does not have the same constitutional right

to custody. “It would be to assert that the constitutional right of procreation includes within it

a constitutionally protected contractual right to

destroy someone else’s right of procreation,” said

the New Jersey Supreme Court (21).

Even if States were obligated to enforce the

agreements, that enforcement need not necessarily extend to ordering “specific enforcement ,“

i.e., full performance of the agreement to relinquish custody of the child and to terminate the

mother’s parental rights (14). Assessing monetary

damages for breach of contract could be considered a sufficiently strong mechanism for ensuring the general regularity of these arrangements,

and should meet any test of a State’s obligation

to facilitate the use of social arrangements for family formation.

Protecting Children Conceived by

Noncoital Techniques

The State has a traditional interest in protecting children from physical harm. Under compelling circumstances, this interest may justify protecting a child from genuine psychological harm

as well, as for example when the State forbids child

labor, which, while not unhealthful, nevertheless

interferes with schooling (35). If children were

genuinely harmed by the fact of their noncoital

conception, then State efforts to regulate or even

ban certain practices might well be held to be constitutional. As procreation is a fundamental right,
Ch. 12—Constitutional Considerations . 227

however, State regulation would have to be narrowly drawn to accomplish its goal of protecting

children while minimizing the interference with

freedom in procreation.

State protection of children conceived by noncoital techniques might be manifested by regulating access to information concerning genetic

and gestational parentage, by regulating or prohibiting surrogacy, or by restricting the kinds of

nontraditional adult groups that might be allowed

to use these techniques in order to forma family.

With the rapidly increasing usefulness of environmental and genetic information in predicting

susceptibility to particular disorders, States might

find that children are entitled to have access to

medical information about their genetic and possibly gestational parents. Indeed, one commentator suggests that the State has an obligation to

provide that such information is gathered for the

child, even in light of the fact that some nonadopted children are unaware of their full genetic

parentage (l).

Adoptees have long argued unsuccessfully that

they have a right to information about their biological parents (38)39), even though some nonadopted children also do not know their full genetic parentage, but scientific developments and

the increase in the number of children conceived

by artificial insemination might persuade legislatures to provide a recordkeeping system that ensures the transmission of nonidentifying medically

useful information. There is little question that

such a law would be constitutional.

Release of identifying information is more troubling, as this might override the genetic or gestational parent desire for privacy. However, if State

regulations were prospective—i.e., if these parents were to know at the time they agree to participate in these arrangements that their identity

might be revealed—then there seems little question that the State interest in even the psychological well-being of these children could justify

making the information available. Research on the

psychological effects of having been conceived

noncoitally is just beginning (see ch. 15).

States might choose to protect children from

custody battles by legislatively adopting a strong

presumption of custody with the intended rearing parents-e. g., the genetic father and adopting mother in the case of surrogacy. This would

help avoid situations in which a child is moved

from one home to another during or following

a lengthy custody dispute, but it raises troublesome questions concerning the violation of the

surrogate mother’s own constitutional rights.

Some argue, for example, that enforcing surrogacy

contract provisions that deny the surrogate

mother parental rights to her child or full control over medical and dietary decisions is tantamount to peonage (32). Peonage, the forced performance of certain personal service contracts

when the employee opts to breach (34), is illegal

in the United States (18 U.S.C. 1581-1588).

In contrast, States might try to protect children

from undesirable custody battles or home arrangements by refusing to enforce surrogacy contracts,

thereby allowing the traditional principles of family law to guide judicial decisions concerning maternity, paternity, and custody. Basing custody of

a child on a surrogacy contract does not allow

a court to make its traditional judgment concerning which home is superior. Such judgments are

normally part of any dispute between parents.

Further, surrogate matching services generally do

not operate as licensed adoption agencies, and

therefore do not screen the intended rearing parents (see ch. 14). Thus, automatic enforcement

of contract terms concerning custody and termination of parental rights might leave the child without the protection of either adoption agency

screening or judicial oversight.

Another possibility for protecting children is to

regulate surrogacy arrangements in some fashion that assures adequate homes to the resulting

children, However, to the extent that such regulatory efforts are used to screen participants for

fitness to be parents, the regulations will raise

questions concerning interference with the right

to procreate and violation of the 14th Amendment’s guarantee of equal protection to all citizens

under the law. The fact that no such screening

takes place for coital reproduction would be a

factor.

To the extent that the right to procreate is

viewed as a fundamental right of the individual,
228 ● Infertility: Medical and Social Choices

any discrimination among types of people must

be justified by a compelling State interest. While

protection of a child against immediate physical

danger would certainly constitute a compelling

circumstance, protection against speculative psychological harms attributable to growing up in

a nontraditional home probably could not.

Thus, while singles and homosexuals have had

limited success in adopting children, as courts have

supported agency decisions to place available infants with parents fitting a more traditional model

(31), such individuals have had conspicuously

more success in obtaining and retaining custody

of their own biological children (50). The speculative harm attributed to growing up in a nontraditional family might be sufficient to place existing

children in the most certainly favorable home, but

it is not sufficient to bar nontraditional parents

from forming and maintaining families generally.

Interference with the exercise of a fundamental right is permitted only when accomplished by

the least restrictive means possible, narrowly tailored to a specific governmental purpose. Further,

even if such harms could be documented in certain cases, a blanket prohibition against any use

of noncoital techniques by singles and homosexuals would likely be considered overly inclusive,

as it would not distinguish among individuals who

could provide a satisfactory home and those who

could not. Although not finding a fundamental

right to engage in homosexual conduct, one 1988

Federal court decision held that homosexuals as

a class may not be subjected to governmental discrimination absent compelling reasons (57).

PROHIBITING COMMERCIALIZATION

OF NONCOITAL REPRODUCTION

Even if the right to procreate extends to the use

of noncoital techniques, donor gametes, and surrogacy arrangements, the question remains whether

the State may prohibit commercialization of these

services —i.e., the payment of fees beyond actual

and reasonable expenses. Commercial relationships are ordinarily subject to a wide range of Government regulation. Nevertheless, the Court is

reluctant to accept limitations on the individual’s

right to spend money to exercise his or her own

individual rights (5) when such exercise does not

directly interfere with the rights of anyone else.

Prohibitions on commercialization would most

likely be based on the need to protect public morality and to avoid the effects of encouraging individuals to view gametes, embryos, mothers, or

babies as articles of commerce (36,37).

The sale of sperm has long been tolerated in

the United States. Sperm selling seems to be socially acceptable, in part because it generally does

not conjure up images of selling a particular, potential human being. In addition, there is no physical risk associated with sperm donation, although

the psychological consequences of selling sperm

are largely unknown. Sale of ova would probably

be tolerated on the same basis if the associated

medical risks of laparoscopy or sonography -

guided retrieval could be minimized (see ch. 7).

Sale of embryos is more troublesome, however,

and has been outlawed by Florida and Louisiana

(see ch. 13). Embryo sales raise the specter of

choosing the likely characteristics of a child in the

way that those seeking artificial insemination can

select the characteristics of a sperm donor, but

beyond that of being able to select an embryo

based on the characteristics of both parents,

rather than only one. Further, selecting embryos

is viewed by some as closer to selection of living

children than is the selection of sperm. Moreover,

there is fear that certain characteristics would garner a premium price. The fear is not totally without justification, as two noncommercial sperm

banks already advertise that they only accept

donors who have superior education or IQ.

Another sperm bank is finding that market demands make certain donors unpopular, and as a

result is no longer anxious to use donors who are

below average height (46).

Protecting public morality against a developing

view of the commercial value of certain kinds of

human beings is one basis on which restrictive

legislation might be proposed. Such legislation
Ch. 12—Constitutional Considerations . 229

Commercial Sperm Bank’s List of Semen Donor Characteristics

DOWN BLOOD ETHNIC ORIGIN BODY SKIN EYE HAIR YEARS

ID# RACE TYPE MOTHER/FATHER HEIGHT WEIGHT BUILD TONE COLOR COLOR/TYPE COLLEGE Occupation SPECIAL INTERESTS

-------- ----- ----- ------------- ------ ----- ----- ---- ----- --------------

#l Cauc

#b Cauc

#~ Cauc

------ ---------- ----------------------

3 Student/Acct Sports,Flshing,Piano

8 S!udent/Dental 6uitar,Swimming,Read

4 Student/Biol Water Spts/Piano/Dance

8 Student/Dental Tennis/Music/Sailing

8 Student/Dental Piano/Sports

2 Student/Anthro 6uitar/Raquet Ball

4 Stu/Real Est Computer/Tennis/Skiing

1 Student/BusAdm Music/skiing

1 Student/Bus/Adm Tennis/Skiing

7 Administrator Music/Sports/Travel

10 Student/Med Contact Sports/Reading

2 Student/BusAdm Racquet Ball/Computers

b Student/Antn Music/Sports/Travel

4 Student/Econ Music/Sports/Reading

2 Student/Intl Piano/Vocal/Sports

3 Student/Psyc Music/Sports/Computers

3 Student/Hist Reading/Art

1 Student/Law Music/Sports

2 Student/BusAdm Sports/Fishing

1 Student/BusAdm Wrestling

7

Student/Engl Guitar/Tennls/Fishing

7 Nurs1ng Ed Music/Running/Language

2 Student/Soc Sports/Coins/Autos

could take the form of regulation to minimize the were a direct interference with procreative rights,

development of explicitly eugenic gamete or em- Legislation based on concern for public morality

bryo banks) or of a complete ban on sales) par- might fail to withstand the strict scrutiny brought

ticularly of embryos. If prohibitions on such sales to bear upon interferences with the exercise of
230 ● Infertility: Medical and Social Choices

fundamental rights. As gametes and embryos can

be obtained without payment, however, a prohibition on the sale of sperm, eggs, or embryos

would not necessarily unduly burden exercise of

the right to procreate. Under such circumstances,

any rational State policy would be sufficient.

The commercialization of surrogate motherhood poses somewhat different questions. Such

arrangements may be justified as freely chosen

techniques for forming a family. The contracts

are entered into by adults at a time when no baby

has yet been conceived, in furtherance of the right

to procreate, and it can be argued that States have

a constitutional obligation to enforce them. The

Michigan appellate court, however, found no constitutional right to employ surrogate mothers,

stating:

While the decision to bear or beget a child has

thus been found to be a fundamental interest protected by the right of privacy, we do not view this

right as a valid prohibition to State interference

in the plaintiffs’ contractual arrangement. The

statute in question does not directly prohibit John

Doe [sperm donor and intended rearing father]

and Mary Roe [surrogate mother] from having the

child as planned. It acts instead to preclude plaintiffs from paying consideration [money] in conjunction with their use of the State’s adoption procedures [citations omitted; explanatory comments

added] (11).

The New Jersey Supreme Court came to the

same conclusion, distinguishing commercial sur -

rogacy, which it banned, from other forms:

We find no offense to our present laws where

a woman voluntarily and without payment agrees

to act as a “surrogate” mother, provided that she

is not subject to a binding agreement to surrender

her child (21).

The Michigan and New Jersey decisions are

premised on the idea that banning payment to

surrogates is not a direct interference with the

right to procreate, but rather a legitimate State

regulation that does not preclude exercising the

right to procreate in other, noncommercial forms,

If viewed as the latter, any rational State interest

could justify the prohibition.

The question may turn on whether there will

be any practical ability to find surrogates should

payments beyond expenses be banned. Women’s

self-reported motivations for becoming surrogates

usually include noncommercial considerations,

such as a desire to help other people, and there

are known instances of intra-family arrangements

that do not involve payment (see ch. 14). Whether

the lack of a large commercial market in surrogates would constitute a direct interference with

procreative liberty is difficult to determine without further guidance from the Federal courts.

Even as statements of “rational” State interest,

though, arguments based on protecting public

morality are generally weak, if only because the

harms to society are usually speculative and attenuated. Opponents of commercialized surrogacy

might be pleased that the technique finally acknowledges the economic value of women’s reproduction, i.e., that “labor” is labor, but at the

same time assert that it makes biological mothers

into “workers on a baby assembly line, as they

try to convert their one economic asset—fertility—

into cash for their other children” (25).

The argument that these women have a right

to sell their reproductive potential is countered

by noting that other sales of the body, whether

in prostitution, peonage, or slavery, are prohibited

under law when there is broad social agreement

that the sale violates basic principles of personhood. These arguments are valuable as part of

the political debate, but should surrogacy be seen

as one aspect of a constitutionally protected right

to procreate, they may not be sufficiently compelling to justify direct State interference or prohibition.

In this case, however, the State rationale is further supported by a history of prohibitions against

buying adoptable babies (see ch. 14), because it

degrades human life and puts children at risk of

being placed in inappropriate homes simply because the occupants were able to outbid a competing set of aspiring parents. The New Jersey

Supreme Court’s Baby M decision considered this

a crucial point:

There is not the slightest suggestion that any

inquiry will be made at any time to determine the

fitness of the Sterns as custodial parents, of Mrs.

Stern as an adoptive parent, their superiority to

Mrs. Whitehead, or the effect on the child of not
Ch. 12—Constitutional Considerations ● 231

living with her natural mother. This is the sale

of a child, or, at the very least, the sale of a

mother’s right to her child, the only mitigating

factor being that one of the purchasers is the father. , . . In surrogacy, the highest bidders will presumably become the adoptive parents regardless

of suitability, so long as payment of money is permitted (21).

Undoubtedly the ban on baby-selling in ordinary

adoption makes it more difficult for some couples to raise a family, but the limitation has been

tolerated in light of the need to protect the interests of the available children. Despite the fact that

childlessness is an unhappy affliction for many,

there has never been a recognized right to obtain

custody of a child.

In surrogacy, however, the child is relinquished

to the genetic father by a woman who may be

quite sure that working as a surrogate for this

particular man is in her own best interests and

those of the child. Although reversed on appeal,

the Baby M trial court considered whether failure to enforce these agreements would interfere

with the adult participants’ liberty to make contracts:

The constitutional test is to balance whether

there is “a fair, reasonable and appropriate exercise of the police power of the State as to an unreasonable unnecessary and arbitrary interference }vith the right of the individual to his personal

liberty to enter into these contracts . . .“Lochner

V. ,Vew York, 198 U.S. 45 (1905). Legislation or

court action that denies the surrogate contract

impedes a couple’s liberty that is otherwise constitutionally protected. The surrogate who voluntarily chooses to enter such a contract is deprived

of a constitutionally protected right to perform

services (21).

The trial court’s opinion cites Lochner, a decision used to strike down laws protecting workers from excessively long hours and excessively

low wages (26). It was used in subsequent years

to strike down laws prohibiting child labor or unsafe work settings. Subsequent to the New Deal

era, the scope of the Lochner decision was reinterpreted, to allow the Government to prohibit

what it saw as inherently exploitative employment

arrangements (53). Essential to those definitions

of exploitative were sociological observations of

class differences between employers and employees, and inherent differences in bargaining power.

If States choose to view the income disparity

between surrogates and those who hire them as

similar to the inequities they identified during the

New Deal, they might have a justifiable interest

in refusing to enforce surrogate contracts or regulating their terms to protect all the participants

from exploitation and undue bargaining power.

This would be sufficient to justify State regulation of surrogacy in order to protect all the parties involved. It is not clear whether it would be

sufficient to justify a general prohibition.

Another concern related to recognizing commercial surrogacy is that its practice might lead

to a view of women as childbearers for hire and

of babies as articles of commerce (16) (see apps.

D, E, F). One leading proponent for the constitutional protection of commercial surrogacy speculated that prohibitions on private, paid adoptions

might indeed be affected by finding that there is

a right to contract for reproductive services:

Recognition of such a [surrogacyl contract right

also raises the question of why contracts to adopt

children made before or after conception but before birth would not be valid, nor why parties

should not be free after birth to make private contracts for adoption directly with women who want

to relinquish their children. The logic . . . is that

persons, at least if married, have a right to acquire a child for rearing purposes, and may resort to the medical or social means necessary to

do so. Although IVF and its variations preserve

a genetic or gestational link with one of the rearing parents, the right at issue may not be so easily confined. It may be that the law of adoption

needs to be rethought in light of the right to contract for noncoital reproductive assistance (emphasis added) (44).

Traditionally, prohibitions on paying for adoptable babies are based on a collective judgment that

certain things simply should not be bought and

sold, Prohibitions against buying human organs

have been based on the same reasoning (56), with

no successful challenge ever mounted to the fact

that this interferes with the rights of individuals

willing to purchase organs without which they
232 ● Infertility: Medical and Social Choices

might die. The New Jersey Supreme Court, considering this point in the Baby M case, stated:

There are, in a civilized society, some things that

money cannot buy. In America, we decided long

ago that merely because conduct purchased by

money was “voluntary” did not mean that it was

good or beyond regulation and prohibition. Employers can no longer buy labor at the lowest price

they can bargain for, even though that labor is

“voluntary,” or buy women’s labor for less money

than paid to men for the same job, or purchase

the agreement of children to perform oppressive

labor, or purchase the agreement of workers to

subject themselves to unsafe or unhealthful working conditions. There are, in short, values that society deems more important than granting to

wealth whatever it can buy, be it labor, love, or

life (citations omitted) (21).

Some assert that surrogacy contracts are not

forms of baby-selling as the “money to be paid

to the surrogate is not being paid for the surrender

of the child to the father. . . .[The biological father pays the surrogate for her willingness to be

impregnated and carry his child to term” (21). This

view is somewhat disingenuous, as fees to surrogates are usually quite minimal unless a baby is

delivered at term; miscarriages or a failure to surrender custody do not entitle the surrogate to full

fees (22) (see ch. 14).

Even if, however, the fee were one for services

rather than for a baby, the transaction overall is

one that has the potential to submerge biological

ties and a child’s interests to monetary and contractual considerations. “The profit motive predominates, permeates, and ultimately governs the

transaction,” said the New Jersey Supreme Court

(21). State regulations forbidding parents to buy

and sell custody rights to each other have long

been recognized as constitutional. Overall, commercialization of familial rights and duties is one

area in which courts have consistently upheld the

constitutionality of legislation based both on protecting the interests of the children involved and

more generally on protecting societal morals.

Finally, surrogacy is viewed by some as an arrangement that can lead to the exploitation of certain women (see chs. 11 and 14; app. D). Because

of the often considerable difference in income between surrogates and those who hire them (see

ch. 14), some argue that there is an inherent element of coercion in surrogacy arrangements, even

if the surrogate is free of the pressure of an unwanted pregnancy at the time she agrees to enter into the contract.

Coercion may include “situational coercion,” in

which an outside force such as poverty or illness

severely reduces a person’s choices (13). A person faced with starvation may choose to work for

less than minimum wages; undocumented aliens

often do, and while their choice is autonomous,

it is not genuinely free. Whether the economic

pressures that lead some women to become surrogates for hire rises to the level of situational coercion that justified overturning the Lochner decision and instituting minimum wage and worker

protection laws in the 1930s and 1940s is a question of both factual inquiry and value judgment.

The New Jersey Supreme Court, while recognizing that surrogates give their consent to the arrangement before conception, nevertheless

equated surrogacy with traditional baby-selling:

The essential evil is the same, taking advantage

of a woman’s circumstances (unwanted pregnancy

or the need for money) in order to take away her

child, the difference being one of degree (21).

One added factor, beyond economic need, that

may need to be considered is that surrogacy may

be the most efficient way for women with children to supplement the family income without

having to leave home. With this consideration, surrogacy may be viewed as either a welcome or sinister relief from the situational coercion created

by the combination of a widespread preference

for in-home parental care of small children, coupled with the small proportion of fathers willing

to take on that responsibility.

Overall, the legitimacy of State efforts to prohibit commercialization of reproductive materials and services is likely to turn on whether courts

view the prohibition as a direct or indirect interference with the right to procreate. If viewed as

a direct interference, States would find it difficult to show that a general prohibition is narrowly

tailored to prevent specific, concrete harms while

interfering only minimally with the exercise of

a fundamental right. They could, however, regulate the arrangements to ensure protection of all
Ch. 12—Constitutional Considerations ● 233

parties to the contract, and to ensure that an ade- public morality, surrogate mothers, and possibly

quate home will be available for the child at birth. even the children conceived by these techniques

If prohibition of paid surrogacy is viewed as an as the justification for forbidding commercializeindirect interference, States might successfully as- tion of reproductive services.

sert a rational State interest based on protecting

SUMMARY AND CONCLUSIONS

Evaluating noncoital reproductive techniques

involves examining the underlying values at stake

in procreative privacy. These include freedom of

association, freedom to make decisions that drastically affect a person’s self-identity, and rights to

have intimate relationships with a view toward

producing a child. Although the Supreme Court

is split on the reach of privacy outside of a heterosexual union, there is no such split concerning

privacy within a heterosexual union when that

union is aimed at procreation.

The Supreme Court might well conclude that

in vitro fertilization and gamete intrafallopian

transfer, if conducted within the context of marriage at least (and probably if done in any stable

heterosexual relationship), are within the ambit

of the right to privacy. Accordingly, only laws

aimed primarily at restricting performance to physicians, monitoring the safety and efficacy of the

procedures, and ensuring informed consent could

be used to regulate these activities.

Where there are public health risks or third parties who may be harmed, stricter regulation or

an outright ban might be permissible. Examples

might include surrogacy, experimentation on human embryos, and gamete donation. Regulations

for artificial insemination by donor or ovum donation could probably also be strict, since they

more indirectly interfere with any right to procreate as well as involve another participant—the gamete donor—whose interests are to be considered.

Governmental involvement in this area could include regulation of information dissemination to

offspring and donors, as well as medical screening.

prohibiting commercialization of surrogacy or

embryo donation may well be constitutional, as

it is consistent with earlier traditions outlawing

the sale of human organs, babies, or familial rights

and duties. In this case, social and legal tradition

Photo credit: Washington Stock Photo, Ar/ington, VA

would probably support legislation specifically

premised on a rejection of the commercialization

of familial relationships. The validity of this justification will likely turn on the degree of interference that prohibitions on payment are deemed

to have on the exercise of the right to procreate.

It is difficult to predict whether the Supreme

Court would uphold legislation restricting the use

of IVF, embryo transfer, donor insemination, and

gamete intrafallopian transfer to traditional families only. To do so requires demonstrating either

that the right to procreate is a right premised
234 ● Infertility: Medical and Social Choices

largely on family privacy, and that nontraditional

families do not enjoy this privacy, or that the right

to procreate is an individual right that must nevertheless be curbed in certain persons because they

pose a compelling danger to their children or society. Historical precedents on these points are

mixed, but recent case law indicates a growing

acceptance of nontraditional homes.

It is, however, the interests of the resulting children that largely determine the extent of the

State’s power to regulate or prohibit noncoital reproductive techniques. Indeed, it is precisely the

creation of children that distinguishes a decision

to procreate from a decision not to procreate,

While the latter can be exclusive to an individual

couple, since no child will result, the decision to

procreate cannot, Whether or not future children

can be seen as having rights, society has an obligation to protect them in reasonable ways from foreseeable harms, and States and the Federal Government have some constitutional authority to do so.

CHAPTER 12 REFERENCES

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7. Cleveland Board of Education v. LaFleur, 414 U.S.

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Annas (eds.) (New York, NY: Plenum Press, 1985).

16. Goerlich, A., and Krannich, M., “Summary of Contributions and Debates at the Hearing of Women

on Reproductive and Genetic Engineering, ”

Documentation of the Feminist Hearing on Genetic

Engineering and Reproductive Technologies,

March 6/7, 1986 (Brussels, Belgium: Women’s Bureau, European Parliament, 1986).

17. Griswold v. Connecticut, 381 U.S. 479 (1965).

18. Hafen, B. C., “The Constitutional Status of Marriage,

Kinship, and Sexual Privacy-Balancing the Individual and Social Interests, ” Michigan Law Review

81:463-574, 1983.

19. Harris v. McRae, 448 U.S. 297 (1980).

20. H.L. v. Matheson, 450 U.S. 398 (1976).

21. In the Matter of Baby M, 525A. 2d 1128, 217 N.J.

Super. 313 (Super. Ct. Chancery Division, 1987),

reversed on appeal, 1988 West Law 6251 (N.J. Supreme Court, Feb. 3, 1988).

22. Keane, N., “60 Minutes)” CBS Television, Sept. 20,

1987.

23. Keane, N., and Breo, D., The Surrogate Mother

(New York, NY: Everest House, 1981).

24. Kritchevsky, B., “The Unmarried Woman’s Right

to Artificial Insemination: A Call for an Expanded

Definition of Family,” Harvard Women’s Law Journal 4:1-42, 1981.

25. Lamanna, M. A., “On the Baby Assembly Line: Reproductive Technology and the Family)” paper presented at University of Dayton conference Reproductive Technologies and the Catholic Tradition,

Oct. 30, 1987.

26. Lochner v, New York, 198 U.S. 45 (1905).

27. Loving v. Vir@”nia, 388 U.S. 1 (1967).

28. Maher v. Roe, 432 U.S. 438 (1977).

29. Meyer v. Nebraska, 262 U.S. 390 (1923).

30. Moore v. City of East Cleveland, 431 U.S. 494 (1977).

31. Opinion of the Justices, 525 A. 2d 1095 (N.H, Supreme Court, 1987).

32. Pakrow, L., and Sangree, S., Staff Counsel, American Civil Liberties Union Foundation Reproductive Freedom Project, personal communication,

Aug. 31, 1987.

33. Planned Parenthood of Missouri v. Danforth, 482

U.S. 52 (1976).

34. Pollack v. Williams, 136 F. Supp. 707 (E.D. Ark.

1905).

35. Prince v. Massachusetts, 321 U.S. 158 (1944).

36. Radin, M.J., “Market Inalienability)” Harvard Law
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Ramsey, P., Fabricated Man: The Ethics of Genetic

Control (New Haven, CT: Yale University Press

1970).

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Learn the Identity of His or Her Birth Parents

(Washington, DC: U.S. Congress, Congressional Research Service, American Law Division, Nov. 30,

1984).

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U.S. Congress, Congressional Research Service,

American Law Division, Dec. 24, 1984).

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Roberts v. United States Jaycees, 468 U.S. 609

(1984).

Robertson, J. A., “The Scientist’s Right to Research—

A Constitutional Analysis,” Southern Caliform”a Law

Review 51: 1203, 1978.

Robertson, J .A., ‘(Procreative Liberty and the Control of Conception, Pregnancy, and Childbirth, ” Virginia Law Review 69: 405-464, 1983.

Robertson, J. A., “Embryos, Families and Procreative Liberty: The Legai Structure of the New Reproduction,” Southern California Law Reviewr 59:

939-1041, 1986.

45. Roe t. tt’ade, 410 U.S. 113 (1973).

46. Rothman, C. M., Director, Southern California Cryobank, personal communication, Dec. 19, 1986.

47. Skinner v. Oklahoma, 316 U.S. 535 (1942).

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424, 1985/86.

Smith v. Organization of Foster Families for Equality and Reform, 431 U.S. 816 (1977).

Somerville, M., “Birth Technology, Parenting and

‘Deviance ’,” International Journal of La w and Psychiatry 5: 123-153, 1982.

Stanley v. Illinois, 405 U.S. 645 (1972).

Thornburgh v. American College of Obstetricians

and Gdvnecolo@”sts, 476 US. 747 (1986).

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NY: Foundation Press, 1978).

Trimb]e v. Gordon, 430 U.S. 762 (1977).

United States v. Vuitch, 402 U.S. 62 (1971).

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New Developments in Biotechnology: Ownership

of Human Tissues and Cells, OTA-BA-337 (Washington, DC: U.S. Government Printing Office, 1987).

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8628 (9th Cir., Feb. 10, 1988).

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Zablocki v. Redhail, 434 U.S. 374 (1978).
chapter 13

Legal Considerations:

Artificial Insemination, In Vitro

Fertilization, Embryo Transfer, and

Gamete Intrafallopian Transfer
CONTENTS

Page

Structure of Applicable Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ..240

Artificial Insemination by Husband . . . . . . . . . . . . . . . . . . . . . . ................241

Improper Handling of Sperm. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .241

Disposal of Sperm After Husband’s Death . . . . . . . . . . . . . . . . . . . . . ..........242

Artificial Insemination by Donor . . . . . . . . . . . . . . . . . . . . . ...................242

Physician Requirement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ., .. ...244

Marital Status of the Recipient . . . . . . . . . . . . . . . . . . . . . ...................246

Requirements for Consent of Recipient’s Husband . . . . . . . . . . . . . . . . . . . . ....246

Husband’s Rights and Duties to the Child . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ,246

Legal Status of Resulting Children . . . . . . . . . . . . . . . . . . . . . ................246

Requirements for Consent of Donor’s Wife. . . . . . . . . . . . . . . . . . . . . . . . . . ....246

Sperm Donor’s Rights and Duties to the Child . ..........................24 6

Professional Responsibility for Screening Sperm. . . . . . . . . . . . . . . . . . . . . .. ...248

Recordkeeping and Confidentiality . . . . . . . . . . . . . . . . . . . . . . ...............249

In Vitro Fertilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . , ., . ............250

Control Over Disposition of Embryos. . . . . . . . . . . . . . . . . . . . . . .............250

Juridical Status of the Extracorporeal Embryo . . . . . . . . . . . . . . . . . . . . . . ....253

Later Implantation for Same Couple . . . . . . . . . . . . . . . . . . . . . . . . . . . ........253

Trusts and Estates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .........254

Gamete Intrafallopian Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .255

Embryo Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ..,255

Existing Legislative Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..256

Professional Responsibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....257

Embryo Donor’s Rights and Duties to Child . ............................25 7

Requirements for Consent of Ovum Donor’s Husband. . ............,......25 8

Embryo Recipient’s Rights and Duties to Child . ..........................25 8

Restricting or Regulating the Sale of Gametes or Embryos, ., . ...............259

Models of State Policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..................261

Summary and Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...262

Chapter 13 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ......262

Box

Box NO. Page

13-A. Summary of State Laws That Specifically Address In Vitro Fertilization. ..252

Tables

Table No. Page

13-1. State Statutes—Artificial Insemination. . . . . . . . . . . . . . . . . . . . . . ..........243

13-2. State Statutes—Fetal Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....251
Chapter 13

Legal Considerations:

Artificial Insemination, In Vitro Fertilization,

Embryo Transfer, and Gamete Intrafallopian Transfer

This chapter reviews the legal rights and duties

related to a variety of the infertility treatment and

circumvention techniques discussed in this assessment. In many cases, the techniques are so new

that little or no guidance is available on how the

law will be applied. There is, however, a great

deal of speculation in the legal literature, along

with a wealth of inadvertently and peripherally

related legislation and case law based on principles that may have some application in the area

of new noncoital reproductive techniques.

The established medical and surgical techniques

for treating infertility do not raise unusual legal

problems. They fall squarely within the larger

area of medical and public health laws, which

encompass questions of informed consent and

professional standards of practice. Noncoital reproductive technologies, however, challenge traditional legal thinking by introducing two novel

factors into human reproduction: the extracorporeal embryo and the child of up to five parents:

genetic mother, gestational mother, rearing

mother, genetic father, and rearing father.

The conflicting interests of the many parties in

noncoital reproductive technologies are difficult

to adjudicate. First, some techniques separate the

concept of ‘(biological mother,” traditionally a unitary term, into two component parts: the genetic mother and the gestational mother. Existing legal models of the role of the purely genetic

connection between parent and child have been

worked out in the context of fathers, not mothers.

For example, a genetic connection between a man

and a child will render him legally and financially

responsible for the child, absent a formal legal

intervention such as adoption (17,38). The intentions of the man to produce offspring or not are

irrelevant.

This legal outcome protects the interests of the

child, and explains the one general exception to

this rule, i.e., that a child born to a married

woman is presumed to be the child of the

woman’s husband, regardless of the genetic realities of the situation. This “presumption of paternity” is common in State legislative codes (9,45).

Provided that the child has two parents, the law

will then consider other interests, such as sanctity of marriage, when adult responsibilities for

child care are allocated. Note that the emphasis

on genetic relationships with men is based on the

self-evident fact that men are incapable of any

other sort of “biological” relationship.

Similarly, a fairly coherent body of law outlines

the rights of “biological” versus “rearing” mothers

in the context of adoption (17). Never before, however, have the component rights and responsibilities associated with gestational versus genetic

relationships been delineated, let alone balanced

against those of social mothers and fathers.

Models of responsibility based on male biological linkages may well be inadequate to cover the

complexities of female biological linkages, which

can entail a gestational relationship as well as one

based on genetics.

A second problem is that many of these techniques involve extracorporeal gametes or embryos. The still imperfect national consensus on

the status of unborn children affects reproductive technologies, as questions arise concerning

the management of unimplanted embryos. Whereas the abortion issue is complicated by the right

of an adult woman to control the physical state

of her body, the extracorporeal fertilized egg

raises the narrower issue of embryo rights. If

such rights are found to exist by virtue of the U.S.

Constitution or are created by legislative action,

then the course of reproductive biology research

and treatment will be profoundly affected by limitations on actions that might harm an embryo.

239
240 ● Infertility: Medical and Social Choices

Finally, new reproductive technologies raise a

host of issues that are familiar to the law, but that

rarely have been seen in such a tangled combination. These include equal access to reproductive

services by the poor, the unmarried, and the

homosexual; the rights of children with respect

to their biological and social parents; the use of

contractual arrangements to govern parental relationships; and the role of governmental and commercial interests in areas typically viewed as private. The arrangements facilitated by noncoital

reproductive techniques invite a fresh consideration of the legal significance of genetic and social connections between parent and child, and

also invite a review of the legal obstacles to the

formation of nontraditional family groupings.

STRUCTURE OF

Both Federal and State law will affect the status of noncoital reproductive technologies. The

Federal Government has limited powers, i.e., only

those powers granted by the U.S. Constitution,

with all residual powers falling to the States or

the people (Ioth Amendment), As a result, States

generally have the authority by judge-made law

(also known as common law) or by State legislation to protect the public health, safety, and

morals. It is on this basis that States have the authority to regulate familial relations, including

marriage, divorce, adoption, inheritance, and

parental duties.

In addition, contracts are generally regulated

by State statute. Thus, contracts to arrange for

a surrogate mother would be subject to State law

rules governing interpretation or enforceability

of the agreement. As each State is free to write

its own laws, a contract may have differing degrees of enforceability from State to State (32).

Some States may consider certain contractual arrangements as entirely void because they are contrary to public policy, such as, for example, a contract of marriage between an adult and a minor.

Another State might consider the contract voidable, i.e., the contract may be voided upon request

of one of the parties. In many cases, the request

to void a contract may come only from the vulnerable party to the transaction, in this case the

minor. Finally, some States may find no public polThis chapter summarizes the legal issues raised

by the use of artificial insemination, in vitro fertilization (IVF), embryo transfer, and gamete intrafallopian transfer (GIFT). These techniques

have in common the possibility of an extracorporeal embryo or the use of sperm or egg donors.

Situations in which a woman gestates a child with

the intention of relinquishing her parental rights

at birth are examined in chapter 14. Overarching constitutional issues concerning the right to

procreate, personal autonomy, the commercialization of procreation, and nondiscriminatory access to noncoital reproductive techniques are discussed in chapter 12.

APPLICABLE LAW

icy reason to treat a contract in any special way,

and therefore hold the contract enforceable according to the general laws of the State.

The distinctions made among void, voidable,

and enforceable contracts are important in the

context of surrogate motherhood arrangements,

which may offend public policy in some States.

Others might view either the surrogate mother

or the infertile couple as a particularly vulnerable party who may initiate an action to void the

contract. Thus, the enforceability of these contracts will likely vary around the country. Even

with a definitive statement from the Federal

courts that part or all of these transactions are

constitutionally protected, individual State regulations may differ considerably.

Another applicable section of State law is

known as torts, which governs most noncontractual situations in which someone harms another.

The two most important areas of tort law cover

intentional harms-e.g., intentionally touching

someone’s body without consent—and unintentional harms. Often the latter are caused by negligence, which occurs if someone behaves in an unreasonable way that breaches a duty of care owed

to someone else, and thereby causes harm, A relevant example would be a physician mistakenly

removing a healthy ovary rather than a diseased

ovary scheduled for removal. After having the dis-
Ch. 13–Legal Considerations: Artificial Insemination, IVF, Embryo Transfer, and GIFT ● 241

eased ovary removed, the woman could sue for

damages to compensate for the additional surgery, for the resulting infertility, and for her pain

and suffering.

Federal law can touch on some of these same

issues if the activity involved is partly or wholly

funded by Federal monies. A hospital, for example, though regulated by a State Department of

Health, may also be subject to conditions on any

Federal money it receives through Medicare or

Medicaid. These conditions on the receipt of Federal money are a kind of Federal regulatory mechanism. The Federal Government also has the

power to regulate interstate commerce. A physician may be subject to State licensure and discipline laws, but if the physician opens up a nationwide business with many offices, the business

itself may be subject to Federal regulations. This

commerce power of the Federal Government has

been interpreted liberally in recent years, and can

serve as the basis for extensive regulation when

an activity is interstate in nature, or when it has

an effect on interstate commerce (76).

Not only can Federal regulatory powers affect

the operation of a State activity, but Federal constitutional protections may affect the structure

of State laws. For example, a State law regulating adoption may specify that single-race homes

are to be given preference to mixed race homes

when placing children. Federal constitutional

guarantees of equal protection under the laws,

however, may void such a requirement as unreasonably discriminatory (76), This and other

aspects of Federal constitutional law affecting the

limits of permissible State legislation concerning

reproductive technologies are discussed in chapter 12.

In general, Federal constitutional law is superior

to Federal statutory law, which in turn is generally superior to State statutory or common law

if there is a direct conflict (33). State constitutions,

however, can go further than the Federal constitution in their protections, and thus forma separate

basis for attacking a State law as discriminatory,

even if the Federal constitutional interpretations

find the law nondiscriminatory (76).

A lawsuit based on an area of State law, such

as contract, tort, or family law, will generally be

heard in a State court. However, if the parties to

the litigation come from different States and if

more than $15,000 is at stake, a Federal court may

hear the case (33). This does not mean that Federal law will be applied to the case; Federal common law on these topics generally does not exist

(31). Rather, the Federal court will determine

which State’s laws ought to apply, using the principles of “choice of law” (4i’). The decision is not

a trivial one, as certain activities maybe governed

in entirely different ways in one State or another.

For example, the practice of surrogate motherhood is now interstate in nature, with surrogates

and intended social parents often coming from

different States. In the event that one State were

to explicitly legalize surrogate motherhood and

another to forbid it, choice~of-law principles might

determine the outcome of a Federal court’s decision with respect to a surrogacy contract.

ARTIFICIAL INSEMINATION BY HUSBAND

Artificial insemination by husband commonly requirements that a physician perform the insemi -

refers to artificial insemination in which the nation. Finally, cryopreservation of semen may

semen is provided by the recipient’s partner, lead to physician or laboratory liabilities when

whether or not she is married to him. This form storage facilities are not properly managed.

of insemination is relatively uncomplicated legally

because no third party is involved; the sperm Improper Handling of Sperm donor is the intended parent of the child. Nevertheless, certain problems can arise, for example, Negligent handling of sperm can give rise to

with respect to disposition of sperm left frozen professional liability if it causes harm. Further,

after a man’s death. Furthermore, artificial insemi - to the extent that sperm are the property of a

nation by husband may be subject to State law man, with a physician storing or using them as
242 ● Infertility: Medical and Social Choices

per the man’s directions, a physician could be

viewed as a bailee, i.e., someone charged with the

responsibility of caring for the property of

another (59). In this capacity, the physician once

again must be reasonably careful. Damages, however, are likely to be quite small for any loss of

sperm or sperm viability, as the sperm can be

replaced at little expense and without dangerous

or invasive procedures.

One exception is the loss of irreplaceable sperm

-e.g., sperm stored prior to irreversible sterilization. In 1987, suit was brought by a couple

whose frozen sperm was damaged during transit from the cryobank to the site of insemination.

The husband, who had stored the sperm before

undergoing radiation and chemotherapy, could

not replace the semen, and sued for his irrevocable loss of ability to genetically parent a child (81).

If the sperm is lost after the death of the husband, and the widow seeks damages for the loss,

the damages might also be high, as the loss is again

irrevocable. In this case, however, the widow

would have a right to recovery by virtue of her

entitlement to her husband’s property; if sperm

are not considered ‘(property, ” she may have no

right to recover at all.

Disposal of Sperm

After Husband’s Death

No State statutes specify whether frozen sperm

remaining after a man’s death are to be considered property of the estate, thereby passing to

heirs by his will or by State law. Nor are sperm

clearly considered property of the widow, to be

used for impregnation or destroyed, per her request, or as abandoned property reverting to the

institution or the State. In the only case to date

on this subject, a French woman successfully sued

in French courts to recover her late husband’s

sperm in order to bear a child of his. The court

declined to consider the sperm as an object of a

commercial contract, or as a donated organ subject to existing French regulations. Rather, it said

that sperm deposition created an obligation for

conservation and restitution, and that the widow’s

family established “without equivocation the formal will of Corinne’s husband to make his wife

the mother of a common child, whether the conception of this child happened while he was living or after his death” (26).

Assuming that a woman uses the frozen sperm

of her late husband in order to have a child by

him, a problem develops with respect to the

‘(after-born” child-one born after the death of

his or her parent. Ordinarily, after-born children

are the legal offspring of the deceased parent, entitled to inherit along with the rest of his children.

In this case, however, the child is not only born

but conceived after the death of its genetic father.

Considering such children as the legal offspring

of the deceased father creates a number of trust

and estate difficulties, most of which are purely

internal aspects of State law and beyond the scope

of this report (49,75).

One obvious problem is that it makes ambiguous the typical language “to my children” as used

in wills. The possibility of an after-conceived child

would make this class of children open to additions much longer than the current 9 months following death, thus making it impossible to probate a will expeditiously. Similar problems could

arise with respect to frozen embryos, with the death

of one or both genetic parents no longer an insuperable obstacle to bringing the child to term.

Louisiana law, which touches on the subject of

inheritance rights of IVF embryos, states that the

embryo will have such rights at the time of its

birth. The law places no time limit on this right,

and so opens the way for inheritance rights in

children whose fathers have died many years before they were brought to term.

ARTIFICIAL INSEMINATION BY DONOR

Sperm donation—the oldest of noncoital tech- in statutes in some 30 States (see table 13-1). Of

niques–has existed as a therapeutic option in the these, eight appear to be modeled on the Uniform

United States since about 1950 and has resulted Parentage Act. Others share some common lan-
Ch. 13–Legal Considerations: Artificial Insemination, IVF, Embryo Transfer, and GIFT ● 243

x

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244 ● Infertility: Medical and Social Choices

guage, but vary widely in their precise wording,

ranging from a detailed code to a terse statement

of their intended legal effect.

Despite the variation in wording, all artificial

insemination by donor statutes make clear that

the offspring of donor sperm shall be treated as

the legal offspring of the consenting husband for

legitimacy, inheritance, and support purposes

(28,40,41,57). Sometimes the legal implications are

directly specified; in other cases they arise by implication from designation of the offspring as the

natural or legitimate child of the consenting husband. Sometimes this effect is certain only if the

precise statutory conditions are satisfied, leaving

open the consequences if statutory conditions

concerning physician, marital status, and the like

are not met, The result is that many questions

are not answered by clear statutory language,

leaving the parties to act on legal predictions of

varying certainty.

The artificial insemination by donor laws appear to follow and implement a contractual approach to offspring status when donor, recipient,

and recipient’s husband agree that the husband

shall assume all rearing rights and duties and the

donor none. It maybe that this model will be followed for donor sperm transactions that do not

follow all statutory specifications, for artificial insemination by donor in States without specific legislation, and for egg and embryo donation as well,

though this will depend on court interpretation

and future legislation.

Although these statutes operate to legitimate

offspring of donor sperm, they fail to grapple with

a number of potential problems discussed in this

section, such as limiting the number of offspring

per donor, screening for infectious and genetic

diseases, clarifying the legal consequences of use

by a single woman, and maintaining adequate

records.

Physician Requirement

Twenty-one’ of the thirty artificial insemination by donor statutes provide that offspring are

‘Alabama, Arkansas, California, Colorado, Connecticut, Georgia,

Idaho, Illinois, Minnesota, Montana, Nevada, New Jersey, New Mexico, Ohio, Oklahoma, Oregon, Virginia, Washington, Wisconsin,

Wyoming.

the legitimate children of the consenting husband

when the insemination is done by a “licensed physician,” “certified medical doctor,” or person “duly

authorized to practice medicine. ”

In States with this specification, the legal effect

of insemination by someone other than a physician, such as husband, lover, donor, friend, family member, or even medical technician, nurse,

or physician’s assistant, may be uncertain. States

such as Ohio avoid this confusion by tating

explicitly that failure to have insemination performed under the supervision of a physician will

not prevent the child from benefiting from the

law’s legitimization provisions. This would probably be the result obtained by judicial decision

in States without such clarifying language (48).

Ambiguities in the statutes raise questions as

to whether inseminations done without the required physician supervision have different legal

consequences (43). For example, in the Jhordan

C. case, the lack of physician-supervised insemination was one factor that persuaded the court

to permit the sperm donor to have visitation

rights. That case was complicated, however, by

the fact that the mother was unmarried but living with another woman who also was to have

visitation rights.

In the nine States that do not specify physician

insemination, State laws against the unauthorized

practice of medicine might nevertheless make it

criminal for third parties to inseminate. In Georgia, Florida, and Idaho it is specifically a crime

for someone other than a physician to do the

artificial insemination. Nevertheless, these laws

would not affect the enforceability of the parties’

agreement concerning rights and duties toward

the offspring.

The reasonableness of State laws that directly

or indirectly require a physician to perform artificial insemination is questionable. The technique

itself can be quickly learned and needs no special equipment. Limiting vendors who screen semen from anonymous donors to those with medical expertise may be easily justified (see ch. 9);

similarly limiting those who use this screened semen for themselves alone is more difficult to rationalize.
Ch. 13—Legal Considerations: Artificial Insemination, IVF, Embryo Transfer, and GIFT 245

d

.

I

Photo credit: Library of Congress

Nineteenth Century Marriage Certificate
246 Infertility: Medical and Social Choices

Marital Status of the Recipient

No statute explicitly makes it illegal for an unmarried woman to be artificially inseminated.

However, most State artificial insemination by

donor laws, directly or by implication, address

the status of offspring where the husband consents to the insemination, thus leaving open the

question of how the statutory provisions will have

effect if there is no husband. when a consenting

husband is present, these statutes cut off the

sperm donor’s rights of fatherhood and grant

them instead to the consenting husband. Not all

statutes are as clear as that of Ohio, which provides that even if no husband is present, sperm

donor’s rights and responsibilities will be cut off

automatically. Another question is whether the

sperm donor may sue to have these rights and

responsibilities reinstated. Donors known to the

recipients have successfully sued for rights of

fatherhood when no husband is present (20,43).

Requirements for Consent

of Recipient's Husband

All the statutes require that the husband consent for the offspring to be treated as his legitimate or natural child and for him to take on rearing rights and duties. Some States specify that the

consent be in writing, four require that it be

signed by both husband and wife (Alabama, California, Illinois, Ohio), and several States require

that it be filed confidentially with the State health

department. The penalty for failure to obtain the

husband’s consent is often unclear.

Husband’s Rights and

Duties to the Child

The only possible exceptions to the husband being the legal father of the resulting child may be

in situations in which the recipient failed to obtain her husband’s consent, as previously discussed, or when the recipient is in fact planning

to relinquish the child to the genetic father (i.e.,

the recipient is a surrogate mother). In the latter

case, a contractual agreement ordinarily purports

to rebut the presumption of paternity or to exempt the parties from the statutory legitimation

of the artificial insemination by donor laws.

Whether such a contractual effort works will depend on the particular laws of the States in which

the parties reside, and whether surrogate parenting contracts will be recognized by those State

courts (see ch. 14).

Legal Status of Resulting Children

The offspring’s status as the natural or legitimate child of the consenting husband brings into

play the State law concerning rights and duties

that fathers owe their natural or legitimate children, and affects the offspring’s right to support

and inheritance. With artificial insemination by

donor, this status means that the consenting husband is listed on the birth certificate and has rearing rights and duties. The offspring inherits

through him either by will or intestacy laws and

not through the donor, The donor loses explicitly

or by implication of law the usual rights and

duties of a natural father.

Requirements for Consent of

Donor’s Wife

None of the 30 artificial insemination by donor

statutes require a man to obtain his wife’s consent before donating sperm, and thereby committing an act intended to produce offspring outside

the context of his marriage. This stands in contrast to the requirement that a wife obtain her

husband’s consent before undergoing artificial insemination, required by every statute (9). One rationalization for the distinction is that the sperm

donor will probably not be legally or financially

responsible for the offspring, at least if he does

not subsequently seek recognition as the father

of the child.

Sperm Donor’s Rights and Duties

to the Child

By direct statement or clear implication, all 30

State artificial insemination by donor laws remove

from the donor any rearing rights and duties to

the offspring when the statutory provisions are

met. Sometimes this is stated directly; sometimes

it occurs by clear implication from recognition

of the consenting husband as legitimate or natural father. Presumably this is the donor’s wishes
Ch. 13–Legal Considerations: Artificial /insemination, IVF, Embryo Transfer, and GIFT ● 247

in those cases as well, thus implementing the contractual agreement among the parties. This arrangement helps to ensure an adequate supply

of donors, for otherwise each would be subject

to an unknown number of claims on his financial and emotional resources at some indeterminate time in the future.

The situation can be different, however, in the

case of a known sperm donor. In the New Jersey case of C.M. v. C. C., a man provided sperm

to his still virginal fiance'e, who desired a child

by him prior to marriage. After the birth, the engagement was broken off. The father sued for

visitation rights, which were contested by the

mother. The court held that in the absence of

another male parent for the child, and in light of

conflicting evidence of the parties’ original intentions, it was in the best interests of the child and

of the State to preserve a two-parent arrangement, even if the parents were unmarried (20).

Decisions such as these demonstrate the strength

of the judicial interest in ensuring two legal parents to a child born as a result of artificial insemination. They also explain, however, the reason

for the demand for anonymous artificial insemination by donor among single and lesbian women.

Obtaining sperm from a friend rather than from

an anonymous donor means that there always exists the possibility of continued involvement by

this friend in the lives of the mother and child,

or even of a custody battle (43). Yet for these

women the very reason for using artificial insemi1. Bride 2. Groom 3. Groom’s daughter from first marriage 4. Bride’s mother

5. Bride’s mother’s current lover 6. Bride’s sperm donor father 7.&8. Sperm

donor’s parents who sued for visitation rights to bride 9. Bride’s mother’s

lover at time of bride’s birth 10. Groom’s mother 11. Groom’s mother’s

boyfriend 12. Groom’~ fath& 13. Groom’s stepmother 14. Groom’s father’s

third wife 15. Groom’s grandfather 16. Groom’s grandfather’s lover 17.

Groom’s first wife

SOURCE: Signe Wilkinson, Philadelphia Daily News (from San Jose Mercury News),
248 ● Infertility: Medical and Social Choices

nation by donor is to avoid such entanglements.

Thus, use of sperm banks and anonymous donors

remains the surest way for such women to achieve

pregnancy without requiring a sustained involvement with a man. This fact brings into focus why

physician reluctance to provide artificial insemination by donor services to singles and lesbians

poses such a troubling dilemma to these women.

An important question left open by most artificial insemination by donor laws is whether parties may actually agree in advance that the donor

will have rearing rights and duties toward the offspring. This will be of special importance when

the donor is providing the sperm as part of a surrogate arrangement, whereby the donor and his

partner will have a child to rear who is genetically related to the donor. One Arkansas statute

does provide for this eventuality (see ch. 14). It

will also be important when the recipient is unmarried and wishes to share parenting rights and

duties to some limited extent with the donor.

Although most statutes do not provide for the

latter contingency, New Jersey, New Mexico, and

Washington specifically allow the donor and recipients to provide that the donor will have such

rights and duties as the parties agree on. However, it is not clear that the parties will be able

to change legitimacy and inheritance implications

of artificial insemination by donor when a consenting husband is present, even if they may

agree not to omit the donor altogether from rearing rights and duties. Even the New Mexico statute has some ambiguity, as it does not directly

address the possibility that the recipient in this

case is married, with a consenting husband who

wishes to share in recognition of the child.

Professional Responsibility

for Screening Sperm

Only 3 of the 30 State statutes address donor

screening. Idaho and Oregon have statutes

directed at the donor, making it a violation or

crime for a man to become a donor if he knows

he has a venereal or genetic disease. Ohio’s statute requires a full physical examination and a

medical and genetic history, and includes a list

of suggested tests for specific infectious and

genetic diseases. Generally, however, the artificial insemination by donor statutes do not address

a physician’s duty to screen donors to prevent

transmission of venereal or genetic diseases to the

recipient and to offspring. Only Idaho and Ohio

require physicians to quarantine frozen semen

and to screen the donors for human immunodeficiency virus (HIV). .

A 1978 survey indicated that many physicians

were inadequately screening donor sperm for

genetic and sexually transmitted diseases (23).

This survey sparked a flurry of journal articles

and conference discussions on ways to improve

screening practices and to avoid liability for poor

screening (6,7,8,13,14,51)65). Physicians and

sperm banks have somewhat improved their

screening practices, particularly with respect to

sexually transmitted diseases (80). For example,

the vast majority of sperm banks now quarantine

sperm while doing followup testing on a donor

(64,80). This is important for identifying donors

who are seropositive for HIV antibodies, as such

results may show up months after the donor was

capable of transmitting the virus through his semen (see ch. 9).

In general, physicians are held to reasonable

standards of care in their screening for genetic

and sexually transmitted diseases. “Reasonable”

is a flexible term in the law, and in this case would

reflect that level of care common among similarly

situated professionals. Failure to exercise such

care would be malpractice, and could leave the

physician liable for the physical and emotional

harm resulting from the transmission of the disease (see ch. 9). For example, in 1987 a California woman brought suit claiming that she suffered from cytomegalovirus (CMV), a mild disease

in adults but one that can cause birth defects in

children, as a result of using semen from a sperm

bank that screened for many infectious diseases

but not for CMV (15,83). A court would be free

to evaluate whether the sperm bank’s screening

protocols were “reasonable.”

The American Association of Tissue Banks and

the American Fertility Society (AFS) have issued

guidelines on gamete donation and operation of

sperm banks (1,3)5), and the American College of

Obstetricians and Gynecologists endorsed the AFS

guidelines (2). Such guidelines are voluntary, but
.— ——

Ch. 13—Legal Considerations: Artificial Insemination, IVF, Embryo Transfer, and GIFT 249

may be considered strong evidence of at least a

minimal level of professional responsibility for

screening, should a court consider a malpractice

claim on these grounds. However, adherence to

these standards is not necessarily evidence of reasonably prudent practice of medicine; courts have

at times found that an entire industry or professional group has been failing to meet such a standard (see ch. 9).

The AFS guidelines, for example, did not until

1988 recommend that all use of fresh sperm be

discontinued, even though only frozen, quarantined sperm can be eventually judged certain to

be incapable of transmitting HIV. Instead, the

1986 AFS guidelines proposed a series of careful

steps to be taken to help judge whether a donor

poses any risk. The AFS guidelines are periodically reviewed, and were amended in early 1988

to express a preference for the use of frozen,

quarantined semen only (58); past guidelines made

no such recommendation. Should someone have

contracted acquired immunodeficiency syndrome

(AIDS) from fresh semen donated in accordance

with the previous AFS standards, a court would

be free to evaluate whether those procedures

were in keeping with then-common practice and

reasonably prudent. This determination could

well be affected by recent reports that at least

two sperm banks have had donors “seroconvert”

during the quarantine period—i.e., donors tested

positive for exposure to HIV soon enough after

having donated sperm that it is possible they were

infectious at the time of donation (66,69,83) (see

ch. 9).

In early 1988, the Centers for Disease Control,

coordinating with the Food and Drug Administration, recommended that all donor semen

should be frozen and quarantined, so that donor

testing for HIV could take place both at the time

of donation and 6 months later (see ch. 9). A physician’s failure to comply with this Federal recommendation would probably be considered negligent by a court. Compliance would not necessarily

preclude a finding of negligence (see ch. 9), but

would be strong evidence of reasonable practice.

A sperm donor who fails to report a genetic or

infectious disease that might harm the recipient

or child may well be violating a common-law duty

of care to these parties. The general lack of recordkeeping in current artificial insemination by

donor practices makes it impossible for most recipients to trace their donors in order to complain

of such behavior, but should that situation change,

sperm donors might conceivably find themselves

responsible for deliberate or negligent misrepresentation of their health. For example, in the

California suit over CMV infection via artificial insemination, the plaintiff sought a court order to

open the sperm bank’s records in order to identify the sperm donor, who has been included as

a defendant in her suit. Although the California

court hearing the case denied the request, similar suits could be brought in other jurisdictions.

Recordkeeping and Confidentiality

Fourteenz State artificial insemination by donor statutes specify that the written consent of

the recipient and her husband be filed with the

State health department, to be kept confidential

except in response to a court order. A few States,

such as Ohio, require the physician to keep the

signed consent forms sealed and confidential

rather than file them with the State. In some cases

the registration requirement applies only after the

birth of the child. The inseminating physician is

required to file the forms only if the physician

is aware of the birth, which may not occur if

another physician delivers the baby. Thus some

States make clear that failure to follow the recordkeeping provisions does not affect the allocation of rearing rights and duties otherwise recognized in the statute.

Adoptees have argued that a person has a right

to know the identity of his or her biological parents (60), claiming that issuing birth certificates

with adoptive parents’ names unconstitutionally

discriminates against adoptees, and violates their

right to privacy (see ch. 12). Their arguments have

been unsuccessful, so it seems unlikely that children conceived with anonymous donor sperm

will have any more success objecting to procedures to guard the identity of their genetic

‘Alabama, California, Connecticut, Idaho, Kansas, Montana, New

Mexico, Nevada, Ohio, Oklahoma, Oregon, Washington, Wisconsin,

Wyoming.

76-580 - 88 - 9 : QL 3
250 . Infertility: Medical and Social Choices

fathers. Further, identification of the donor’s iden- adoptees with nonidentifying information contity may discourage many men from offering to cerning the health, interests, and ethnic backbecome sperm donors, thus reducing the supply ground of the biological parent (61), and such statof semen for artificial insemination. However, utes could be held to apply or be extended to

many States have passed legislation to provide cover children of sperm donor fathers.

IN VITRO FERTILIZATION

Although used in an estimated 169 programs

nationwide, little statutory regulation exists on

IVF. Only two State statutes, those of Pennsylvania

and Louisiana, explicitly address therapeutic IVF.

Fetal research statutes do not appear to have

much of an impact, despite broad language in

some that might be deemed to apply to embryos

(see apps. C and F). There seem to be no statutory restrictions on IVF with egg and sperm provided by the intended social parents. Couples

probably have a legal right to resort to IVF or to

donate embryos to others, and, except in Louisiana, to discard unwanted embryos. They also

appear to face no legal barriers, other than restrictions on research, to freezing their own embryos for later use by themselves.

Control Over Disposition of Embryos

States with laws regulating fetal research use

terms such as “embryo,” “product of conception,”

and “unborn child” that could be read to include

preimplantation embryos (see table 13-2), raising

the question of whether the statutory use of these

terms might restrict clinical use of IVF and any

of its variations. Further, five States have now

adopted laws aimed specifically at IVF research

or therapeutic applications (see box 13-A). At issue

is whether any legal constraints prohibit couples:

●

●

●

●

from using basic IVF to initiate pregnancy,

from deciding not to transfer all the embryos

to a uterus,

from cryopreserving and thawing embryos

for later transfer, or

from donating embryos to willing recipients.

Fetal research statutes, many of which address

questions of research with aborted fetuses, do not

generally speak to these issues. For example, they

do not appear to prohibit clinical use of IVF. First,

most apply only to aborted embryos or fetuses,

and not to preimplantation embryos. Second, they

ban research or experimentation, not nonexperimental therapeutic applications of techniques that

aim at bringing healthy offspring into being. (See

ch. 9 for discussions of the status of IVF as experimental or therapeutic, and of State and Federal limits on embryo research.) Nor would the

statutes clearly ban cryopreservation of embryos,

as enabling embryos to be transferred during a

later cycle may fall within the statutory exceptions for research done to benefit or avoid harm

to embryos.

Finally, the validity of fetal research statutes remains to be determined; in the only challenge to

date, a Louisiana ban on experimentation with fetuses obtained from induced abortions was struck

down for vagueness (50). In its decision, the Court

focused on the fact that it is difficult to distinguish

between experimentation on the fetus, and tests

on the fetus that are necessary for ensuring

maternal health. As a result, physicians would be

unsure of whether their actions were banned by

the statute. Adoption of this reasoning by other

courts would make it unlikely that statutory bans

on fetal experimentation, unless quite narrowly

drawn, could survive constitutional challenge.

A concurring opinion in this case focused on

the unsubstantiated distinction between fetal tissue obtained by induced abortion and fetal or

otherwise human tissue obtained from different

sources. (A concurring opinion is a separate opinion written by a judge of the court who agrees

with the outcome of the case, in this case, striking down the Louisiana statute, but who prefers

alternative reasoning.) Finding no rational reason

to ban experimentation on fetal tissue derived

from induced abortion while at the same time allowing experimentation on corpses and fetal tissue derived from miscarriages, the concurring

opinion concluded that the statutory ban was part
Ch. 13–Legal Considerations: Artificial Insemination, IVF, Embryo Transfer, and GIFT ● 251

Table 13-2.—State Statutes—Fetal Research

Restricts Prohibits sale of Mentions May restrict research

State fetal research fetus or embryo preimplantation embryos a with pre-embryosb

Alabama . . . . . . . . . . . . . . . .

Alaska. . . . . . . . . . . . . . . . . .

Arizona . . . . . . . . . . . . . . . . .

Arkansas . . . . . . . . . . . . . . .

California . . . . . . . . . . . . . . .

Colorado . . . . . . . . . . . . . . .

Connecticut . . . . . . . . . . . . .

District of Columbia. . . . . .

Delaware . . . . . . . . . . . . . . .

Florida . . . . . . . . . . . . . . . . .

Georgia . . . . . . . . . . . . . . . . .

Hawaii . . . . . . . . . . . . . . . . .

Idaho . . . . . . . . . . . . . . . . . . .

Illinois . . . . . . . . . . . . . . . . .

Indiana . . . . . . . . . . . . . . . . .

Iowa . . . . . . . . . . . . . . . . . . .

Kansas . . . . . . . . . . . . . . . . .

Kentucky . . . . . . . . . . . . . . .

Louisiana . . . . . . . . . . . . . . .

Maine . . . . . . . . . . . . . . . . . .

Maryland . . . . . . . . . . . . . . .

Massachusetts . . . . . . . . . .

Michigan . . . . . . . . . . . . . . .

Minnesota . . . . . . . . . . . . . .

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Montana . . . . . . . . . . . . . . . .

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Utah . . . . . . . . .

Vermont . . . . . .

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252 ● Infertility: Medical and Social Choices

B OX 13-A. —Summary of State Laws That Specifically Address In Vitro Fertilization

Kentucky.–Kentucky mentions IVF in its adoption statutes, only to say that nothing in a statute

prohibiting adoption in certain instances prohibits

IVF.

Illinois.—Illinois’ fetal research statute specifically says that it is not intended “to prohibit the performance of in vitro fertilization,” when it says that

nontherapeutic experimentation on a “fetus

produced by the fertilization of a human ovum by

a human sperm” is prohibited.

Louisiana.—Louisiana passed a law in 1986 concerning “in vitro fertilized” ova, thereby seemingly

excluding embryos created in vivo, whether or not

subsequent lavage and transfer were contemplated.

The law forbids the purposeful creation of an in

vitro embryo solely for the purpose of research or

sale. The law also expressly prohibits the sale of

a human ovum.

The Louisiana law is novel in that it expressly

grants the status of “juridical person” to the fertilized ovum, until such time as it is implanted in a

uterus, when presumably its status is governed by

State law applying to products of conception in

utero. As a juridical person, the fertilized ovum may

sue or be sued, and may not be considered property. Instead, the gamete donors are considered its

parents, and if they are unidentifiable, the medical facility is considered guardian of the fertilized

ovum. The gamete donors may allow another couple to adopt the embryo. Inheritance rights do not

attach until birth, and then attach to the birthing

or adopting parents, rather than the genetic parents. No person, including the gamete donors, may

intentionally destroy an in vitro embryo that appears capable of normal development. IVF facilities

are particularly noted as having a direct responsibility for the safekeeping of the embryo. Further,

while such facilities and their personnel are protected from strict liability claims by the embryo,

they are not so protected from strict liability claims

brought by other interested parties.

The law restricts IVF practice to those facilities

complying with the personnel qualification and

physical plant guidelines of the American Fertility

SOURCE: Office of technology Assessment, 1988

Society or the American College of Obstetricians

and Gynecologists.

New Mexico.–New Mexico defines IVF and then

states that ‘(clinical research” is to be construed

“liberally to embrace research concerning all physiological processes in man and includes research

involving human in vitro fertilization, but shall not

include human in vitro fertilization performed to

treat infertility; provided that this procedure shall

include provisions to insure that each living fertilized ovum, zygote or embryo is implanted in a human female recipient, and no physician may stipulate that a woman must abort in the event the

pregnancy should produce a deformed or handicapped child” [Sec. 324-9 A-1 (D)].

The restrictions on research thus do not apply

to IVF conducted to treat infertility, even if they

are experimental or unproven in some sense. Thus

this law’s effect on IVF does not appear to be significant.

Pennsylvania.—Pennsylvania defines IVF as “the

purposeful fertilization of a human ovum outside

the body of a living human female” (Sec. 3203). It

then requires that all persons conducting or experimenting in IVF “file quarterly reports with the

department which shall be available for public inspection and copying. ” The reports must include

the names of the persons conducting or experimenting in IVF, the locations, the sponsor of the

research, number of eggs fertilized, number destroyed or discarded, and number transferred (“implanted”) in a woman. The names of the persons

or couple providing the gametes are not required

to be reported. Failure to file a report is subject to

a fine of $50 a day.

A telephone call to the State official in charge of

these records in 1985 revealed that reports are filed

by many programs, though no effort to monitor

programs to see if they are complying with the law

has occurred. Nor is it clear what purpose collection of these data now serves, since they do not appear to have been used for any regulatory purpose

or sought by researchers.
Ch. 13–Legal Considerations: Artificial Insemination, IVF, Embryo Transfer, and GIFT . 253

of an attempt to discourage the use of abortion

(other aspects of the statute were found to have

this purpose), and for that reason was unconstitutional. If this latter reasoning were adopted by

other courts, it would increase the possibility that

general bans on experimentation with fetal tissue, regardless of source, could survive constitutional scrutiny because they would no longer

make the unjustifiable distinction between fetal

tissue obtained by abortion and that obtained by

miscarriage.

Discretion over discard of embryos does not generally appear to be considered by fetal research

statutes. Almost all address what can be done with

the product of abortion, but do not address restrictions on abortion itself. Thus, they would not

appear to affect the decision to discard an embryo.

Even the four States that would arguably prevent

research on discarded embryos (see table 13-2)

do not address the legality of discard itself.

Discretion over discard of embryos is specifically addressed, however, by Louisiana’s IVF law,

which states that even the gamete donors may

not discard a viable embryo. Instead, they may

preserve it for later use or donate it (without compensation) to another couple. Physicians and IVF

facilities are directed to take every precaution to

preserve the viability of the IVF embryo.

Although some prosecutorial authorities have

indicated that they will not prosecute IVF programs under their fetal research laws if all embryos are transferred to a uterus, it is not clear

they have a statutory basis for such a position.

Further, transfer of grossly abnormal embryos

resulting in miscarriage might be a violation of

a physician’s duty to the patient.

Juridical Status of the

Extracorporeal Embryo

There are mixed indications of whether the

preimplantation embryo will be treated as the

property of the gamete donors. Some commentators have written about viewing sperm and ova

as property, and have speculated about the extension of this concept to embryos (42). Judicial

decisions have begun to wrestle with the question as well. For example, in a challenge to the

Illinois IVF law, a court accepted the notion that

an IVF patient is pregnant as of the moment her

egg is fertilized, even though the fertilization is

extracorporeal (71). The implication is that any

decision concerning disposal, particularly destruction, must be made with the woman’s consent,

as is done for any form of pregnancy termination. In such a case, it is unclear whether this privilege is based on notions of control of property.

On the other hand, a couple successfully sued

for $50,000 in damages when their preimplantation embryo was deliberately destroyed after an

IVF treatment was canceled by the clinic (24).

Nevertheless, the trial-level case set no precedent

outside its own district; further, it awarded damages for intentional infliction of emotional distress, rather than for conversion or trespass to

chattel, which are causes of action for interference with the property rights of another (59).

The Louisiana IVF law defines the extracorporeal in vitro fertilized ovum as a “juridical person, ” specifically stating that the gamete donors

have parental rather than property rights with

respect to the embryo. It further states that the

extracorporeal embryo is able to sue and be sued,

implying that actions adversely affecting its viability or its health upon birth are subject to legal

consequences. In many States, persons have the

right to sue for injuries sustained prenatally

(10,44,63), but the Louisiana law goes further,

granting to the embryo the right to sue for injuries, rather than having these rights accrue upon

birth. Granting rights of personhood to an embryo, extracorporeal or in utero, could conflict

with the U.S. Supreme Court ruling in Roe v.

Wade, which stated explicitly that the unborn are

not “persons” within the meaning of the 14th

Amendment’s due process and equal protection

clauses (62). However, the Louisiana law has not

yet been tested in court.

Later Implantation for Same Couple

The physician or institution providing the in

vitro service will be responsible for adequate storage of any frozen embryos being kept for later

use by the same couple. Failure to exercise rea -
254 ● Infertility: Medical and Social Choices

sonable care could leave the service provider open

to liabilities stemming from medical malpractice,

negligence, intentional or negligent infliction of

mental distress, interference with property, or

breach of contract. Such a case could arise, for

example, where a malfunctioning incubator damages stored embryos.

Not every embryo loss would leave the provider

liable; the technology of embryo freezing and

storage is still too undeveloped to offer any guarantee that the embryos will all survive. Yet, failure to operate a storage facility that meets the

average standards of practice of the industry certainly would be strong evidence of negligence (53).

Furthermore, any deliberate destruction of the

embryo, such as took place in the case mentioned

in the preceding section, would almost certainly

leave the provider liable. The Louisiana IVF law

specifically prohibits the physician or institution

from destroying the embryo. It absolves the’ phy -

sician and institution from strict liability for

screening, fertilization, preservation, and transfer of the ovum, but only with respect to actions

brought on behalf of the fertilized ovum. Thus,

strict liability might be applicable in a suit by the

gamete donors. Further, it absolves the physician

and institution from any liability to the embryo

if actions were taken in “good faith,” but fails to

clarify whether a well-intentioned but negligent

action would be covered.

“Strict liability” is a legal doctrine generally applied to either ultrahazardous or unnatural activities with a great propensity for harm regardless

of how carefully undertaken. Under this doctrine,

in order to collect damages a plaintiff need only

show that the defendant’s actions harmed the

plaintiff. It is unnecessary to show that the defendant was negIigent. In essence, the doctrine places

financial responsibility for harm on those who

choose to undertake these activities, regardless

of their efforts to be careful or their good intentions. The activities that might qualify for strict

liability have been the subject of much discussion,

a number of cases, and several efforts by the

American Law Institute’s codifications of case law,

known as “Restatements” of the law. In light of

the high rate of early embryo loss in both natural and in vitro fertilization, it is difficult to predict whether IVF would ever become subject in

any particular State to strict liability principles.

Calculating the damages from the loss of an embryo would be difficult as this is an unsettled area

of law. One calculation could focus on the cost

of obtaining a replacement embryo. Another

could be the calculation of the net value of the

potential child that was lost (35).

Trusts and Estates

Problems regarding trusts and estates are raised

by the prospect of frozen embryos left unimplanted after the death of one or more of the

genetic parents, as occurred in the Australian case

of the Rios embryos (see box 11-A in ch. 11). Controversy developed over whether the embryos

should be discarded, given to another couple to

gestate and raise as theirs, or given to another

to gestate and raise as the orphaned children of

the Rioses. Although the embryos were genetically related only to Mrs. Rios, the intended rearing father (her husband) had consented to the use

of donor sperm, a fact that would have made him

the legal father of the embryos upon birth. This

last scenario could conceivably have made the offspring heir to the considerable Rios fortune, and

explains in part the international attention that

was focused on these frozen embryos (70).

Further, in other areas of trusts and estates Iaw,

the validity of certain legacies is determined by

whether the beneficiaries will be completely identifiable within a certain period of time, This period

of time depends partly on identifying those “lives

in being” at the time the legacy is created (16).

Although clearly frozen extracorporeal sperm are

not lives in being, the same cannot be stated as

categorically for a frozen embryo, although constitutional decisions holding that the unborn are

not “persons” under the 14th Amendment may

prevent States from defining frozen embryos as

“lives in being” (62).

The Louisiana IVF law grants inheritance rights

to the embryo at the time of birth. Further, the

resulting child would inherit from the woman

who gives birth (and her husband, if any), rather

than from the gamete donors. The provision is
Ch. 13—Legal Considerations: Artificial Insemination, IVF, Embryo Transfer, and GIFT ● 255

unclear, however, with respect to a number of father’s will in order to account for this new child.

problems. For example, if the woman giving birth With no time limit specified for inheritance purwere unmarried, it is unclear whether the child poses, such events pose real problems for the orcould inherit from the genetic father if his sperm derly disposition of estates. The ambiguities in the

were used as that of an anonymous sperm donor Louisiana effort to account for inheritance rights

rather than an intended rearing parent. Further, of extracorporeal embryos simply point out some

if the genetic father is deceased but his wife, the of the many complexities of trusts and estates law

genetic mother, gives birth many years later by in this area, a topic beyond the scope of this

bringing to term a previously frozen embryo, it report.

would appear necessary to reopen probate of the

GAMETE INTRAFALLOPIAN TRANSFER

Gamete

fer of ova

intrafallopian transfer involves transand sperm by catheter to the fallopian

tubes, where fertilization may take place (see chs.

7 and 15). As both donor sperm and donor eggs

can be used, GIFT can raise all the same questions

of relative rights and responsibilities among gamete donors and gestators as are raised by IVF.

In one sense, GIFT simplifies the legal issues raised

by noncoital reproductive technologies, because

it eliminates the presence of the extracorporeal

embryo. This avoids the difficulties posed when

embryos are left frozen after the death of the

genetic parents, and also avoids the possibility of

commercial cryobanking of embryos.

EMBRYO TRANSFER

This section considers

child will be raised by a

the situation in which a

gestational mother and

her husband or partner, using an embryo that

was donated. Embryos may be donated in one of

two ways. First, embryos may be donated by couples who have embryos left over from an IVF procedure. In this situation, the gestational mother

will rear a chiId to whom neither she nor her husband are genetically related. The genetic parents

of the embryo are referred to as embryo donors.

Although this can occur with fresh embryos,

problems of synchronizing the recipient’s cycle

make it more likely to occur as cryopreservation

of embryos becomes more common.

Second, a woman may deliberately undertake

to donate an ovum to another. For example, she

may undergo laparoscopy or sonography-guided

egg retrieval so that the recovered eggs can be

fertilized in vitro before being implanted in

another woman’s womb. In this situation, the

gestational mother’s husband usually donates the

sperm to be used for the fertilization, and the

term ovum donor is used to refer to the woman

undergoing egg retrieval.

A variation on this method for donation is for

the ovum donor to become pregnant by artificial

insemination with the intended gestational mother’s

husband’s sperm, in order to have the fertilized

egg washed from her uterus by lavage and then

donated to the gestational mother. Since the

lavage removes an embryo from the uterus before it has implanted, it probably cannot be considered an abortion; use of an intrauterine device

may also induce the removal of a fertilized ovum

before implantation, but is not viewed under the

law as equivalent to an induced abortion. Nevertheless, the precise classification of artificial insemination followed by uterine lavage remains

somewhat ambiguous. Embryo donation by artificial insemination and lavage, or by egg retrieval

and IVF with the intended rearing father’s sperm,

is quite rare and may remain uncommon (see ch.

15).

The situation in which an embryo is carried to

full term by a gestational mother and then

returned to the gamete donors for rearing—ges -

tational surrogate motherhood—is considered in

chapter 14.
256 Infertility: Medical and Social Choices

Existing Legislative Controls

With the exception of Louisiana and Kentucky,

no State has statutes specifically addressing embryo donations of any type. The tendency or practice of some persons to speak of embryo donations as “embryo adoptions” can be misleading

legally, since State adoption laws have always involved transfer of rearing rights and duties in a

live-born infant rather than in an unimplanted

embryo.

Fetal research statutes generally cannot be read

to prevent the donation of embryos created in

vitro or by artificial insemination followed by

lavage. In five States)

3 however, prohibitions on

donating fetuses for research or experimentation

might be interpreted to include embryo donation

for gestation, if the definition of fetus were extended to include embryos and the transfer process were viewed as experimental. In Nebraska and

Wyoming, this same conclusion might be drawn

if, in addition, the embryo resulted from an abortion, arguably true in the case of artificial insemination followed by lavage for the purpose offertilized ovum donation (4).

By contrast, the Louisiana IVF law (which applies only to ova fertilized in vitro rather than by

artificial insemination) specifically preserves the

possibility of donating the embryo, but does not

permit any compensation for the donation. It allows gamete donors to renounce their parental

rights, at which time the embryo can be donated

to another. The drafting of the statute makes it

unclear, however, whether only married couples

may accept the donated embryo. It is also unclear

from the drafting whether the IVF facility can

limit donations to persons meeting criteria it

specifies.

Kentucky Revised Statutes Section 199.590,

which prohibits payment in connection with

adoption, was revised in 1984 to read:

Nothing in this section shall be construed to prohibit in vitro fertilization. For the purposes of this

section, in vitro fertilization means the process

whereby an egg is removed from a woman, then

fertilized in a receptacle by the sperm of the hus3Maine, Massachusetts, Michigan, North Dakota, Rhode Island.

band of the woman in whose womb the fertilized

egg will thereafter be implanted.

Subsequent court dictum in the 1986 Kentucky

case Surrogate Parenting Association interpreted

the section to mean that embryo donation is permitted when the gestational mother and genetic

father are married to one another and intend to

raise the child themselves (74). (“Dictum” is commentary that is not strictly necessary to the decision on the case before the court; it is used by

judges to explain their reasoning and to draw

analogies to other fact situations. Although dictum has no precedential value, it can be persuasive to other courts, and can provide a clue as

to future judicial decisions in related areas of law.)

However, no case has arisen in Kentucky to test

this interpretation or to determine legal maternity in the event of a dispute between a genetic

and a gestational mother.

The Kentucky statute addresses embryo transfer involving an ovum donor who undergoes egg

retrieval so that the ova may be fertilized with

the gestational mother’s husband’s sperm, but it

does not address the question of the more common form of embryo donation, which involves

the transfer of “surplus” embryos from one couple to another. By its terms, the Kentucky statute cannot apply to this situation, as the gestational mother’s husband would not be the genetic

father of the resulting child. However, there is

nothing in existing Kentucky law that prohibits

such transfers either.

No other State statutes address embryo transfer. Nor can the State artificial insemination by

donor laws be easily interpreted to extend to male

and female gametes alike, since they use the term

“sperm” or “semen. ” It is likely that courts would

give legal effect to the agreement between the

parties to an embryo donation if it paralleled

sperm donation—i.e., if an ovum donor has no

rearing rights and duties and the consenting embryo recipient (who will also gestate) and her partner (who will be the genetic father) assume them.

Yet, embryo donation entails greater risk to the

ovum donor than does sperm donation.

The risks of ovum donation depend on a number of factors, including the method by which the

ova are recovered. Laparoscopy involves the risks
Ch. 13—Legal Considerations: Artificial Insemination, IVF, Embryo Transfer, and GIFT . 257

of abdominal surgery, such as infection and anesthesia. Sonography-guided vaginal retrieval also

poses a risk of infection, and both egg recovery

techniques may be used in conjunction with drugs

to stimulate ovulation, thus posing the risk of side

effects. Artificial insemination followed by uterine lavage and embryo retrieval risks unintended

or ectopic pregnancy, as well as the transmission

of infectious disease by the semen used for the

insemination.

These risks may strongly influence the development of paid ovum donation, as professional

societies such as the American Association of Tissue Banks recommend that their members not accept tissues if it entails “undue risk” to the donor.

The difference in risk associated with these forms

of embryo donation as opposed to sperm donation might be used by professional societies and

lawmakers to justify regulation or prohibition of

paid embryo donation, at least when it is undertaken solely to earn money and not in conjunction with a therapeutic or diagnostic procedure

needed by the ovum donor herself.

Some restrictions on commercial embryo donations do exist. Payment for a human embryo

is specifically banned in Louisiana and Florida,

and some of the State fetal research statutes prohibit the sale or transfer of embryos for experimental purposes. Eleven States that prohibit selling fetuses for experimentation use language

potentially broad enough to affect the sale of embryos conceived in vivo (10, I1,12).

Professional Responsibility

Professionals who facilitate embryo transfer

have responsibilities with regard to ensuring that

there is informed consent by all parties to the procedure, that the sperm and ova are properly

screened, and that the resulting embryo is preserved as well as current technology permits.

Ensuring informed consent is difficult when the

risks of a procedure are still poorly understood.

Under these circumstances, physicians are generally required to err on the side of caution and

to present even those risks that seem quite remote (34). Relatively unexplored procedures, such

as artificial insemination followed by lavage, pose

just this dilemma.

There are no State laws on recordkeeping and

confidentiality with respect to embryo donation.

As these donations require a medical procedure,

however, hospital or at least office records are

likely to exist for each donor. Such records are

ordinarily held in confidence, but are subject to

disclosure upon court order or at the request of

the patient herself (39).

No legal constraints on techniques for ovum

screening exist, although professional guidelines

have been issued by the American Fertility Society, in addition to those issued with regard to

sperm donation. Further, there are no statutory

requirements that physicians screen fertilized ova

for morphological indications that they are not

viable, but it is nevertheless a common practice

at IVF clinics. Even so, some clinics transfer embryos that may have little chance of implanting

and coming to term, both because the dearth of

embryo research has made it difficult to predict

with certainty which embryos will implant successfully and because of a desire to avoid the ethical issues raised by the deliberate discard of fertilized eggs (84).

Responsibility for storage of a cryopreserved

embryo will always fall on the institution providing the service. But the party to whom the institution is liable in the event of negligence may

change, depending on who is considered the

“owner” of the frozen embryo and who intends

to raise the resulting child. If an embryo has been

donated to another couple, and this donation is

evidenced by some sort of written or oral agreement, the intended recipients might be viewed

as the “owners, ” at least with respect to control

over decisions concerning disposition of the embryo. This scenario has not yet been tested

court of law.

Embryo Donor's Rights

and Duties to Child

Using the analogy of the sperm donor’s

and duties to his genetic offspring, a couple

in any

rights

donating an embryo to another would presumably have

no rights or duties to the child. As only the donors

are familiar with their own genetic backgrounds,

however, they might have a duty to warn the recipient of potential genetic problems in the off-
258 ● Infertility: Medical and Social Choices

spring, If the resulting child is in fact born with

a genetic problem that could have been identified if the donors had warned the recipient of its

possibility, there might be two causes of action.

First, the recipient might sue to recover the extra costs of raising a child with these problems.

Second, the child might sue the donors. If the

problem would have been correctable, then the

suit would be for the pain and suffering of living

with the disease. If the problem were unavoidable except by abortion, the child might sue for

‘(wrongful life)” alleging that nonexistence would

have been preferable to diseased existence.

Such wrongful life suits have met with limited

success in U.S. courts, but as the number of identifiable genetic disorders increases, they might become more common (19,21)56)63). Usually they

are directed at the physician or genetic counselor

who failed to properly advise the parents of the

condition. In this situation, both the parents and

the gamete donors have a role in identifying the

disorder, and thus may be liable to the potential

child. A suit against the gamete donors is somewhat analogous to a suit against the genetic counselor, as in both cases a duty exists to disclose information that is uniquely held by that person.

When these suits are directed at the child’s rearing parents, it appears at first to be a futile attempt to move funds from the parents’ pockets

to the child’s. In fact, however, the purpose may

simply be to obtain funds from the parents’ insurer. To date, courts and legislatures have not

shown a willingness to countenance such suits

against a child’s parents (30)67)68). Should this reaction change, however, insurance coverage for

such liabilities may be an important factor in the

growth of these particular lawsuits. Another key

factor would be the development of recordkeeping practices that allow identification of the embryo donors; if they are kept anonymous, then

the child and the child’s rearing parents would

be unable to bring suit. Such anonymity has been

a factor in restricting analogous suits against

sperm donors.

Requirements for Consent of

Ovum Donor% Husband

A husband may have an interest in his wife’s

decision to be artificially inseminated for subsequent lavage and recovery, There is, however, no

common law or statutory duty for a physician to

obtain the consent of an ovum donor’s husband.

Using the analogy of sperm donation, if the ovum

donor has no legal rights or responsibilities to the

child, it is unlikely that a consent requirement will

be developed. There is a key distinction, however,

between being an ovum donor and being a sperm

donor that might affect consent requirements: the

former may inadvertently become pregnant. If

she does, and if she chooses to sustain the pregnancy, then her husband could become legally

responsible for the child.

Embryo Recipient's Rights and

Duties to Child

As the embryo recipient is the intended rearing parent, her responsibilities will probably be

identical to those of any mother. Her rights, however, are less clear. As a “gestational mother,” she

is not clearly recognized in law as the sole woman

with claim to be recognized as the “legal” mother.

Analogies to date have been limited to questions

surrounding fatherhood, in which genetic relationship is generally determinative of parentage

(37).

One major exception, however, is the presumption of paternity, which is designed both to protect the needs of the child to have two parents

and to preserve the institution of marriage. Similar policies might come to be used to justify a

State policy favoring a gestational mother or an

intended rearing parent’s primacy in any conflict

with the genetic mother over custody to the child.

In the only two court cases to date, however, prebirth uncontested petitions to have the genetic

mothers (rather than gestational mothers) recognized as the legal mothers of the children were

granted, subject to postbirth confirmation (72)73).

The cases, however, were from lower courts, and

so have limited precedential value even within the

States in which the courts were sitting. A ruling

on a similar case in Virginia is expected in early

1988 (27).

It should be noted, too, that embryo donation

will be made by a woman who has undergone

an IVF procedure and who has had several embryos left over after the procedure. In other

words, the embryo results from an invasive sur-
Ch. 13–Legal Considerations: Artificial Insemination, IVF, Embryo Transfer, and GIFT . 259

gical laparoscopy done on a woman who herself

was having trouble conceiving. If such a woman

subsequently finds that she is unable to have a

child, perhaps because she is unable to carry to

term, there may be an emotional demand for custody of any child that resulted from one of the

embryos, regardless of the gestational mother’s

own attachment after pregnancy. There is no

tested law at all on this subject, and as yet no

established principles to predict the outcome in

the event of such a controversy.

when a woman seeks an embryo transfer from

an ovum donor, despite the analogy to artificial

insemination. Physicians can be expected to individually require such consent if they know that

the woman is married, just as many have in the

context of artificial insemination. Absent legal constraints, however, such consent is not required.

Nevertheless, the presumption of paternity will

probably render the husband the legal father of

the child, even if his sperm were not used to inseminate the ovum donor nor his consent obtained.

With regard to the embryo recipient’s husband,

no statutory requirement for his consent exists

RESTRICTING OR REGULATING THE SALE

OF GAMETES OR EMBRYOS

Most States do not prohibit the sale of blood,

plasma, semen, or other replenishing tissues if

taken in nonvital amounts (55,79), although the

prohibitions on organ sales in three States are conceivably broad enough to cover semen sales as

well (12). Florida, however, outlaws the sale of

human embryos: “No person shall knowingly advertise or offer to purchase or sell, or purchase,

sell or otherwise transfer, any human embryo for

valuable consideration” [Fla. Stat. Ann. Sec.

873.05(1)]. Similarly, Louisiana’s IVF law prohibits

paid transfers of fertilized ova.

State laws usually characterize these paid transfers as provision of services rather than sale of

commodities, either in the State’s version of the

Uniform Anatomical Gift Act or in their version

of the Uniform Commercial Code (UCC), which

governs various commercial transactions, including contracts for the sale of goods. The primary

reason for this characterization is to avoid liability for defective products under either general

product liability principles or the UCC’S implied

warranty provisions (18,22,36). In addition, services are not subject to the UCC’S specific performance provisions.

Product liability is the name given to the area

of law involving the liability of suppliers of goods

or products for the use of others, and their responsibility for various kinds of losses resulting

from defects in those products. Four possible theories of recovery are available under product liability law:

●

●

●

●

strict liability in contract for breach of an express or implied warranty,

strict liability in tort largely for physical harm

to persons and tangible things,

negligence liability in contract for breach of

an express or implied warranty that the product was designed and constructed in a workmanlike manner, and

negligence liability in tort largely for physical harm to persons and tangible things (59).

Generally, negligence liability may exist with respect to both products and services, but strict liability is applicable only to products, Thus, characterization of blood and semen sales as services

enables blood and semen banks to avoid liability

if a specimen is contaminated or infected, provided that the bank was not negligent (46).

If sales of gametes and embryos were to be

treated as those of goods as opposed to services,

then UCC warranties would apply. The UCC provides that commodity contracts (but not service

ones) are subject to:

● the implied warranty of merchantability,

which requires goods to be of “fair average

quality” within the description provided by

the seller and fit for the ordinary purposes

for which such goods are used (UCC Sec. 2-

314), and
● the implied warranty of fitness, which requires goods to be suitable for the buyer’s

particular purpose to the extent this purpose

is known by the seller (UCC Sec. 2-315).

The merchantability warranty only applies to

sales by “merchants,” defined by the UCC as those

who regularly supply the product (e.g., hospitals,

tissue banks), but not by occasional sellers [UCC

Sec. 2-104(1)]. The fitness warranty applies equally

to regular dealers and occasional sellers (UCC Sec.

2-315).

If these transactions were treated as sales of

commodities, these implied warranties could result in substantial liability for injuries resulting

from transfusion or insemination with a specimen

capable of transmitting hepatitis, AIDS, or another

contagious disease. Insemination with sperm containing a genetic defect could also result in substantial liability. Since the suit would be based on

strict liability for breach of warranty rather than

negligence principles, careful examination of

specimens for contamination or a genetic flaw

would not entitle the providing entity to avoid liability if an injury occurred.

If exchanges involving human gametes and embryos are treated like those involving blood–i.e.,

if such exchanges are considered to be transactions for services rather than commodities—

then certain types of liability may similarly be

avoided by tissue and cell banks, research institutions, hospitals, and companies. Although liability would continue to exist for negligence (e.g.,

failing to use an available and appropriate test to

screen suppliers for viral infections), there would

be no liability for imperfect specimens in the absence of negligence. Avoiding the concept of an

imperfect specimen with respect to embryos

might also help avoid some of the ethical questions raised by treating embryos as traditional

articles of commerce.

The Federal Government has the authority to

enter this area to regulate gamete and embryo

sales by virtue of the interstate commerce clause

(see ch. 9). The ultimate regulation of interstate

commerce might be to ban the sale of an article

altogether. Of course, the Food and Drug Administration does this implicitly for all drugs and medical devices that have not been proven safe and

effective. But Congress has also indicated its willingness to ban the purchase and sale of human

body parts, and could certainly ban the interstate

sale of human embryos, as well as sperm and ova.

In 1984, for example, Congress passed the National Organ Transplant Act. Although most of

the act is aimed at promoting organ transplantation in the United States, Title III is directed exclusively toward prohibiting organ purchases:

It shall be unlawful for any person to knowingly

acquire, receive, or otherwise transfer any human organ for valuable consideration for use in

human transplantation if the transfer affects interstate commerce. For the purposes of this act,

“human organ” is defined to mean “the human

kidney, liver, heart, lung, pancreas, bone marrow,

cornea, eye, bone, and skin. . . .“ Violation carries

a five year maximum prison sentence, and a

$50,000 fine [Public Law 98-507 (1984)1.

Thus, the statute bans the profitable sale of

organs, although not the recompense of expenses

incurred by the donor. The statute’s organ sale

prohibition was based primarily on congressional

concern that permitting the sale of human organs

might undermine the Nation’s system of voluntary organ donation (77). It was also driven by

concern that the poor would sell their organs to

the rich, to the detriment both of poor people

who might feel economically coerced to become

organ suppliers and those who need but cannot

afford transplantable organs. It may also reflect

congressional distaste for sales of human body

parts generally.

These considerations may or may not apply to

the sale of gametes and embryos (29). Semen sales,

in particular, involve no physical risk to the donor

and have long been tolerated in the United States.

Ova sales involve risk to the donor, as she may

well be prescribed drugs to induce superovulation, undergo laparoscopy for retrieval of the

eggs, or be impregnated by artificial insemination

and risk ectopic pregnancy from the lavage technique used to recover the fertilized ovum. Embryo sales may involve the risks of ovum donation, and also raise ethical considerations not

present in the sale of gametes (see ch. 11).
Ch. 13—Legal Considerations: Artificial Insemination, IVF, Embryo Transfer, and GIFT . 261

MODELS OF

The approaches taken by State legislatures to

the oversight or regulation of noncoital reproduction may be broadly grouped into five categories:

static, private ordering, inducement, regulatory,

and punitive (25,82). These models are of interest both because they reflect the variation in proposed State legislation and because they serve as

an informative guide to Congress, should it choose

to consider legislation in this field. Further, constitutional challenges to these State laws could illuminate the boundaries of the right to procreate.

The static approach, one of State legislative inaction, leaves the resolution of familial relationships to case-by-case consideration by the courts.

For example, in the District of Columbia and the

20 States without legislation on the topic of artificial insemination, challenges to the legitimacy

or legal status of the resulting child could be

brought, and judicial determinations would be

made based on the effect of any general State

legislative presumptions of paternity, the best interests of the child, the understanding of the parties to the insemination, the existence (if any) of

an underlying contractual agreement, and other

pertinent facts. This nonlegislative approach can

be indicative of a lack of consensus among State

legislators, or a temporary absence of legislative

leadership while courts are given an opportunity

to consider several test cases. Alternatively, it

could be an expression of hostility to an activity

altogether. By failing to provide legislative guides

to resolving possible disputes, the legislature can

effectively decrease the frequency of the activity within the State by making it a more legally

risky venture for the participants.

Private ordering approaches allow the State to

validate private arrangements by recognizing

underlying agreements or contracts to allocate

familial roles to those who participate in artificial insemination by donor or the transfer of embryos for IVF, Artificial insemination statutes that

identify the recipient’s husband as the legal father

of her child only if he consented to the insemination follow this model. others allow participants to specify that a sperm donor may have a

continuing parental role for the child. LegitimizSTATE POLICY

ing these choices by State statute and enforcing

them by judicial action places the State in the role

of facilitating individual choices of all sorts.

By contrast, inducement approaches only validate the parties’ underlying intentions or agreements if their actions meet certain legislative conditions. For example, many of the State artificial

insemination statutes contemplate only those inseminations done by a physician. The physician

requirement can be premised on a number of policies, such as ensuring the physical and genetic

health of both sperm donor and recipient, maintaining artificial insemination as a form of medical practice despite the ability of laypersons to

perform the procedure, encouraging the use of

anonymous donation only, or facilitating the role

of physician as a gatekeeper who screens out socially unacceptable recipients and donors. Such

a law can encourage conformity to State-sanctioned procedures by denying nonconforming

artificial insemination participants the advantage

of certain legitimation of the resulting child under State paternity law, or by denying a recipient the advantage of knowing that the sperm

donor is unable to reenter her life with a request

to be acknowledged as the father of her child.

The case of Jhordan C. (43) in California exemplifies the results of the inducement approach,

as the lack of physician-supervised insemination

allowed the court to fashion a unique distribution of parental rights and responsibilities that

precisely followed neither the parties’ original intentions nor those set forth under the California

artificial insemination by donor statute.

A prominent example of a regulatory approach

is the Louisiana IVF law, which specifies that IVF

be done in accordance with the standards of practice suggested by prominent medical professional

societies. This translates into legalization of clinics

staffed and equipped to the levels identified as

desirable by groups such as the American Fertility Society or American College of obstetricians

and Gynecologists, and implicitly makes illegal

those clinics that fail to meet these guidelines. Further, the Louisiana law attempts to specify a variety of rights held by an embryo in vitro and
262 ● Infertility: Medical and Social Choices

responsibilities or limits on discretion for the phy - a technique entirely. The Louisiana and Florida

sicians and gamete donors involved. The permis- bans on the sale of embryos exemplify this apsible limits of such State regulation may be sub- preach. These bans have not yet been challenged,

ject to constitutional challenge, as would any State and so an explicit determination of their constitueffort to take a punitive approach by outlawing tionality has not yet been made.

SUMMARY AND CONCLUSIONS

The use of noncoital reproductive technologies

raises questions concerning the relative rights and

responsibilities of gamete donors and rearing parents. In many cases, these questions are so new

that there is little or no guidance as to how the

law will be applied. Legal literature and analogies

drawn from other areas of law are available in

the meantime, to guide participants and courts

in their analyses of the rights and duties created

by these techniques.

With several configurations of parents available,

it is probably not practical to draw an inflexible

rule generically stating that all gamete donors are

the legal parents of their progeny, or that all

intended rearing parents have sole rights and responsibilities to their children. Case-by-case consideration of the parties’ intentions, however,

would probably yield a collection of rules. To date,

the courts have not been presented with the full

range of these situations, and thus have been

restrained by the Constitution from making proCHAPTER 13

1. American Association of Tissue Banks, Standards

for Tissue Banking (Rockville, MD: 1984).

2. American College of Obstetricians and Gynecologists, Newsletter (Practice Perspectives) (Washington, DC: May 1987).

3. American Fertility Society, Report of the Ad Hoc

Comm”ttee on ArUfi”cia] Insemination (Birmingham,

AL: 1980).

4. American Fertility Society, Ethics Committee, “Ethical Considerations of the New Reproductive Technologies,” Fertility and Sterility 46:1 S-94S, 1986.

5. American Fertility Society, “New Guidelines for the

Use of Semen Donor Insemination,” Fertility and

Sterility 46:95 S-104S, 1986.

6. American Society of Law and Medicine, National

Symposium on Genetics and the Law 11 (Boston,

MA: 1979).

nouncements on all possible parental configurations.

Legislation, which is prospective rather than

retrospective in nature, could be drafted to clarify

these relationships and to safeguard the interests

of the children born as a result. Legislation, too,

could fill in the gaps concerning the status of children born to single women using artificial insemination, the control over the disposition of ex -

tracorporeal embryos, and the maintenance of

records documenting the genetic parentage of

children born by these techniques.

Absent legislative directives, courts will continue to decide cases that come before them, and

to develop rules that help make the legal implications of these parental relationships more predictable. But as the courts in the District of Columbia and each of the 50 States are free to come

to their own conclusions concerning these rules,

there may long be significant State-to-State variations in the law.

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the Law 111 (New York, NY: Plenum Press, 1985).

53. Murphy, A. W., Santagata, K, V., and Grad, F. P., The

Law of Product Liabilit-y: Problems and Policies,

Prepared by the Legislative Drafting Research Fund
264 “ Infertility: Medical and Social Choices

54,

55.

56.

57.

58.

59,

60.

61.

62.

63.

64.

65.

66.

67.

68.

69.

of Columbia University (New York, NY) for the National Chamber Foundation (Washington, DC: National Chamber Foundation, 1982).

National Conference of Commissioners on Uniform

State Laws, Uniform Commercial Code (“UCC”)

(Official Text) (Philadelphia, PA: American Law Institute, 1978).

Note, “The Sale of Human Body Parts, ” Michigan

Law Review 72:1182, 1974.

Note, “Preference for Nonexistence: Wrongful Life

and a Proposed Tort for Genetic Malpractice, ”

Southern California Law Review 55:477, 1982.

People v. Sorenson, 668 Cal. 2d 280, 437P. 2d 495,

66 Cal. Rptr. 7 (1968).

Petersen, E. P., Alexander, N.J., and Moghissi, K. S.,

“A. I,D. and AIDS—Too Close for Comfort,” Fertility and Sterility 49:209-210, 1988.

Presser, W., and Keeton, W., The Law of Torts,

5th ed. (St. Paul, MN: West Publishing, 1984).

Reimer, R., Legal Right of an Adopted Child to

Learn the Identity of His or Her Birth Parents

(Washington, DC: U.S. Congress, Congressional Research Service, American Law Division, Nov. 30,

1984).

Reimer, R., Adopters’ Right to Receive Medical Information on Their Birth Parents (Washington, DC:

U.S. Congress, Congressional Research Service,

American Law Division, Dec. 24, 1984).

Roe v. Wade, 410 U.S. 113 (1973).

Rogers D.T. III, “Wrongful Life and Wrongful Birth:

Medical Malpractice in Genetic Counseling and

Prenatal Testing, ” South Carolina Law Review

33:713, 1982.

Rothman, C. M., Director, Souther California Cryobank, personal communication, Dec. 21, 1986.

Shaman, J. M., “Legal Aspects of Artificial Insemination,” Journal of Famif’y Law 18:331, 1980.

Shapiro, S. S., Director, Gynecology and Endocrinology Clinic, University of Wisconsin Health Sciences Center, personal communication, Nov. 27,

1987.

Shaw, M. W., “The Potential Plaintiff: Preconception and Prenatal Torts,” Genetics and the Law 11,

G.J. Annas and A. Milunsky (eds.) (New York NY:

Plenum Press, 1980).

Shaw, M.W., “Conditional Prospective Rights of the

Fetus,” Journal of Legal Medicine 5:63, 1984.

Sims, C., Director, Souther California Cryobank,

personal communication, Nov. 8, 1987.

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72,

73,

74.

75.

76.

77.

78.

79.

80.

81.

82.

83.

84.

85.

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Smith & Smith v. Jones & Jones, 85-532014 DZ,

Detroit MI, 3d Dist. (Mar. 15, 1986), as reported

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al. (eds.) (Frederick, MD: University Publishers of

America, 1986).

Surrogate Parenting Association v. Commonwealth

of Kentucky ex. rel. Armstrong, 704 S.W. 2d 209

(1986).

Thies, W .P., “A Look to the Future: Property Rights

and the Posthumously Conceived Child,” Trust and

Estates 110:922, 1971.

Tribe, L., American Constitution Law (Mineola, NY:

Foundation Press, 1978).

U.S. Congress, Committee on Energy and

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(Washington DC: U.S. Governrnent Printing Office,

1984).

U.S. Congress, Office of Technology Assessment,

Reproductive Health Hazards in the Workplace,

OTA-BA-266 (Washington, DC: U.S. Government

Printing Office, 1985).

U.S. Congress, Office of Technology Assessment,

New Developments in Biotechnology: Ownership

of Human Tissues and Cells, OTA-BA-337 (Washington, DC: U.S. Government Printing Office, 1987).

U.S. Congress, Office of Technology Assessment,

“Artificial Insemination: Medical and Social Issues, ”

forthcoming.

Vegas v. Genetic Reserves Corp., as reported by

Associated Press, Mar. 23, 1987.

Wadlington, W., “Artificial Conception: The Challenge for Family Law,” Virginia Law Review 69:

465, 1983.

Weixel, J., Food and Drug Administration, personal

communication, Nov. 10, 1987.

Winslow, R. C., “Reproductive Technologies: State

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WwVcko v. Gnodtke, 361 Mich. 331, 105 N.W. 2d 118

(1960).
Chapter 14

Legal Considerations:

Surrogate Motherhood
CONTENTS

Finding and Choosing A Surrogate Mother

Who Hires A Surrogate Mother?. . . . . . .

.,

. .

Commercial Surrogate Matching Services .

Physicians. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Attorneys . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Who Becomes A Surrogate Mother?. . . . . .

Requiring Consent From the Husband of the

Recordkeeping and Confidentiality . . . . . . . . .

Typical Contract Provisions. . . . . . . . . . . . . . .

Fees . . . . . . . . . . . . . . . . . . . . . . . . . .

Limitations on Behavior During Pregnancy

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

. . . . . . . . .

Surrogate

. . . . . . . . .

. . . . . . . . .

.. . . . .

. . . . . . . . .

Limitations on Control Over Medical Decisions. . . . . .

Choice~of-Law Provisions . . . . . . . . . . . . . . . . . . . . . . . .

The Surrogate Mother’s Rights to the Child . . . . . . . .

Adoption. . . . . . . . . . . . . . . . . . . . . . .

The Surrogate Gestational Mother . . .

Models of State Policy . . . . . . . . . . . . .

The Static Approach . . . . . . . . . . . . .

The Private Ordering Approach . . .

The Inducement Approach . . . . . . .

The Regulatory Approach . . . . . . . .

The Punitive Approach. . . . . . . . . . .

Summary and Conclusions . . . . . . . . .

References. . . . . . . . . . . . .

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.,$... . . . . . . . . .

. . . . . . . . . . . . . . .

...,, . . . . . . . . . .

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,... . . .

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. . . . . . .

Mother

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!,,.. . .

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. . . . . . .

. . . . . . .

. . . . . . .

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.,,.. . .

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Boxes

Page

. . . . . . . . . . . . . . 269

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. . . . . . . . . . . . . . 271

. . . . . . . . . . . . . . 272

. . . . . . . . . . . . . . 273

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. . . . . . . . . . . . . . 277

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. . . . . . . . . . . . . . 288

Box No. Page

14-A. The Case of Baby M. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .,268

14-B, The OTA 1987 Survey of Surrogate Mother Matching Services . .........269

Tables

Table No. Page

14-1. Demographic Surveys of Surrogate Mothers . . . . . . . . . . . . . . . . . . . . . ..., .274

14-2. State Adoption Laws . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ....281
Chapter 14

Legal Considerations:

Surrogate Motherhood

Surrogate motherhood is more a reproductive

arrangement than a reproductive technology, It

may require neither physician nor complicated

equipment. It does require more complicated personal arrangements than are usual for bringing

a baby into the world. Most often, it is used by

a married couple in which the wife is either unable to conceive or unable to carry a pregnancy

to term. It has also been used by at least one single man wishing to form a family.

By the beginning of 1988, almost 600 babies had

been born through surrogate motherhood arrangements. For many who use the arrangement,

it is an alternative to adoption, which can take

years to complete and maybe unavailable to those

not meeting traditional criteria for an adopting

home. For others, it is the only way to have a child

genetically related to the rearing father. For these

people, adoption is not an acceptable alternative.

Most commonly, “surrogate mothers” are women

who are impregnated by artificial insemination

with the sperm of a man who intends to raise the

baby, He is generally married, with an infertile

wife. of course, donor sperm could be used if the

man were also infertile. This, however, may

change the legal consequences of the contract arrangements, as the intended rearing father would

not have the legal status generally enjoyed by biological fathers.

Surrogacy can also be used with embryo transfer. In this case, a “surrogate gestational mother”

is impregnated with an embryo created in vitro.

Usually the embryo is formed with the sperm and

egg of the intended rearing parents, but donor

sperm and egg can be used instead. once again,

the use of donated gametes may have legal consequences.

Commercial surrogacy arrangements generally

provide that a woman will be paid for the time

and effort it takes to conceive and carry the pregnancy to term, with the bulk of the payment coming at the time she relinquishes the child and her

parental rights to the intended rearing father. Surrogate motherhood is viewed by some as unacceptable, as a form of baby-selling; others see it

a viable alternative for couples who would otherwise wait years for an adoptable baby and for

those who want a child genetically related to the

rearing father.

Despite a considerable amount of earlier publicity, it was the controversy over Baby M (see box

14-A) that thrust surrogate motherhood squarely

into the national consciousness. Although the case

Media coverage of Baby M Case.

SOURCE: Newsweek.

267
.

268 ● Infertility: Medical and Social Choices

exemplified some of the difficulties associated with

this particular reproductive arrangement, most

surrogate matching services reported to OTA that

inquiries increased after surrogate mother Mary

B OX 14-A. —The Case of Baby M

William and Elizabeth Stern were a couple with

no children. Mary Beth Whitehead responded to

an advertisement by the Infertility Center of New

York, was quickly approved, and became pregnant by artificial insemination with William

Stern’s semen. She was to earn $10,000 on the

day she delivered a baby to the Sterns. If she miscarried, she would have earned a nominal fee.

Immediately after the birth of the baby girl,

Mrs. Whitehead became distraught at the thought

of giving her up. She convinced the Sterns to let

her have the baby for a few days, and then fled

to Florida, where she remained despite a court

order directing her to deliver the baby into the

custody of Mr. Stern. The baby lived with Mrs.

Whitehead for 4 months, until Mr. Stern regained

temporary custody of the child. Baby M then

lived with the Sterns for 8 months while a trial

went on in Hackensack, NJ, to determine whether

the surrogacy contract signed by the Whiteheads

and the Sterns was enforceable.

On March 31, 1987, the judge issued a 120-page

ruling in which he awarded permanent custody

to Mr. Stern (30). Further, he permanently cancelled Mrs. Whitehead’s visitation privileges, terminated her parental rights, and processed Mrs.

Stern’s petition for adoption. The court based its

ruling both on the enforceability of the underlying surrogacy contract, and upon a finding that

it was in the best interests of the child to live

with the Sterns.

On February 3, 1988, the New Jersey Supreme

Court reversed the trial court, finding that the

surrogacy contract violated New Jersey law concerning baby-selling, adoption, and termination

of parental rights (3o). The court voided Mrs.

Stern’s adoption proceeding, and reinstated Mrs.

Whitehead’s status as legal mother of the child,

but upheld the trial court’s order based on the

best interests of the child) to award custody to

the Sterns, with visitation provisions to be worked

out by the families and the trial courts.

}OIINX:: office of “1’echndogy Assessment, 1988.

Beth Whitehead refused to give up her parental

rights in favor of those of Elizabeth Stern, wife

of the baby’s genetic father, even inquiries to the

agency directly involved in the Baby M case (38).

At the same time, more custody suits have been

initiated by women wishing to retain custody of

the children they bore pursuant to surrogate contracts (54,69).

Although there have been a number of lawsuits

concerning custody or challenging adoption laws

that appear to prohibit payments to surrogates,

the majority of surrogacy arrangements proceed

without judicial involvement, with few reported

instances of parties reneging on their agreements.

Preliminary psychological and demographic studies

and as well as surrogate matching service reports

to OTA demonstrate that women who have volunteered to be surrogates are distinctly less well educated and less well off than those who hire them,

but their self-reported motivations for offering

to be surrogates include noncommercial considerations (26,43)51,52)57)65). It should be noted, however, that absent financial remuneration, few say

that they would offer to participate as surrogates

(51,52).

This chapter reviews the legal issues raised by

surrogate motherhood, and summarizes the legislative approaches proposed to date, It also reports

on the findings of OTA’s survey of surrogate

matching services in the United States (see box

14-B). The chapter focuses largely on the situation in which a woman agrees to be artificially

inseminated and to relinquish the child at birth

to the genetic father. Instances have already arisen,

however, in which women have been asked to

carry to term fetuses to whom they are genetically unrelated, by implantation of an embryo conceived by artificial insemination followed by

lavage, or by in vitro fertilization (IVF). The parental configurations arising from such arrangements

can be quite complicated. For example, a 48-yearold grandmother in South Africa carried to term

three embryos created in vitro with the eggs of

her daughter and the sperm of her son-in-law (7).

The special legal issues associated with this type

of surrogacy are considered separately near the

end of this chapter. Embryo donation to a gestational mother who intends to raise the child she

bears is discussed in chapter 13.
Ch. 14—Legal Considerations: Surrogate Motherhood c 269

Box 14-B—The OTA 1987 Survey of Surrogate Mother Matching Services

As part of this assessment, OTA surveyed surrogate mothering matching services around the country.

Names and addresses were obtained from one 1985 publication (3), from Associated Press wire service

reports, and from word-of-mouth. Of 27 services contacted, 5 were no longer in business, 5 had moved with

no forwarding address, 4 failed to respond, and 13 returned completed questionnaires.

The questionnaire asked for information on agency demographics (time in operation, personnel, extent

and nature of matching services); physical, medical, psychological, and social criteria for screening clients

and surrogates; typical contract terms, including fees; demographics of the client and surrogate populations (age, race, religion, economic and educational attainments, marital status, and sexual orientation);

and opinions held by the directors on the subject of potential State and Federal regulation of surrogate

motherhood. Each service was contacted at least three times by mail and once by telephone in an effort

to obtain a response.

Because it is difficult to identify all the services, physicians, and lawyers who occasionally make a match,

the results of the survey are not presented as projections to the entire population of surrogates, clients,

or matching services. Further, one of the nonrespondents reputedly has the largest practice in the United

States, although his own publications and interviews (37,39) reflect a practice that is substantially identical

to most of those responding in this survey.

S()[IRCE Office of Technology’ Assessment, 1988

FINDING AND CHOOSING

Who Hires A Surrogate Mother?

Surrogate mothers can be sought privately by

asking friends or by placing an advertisement in

a newspaper. In addition, a number of organizations have sprung up that attempt to provide surrogate matching services. These groups reported

to OTA that the overwhelming majority of their

clients are in their late thirties or early forties.

While all services reported that at least 90 percent of their clients are married couples, there

are five reports of unmarried couples and nine

reports of single men who were accepted by an

agency to hire a surrogate mother. The number

of homosexual individuals or couples who seek

to hire a surrogate mother is consistently reported

as no more than I percent, but three agencies have

sought surrogates for a homosexual male couple,

and one for a homosexual female couple. Several

agencies also stated that they would provide service to singles or homosexual couples should they

be asked. One agency found a surrogate mother

for a single man who also sought to select sperm

(see ch. 15) to increase the chances of having a

boy (39).

A SURROGATE MOTHER

Clients are drawn from a wide range of religious affiliations, with approximately 25 percent

Catholic, a similar proportion Jewish, and approximately 42 percent Protestant. More than 95 percent are reported as white couples, and on average the agencies reported that about 25 percent

of the couples are already raising a child.

Agencies uniformly reported that clients must

be in good health and economic circumstances

to hire a surrogate; two-thirds offer or suggest

psychological counseling but do not require home

review. The sperm donors are required by at least

half the agencies to undergo a physical examination and two-thirds require testing for sexually

transmitted diseases. This latter practice may

change in the future if there is continued Federal

interest in the risks associated with artificial insemination (see ch. 9).

Those seeking to hire a surrogate mother are

generally well off and well educated. Overall, agencies reported that approximately 64 percent of

their clients have a household income over $50,000,

with an additional 28 percent earning $30,000 to

$50,000 per year. One-third of the services re-
270 . Infertility: Medical and Social Choices

ported that at least half of their clients have been

to graduate school, and another third reported

that at least 80 percent of their clients have been

to graduate school. Overall, the services reported

that at least 37 percent of their clients are collegeeducated, and another 54 percent have attended

graduate school.

Commercial Surrogate Matching

Services

Some surrogate matching services are staffed

by multidisciplinary teams of medical doctors, psychiatrists, lawyers, and administrators; others are

primarily law firms with connections to other

professionals should their clients wish a referral.

Most services surveyed by OTA had been in business more than 3 years, but a number of those

listed in a 1985 publication (3) were no longer active by 1987. With one exception, their volume

of business was quite small, but as of late 1987

these agencies were making at least 100 matches

a year, and over time their matches had been responsible for the births of almost 600 babies.

Brokers who enter the business of recruiting

and matching surrogates to intended parents are

in a novel industry. Nevertheless, in general, any

commercial service is held to a standard of careful practice at least akin to general industrywide

practice. Commercial brokers may well be held

to “expert)” high standards of care, and may share

responsibility with physicians and attorneys for

failing to adequately inform, screen, and counsel

participants. Brokers who are themselves physicians or lawyers will also be subject to ethical and

regulatory standards of conduct set by their

respective professions and by State law.

At least four centers have been involved in lawsuits arising from arrangements that went awry—

e.g., for failure to provide adequate medical information, failure to have a signed contract prior

to insemination, approval despite a history of heart

disease, and use of fertility drugs to induce ovulation in a woman who was still nursing her son

(24). Another lawsuit concerned a baby born with

severe health problems and unwanted by either

the sperm donor or the surrogate mother he had

hired. In a Washington State case, an already pregnant woman was screened and accepted for a surrogate program, leading to charges of theft and

fraud when she failed to give back the money she’d

been paid (8). The outcome of such lawsuits will

help clarify the standard of practice that will be

demanded of surrogate matching services.

Screening of surrogates varies somewhat among

the matching services. All require that the surrogate be in good health (verified by a physical

examination), and all but one require that the surrogate be in a stable relationship and have had

a prior conception. Half require that she be economically self-supporting, often explicitly excluding those on welfare. Agencies generally accept

only women between the ages of 21 and 35 to

be surrogates, but at least two accept women at

age 20, and at least one at age 18. Over half require some sort of psychological screening or

counseling, but the extent of that counseling is

not clear from the OTA survey results.

Commercial brokers may also find that they are

subject to existing State licensing laws. Several

States require that persons or agencies arranging adoptions be licensed. Such a requirement

could apply to the intermediaries who recruit surrogates for interested parties, who negotiate and

write the contracts, and who then handle the postbirth adoption proceedings. In these States, refusal to license such brokers could have a sub-
Ch. 14—Legal Considerations: Surrogate Motherhood ● 271

stantial impact on the availability of surrogate

services.

Two States appear to require such licensing, at

least in order to charge a fee for the matching

service. In an unchallenged advisory opinion, the

Ohio attorney general stated:

The Department of Welfare may reasonably

conclude that a person or organization not licensed by the Department as a child placing

agency . . . is prohibited . . . from engaging in any

of the following activities: (I) the solicitation of

women to become artificially inseminated . . . for

the purpose of the women bearing children and

surrendering possession of the children and all

parental rights to such men and their spouses (49).

The attorney general of Louisiana stated that

‘([only] if the go-between is a nonprofit agency

properly licensed [is] there . . . no jeopardy in accepting [the state] authorized [adoption] fees” (44).

These fees are set by the State, and Louisiana adoption law prohibits any further payments, except

for the actual medical and associated expenses

of the mother during her pregnancy.

On the other hand, at least one State has explicitly recognized the right of a nonlicensed corporation to act as a surrogate matching service.

The Supreme Court of Kentucky has held that

preconception agreements to relinquish a child

for money do not violate Kentucky law, and therefore declined the Kentucky attorney general’s request to revoke the charter of Surrogate Parenting Associates, a matching service in Louisville.

(64). Similarly, a New York court held that an attorney who facilitated an adoption proceeding

pursuant to a surrogate motherhood arrangement

was entitled to receive $3,500 for his services (29).

If commercial brokers are subject to adoption

agency licensing, licensure may also determine

whether an agency can advertise for clients. For

example, Alabama, Georgia, Nevada, New York,

North Carolina, and Oklahoma permit only licensed “child-placing agencies” to advertise. Only

Kansas has addressed this question with respect

to surrogacy: In 1984, its State adoption code was

amended so that restrictions on advertising did

not apply to surrogacy arrangements. However,

no accompanying legislation addressed the legality of paid surrogacy or the enforceability of surrogacy contracts (Kansas Statutes Annotated Sec.

65-509) (50).

At this time no explicit restrictions have been

placed on the techniques used by matching services to seek surrogate mothers, and OTA identified at least 10 centers that do use advertising or

direct mail solicitation to find potential surrogates.

one service has run advertisements in a student

newspaper whose readership is largely between

the ages of 16 and 23 (10). Advertisements suggesting that girls under the age of 21 might deliberately become pregnant in order to earn a fee

may be a cause for concern.

Physicians

Physicians are often involved in surrogacy arrangements when they are called upon to screen

surrogates or intended rearing parents for their

physical and mental health. They are also usually

responsible for performing the artificial insemination. To the extent that they are participants

in a surrogate matching service, they may incur

obligations to their partners and clients beyond

those normally associated with a patient-physician

relationship.

Physicians have a professional responsibility to

examine patients thoroughly and to explain the

consequences of any medical procedure. Such a

requirement falls within the guidelines of professional societies, State laws, and medical malpractice case law (see ch. 9). For surrogate mothers,

this would include information on the risks of insemination, pregnancy, and childbirth. It might

also include a duty to screen the genetic father

for infectious diseases that might be transmitted

by his semen during artificial insemination. To

the extent that physicians work within a brokering agency, they may also owe a duty to the inAdvertisements for surrogate mothers.

SOURCES: San Francisco Chronicle; University of Wisconsin Badger Herald
272 ● Infertility: Medical and Social Choices

tended rearing parents, depending upon the nature of the commercial arrangement.

The extent of such medical responsibilities may

be greater than some physicians might imagine.

For example, an intrafamilial surrogacy arrangement in 1987 ended in calamity when physicians

screened the sperm donor for human immuno -

deficiency virus, but not his sister-in-law, the surrogate mother. Neither the sperm donor nor his

wife suspected that the wife’s sister had been an

intravenous drug user nearly 5 years beforehand,

and the physicians’ medical history failed to elicit

this fact. Five months into the pregnancy, the surrogate mother underwent testing and was shown

to be seropositive, as was the baby when it was

born. Neither the surrogate mother nor the intended rearing parents wished to take custody

of the baby (2o). Physician liability in such a situation is unclear,

With the introduction of court-ordered and contractually limited behaviors by women, such as

refraining from alcohol or submitting to cesarean section (discussed later in this chapter), physicians may find themselves with a novel duty—

to adequately screen surrogate mothers for their

potential willingness to abide by such directions.

OTA identified at least 10 matching services that

do some sort of psychological screening before

the surrogate mother attempts a conception.

Psychiatrists are familiar with the duty to predict patient behavior and to warn potential victims of a patient’s likely misdeeds (66). This is generally restricted, however, to circumstances in

which there is an identifiable person at risk of

physical violence, and it is unclear if such a

doctrine could extend to victims of a breach of

contract.

With the widespread use of contractual arrangements for collaborative reproduction, involving

large sums of money and emotionally charged arrangements, efforts may be made to hold physicians liable for inadequate psychiatric screening

should contracts be breached by surrogate mothers

or intended rearing parents. This is not only because the parties are likely to identify the physician as one of the persons who could have avoided

the difficulties by adequate screening, but also

because physicians generally have generous mal -

practice insurance coverage, and therefore may

be viewed as “deep pockets” from whom to obtain damages.

One example of the kind of practice that might

lead to suits is a physician’s choice not to screen

for women who are unlikely to be able to relinquish the child at birth (24). Such practice might

leave psychiatrists vulnerable to charges from the

intended parents that inadequate precautions

were taken to ensure the smooth operation of the

contract.

Services offering surrogate gestational mother

matching may find that their physicians have an

additional area of responsibility, this time with respect to the transferred embryos. The Louisiana

IVF statute (see ch. 13) grants in vitro embryos

certain legal rights ordinarily accorded only to

live-born children, such as the right to bring suit

through a legal guardian, and places specific

responsibilities upon physicians to guard the embryo from harm. The combination of these two

principles could enormously expand the potential liabilities of physicians subject to that or any

other similar law.

Attorneys

About 25 percent of the surrogate matching

services surveyed by OTA have an attorney on

staff; others generally have a regular attorney to

whom they can refer surrogates and clients. Inhouse attorneys are usually used to represent the

clients, rather than the surrogates. Attorneys negotiate terms of the surrogacy contract, advise

clients of the likelihood that the contracts are legally and practically enforceable, handle any legal action necessary to enforce provisions of the

contract, supervise the transfer of funds and of

medical or expense payments to the surrogate,

and manage the postbirth details concerning relinquishment of parental rights by the biological

mother, transfer of custody to the biological father, and adoption by the father’s wife.

Attorneys generally owe a duty of professional

service and confidentiality to their clients and to

no others. For this reason, every State has ethics

rules that forbid an attorney from representing

two parties whose interests may conflict. Thus,

an attorney who represents both the surrogate
Ch. 14—Legal Considerations: Surrogate Motherhood ● 273

mother and any other party to a surrogate arrangement without obtaining appropriate permissions from both parties may be subject to professional discipline by the State bar, as well as to

malpractice suits by the affected clients. Surrogate

matching agencies uniformly reported that their

attorneys do not routinely represent both clients

and surrogates, but one agency does state that

this can happen if all parties make such a request.

Nor can an attorney who represents infertile couples arrange to refer all prospective surrogates

to a particular attorney, with whom he or she splits

a fee. Such fee-splitting arrangements are forbidden in most States as prejudicial to the interests

of the person being referred. Nevertheless, at least

one matching service routinely refers surrogates

to a particular attorney (30).

In addition, most States have ethical codes forbidding attorneys from drawing up contracts that

they know are illegal, unenforceable, or coercive.

This poses a problem for attorneys working in

a novel field, such as surrogacy, as it may be unclear at the outset whether the contracts are legal and enforceable in any particular State. To

date, no attorney has been subject to disciplinary

proceedings for developing surrogacy contracts.

Who Becomes A Surrogate Mother?

OTA asked surrogate matching agencies to describe some of the characteristics of the women

who had passed through their screening procedures and were waiting to be hired as surrogate

mothers. On average, they were women of 26 to

28 years of age, almost all heterosexual, and approximately 60 percent of them married. Almost

90 percent of the women waiting to be hired

through the agencies surveyed are reported to

be non-Hispanic whites, approximately two-thirds

Protestant, and nearly one-third Catholic (see table

14-1).

All but one of the agencies reported that all its

surrogates had had a prior pregnancy, and overall the agencies reported that approximately 20

percent of the surrogates had had either a miscarriage or an abortion in the past. Generally

fewer than 10 percent of the women had previously relinquished a child through adoption, and

overall the agencies reported that fewer than 7

percent of the women were acting as surrogates

for the second time. Agencies reported that approximately 12 percent of the women were themselves adopted.

Overall, agencies reported that fewer than 35

percent of the women had ever attended college,

and only 4 percent had attended any graduate

school. Agencies draw the bulk of the surrogates

from the population earning $15,000 to $30,000

per year (approximately 53 percent), with 30 percent earning $30)

000 to $50,000 per year, and at

most 5 percent earning more than $50,000. Six

agencies reported no women earning less than

$15,000 per year who were currently waiting to

be hired as surrogates, partly due to the fact that

some agencies will not accept surrogates who are

on welfare or who are not “financially independent.” Overall, agencies reported that approximately 13 percent of the women had household

incomes of less than $15)

000 per year.

REQUIRING CONSENT FROM THE HUSBAND

OF THE SURROGATE MOTHER

Many surrogate contracts are written to include tion with donor sperm. (See ch. 13 for a descripconsent by the surrogate’s husband, even though tion of the effect of husband consent on presumpno State law requires it (9)11,12). Other contracts, tions of paternity.)

such as the one used in the Baby M case, require

both the husband’s consent to the surrogacy ar- Even if a husband were required by State law

rangement and his explicit statement that he does to consent to his wife’s agreement to be a surnot consent to the insemination, This fiction is rogate mother, it would be difficult to enforce.

designed to obviate the State’s automatic presump- Of course, failing to get consent would probably

tion of the husband’s paternity, which applies serve as grounds for divorce, whether as a novel

when a husband consents to his wife’s insemina - interpretation of adultery or as emotional cruelty.
274 Infertility: Medical and Social Choices

However, as grounds for divorce are no longer means little (21). The only effective way to enforce

needed in most States, and as property distribu- such a requirement would be to direct penalties

tions are largely made with little regard for mari- at the professionals associated with arranging

tal misconduct, this enforcement mechanism these contracts, namely the commercial brokers,

Table 14-l.– Demographic Surveys of Surrogate Mothers

OTAa

Linkins b Hanifin c Parker Id Parker 2° Franksf

Sample size. . . . . . . . . . . . . . . . . . .

Average age . . . . . . . . . . . . . . . . . .

Marital status:

Married. . . . . . . . . . . . . . . . . . . . .

Single. . . . . . . . . . . . . . . . . . . . . .

Divorced . . . . . . . . . . . . . . . . . . .

Unknown . . . . . . . . . . . . . . . . . . .

Number of children . . . . . . . . . . . .

Race/ethnicity. . . . . . . . . . . . . . . . .

White non-Hispanic . . . . . . . . . .

Hispanic . . . . . . . . . . . . . . . . . . .

Black non-Hispanic . . . . . . . . . .

Asian . . . . . . . . . . . . . . . . . . . . . .

Other . . . . . . . . . . . . . . . . . . . . . .

Religion . . . . . . . . . . . . . . . . . . . . . .

Protestant . . . . . . . . . . . . . . . . . .

Catholic . . . . . . . . . . . . . . . . . . . .

Jewish . . . . . . . . . . . . . . . . . . . . .

Other . . . . . . . . . . . . . . . . . . . . . .

Household income. . . . . . . . . . . . .

<$15,000 . . . . . . . . . . . . . . . . . . .

$15,000-$30,000 . . . . . . . . . . . . . .

$30,000-$50,000 . . . . . . . . . . . . . .

>$50,000 . . . . . . . . . . . . . . . . . . .

Average . . . . . . . . . . . . . . . . . . . .

Range. . . . . . . . . . . . . . . . . . . . . .

Education . . . . . . . . . . . . . . . . . . . .

Some high school . . . . . . . . . . .

High school graduate . . . . . . . .

Some college . . . . . . . . . . . . . . .

College graduate . . . . . . . . . . . .

Some graduate school . . . . . . .

Previously:. . . . . . . . . . . . . . . . . . . .

Was surrogacy mother . . . . . . .

Gave up child for adoption. . . .

Had abortion or miscarriage . .

Are themselves adopted . . . . . . . .

> 334’

27

600/0

40%2

●

88%0

2%

<10/0

2%0

8 % 3

670/o

280/o

3%

2%

13%0

530/0

300/0

4%0

●

●

61 0/04

35%04

4%04

7%

7%

20 ”/0

12%

34

28

73%

180/0

90/0

1.8

●

●

●

●

$18,000

$5K-$68K

12 ”/0

380/o

47%

3 %

●

89

28

80%

14 ”/0

5%

2.0

850/o

14 ”/0

<10/0

<1 ”/0

<10/0

74 ”/0

250/o

<10/0

<10/0

●

520/o

240/o

240/.6

●

1%

37%

1%

30

25

870/o

10%0

3%

1.9

100 ”/0

53%

47 ”/0

●

20%

53%

270/o

●

10 ”/0

230/o

1%0

125

25

530/0

19%

22 ”/0

60/0

1.4

100 ”/0

550/0

40 ”/0

1%

4%

●

●

$6K-$55K

18°/05 540/.5

2 6 %

20/ 0 5

●

90/0

260/o

1%

10

26

50%

40%

10%

1-3

●

●

●

$6K-$55K(moderate-modest)

(average for sample)

●

SOURCES:

%ffice of Technology Assessment, 1988.

bK, Linkins H. Daniels, R. Richards, and D. Kinney, McLean Hospital, Belmont, MA, personal communication, Feb. 9, 19~.

CH. Hanifin: The Surrogate Mother: An ~xP/orato~ Study (Chicago, IL: IJniversity Microfilms International, Iw); H. Hanifin, “Surrogate parenting: Reassessing Human Bonding,” preaented at the Annual Meeting of the American Psychological Association Convention, New York, August 1987.

dp.J. pa~er, ,.The psychology of the Surrogate Mother: A Newly updat~ Report of a Longitudinal pilot Study,” presented at the American Orthopsychiatric Association General Meeting, Toronto, Apr. 9, 1984.

ep.J parker, ‘$ Motivations of surrogate Mothers: Initial Findings,” American Journa/ Of Psychiatry 140:1 17-118 (1983).

fD.D. Franks, “Psychiatric Evaluation of Women in a Surrogate Mother pro9ram,” American Journal of PsychhWy, 138:137R1379 (1981).
Ch. 14—Legal Considerations: Surrogate Motherhood ● 275

physicians, and attorneys. To consider the con- undesirable result

tract itself unenforceable absent the consent is clearly identifiable

another possibility, although it might lead to the

that a child is left without

legal parents.

RECORDKEEPING AND CONFIDENTIALITY

Births are ordinarily registered by having a birth

certificate filled out in the hospital. The mother’s

name is entered, as is the name of her husband

or the reported father of the child, Absent a court

order, it is not possible to substitute an adopting

mother’s name on a birth certificate, Just such

court orders have been used, however, for surrogate arrangements. In one case a birth mother

refused to terminate her parental rights, so the

genetic father dropped his custody suit in exchange for a court order to place his name on

the birth certificate (31). In another case, a Michigan court entered an order that an ovum donor

and her sperm donor husband should have their

names entered on the birth certificate of the child

borne for them by a woman hired to be the child’s

gestational mother (63). The same was done a year

later by a California court (62).

A Massachusetts couple has asked a Virginia

court to do the same for them with respect to a

baby born on December 21, 1987, to a surrogate

gestational mother (17). These cases are notable

because it is a new development in law to settle

by either contract or court order, prior to birth,

the identity of the legal parents whose names will

appear on the birth certificate,

The only State law as of early 1988 that addresses this problem in the context of surrogate

motherhood is Arkansas Statute Section 34-721,

which states:

For birth registration purposes, in cases of surrogate mothers, the woman giving birth shall be

presumed to be the natural mother and shall be

listed as such on the certificate of birth, but a substituted certificate of birth can be issued upon

orders of a court of competent jurisdiction.

Thus, even in Arkansas, a court order is needed

to issue a birth certificate with the name of the

woman who intends to raise the child.

Adoptees argue they have a right to know the

identity of their birth parents (55), claiming that

issuing birth certificates with adoptive parents’

names unconstitutionally discriminates against

adoptees and violates their right to privacy. (See

ch. 12 for discussion of the right to privacy.) Their

arguments have been unsuccessful, so it seems

unlikely that children of surrogates will have any

more luck objecting to State procedures to guard

the identity of their birth mothers. However, many

States have passed legislation to provide adoptees

with nonidentifying information concerning the

heaIth, interests, and ethnic background of their

biological parents (56), and such State statutes

could be held to apply or could be extended to

cover children of surrogacy arrangements.

Absent legislative protections, children conceived by surrogacy will have no recourse but

to their rearing parents for information about the

women who gave birth to them. All but one agency

surveyed allow clients and surrogates to meet and

to have contact during and after the pregnancy,

if it is mutually desired. Four agencies will supply names and addresses, while others presumably arrange meetings at their offices, only one

surveyed agency has a strict policy of mutual

anonymity.

TYPICAL CONTRACT PROVISIONS

Fees portation to the matching center or physician, necessary laboratory tests, and the delivery, a figure

As reported to OTA, the most common fee for that has not changed since 1984 (2,14), although

a surrogate mother is $10,000 plus expenses for two agencies reported a fee of $12)

000 and three

life insurance, maternity clothes, required trans - stated that each fee is negotiated individually. In
276 . Infertility: Medical and Social Choices

addition, fees are paid to the commercial broker

who found the surrogate and matched her to the

couple seeking a child (commonly between $3,OOO

to $7,000, but ranging up to $12,000); to the physicians who examine the parties and perform the

artificial insemination (from $2,000 to $3)000); to

the psychiatrist or other psychological counselor

(from $60 to $150 per hour); and to the attorneys

who counsel the parties, draw up and negotiate

the contract, and arrange for the proper adoption procedures to be followed after the child’s

birth (up to $5,000). The total cost of all these fees

and expenses can be roughly $30,000 to $50,000,

meaning that about $1 of every $4 actually goes

to the surrogate mother herself.

At least 36 States make it illegal to induce parents to part with offspring or to pay money beyond medical, legal, and certain other expenses

to give a child up for adoption. Some 12 statutes

specifically make it a crime to offer monetary inducements beyond medical expenses. Although

not clearly criminal, the statutes in the other 24

States could render voidable the surrogate mother’s

agreement to relinquish rearing rights and duties

in exchange for such inducements.

Whether these statutes will be applied to surrogate transactions is uncertain and will depend

upon judicial decisions in each State affected, as

well as upon interpretations of State and Federal

constitutional protections of the right to procreate. The agreement is entered into before conception or implantation, and thus lacks any coercive pressure from unwanted pregnancy or recent

childbirth. It is the influence that these pressures

might have on the ability to make a truly voluntary decision, coupled with concern over child

placement, that underlies the many State laws

against exchanging funds for a baby (36). Furthermore, one can argue that the money is paid to

the surrogate for her service: “The biological father pays the surrogate for her willingness to be

impregnated and carry his child to term. At birth,

the father does not purchase the child. It is his

own biological genetically related child. He cannot purchase what is already his,” stated the Baby

M trial court (30). Some contracts are written to

pay the mother a monthly fee, rather than a lump

sum upon relinquishment of the child, perhaps

to enhance the impression that it is her services

that are being bought, not the baby (15).

On the other hand, the agreement to relinquish

custody and parental rights at birth is a central

part of the surrogate’s bargain. The hiring couple has no interest in obtaining her services unless she will relinquish the child at birth. If she

does not relinquish her parental rights, generally

no fee is paid. Furthermore, reports to OTA and

other sources indicate a miscarriage often results

in only a nominal fee being paid, ranging from

nothing to $3)000 (24). A stillbirth can result in

no fee at all in at least two centers, with two others

paying only a portion of the fee (37), all further

giving the impression that these contracts are in

fact a direct exchange of funds for exclusive custody and parental rights to a baby.

In addition, at least two centers reduce or eliminate the fee entirely if the surrogate is found to

have behaved in a way that caused a health problem in the child, furthering the parallel between

the transfer of the baby and the transfer of manufactured property. The Kansas Attorney General,

considering this point, concluded “we cannot escape the fact that custody of the minor child is

decided as a contractual matter” involving the exchange of funds, which violated public policy that

“children are not chattel and therefore may not

be the subject of a contract or a gift” (35).

If the State laws prohibiting monetary inducements to adoption are deemed applicable to paid

surrogacy, they would make payment of money

to surrogates illegal baby-selling, For example, an

Indiana court held that paid surrogacy violated

both the letter and policy of Indiana’s statute prohibiting the exchange of funds beyond expenses

for any adoption (46), as did the New Jersey Supreme Court in the 1988 Baby M case (30).

Similarly, a 1983 case stated that Michigan law

prohibits paid surrogacy, and furthermore that

such a prohibition does not violate the fundamental right to bear children (16). The court noted

that the prohibition on payment does not forestall medically assisted pregnancy, adoption, or

even unpaid surrogacy. Instead, in the court’s

view, the prohibition legitimately protects children

from becoming articles of commerce. of course,
Ch. 14–Legal Considerations: Surrogate Motherhood ● 277

decisions holding baby-selling prohibitions applicable to surrogacy arrangements might adversely

affect the interests of some children if the result

is that rearing parents forgo the necessary steps

to ensure adoption by the nonbiological mother

in order to avoid judicial scrutiny of the underlying surrogacy agreement.

The New York and Kentucky courts, unlike

those in Indiana, Michigan, and New Jersey, have

held that their State baby-selling prohibitions do

not specifically address the situation created by

surrogate motherhood, and that therefore payments are allowable until the State legislature

decides otherwise (29)64). The fact that the transfer of custody is between biological parents influenced these decisions, as it makes the arrangement one of payment for exclusive custody and

termination of parental rights, rather than the classic baby-selling envisioned in most State laws.

In 1987, amendments to Nevada’s adoption law

exempted “lawful” surrogacy contracts from the

provisions of Nevada’s statute prohibiting payment

to a mother beyond her expenses (Nevada Revised

Statutes, ch. 127). It should be noted, however,

that the law still invalidates a mother’s consent

to relinquish a child for adoption if made less than

48 hours after birth. It is not clear whether a sur -

rogacy contract that commits the mother to relinquish the child is in and of itself a violation of the

law, making the contract “unlawful” and therefore outside the provisions of this amendment.

Further, the statute is not clear on how the courts

should balance the competing provisions of the

contract terms and the statutory 48-hour coolingoff period, should there be a dispute. Although

the intent of the amendment clearly seems to be

to exempt surrogacy from the prohibitions on

baby-selling, it is not clear whether the amendment is also intended to render surrogacy agreements fully enforceable.

Whether prohibitions on exchanging money for

termination of parental rights and custody are

held to make surrogacy arrangements criminal

or merely unenforceable, they would effectively

prevent surrogacy from becoming a freely available alternative to adoption, since few nonrelated

women will be surrogates on altruistic grounds

(51,52). The constitutionality of such a ban on paid

surrogacy remains to be determined by most

States and by the Federal courts.

Limitations on Behavior

During Pregnancy

Typical contract provisions reported to OTA and

other sources include prohibitions on smoking,

alcohol, and illegal drugs (2)9). Some may go further and consider types of permissible exercise

or diet. A practical problem with provisions such

as these is the difficulty of enforcement. It is hardly

feasible to follow a woman around to observe or

control her behavior. A more general problem is

that such contract provisions, particularly if they

were required by State law, could unconstitutionally interfere with individual rights to privacy, personal autonomy, and bodily integrity (see ch. 12).

An alternative enforcement mechanism is to sue

for breach of contract should the mother fail to

abide by these restrictions, However, it is unlikely

that any minor breach of these behavioral restrictions will lead to an identifiable health problem

in a child, leaving it unclear how to assess damages.

Even damages agreed upon in advance for breach

of a contractual provision (known as “liquidated

damages”) cannot be used unless the figure set

for the damages bears some reasonable relationship to the harm caused by the breach. Thus, both

prenatal efforts to enforce the behavioral lifestyle

restrictions or postnatal attempts to collect damages

for their breach are difficult propositions.

However, a pregnant woman may possibIy have

a noncontractual duty to prevent harm to her fetus (59), regardless of whether she intends to raise

the child. This is a controversial and developing

area of law, and a number of commentators have

expressed concern that the identification of such

a duty might unconstitutionally limit women’s

bodily autonomy (5,18,22)23,33,34). A few courts

have held that women not only may have an obligation to refrain from harmful behaviors–such

as taking drugs—but may also have an obligation

to take affirmative steps to prevent harm, such

as undergoing cesarean sections (58).

Surrogate motherhood arrangements could affect the development of this evolving area of law
278 ● Infertility: Medical and Social Choices

because the pregnant woman is often unrelated

to the intended rearing parents of the child. The

couple generally invest a great deal of time and

money in trying to ensure that they will raise the

child she bears. They might conceivably be less

reluctant to use legal methods to try and control

her behavior.

Limitations on Control Over

Medical Decisions

Typically, the surrogate agrees in the contract

to abide by her physician’s orders. Such orders

can extend to whether or not to undergo amniocentesis, electronic fetal monitoring, or a cesarean delivery. Further, two-thirds of the agencies

surveyed report that their contracts allow the client to exercise some control over whether the surrogate mother will undergo chorionic villi sampling, amniocentesis, or abortion, as well as the type

of prenatal care she will receive. Placing such provisions in the contract gives the client the possibility of more extensive control over the surrogate

mother’s pregnancy, as it gives the client another

basis upon which to go into court to seek an injunction to force her to comply or to seek damages

should she refuse to comply. Principles of personal

autonomy probably prevent the enforcement of

any requirement to undergo amniocentesis or

abortion, and many proposed State laws would

prohibit enforcement of such clauses. But a surrogate’s refusal to comply with these requests

might serve as a justifiable cause for breaking the

contract and requiring the return of any monies

received.

In the Baby M case, the trial court stated in

dictum that such clauses are not specifically enforceable, but did not state whether any form of

monetary damages would be owed (3o). “Specific

enforcement” or “performance” is a judicial remedy

for breach of contract. It means that the court

orders that the terms of the agreement be carried out, rather than that monetary damages be

paid. Here, specific performance refers to ordering the woman to submit to amniocentesis or abortion, something that raises constitutional questions

concerning her right to bodily integrity and autonomy. With respect to other aspects of surrogate

contracts, it could refer to relinquishing custody

and parental rights. It could also be used to try

to enforce an agreement not to smoke or drink

or work in the presence of toxic materials. Specific performance is rarely ordered for these last

types of promises, as it is virtually impossible to

ensure compliance (19).

The contractual arrangement with the surrogate

mother and the evidence of intent to rear the child

might be used by the client, however, to argue

that he and his partner have standing to seek an

injunction ordering the mother to undergo a medical procedure such as a cesarean section. “Standing” generally means the right to be a plaintiff in

a suit before a court. only persons who have a

legally recognizable interest in the case are granted

standing. This is particularly important in light

of the controversy surrounding the use of court

orders to force women to undergo cesarean sections because their physicians or husbands disagree with their decision to forgo the procedure

(41,58). HOW the courts might react in the contractual surrogacy situation, however, is difficult

to predict, as is the extent to which judicial decisions would be taken to apply equally to women

who intend to raise the children they bear.

Choice-of-Law Provisions

Some contracts used by the surveyed agencies

provide that disputes will be resolved by courts

located in a particular jurisdiction or by application of the laws of a particular State. Such provisions are important, as the arrangements often

involve participants and brokers from different

States. State court decisions vary concerning the

acceptability of paid surrogacy and the enforceability of the contracts, as do individual State law

provisions concerning the mechanics of adopting

a child or identifying legal paternity of a child conceived by artificial insemination. Thus, the outcome of a dispute concerning a surrogacy arrangement could depend largely upon which State’s laws

are applied.

In any litigation involving parties from different States, often the first task facing a court is

to decide which court should hear the case and

which State’s laws should be applied. Contract provisions can often, but not always, be used to settle these questions before a dispute has arisen (42).
This is particularly important with respect to disputes concerning custody of a child, as delays

could affect the amount of time the child spends

with one of the parents, in turn affecting the

court’s willingness to change the child’s custodial

parent. For example, the New Jersey Supreme

Court explicitly noted in its Baby M decision that

court orders should no longer be issued in New

Jersey to force a woman to relinquish a baby, even

temporarily, pursuant to a surrogacy contract (30).

With the passage of conflicting legislation in Arkansas and Louisiana–with one State facilitating

and the other inhibiting commercial surrogacy—

choice-of-law questions have gained importance.

This is particularly relevant since every service

surveyed by OTA said it had matched surrogates

and clients from different States, at least nine services had made matches with surrogates or clients

outside the United States, and two services had

tried to open branches in Europe (37,38,67).

The Surrogate Mother’s Rights

to the Child

Surrogate contracts typically require the mother

to immediately relinquish custody of the newborn

baby. (Only three agencies do not use this provision, each reporting that it would appear to be

unenforceable under State law.) She then is required to sign papers terminating her parental

rights. Custody and parental rights are different:

A parent may have the right to visit his or her

children without having the right to live with

them. Terminating parental rights means terminating visitation, intervention in the education and

training of the child, and indeed all rights to the

child. Legally, the parent becomes a stranger to

the child. The same is true in the case of more

ordinary forms of adoption, although there has

been considerable legislative activity in the States

to provide children and their biological parents

the opportunity to learn each other’s identity if

mutually desired, and in some cases to give adopted

children access to nonidentifying medical information concerning their biological parents (55,56).

Almost all surrogacy contracts provide that the

genetic father will take custody regardless of the

sex or health of the child, and that his wife will

assume custody if he should die. (At least one servCh. 14—Legal Considerations: Surrogate Motherhood ● 279

ice, however, writes contracts that do not require

the genetic father to take custody if the child is

born with a health problem that seems to be the

result of some action by the surrogate mother;

it is not clear that such an exemption is valid under State law.) If both intended parents die before the birth of the child, the surrogate mother

could keep the baby or put the child up for

adoption.

As indicated earlier, a central issue in surrogacy

is whether a contract can determine custody and

parental rights when the surrogate mother refuses

to relinquish either. Courts and attorney general

opinions have consistently stated in dictum that

a surrogate mother has all the same rights to her

child as does a mother who conceived with the

intention of keeping her baby. In other words,

in the event of a custody dispute between the

genetic father and surrogate mother, both would

stand on equal footing and the best interests of

the child would dictate the court’s decision (29,

35,44,46,49,64). The courts reasoned that a surrogate motherhood contract, while not void from

inception, is nevertheless voidable. This means

that if all parties agree to abide by the contract

terms, and the intended rearing parents are not

found to be manifestly unfit, then a court will enter the necessary paternity orders and approve

the various attorney’s fees agreed upon (29). If,

on the other hand, the surrogate mother changes

her mind about giving up her parental rights

within the statutory time period provided by the

applicable State law, then ‘{

[s]he has forfeited her

rights to whatever fees the contract provided, but

both the mother, child and biological father now

have the statutory rights and obligations as exist

in the absence of contract” (64).

Until the Baby M (30) and Yates v. Huber (69)

cases, no custody dispute ever made it to trial in

the United States (see app. E for a description of

events in other countries). In both of these 1988

decisions, however, surrogate motherhood contracts were voided, and held irrelevant to determining custody of a child wanted by both the surrogate mother and the genetic father. The New

Jersey decision, particularly important because

it comes from the highest court in the State, went

further than many of the prior advisory opinions,
280 . Infertility: Medical and Social Choices

and held that commercial surrogacy contracts are

void (and possibly criminal), not merely voidable.

Finding the contract void has several important

consequences. First, as noted earlier in this chapter, it removes an important basis on which a court

could order a surrogate mother to relinquish a

child to the genetic father pending resolution of

a custody dispute. Second, it eliminates the contractual authority of a genetic father to control

the behavior of a surrogate mother during pregnancy, or to specify the conditions of her prenatal care and delivery. Finally, it makes a surrogacy

contract unenforceable, so that courts would not

be allowed to order even monetary damages for

its breach. This complete lack of enforceability

could be a tremendous deterrent to the further

popularization of surrogate motherhood, although

it should be noted that similar unenforceability

with regard to prenatal independent adoptions

has not eliminated that practice. The Baby M decision only applies to cases decided under New

Jersey law, of course, but its reasoning may be

influential in many other States.

The Baby M reasoning was based on three factors. First, the New Jersey Supreme Court found

that the contract conflicted with laws that prohibit exchange of funds in connection with adoption, dismissing arguments that the payments

were for a surrogate’s services. Second, the contract violated State statutes under which parental rights may only be terminated for parental

unfitness or abandonment, as well as case law

holding that parents may not agree between themselves by contract to terminate rights or determine custody of a child, noting that such laws are

designed to ensure that a child’s best interests,

rather than the wishes of parents, are paramount

at all times. Finally, the court held that the contract violated State law making a parent consent

to adoption revocable for a certain time period

following birth.

The same reasoning with regard to consent for

adoption has been used by other State courts. Permission to adopt a child is not valid if given before birth (see table 14-2), leading a number of

courts to state that this would bar specific performance of the custody and termination of parental rights provisions of surrogacy contracts (29,

46,64). Acknowledging that the surrogate’s consent to adoption is made before conception, and

therefore not under the duress of an unintended

pregnancy (36), the New Jersey Supreme Court

nevertheless stated:

The natural mother is irrevocably committed

before she knows the strength of her bond with

her child. She never makes a totally voluntary,

informed decision, for quite clearly any decision

prior to the baby’s birth is, in the most important

sense, uninformed, and any decision after that,

compelled by a pre-existing contractual commit -

ment) the threat of a lawsuit, and the inducement

of a $10,000 payment, is less than totally voluntary (30).

Informed consent to engage in a surrogacy arrangement is made even more problematic in

translational surrogacy arrangements, where language barriers, absence of legal counsel, and immigration considerations may affect the transaction.

For example, one surrogacy contract between an

American couple and a Mexican woman who is

second cousin to the infertile wife has resulted

in a custody dispute complicated by allegations

of misunderstanding and violations of immigration law. The surrogate mother has said that she

understood that she was to be impregnated by

artificial insemination and that the embryo was

then to be transferred to the uterus of the infertile woman. The couple asserts that the handwritten contract and oral understandings always contemplated a full-term pregnancy, with the child

relinquished to the genetic father and his wife

at birth. In exchange, the couple was to provide

clothing, medical care, food, and assistance at obtaining a visa for permanent residency in the

United States (27,67).

The arrangement was complicated by the fact

that it included providing housing in the United

States for the Mexican mother, in violation of immigration regulations. The case has had preliminary hearings in U.S. courts, and temporary custody was awarded to the couple, with visitation

rights granted to the surrogate mother. Translational contracts such as these, made difficult by

language problems (the surrogate mother in this

case spoke no English and was not represented

by an attorney) and the vulnerability of women

hoping to enter the United States from poorer
Ch. 14—Legal Considerations: Surrogate Motherhood ● 281

Table 14-2.—State Adoption Laws

Prohibit payment Permission to adopt Adoption agencies

State/jurisdiction beyond expenses invalid before birtha must be licensed

Alabama. . . . . . . . . . . . . . . . . . . . .

Alaska . . . . . . . . . . . . . . . . . . . . . .

Arizona . . . . . . . . . . . . . . . . . . . . . .

Arkansas . . . . . . . . . . . . . . . . . . . .

California . . . . . . . . . . . . . . . . . . . .

Colorado . . . . . . . . . . . . . . . . . . . .

Connecticut . . . . . . . . . . . . . . . . .

Delaware . . . . . . . . . . . . . . . . . . . .

District of Columbia . . . . . . . . . .

Florida . . . . . . . . . . . . . . . . . . . . . .

Georgia . . . . . . . . . . . . . . . . . . . . .

Hawaii . . . . . . . . . . . . . . . . . . . . . .

Idaho . . . . . . . . . . . . . . . . . . . . . . .

Illinois . . . . . . . . . . . . . . . . . . . . . .

Indiana . . . . . . . . . . . . . . . . . . . . . .

Iowa . . . . . . . . . . . . . . . . . . . . . . . .

Kansas . . . . . . . . . . . . . . . . . . . . . .

Kentucky . . . . . . . . . . . . . . . . . . . .

Louisiana . . . . . . . . . . . . . . . . . . . .

Maine . . . . . . . . . . . . . . . . . . . . . . .

Maryland . . . . . . . . . . . . . . . . . . . .

Massachusetts . . . . . . . . . . . . . . .

Michigan . . . . . . . . . . . . . . . . . . . .

Minnesota . . . . . . . . . . . . . . . . . . .

Mississippi . . . . . . . . . . . . . . . . . .

Missouri . . . . . . . . . . . . . . . . . . . . .

Montana . . . . . . . . . . . . . . . . . . . . .

Nebraska . . . . . . . . . . . . . . . . . . . .

Nevada . . . . . . . . . . . . . . . . . . . . . .

New Hampshire . . . . . . . . . . . . . .

New Jersey . . . . . . . . . . . . . . . . . .

New Mexico . . . . . . . . . . . . . . . . .

New York. . . . . . . . . . . . . . . . . . . .

North Carolina . . . . . . . . . . . . . . .

North Dakota . . . . . . . . . . . . . . . .

Ohio . . . . . . . . . . . . . . . . . . . . . . . .

Oklahoma . . . . . . . . . . . . . . . . . . .

Oregon . . . . . . . . . . . . . . . . . . . . . .

Pennsylvania . . . . . . . . . . . . . . . . .

Rhode Island . . . . . . . . . . . . . . . . .

South Carolina . . . . . . . . . . . . . . .

South Dakota . . . . . . . . . . . . . . . .

Tennessee . . . . . . . . . . . . . . . . . . .

Texas . . . . . . . . . . . . . . . . . . . . . . .

Utah . . . . . . . . . . . . . . . . . . . . . . . .

Vermont . . . . . . . . . . . . . . . . . . . . .

Virginia . . . . . . . . . . . . . . . . . . . . .

Washington . . . . . . . . . . . . . . . . . .

West Virginia . . . . . . . . . . . . . . . .

Wisconsin . . . . . . . . . . . . . . . . . . .

Wyoming . . . . . . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . . .

x

x

x

x

. . . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . . .

x

x

. . . . . . . . . . . . . . . . .

x

x

x

x

x

x

x

x

x

x

x

. . . . . . . . . . . . . . . . .

x

x

x

. . . . . . . . . . . . . . . . . Xb

. . . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . . .

x

x

x

x

x

. . . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . . .

x

x

x

x

x

. . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . . .

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

x

. . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . .

x

x

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

x

x

. . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

x

x

. . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . .

x

x

. . . . . . . . . . . . . . . .

x

x

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . .

x

. . . . . . . . . . . . . . . .

alncludes statutory and judge-made law.

bsurrogate mot hering exempt from prohibition by 1987act of le9iSlatWe.

SOURCES: National Committee for Adoption, Adoption factbook: Urrited Sfates Data, Issues, Regulations, and Resources( Washington, DC: 1985~J. A Robertson,

“StateStatuteson IVF, Artificial insemination, and Surrogate Motherhood,” prepared forthe Office ofTechnology Assessment, US Congress, Washington,

DC, November 1988.

countries, are particularly subject to attack. Infact, Adoption

in this particular case, the contract claims were

dropped by the couple) and the custody dispute Surrogacy contracts usually require an adopwas heard in family court. tion by the genetic father’s spouse. Insome States,
282 ● Infertility: Medical and Social Choices

the genetic father may already be identified as

the legal father (e.g., by a judicial finding of his

uncontested paternity) and thus able to initiate

expedited stepparent adoption proceedings for his

wife. A number of States have special procedures

for stepparent adoptions that expedite adoption

waiting periods and avoid the use of adoption

agencies. In other cases, the genetic father and

his wife will both have to adopt the child, requiring a series of home inspections, references, and

court approvals (47).

As some States do not allow anyone but a husband to bring a suit to counter the presumption

of his paternity (12,25,61), a genetic father and

his wife may be faced with a tremendous difficulty in the event that the surrogate is married,

and she and her husband refuse to relinquish the

child. By not allowing a challenge to be brought

to his presumed paternity, the surrogate mother’s

husband could thwart the genetic father’s attempts to establish his own paternity in order to

contest custody of the baby.

Courts might avoid this result by not reading

such laws literally when a husband consents to

his wife being inseminated as part of a surrogate

transaction but does not consent to assuming rearing rights and duties for offspring. Such a result

is most likely in New Jersey, New Mexico, and

Washington, which specifically allow the parties

to agree separately about donor rights and duties.

However, other jurisdictions might also reasonably find that the artificial insemination laws were

not intended to regulate surrogate inseminations.

For example, the “sperm donor” in a surrogate

situation is in fact not donating sperm for pay or

altruism, but with the intention of taking custody

of any resulting child. Courts might find that such

persons are not “sperm donors” for the purpose

of artificial insemination statutes.

one State law attempts to avoid some of these

difficulties. Arkansas Statute Section 34-721(B)

states:

A child born by means of artificial insemination

to a woman who is unmarried at the time of the

birth of the child, shall be for all legal purposes

the child of the woman giving birth, except in the

case of a surrogate mother, in which event the

child shall be that of the woman intended to be

the mother.

This provision avoids the complications of adoption by declaring the intended rearing mother to

be the child’s legal parent. Thus, if all parties agree

to fulfill the contract terms, the surrogate mother’s

rights should be cut off in favor of the intended

rearing mother, without the need to get a court

order or approval.

The statute is unclear, however, on certain

points. First, by its terms it applies only to unmarried women, leaving open the question of the

child’s legal parentage if the surrogate is married.

(In 1987 a bill to extend the provision to married

women was passed by the Arkansas legislature

but vetoed by the Governor.) Section 34-721(A)

of the statute states without reservation that a

child born by artificial insemination to a married

woman is presumed to be her husband’s child.

Second, the statute concerns “presumptions” of

legal parenthood. Unless clearly stated otherwise,

presumptions are generally rebuttable. The statute does not address the problem of a surrogate

mother changing her mind and deciding to retain

parental rights, and it is unclear whether this statute would automatically cut off her rights should

she choose to rebut the presumption. Artificial

insemination statutes concerning paternity are

similarly written in terms of “presumption of

paternity,” and those presumptions are rebuttable under certain circumstances–for example, if

the husband can show that he did not consent

to the insemination. The reasons for which a surrogate mother can rebut the presumption of

maternity are not stated in the Arkansas law.

THE SURROGATE GESTATIONAL MOTHER

For many years, a woman who bore a child was by gestation”) (45). This certainty is no longer unclearly the mother of that child, a doctrine recently equivocal. The separation of biological motherexpressed in classical fashion as mater est quam hood into genetic and gestational components

gestatio demonstrate (“the mother is demonstrated opens the door to fresh legal consideration of the
Ch. 14—Legal Considerations: Surrogate Motherhood . 283

crucial aspect of motherhood that entitles a particular woman to a priori rights to a child. The

developing law of surrogate motherhood may not

help, as it pits the rights of a genetic and gestational mother against the rights of a genetic father, with an underlying preconception agreement

between the two as a key factor. Surrogate gesta -

tional motherhood concerns somewhat different

relationships. The two factors of similarity, however, are the existence of an underlying agreement that reflects the intentions of the parties, and

the surrogate mother’s experience of pregnancy.

Women who are unable to carry a pregnancy

to term, whether due to disease (such as certain

forms of diabetes), physical handicap, or repeated

idiopathic miscarriage, may wish to have an alternative to adoption. To have a child to whom they

are genetically related, one developing although

still rather rare option is the employment of a surrogate gestational mother, in whom is implanted

an embryo conceived with the sperm and egg of

the intended rearing parents. Women who carry

to term babies to whom they are not genetically

related, and who intend to relinquish the child

at birth to the genetic mother, may have fewer

rights with respect to the child than do the surrogate mothers who are genetic as well as gestational parents. Their lack of a genetic connection,

combined with their original intent to bear the

child for someone else, may work to deny them

equal footing with the baby’s genetic parents

should a custody dispute arise.

A further consideration in this area is that this

technique could be used to allow Caucasians to

hire non-Caucasians from this country or abroad

to bear babies. Concern has been expressed that,

particularly with surrogates drawn from developing countries or the American underclass, the

technique could be used to lower costs for the

intended rearing parents, as payments of far less

than $10)000 would nevertheless constitute a considerable sum to the surrogate gestational mother

(28). Of course, as the technique requires sophisticated medical procedures to transfer the embryo

from the ovum donor or petrie dish to the gesta -

tional mother, it is likely to have limited application. Nevertheless, it could be used, and some fear

abused (13). The problems arising from the MexicanAmerican surrogacy contract previously discussed

illustrate some of the possible areas for abuse.

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

21

22

a

24

23

M

27

2a

1

a

3

4

3

d

7

a

9

la

11

12

1:

14

1!

1(

17

11

Pre-Birth Judicial Order

This order declares a genetic mother and tat her to be the legal

parents of a child still being carried by a

gestational surrogate mother.

SOURCE: Superior Court of the State of California for the County of Los Angeles.

The fact that surrogate mother matching services have been opened in European countries, so
284 ● Infertility: Medical and Social Choices

that Europeans forbidden under their own laws

from the practice (see app. E) might seek a surrogate mother in the United States, indicates that

the practice may well soon take on a significant

international character.

Whether it is because they are not genetically

linked to the fetuses they carry or because they

are impoverished or non-American, the rights of

surrogate gestational mothers may be diminished

as compared with those of other mothers. However, the evidence of their pregnancy and the fact

that they gave birth make these women appear

to be the babies’ “natural” mothers. Thus, their

dilemma most clearly poses the question of whether

a genetic or gestational relationship, in and of itself, ought to generically determine maternal parentage and legal rights.

One approach is to mimic the law of paternity,

by providing that genetic parentage is definitive

parentage. This would mean that a genetic mother

could apply to a court for a ruling that she is the

legal mother of a child being carried to term by

another. Such a ruling has been issued at least

twice (62)63)) although in those cases the orders

were made with the consent of all the parties involved and in furtherance of their stated intentions. A similar request was made in 1987 by a

Massachusetts couple who had a Virginia woman

carry their genetic child to term and relinquish

the infant at birth, with a court decision expected

in 1988 (17). The very need to resort to a court

order, however, indicates that a de facto presumption exists that the birth mother is the child’s legal mother. In many ways this is analogous to determining paternity, in which a presumption exists

that the husband of a pregnant woman is the father of her child, with the presumption rebuttable by evidence that another man is the genetic

father.

Another approach is to consider the woman who

bears the child as the legal mother, with any further changes in parental rights to be made as per

agreement, or in the event of a dispute, as per

court order (6). Such an approach implicitly asserts the primacy of the g-month pregnancy experience as the key factor in designating a

“mother. ” The approach has simplicity as one

advantage. For example, hospital officials would

always know at the time of birth the identity of

the legal mother. This is also the approach taken

in the Arkansas statute discussed previously,

which addressed the use of birth certificates in

the context of surrogate mother agreements.

Of course, such an approach would undercut

efforts to regularize surrogate motherhood, as the

intended parents would live with uncertainty over

whether the birth mother would in fact abide by

earlier stated intentions. As the legal mother of

the child, the woman giving birth would not be

automatically barred from asserting her parental rights. This development might prevent surrogate gestational motherhood from ever becoming widely used, as the uncertainty of the success

of the arrangement could dissuade individuals

from making the necessary emotional and financial investment. Nevertheless, similar uncertainty

surrounds prebirth adoption agreements, which

remain an extremely popular way for couples to

form a family.

A third approach is to enforce these underlying

agreements, regardless of the various genetic,

gestational, and intended social arrangements.

This would grant the parental rights of motherhood to a genetic mother who intends to rear a

child brought to term by another. Such an approach was taken for the first time when the

Wayne County Circuit Court in Michigan issued

an interim order declaring a gamete donor couple to be the biological parents of a fetus being

carried to term by a woman hired to be the gesta -

tional mother. The judge also held that the interim

order would be made final after tests confirmed

both maternity and paternity (40), Upon birth, the

court entered an order that the names of the ovum

and sperm donors be listed on the birth certificate, rather than that of the woman who gave

birth, who was termed by the court a “human

incubator” (63).
Ch. 14—Legal Considerations: Surrogate Motherhood 285

MODELS OF STATE POLICY

Legislation related to surrogate motherhood has

been introduced in over half the State legislatures

since 1980 (1,4,32,36,48,53), much of which is still

pending. Only Arkansas, Kansas, Louisiana, and

Nevada have passed legislation; their approaches

have differed, with Arkansas endorsing surrogacy,

Louisiana making the arrangement unenforceable, Kansas simply exempting surrogacy from prohibitions on adoption agency advertising, and

Nevada exempting it from its prohibition on babyselling. As indicated in chapter 13, the approaches

taken by State legislatures maybe broadly grouped

into categories: static, private ordering, inducement, regulatory, and punitive (14,68). Should Congress choose to follow one of these models, its

legislative action would most likely be based on

the interstate commerce clause, although conditions on receipt of Federal grants or approval of

interstate compacts are other possible routes to

Federal involvement (see ch. 1).

The Static Approach

To date, the static approach has had mixed results. While several courts have so far declined

to find that surrogates lose their rights of motherhood by virtue of their preconception agreement

to relinquish parental rights, most courts have at

the same time agreed to enforce the paternity and

fee payment provisions of these contracts, at least

when all parties to the agreement still desire its

enforcement. In other words, although these

courts have found surrogate agreements to be

voidable, thev generally have not found them to

be void. A notable exception is the New Jersey

Supreme Court, which held that these agreements

are void (3o).

This socially and psychologically conservative

approach seeks to minimize the impact of noncoital reproductive techniques upon the structure

and relationships of the traditional family, mainly

by refusing to recognize legally new parental configurations. “The family unit has been under severe attack from almost every element of our modern commercial society, yet it continues as the

bedrock of the world as we know it. Any practice

which threatens the stability of the family unit

is a direct threat to society’s stability, ” stated the

dissenting justice in Surrogate Parenting Associa -

tion, Inc., the 1986 case finding that paid surrogate

matching services are permissible under Kentucky

law. This attitude is typical of the static approach,

which aims to support traditional family configurations.

one legislative method for furthering this viewpoint would be the adoption of a definition of

“mother” as a woman who gives birth to a child

or who obtains a child through a legal adoption

proceeding. Such a definition could guarantee surrogate mothers at least those rights held by all

mothers with respect to their children and control of their pregnancies.

Although the static approach will undoubtedly

slow the growth of surrogate motherhood as an

industry, it will not eliminate it entirely. The expansion of these services since 1980, in the absence of judicial or legislative guidelines, demonstrates that this arrangement can be used when

all parties abide by their original intentions. There

can be some problems with the use of State laws

and courts to manage birth certificate recordations and paternity orders, but it is primarily when

the parties change their minds that State action

becomes important and the absence of governmental guidelines becomes an active barrier to

the successful conclusion of the arrangement.

The Private Ordering Approach

The private ordering approach views a government’s role primarily as that of facilitating individual arrangements, and thus would compel recognition and enforcement of any conception and

parenting agreement freely formed among consenting adults. Such an approach could accommodate commercializing the services of surrogate

mothers (14). Private ordering is of course subject to some constraints, for example by allowing

special protection of vulnerable parties to the

transaction. Children are traditionally viewed as

such vulnerable parties, and thus judicial inter-
vention to ensure that custody is awarded to a

fit parent would be consistent even with this approach of limited governmental intervention.

Examples of such private ordering philosophy

can be found in several of the bills introduced

in State legislatures, such as the Nevada amendment that exempts surrogacy from prohibitions

on baby-selling. proposed legislation in Oregon

would also follow this model, while another Oregon proposal goes further and specifically legalizes paid and unpaid surrogacy, while providing

for specific enforcement and damages as remedies for breach of contract. An early Rhode Island bill also aimed to make surrogacy contracts

enforceable, stating that surrogate motherhood

“is to be viewed as a business venture, ” and that

the “rights of motherhood” do not apply to the

surrogate mother (H.B. No. 83 H-6132, 1983).

Without addressing the question of enforceability of surrogacy contracts, an amendment to

an Arkansas artificial insemination statute explicitly contemplates surrogate arrangements, and

at least with respect to unmarried women allows

an exception to the presumption that the childbearing mother is the legal mother of a child. It

states that in the case of surrogate motherhood,

the child “shall be that of the woman intended

to be the mother. ” The statute does not address

questions of evidence, such as the kind of agreement necessary to demonstrate who was intended

to be the mother, or the enforceability of these

arrangements. Nevertheless, it is the first statute

in the United States of its kind. A Wisconsin bill

calling for a presumption that the intended social

parents are in fact more fit to raise the child also

exemplifies the private ordering approach, but

with some protection for the vulnerable child. Further, the bill attempts to ensure that if all the adult

parties refuse custody, an adoptive home for the

child would be found.

Consistent with the private ordering approach

are State law provisions to ensure informed and

voluntary consent by all parties. A number of bills

require that the surrogate and the intended rearing parents be represented by attorneys, many

further specifying that the parties be represented

by separate counsel. Bills in at least five States require that the intended rearing parents review

the results of medical, psychological, and genetic

examinations of the surrogate mother before

agreeing to hire her. Bills in Michigan and the District of Columbia propose that at least 30 days

pass between the time that the contract is signed

and the first insemination, to allow a cooling-ff

period (4). It is unclear if such provisions could

meet all the objections of the New Jersey Supreme

Court (see ch. 12), but the Baby M decision did

say that State legislatures could legalize and regulate surrogacy, within constitutional limits (30).

The private ordering approach can be inadequate if parties fail to agree to a contract that spells

out all contingencies and their outcomes. For example, a contract might fail to specify a remedy

if one or both of the intended social parents were

to die, leaving it unclear whether the surrogate

mother or the State is responsible for the child.

Contracts may also fail to specify the medical tests

to be performed during pregnancy, remedies for

failure to abide by lifestyle restrictions, or the lines

of authority for emergency medical decisions concerning the health of the newborn. In the absence

of State guidelines that create presumptive responses to these situations, private contracts may

lead to disagreement and confusion. Courts attempting to enforce the contracts and carry out

the parties’ intentions could find it necessary to

decide on matters not explicitly contemplated under the contract, making even these arrangements

unclear as to their outcome and highly variable

from State to State.

The Inducement Approach

The inducement approach offers individuals an

exchange. By agreeing to follow prescribed practices—such as judicial review of the contract,

adherence to a model set of terms and conditions,

or use of a licensed surrogate matching service—

the State facilitates legal recognition of a child born

by the arrangement (14). For example, a Missouri

bill introduced in 1987 would require that judges

approve surrogate contracts before insemination

takes place. In exchange, the bill would automatically terminate the rights of the surrogate mother,

thereby offering the intended rearing parents the

certainty that they will be able to gain custody

of the child. The penalty for failure to follow these
Ch. 14–Legal Considerations: Surrogate Motherhood 287

practices might be that the contract is unenforceable under State law or that adoption proceedings are ineligible for expedited treatment. of

course, penalties that harm a baby’s psychological, physical, or even legal well-being would probably be unacceptable. A preliminary draft by the

National Conference of Commissioners on Uniform State Laws takes a similar approach (60).

Another form of this approach is to induce use

of a particular approved procedure or agency by

offering some Government assurance of its quality. Thus, for example, Government could license

particular adoption agencies to operate as surrogate matching services. As a condition of licensing, the agency could agree to certain conditions,

such as use of a standard contract or psychological screening of participants. The State would also

ensure that the personnel of the agency meet certain minimum criteria, such as years in practice

or professional training. Although there would

be no penalty for failure to use the service, many

participants would likely be interested in assuring themselves that the surrogates they hire have

been screened for drug or alcohol abuse, that the

persons for whom they bear children have been

interviewed to identify the kind of home they plan

to provide for the child, or that the contract they

sign has been reviewed for fairness, completeness,

and enforceability.

Any inducement approach that relies at least

partly upon licensing surrogate matching agencies permits the Government to prevent abuses

without necessarily limiting the freedom of individuals who wish to pursue these agreements. For

example, licensing could specify permissible and

impermissible ways of recruiting surrogates and

infertile couples, standardize the medical testing

and screening of the participants and their gametes, require monitoring of the health of the

baby, or set standard fees and expenses. To

broaden access to the poor, licensing could provide sliding fee scales and agency-financing.

Inducement or regulatory approaches may also,

however, enable the Government to specify who

will be permitted to take advantage of the agencies. Thus, for example, agencies might be limited

to serving married couples, thereby leaving unmarried couples, homosexual couples, and single

persons without access to the advantageous, Stateapproved method of surrogate adoption. Any such

limitations would be subject to constitutional review, particularly to the extent that they are

viewed as State interference in the right to privacy

with regard to procreative decisions (see ch. 12).

The Regulatory Approach

State regulation can also be used to create an

exclusive mechanism by which an activity may

be carried out. A number of proposals have been

made to regulate surrogacy. Bills in Florida, Illinois,

New Jersey, and South Carolina, for exampIe,

would permit only married couples to hire a surrogate, and bills in at least eight States would further specify that surrogates might be used only

for medical reasons, such as inability to conceive

or to carry a pregnancy to term (4). A South Carolina bill would require extensive investigation of

intended rearing parents’ homes, as is generally

done prior to adoption. Bills also propose standards for potential surrogate mothers, for example excluding women who have never had children before.

Besides regulating who may participate in surrogacy arrangements, a number of bills specify

that the surrogate and at times the intended rearing parents undergo psychological screening or

counseling, and some bills would require the biological mother and father to undergo testing for

sexually transmitted diseases. This latter point

takes on particular importance after the report

that one surrogate was not stringently screened

before she became pregnant, resulting in a child

born seropositive for the human immunodeficiency

virus, and rejected by the biological father and

his wife (2o). Regulations have also been proposed

in South Carolina to require the surrogate mother

to follow physician orders during pregnancy, to

adhere to a particular prenatal care schedule, and

to forgo abortion unless medically indicated.

Regulations have also been proposed to limit

compensation to the surrogate mother, or to set

forth pro rata schedules of fees in the event of

abortion, miscarriage, or stillbirth. Some proposals

have also been made to maintain State records

of surrogacy arrangements, and in a few cases,

to provide the child, at age 18, with information
288 ● Infertility: Medical and Social Choices

about his or her conception, State proposals have

split on whether to allow the surrogate a period

after birth in which to change her mind about

relinquishing custody, and whether the remedy

should she do so would be monetary damages or

specific enforcement of the contract custody provisions (4,36).

The Punitive Approach

The punitive approach imposes sanctions upon

certain specified practices, prohibits commercialization of the surrogacy arrangement, or denies

enforceability to surrogate contracts. Thus, for

example, a bill could prohibit payment of fees to

surrogates, by stating that commercial surrogacy

contracts are void and therefore unenforceable.

This was the approach taken in the 1987 Louisiana law. Proposals in Alabama, Minnesota,

Nebraska, and New York take this same approach,

while proposals in Connecticut, Illinois, North

Carolina, and Rhode Island would void even noncommercial contracts. Voiding these contracts

means that should the surrogate change her mind

about relinquishing the child, she will stand on

at least equal footing with the genetic father when

she seeks permanent custody. In some States, if

she is married, her husband will be presumed by

law to be the child’s father (see ch. 13), leaving

the genetic father with a difficult task should he

seek custody of the baby.

Punitive measures may be directed at a variety

of parties. Civil and criminal sanctions could attach to the professional matching services, to the

physicians and attorneys who are involved in the

arrangements, or to the surrogates or couples

themselves (14). Nevada’s legislature, for example, is to consider a bill making surrogate matching a felony punishable by up to 6 years in prison.

A Michigan bill also makes surrogate matching

a felony, with stiff penalties for any person who

matches a couple to a surrogate who is not of legal age. The bill would make the participation by

the surrogate and the genetic father a felony as

well. However, the fact that surrogacy does not

always require the services of a physician or an

attorney, and therefore is not easy to detect, means

that punitive approaches are unlikely to completely eliminate surrogate arrangements, although

they may drive them underground.

SUMMARY AND CONCLUSIONS

The legal status of surrogate arrangements is

still unclear. Despite activity in over half the State

legislatures, only Arkansas, Kansas, Louisiana, and

Nevada have enacted legislation either facilitating or inhibiting the arrangement. Louisiana has

voided commercial surrogacy contracts, while Arkansas has begun to regularize the legal parentage of the child. Nevada has exempted surrogacy

contracts from its baby-selling prohibition, and

Kansas, from its prohibition on adoption agency

advertising.

State court decisions are similarly sparse, but

consistently find surrogacy contracts unenforce -

CHAPTER 14

1. American College of Obstetricians and Gynecologists, Governmental Affairs Division, personal communication, Nov. 23, 1987.

able in the event of a custody dispute, although

the decisions do split on whether the contracts

necessarily violate State adoption law. The 1988

Baby M case held that commercial surrogacy contracts are completely void and possibly criminal.

This decision, coming from the highest court in

New Jersey, may well be influential in other State

courts. Nevertheless, absent Federal legislation or

a Federal judicial decision identifying constitutional limitations on State regulation in this field,

State courts and legislators are likely to continue

to come to different conclusions about whether

these arrangements can or should be enforced,

regulated, or banned.

References

2. Andrews, L. B., “The Stork Market: The Law of the

New Reproduction Technologies, ” American Bar

Association Journal 70:50-56, 1984.
Ch. 14—Legal Considerations: Surrogate Motherhood ● 289

3. Andrews, L. B., New Conceptions (New York, NY:

Ballantine Books, 1985).

4. Andrews, L. B., ‘

(The Aftermath of Baby M: Proposed State Laws on Surrogate Motherhood,” Hastings Center Report 17(5):31-40, 1987.

5. Annas, G., “Pregnant Women as Fetal Containers, ”

Hastings Center Report 16(6):13-14, 1986.

6. Annas, G., and Elias, S., “In Vitro Fertilization and

Embryo Transfer: Medicolegal Aspects of a New

Technique To Create A Family, ” Fami@ La\v Quarter~v 17:199-233, 1983.

7. Associated Press, Apr. 7, 1987.

8. Associated Press, Jan. 13, 1987.

9. Brophy, K. M., “A Surrogate Mother Contract to

Bear a Child, ” University of Louisville Journal of

Fam”fy Lawr 20:263-291, 1982.

10. Columbia Spectator, p. 7, Mar. 27, 1984.

11. Comment, “Surrogate Motherhood in California:

Legislative Proposals, ” San Diego Law Revielv 18:

341-385, 1981.

12. Comment, “Wrongful Birth and Wrongful Life:

Questions of Public Policy)” Loyo/a Law Review

28:77-99, 1982.

13. Corea, G., The Mother Machine (New York, NY:

14

15

16.

Harper and Row, 1985).

Dickens, B., ‘(Surrogate Motherhood: Legal and

Legislative Issues, ” Genetics and the Law III, A.

Milunsky and G.J. Annas (eds.) (New York, NY: Plenum Press, 1985).

Dickens, B., University of Toronto, Facuhy of Law,

personal communication, Oct. 12, 1987.

Doe v. Kel@, 122 JMich. App. 506, 333 N.W. 2d 90

(1983).

17. Doe v. Roe, Fairfax Countv (\/A) Circuit Court

18

19

20

(Chancery No. 103-147), as r;ported by Associated

Press, Aug. 16, 1987, and Jan. 12, 1988.

Dworkin, R.B, “The New Genetics, ” BioLa\v, J. Chil -

dress, P. King, K. Rothenberg, et al. (eds.) (Frederick, MD: University Publishers of America, 1986).

Farnsworth, E. A., The Law of Contracts (Mineola,

NY: Foundation Press, 1982).

Frederick, W .R., Delapenha, R., Gray, G., et al., “HIV

Testing on Surrogate ‘Mothers,” iVew England Journal of Medicine 317:1351-1352, 1987.

21. Freed, D. J., and Walker, T.B., “Fami]y Law in the

Fifty States: An Overview, ” Fami@ Law Quarter@

19:331-442, 1986.

22. Gallagher, J., “The Fetus and the Law–Whose Life

Is It Anyway?” Ms. Magazine, November 1984.

23. Gallagher, J., “Prenatal Invasions & Interventions:

What Wrong With Fetal Rights, ” Harvard Women

Law Journal 10:9-58, 1987.

24. Gladwell, M., and Sharpe, R., “Baby M Winner,” The

ATew Republic, Feb. 16, 1987, pp. 15-18.

25. Graham, M. L., “Surrogate Gestation and the Pro26

tection of Choice, Santa Clara La~ir Review 22:291,

1982.

Hanifin, H., “Surrogate Parenting: Reassessing

Human Bonding,” paper presented at the Annuai

Meeting of the American Psychological Association,

New York, August 1987.

27. Haro v. Munoz, as reported by Associated Press,

June 10 and Nov. 29, 1987.

28. Hubbard, R., Department of Biology, Harvard LJniVersitv) personal communication, Sept. 15, 1987.

29. In th; Matter of Adoption of Bab}~ Gir), L.J., 505

N.Y.S. 2d 813, 132 Misc. 2d 172) (Surr. Ct. Nassau

Cty. 1986).

30. In the Matter of l?ab~~ M, 525 A.2d 1128, 217 N.J.

Super. 313 (Superior Ct. Chancery Di\tision 1987),

reversed on appeal, 1988 West La\v 6251 (N .J. Supreme Court, Feb. 3, 1988).

31. In the Matter of James Akyes, No. CF 7614, California Superior Court, Feb. 1, 1981.

32.

33.

34

35

36

37.

38.

39.

40.

41.

42.

43.

44.

45.

46.

Jaeger, A., and Andrews, L., American Bar Foundation, personal communication, Nov. 24, 1987.

Johnsen, D. E., “The Creation of Fetal Rights: Conflicts with Women’s Constitutional Rights to Liberty, Privacy and Equality, ” Yale Law Journa) 85:

599-625, 1986.

Johnsen, D. E., “A New Threat to Pregnant \$romen’s

Authority,” Hastings Center Report 17(4):33-38,

1987.

Kansas Attorney General Opinion No. 82-150, 1982.

Katz, A., “Surrogate Motherhood and the Baby Selling Laws, ” Columbia Journal of La\+r and Social

Problems 20:1-53, 1986.

Keane, N., “60 Minutes, ” CBS Television, Sept. 20,

1987.

Keane, N., and Blankfeld, H., “ABC t$’orld News Tonight, ” Feb. 24, 1987.

Keane, N., and Breo, D., The Surrogate Mother

(New York, NY: Everest House, 1981).

King, P., “Reproductive Technologies, ” l?io~a~~r, J.

Childress, P. King, K. Rothenberg, et al. (eds.)

(Frederick, MD: University Publications of America, 1986).

Kolder, V. E. B., Gallagher, J., and Parsons, M. T.,

“Court ordered obstetrical Interventions,” New

England Journal of Medicine 316:1 192-1196, 1987.

Kern, H., “The Choice-of-Law Revolution: A Critique)” Columbia Law Re\rien7 12: 772-973, 1983.

Linkins, K., and Daniels, H., McLean Hospital, Belmont, MA, personal communication, Jan. 8, 1988.

Louisiana Attorney General Opinion NO. 83-869,

1983.

Mason J. K., and MacCall-Smith, R. A., Law and Medical Eth”cs, 2d ed. (London, UK: Butterworths,

1987).

Miroff v. Surrogate Mother, Marion Superior
Z$W ● Infertility: Medical and Socia/ Choices

Court, Probate Division, Marion County, Indiana

(october 1986).

47. National Committee for Adoption, Adoption Factbook: United States Data, Issues, Regulations and

Resources (Washington, DC: 1985).

48. National Committee for Adoption, personal communication, Oct. 13, 1987.

49. Ohio Attorney General Opinion No. 83-001, 1983.

50. O’Brien, S., “Commercial Conceptions: A Breeding

Ground for Surrogacy,” North C2molina Law Review

65:127-153, 1986.

51. Parker, P.J., “Motivation of Surrogate Mothers: Initial Findings, ’’American Journal of Psychiatry and

Law 140:1-4, 1983.

52. Parker, P.J., “Surrogate Motherhood, Psychiatric

Screening and Informed Consent, Baby Selling, and

Public Policy,” Bulletin of the American Academy

of Psychiatry and Law 12:21-39, 1984.

53. Pierce, W., “Survey of State Activity Regarding Surrogate Motherhood )’’F’amily La w Repofier 11:3001,

1985.

54. Reams v. Stotski, as reported by Associated Press,

Aug. 12, 1987.

55. Reimer, R., Legal fi”ght of an Adopted Child to Learn

the Identity of His or Her Birth Parents (Washington, DC: U.S. Congress, Congressional Research

Service, American Law Division, Nov. 30, 1984).

56. Reimer, R,, Adoptees’Right to l?eceive Medical Information on Their Birth Parents (Washington, DC:

U.S. Congress, Congressional Research Service,

American Law Division, Dec. 24, 1984).

57. Richardson, R., McLean Hospital, Belmont, MA, personal communication, Dec. 12, 1987.

58. Rhoden, N., “The Judge in the Delivery Room: The

Emergence of Court-Ordered Cesarean,” California Law Review 74:1951-2030, 1986.

59. Robertson, J., and Schulman, J., “Pregnancy and

Prenatal Harm to Offspring: The Case of Mothers

With PKU,” Hastings Center Report 17(4):23-28,

1987,

60. Robinson, R.C., Chair, National Conference of Commissioners on Uniform State Laws Committee on

the Status of Children, Portland, ME, personal communication, Oct. 17, 1987.

61. Rushevsky, C. A., “Legal Recognition of Surrogate

Gestation,” Women’s Rights Law Reporter 7:107-

143, 1982.

62. Smith v. Jones, CF 025653 (Los Angeles (CA) Superior Court, 1987).

63. Smith & Smith v. Jones & Jones, 85-532014 DZ,

Detroit MI, 3d Dist. (Mar. 15, 1986), as reported

in BioLaw, J. Childress, P. King, K. Rothenberg, et

al. (eds.) (Frederick, MD: University Publishers of

America, 1986).

64, Surrogate ParentiqgAssocia tes v. Commonwealth

65

66.

of Kentucky, ex rel Armstrong, 704 S.W. 2d 209

(1986).

Sutton, J., paper presented to the Pennsylvania

State Legislature on Behalf of the National Association of Surrogate Mothers, 1987.

Tarasoff v. Regents of the University of California,

17 Cal. 3d 425, 551 P,2d 334, 131 Cal. Rptr. 14

(1976).

67. U.S. Congress, House Committee on Energy and

Commeme, Subcommittee on Transportation, Tourism, and Hazardous Wastes, Hearings on H.R. 2433

(“The Anti-Surrogacy Act of 1987”), Oct. 16, 1987.

68. Wadlington, W., “Artificial Conception: The Challenge for Family Law,” Vir#”nia Law Review 69:465-

514, 1983.

69. Yates v. Huber, as reported by Associated Press,

Sept. 2, 3, and 10, 1987, and Jan. 22, 1988.
Chapter 15

Frontiers of

Reproductive Technology
CONTENTS

Page

In Vitro Fertilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .........293

Gamete Intrafallopian Transfer . . . . . . . . . . . . . . . . . . . . . ....................297

Uterine Lavage To Retrieve a Fertilized Ovum. ..., . . . . . . . . . . . . . . . . . . . . ....298

Freezing Embryos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...........298

Freezing Eggs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .......................,.299

Micromanipulation of Sperm Into Ova . . . . . . . . . . . . . . . . . . . . . . . . . . . ........299

Sexing Sperm Cells.... . . . . . . . . . . . . . . . . . . . . . ....... . .................300

Sexing Embryos . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..........,..301

Genetic Screening of Gamete Donors . . . . . . . . . . . . . . . . . . . . . ...............301

Health of Infants Conceived by IVF or GIFT . . . . . . . . . ......................302

Maternal Health Consequences of IVF and GIFT . .........................,303

Psychological Evaluation of Participants in Noncoital Reproduction . ..........304

Summary and Conclusions . . . . . . . . . . . . . . . . . . . . . . . ......................305

Chapter 15 References. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....307

Boxes

BOX NO. Page

15- A.A Look Back . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ......294

15-B. A Look Ahead . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .....................306

Tables

Table No. Page

15-1. In Vitro Fertilization in the United States, 1986 . . . . . . . . . . . . . . . . . . . . ...295

15-2. Statistical Profile of an Expert In Vitro Fertilization Program, 1983-87 ....295

15-3. Sources of IVF Byproducts and Some Possible Uses in Research . ........296

15-4, Clinical Pregnancies Following GIFT . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...297
Chapter 15

Frontiers of Reproductive Technology

The field of reproductive endocrinology began

to blossom in the 1930s with the description of

reciprocal hormonal control of the ovaries and

testes by the pituitary gland. Soon after, at the

close of World War II, the modern era of biomedical research began. Inspired by Federal funding

through the National Institutes of Health (NIH),

rapid advances were recorded in the United States

in broad areas of biology and medicine, including reproduction.

In the 1960s, the technique of radioimmunoassay enabled measurement of minute amounts of

reproductive hormones and permitted characterization of both normal reproductive health and

pathology. In the 1960s and 1970s, synergism between contraceptive research and fertility research

led to identification and purification of numerous natural and synthetic reproductive hormones.

This era also saw an increased research effort on

mammalian eggs and early embryos that was facilitated by advances in nonhuman in vitro fertilization (IVF) and preimplantation development. Beginning in the 1970s, advances in microsurgery,

fiber optics, and ultrasound–allowing for the first

time routine visualization and retrieval of eggs—

propelled novel reproductive technologies into

clinical practice.

Today, advances in infertility prevention and

treatment depend heavily on reproductive research in both humans and animals. Large domestic animal species such as cattle and pigs, because

of their economic importance, play a particularly

prominent role in reproductive research. Several

methods of assisted reproduction are, in fact, better developed in animals than in humans. The frequency and success of embryo freezing, for example, have soared in the 1980s as the basis for

a large commercial industry developed for improved breeding of cattle. The use of IVF, on the

other hand, is most well developed in humans.

This chapter reviews the state of the art in selected areas of reproductive technology and, where

possible, projects potential developments over the

next decade. Humans have made great strides in

understanding reproduction (for a historical perspective, see box 15-A), but a great deal of human

reproduction remains a profound mystery.

The developments in reproductive technology

discussed in this chapter have been accompanied

by an emerging literature in the social sciences,

Through the next decade, researchers are likely

to report with increasing frequency on the positive and negative impacts of reproductive and allied technologies on the behavior of individuals

and society as a whole.

IN VITRO FERTILIZATION

Ten years have passed since the birth of baby

Louise Brown, the first human to be conceived

by IVF. Some 5,000 IVF babies worldwide have

been born since. If the prevailing rate of successful pregnancies (i.e., pregnancies resulting in live

births) at today’s most expert clinics–about 15

to 20 percent per case in which embryos are transferred—is ultimately achieved at other clinics,

some 6,000 successful IVF pregnancies per year

may take place by the turn of the century. (One

recent estimate assumes that 220 active IVF programs worldwide will undertake 30,000 IVF treatment cycles annually by then, Each treatment cy -

cle involves the attempted insemination of five

oocytes, for a total of 150,000 oocytes per year.

Twenty percent of the 30,000 cycles are assumed

to result in successful term pregnancies, including some multiple births (22). ) This means that

IVF would account for fewer than 1 percent of

the babies born each year in the United States.

Since the first report of pregnancy following

IVF (12), the methods of human IVF and embryo

culture have to a large extent been simplified and

standardized, although there is no universally accepted set of techniques. One index of the research

293
294 ● Infertility: Medical and Social Choices

Box 15-A.—A Look Back

From ancient times until the early 1600s, the

view persisted that babies were conceived by

mixing menstrual and seminal fluids. Aristotle

maintained 2,300 years ago that development begins when the male provides the active form to

the passive female substance. In 1651, William

Harvey raised the fundamentally different claim

that all animals are derived from an ovum, with

the innate capacity to develop being influenced

by the male semen. The discovery by Reinier de

Graaf that follicles within the “female testes” were

released prior to the appearance of embryos

within the uterus gave credence to this belief,

although the actual origin and nature of an egg

remained obscure,

Despite the discovery of sperm by Anton van

Leeuwenhoek in the 1670s, the view prevailed

that all organisms arise from eggs that require

the stimulating effects of male semen to develop.

Most naturalists of the 1700s believed sperm to

be parasites of the testis with no function in fertilization. With the introduction of cell theory

in the rnid-1800s, sperm changed from being seen

as parasitic organisms to cells necessary for fertilization. Only some 135 years ago—in the 1850s

—was it resolved whether sperm played no role

in fertilization, kept the seminal fluid in circulation, activated the egg by mere contact, or actually penetrated the egg. By then, fertilization was

believed to involve the penetration and dissolution of the sperm within the egg, thus providing

a basis for belief in inheritance,

The manufacture of microscope lenses free

from chromatic and spherical aberration in the

late 1800s and the refinement of fixing, staining,

and sectioning techniques led to extensive investigations into cell and nuclear division. The discovery at that time of cell nuclei and chromosomes

generated a further controversy, not resolved

until the early 1900s, between those who argued

that fertilization involved a complete fusion of

male and female nuclear material and those who

denied this. To the former, fertilization was a

conservative blending process, while to the latter it led to variations in offspring. Recognition

of meiosis and chromosomal recombination in

the formation of sperm and egg cells resolved

this debate.

SOURCE: Adapted from W F. Bynum, E.J Browne, and R, Porter, Dictionary of

the Histo~ofScieme (Princeton, NJ” Princeton University press, 1981)

Photo credit: Mart/n Quigley

In vitro fertilization laboratory setup

activity in this area is the rapid growth of the biomedical literature on IVF and embryo transfer—

from only 8 papers in 1980 to over 300 in 1986

(11). The laboratory techniques of IVF and embryo culture no longer represent the major weak

point of noncoital reproduction, as repeatable

techniques move from program to program (29).

The principal determinant of the success of IVF

today may well lie in the physiological state and

developmental competence of sperm and eggs

used in the procedure (38). An additional determinant is synchronization of the cultured, cleaving embryos with receptivity of the uterine endometrium, and transfer at the optimum time.

Important scientific information concerning this

uterine “window of receptivity” is now becoming available (33).

Indications for IVF have broadened and will

likely continue to broaden beyond couples with

untreatable, tubal-factor infertility to include couples with endometriosis or with cervical factor,

male factor, or unexplained infertility-and essentially all infertile couples with whom conventional

infertility therapy (see ch. 7) has been used unsuccessfully or for whom there is no other therapy

available. As IVF is used in an increasing number

of circumstances that do not positively preclude

natural conception, conceptions that are actually

independent of treatment can be expected in these

programs (20,31). Such treatment-independent

pregnancies will overstate the apparent success

rate of IVF, although to what degree is uncertain.
Ch. 15–Frontiers of Reproductive Technology ● 295

The most comprehensive data on IVF success

rates in the United States come from 41 clinics

that treated 3,055 different patients in 1986 (28).

The clinics performed 4,867 stimulation cycles,

or 1.6 cycles per patient; the outcomes of these

cycles are listed in table 15-1. Some 59 percent

(2,864) of the stimulation cycles were followed by

embryo transfer. The median number of embryos

transferred was three.

Embryo transfer led to clinical pregnancies—

i.e., a positive fetal heart documented by ultrasound—in 485 cases, or 17 percent of the time.

The 485 clinical pregnancies led to 311 live births,

an unreported fraction of which were multiple

births. Thus, embryo transfer led to a live birth

less than 11 percent of the time. Put another way,

about 6 percent of the initial stimulation cycles

resulted in a live birth (28).

At the most expert IVF programs, success rates

exceed the average. One program that treated 650

different patients from 1983 through 1987 is profiled in table 15-2. The program performed 723

oocyte recovery procedures that led to 662 embryo transfer cycles. The average number of embryos transferred was four (35).

Embryo transfer led to confirmed pregnancies—

i.e., either a gestational sac confirmed by ultrasound or the products of conception identified

by pathologic specimen —in 208 cases, or 31 percent of the time. The 208 clinical pregnancies led

to 103 live births, an unreported fraction of which

were multiple births. Thus, embryo transfer led to

Table 15=1.—ln Vitro Fertilization in the

United States, 1986°

Outcome Number

Patients seen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3,055

Stimulation cycles . . . . . . . . . . . . . . . . . . . . . . . . . . . 4,867

Embryo transfer cycles . . . . . . . . . . . . . . . . . . . . . . . 2,864

Embryos transferred per cycle (median) . . . . . . . 3

Clinical pregnancies . . . . . . . . . . . . . . . . . . . . . . . . . 485

Ectopic pregnancies . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Miscarriages or stillbirths . . . . . . . . . . . . . . . . . . . . . 156

Live birthsc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311

aRetrospective data reported voluntarily by 41 U.S. clinics.

bpositivefetal hearf documented by ultrasound.

clncludes an unreported number of multiple bi~hs.

SOURCE: Medical Research International and the American Fertility Society Special Interest Group, “In Vitro Fertilization/Embryo Transfer in the United

States: 1965 and 1966 Results From the National IVF/ET Registry,” Ferti//ty and Sterility 49:212-215, 1966,

Table 15-2.-Statistical Profile of an Expert

In Vitro Fertilization Program, 1983.87°

Outcome Number

Patients seenb 

. . . . . . . . . . . . . . . . . . . . . . . . . . 650

Stimulation cycles. . . . . . . . . . . . . . . . . . . . . . . (not reported)

Oocyte recovery procedures . . . . . . . . . . . . . . 723

Oocytes recovered . . . . . . . . . . . . . . . . . . . . 3,759

Oocytes recovered per procedure (mean) . 5

Embryo transfer cycles. . . . . . . . . . . . . . . . . . . 662

Embryos transferred per cycle (mean) . . . . 4

Confirmed pregnanciesc. . . . . . . . . . . . . . . . . . 208

Live births . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 103

aData reported by the three facilities of National Fertility Institute, Inc. (Norfhern Nevada Fertility Center, Reno, NV; Pacific Fertility Center, San Francisco,

CA; Pacific IVF Institute, Honolulu, HI).

bAll women were under age 40; primary diagnoses were tubal disease (65 Percent), maie factor infertility (19 percent), and unexplained infertility (16 percent).

cGestational sac confirmed by ultrasound or products Of conception confirmed

by pathologic specimen.

dlncludes an unreported number of multiple biflhs.

SOURCE: G. Sher, Director, Pacific Fertility Center, San Francisco, CA, personal

communication, Jan. 25, 1966.

a live birth about 15 percent of the time. Put another

way, about 14 percent of the oocyte recovery procedures (and a smaller percentage of the initial

stimulation cycles) resulted in a live birth (35).

It maybe difficult for the most expert IVF programs to sustain their success rates as their good

reputations attract patients with the most difficult cases of infertility (e.g., unexplained infertility). Similarly, an increase in the average age of

patients would likely trim an IVF program’s success rates. Information about a clinic’s patient mix

is crucial to interpreting its success rates (see ch. 9).

IVF programs can serve as a source of biological materials, providing an opportunity for experimentation that adheres to legal and ethical principles and that yields valuable information about

human fertilization. Table 15-3 gives an overview

of components of the IVF procedure whose examination, correlated retrospectively with the outcome of a given case of IVF, could yield relevant

information for human fertility research (38).

An offshoot of research surrounding IVF is likely

to be, paradoxicaIIy, progress in contraceptive development. Contraceptive methods that precisely

block the interaction between sperm and egg–

thus preventing fertilization without systemic ef -

fects on the body as a whole—have long been

sought by reproductive scientists (42). By bringing sperm and egg together under laboratory scrutiny, IVF provides this research opportunity (22).
——-

296 . Infertility: Medical and Social Choices

Table 15-3.—Sources of IVF Byproducts and Some Possibie Uses in Research

Source of IVF byproduct Research use

Sperm sampling Examination of sperm

(membranes, enzymes, bound antibodies, effects

of illness, studies of normal development)

Analyses of seminal plasma

(chemical composition, proteins, sperm

antibodies, function of seminal vesicles, prostate

function, screening for prostate cancer)

Recovery of oocyte/cumulus cells Analyses of follicular fluid

(hormones, proteins, sperm antibodies)

Sperm washing and preincubation Examination of preincubated sperm

(membranes, enzymes, bound antibodies,

character of motility, fertilizing capacity)

Change of media after in vitro Analyses of spent insemination media

insemination (secretions of cells that surround the oocyte:

steroids, peptides, proteins, biological effects)

Examination of cultured cumulus cells

(ultrastructure, steroid-producing enzymes, other

proteins)

Examination of supernumerary sperm

Examination of eggs that failed to cleave

(ultrastructure, chromosomes, zona antibodies,

interaction of sperm with zona pellucida)

Analyses of spent growth media

(steroids, proteins of embryonic origin)

Monitoring of pregnancy Examination of spontaneously aborted

conceptuses (chromosomes)

SOURCE: AdaDtad from J. Tesarik. “From the Cellular to the Molecular Dimension: The Actual Challenoe for Human Fertilization

Embryo transfer

Research,” Gamete Research 13:47-89, 1988

Despite the widespread practice of IVF in the

United States, there is today a de facto moratorium on Federal funding of any research involving in vitro fertilization of human sperm and egg,

fertilized ova, or early embryos. Research that involves in vitro fertilization of human sperm and

eggs is in effect excluded from Federal support

because of the absence since 1980 of an Ethics

Advisory Board within the Department of Health

and Human Services (DHHS); such a board is required to advise the Secretary as to the ethical

acceptability of such research (45 CFR 46.204(d)).

Within DHHS, research funding for human IVF

is under the jurisdiction of the Center for Population Research of NIH. Although the Center’s Reproductive Sciences Branch (with a fiscal year 1987

budget of $83.1 million) supports research on, for

example, sperm maturation and follicular hormone

production, it does not support research that involves fertilizing human eggs with human sperm

unless that research is directly related to IVF carried out as a part of an infertile couple’s routine

clinical care.

The Center reports receipt of 10 grant applications related to human IVF between 1980 and

1987. One proposal, for example, involved injection of human sperm into human ova in an attempt to overcome infertility that was thought

to be due to sperm antibodies in the female. Three

others proposed to correlate sperm characteristics (e.g., motility) with successful pregnancies.

Seven of the ten grant applications were approved

on scientific merit, but did not rank high enough

to be funded. In failing to achieve a fundable ranking, these applications were not candidates for

the next step, ethical review. Thus, from 1980 to

1987, no grant application involving human IVF

actually made it to the point where review by the

Ethics Advisory Board was required (21).

This blanket statement is misleading, however.

Investigators indicate that they do not submit
—

Ch. 15–Frontiers of Reproductive Technology ● 297

proposals involving in vitro fertilization of human related to human IVF if the Ethics Advisory Board

egg and sperm because of a widespread aware- were extant (21). At the moment, funding for reness of the de facto ban on such research. The search on human IVF comes from the private sec -

dimensions of this chilling effect of the morato- tor, including pharmaceutical companies and IVF

rium on IVF research are such that NIH estimates patients, through their fees, and from university

it might receive more than 100 grant applications and medical center operating budgets.

GAMETE INTRAFALLOPIAN TRANSFER

Since the first description of gamete intrafallopian transfer (GIFT) in 1984 (6), numerous reports

have appeared confirming its utility in treating

some types of infertility. One report combining

data from clinics in nine countries ranked the chief

diagnoses among GIFT patients as unexplained

infertility, endometriosis, and male factor infertility (see table 15-4). Overall, 29 percent of the

stimulation cycles resulted in clinical pregnancies

established by GIFT, making it biologically competitive with, if not superior to, IVF.

Table 15-4 indicates a broad range of effectiveness of GIFT, depending on the factors contributing to a couple’s infertility. Success in achieving a clinical pregnancy by means of GIFT ranged

from only 10 percent among couples with immunologically based infertility to a peak of 56 percent success among women with premature ovarian failure. It is important to note that as many

as one in three clinical pregnancies fails to go to

term.

It is unlikely, however, that gamete intrafallopian transfer will replace IVF. In most cases of

damage to the oviducts, for example, GIFT is not

an option (because the gametes need to be placed

into the oviduct), whereas IVF is possible (because

fertilized ova are placed in the uterus, bypassing

damaged oviducts). Yet in the years ahead gamete

intrafallopian transfer will likely become an increasingly popular option for cases of chronic unexplained infertility, for some cases of endometri -

osis, for cases where artificial insemination by

donor has failed, for infertility due to cervical factors, for men with various seminal deficits, and

for women with premature ovarian failure.

Proficiency with gamete intrafallopian transfer

is rapidly spreading among clinicians, and there

is no apparent technical barrier to it being offered

By most units that deal with reproductive medicine and treatment for infertility. Unlike IVF, no

requirement exists for expertise in, or a facility

for handling, embryo culture. On the other hand,

a clinical drawback to GIFT is that—if no pregnancy ensues—the procedure provides no diagnostic information about the fertilizability of the

female’s oocytes by the male’s sperm. Defects in

Table 15-4.—Clinical Pregnancies Following GIFTa

Number of Number of Success rateb

Etiology stimulation cycles clinical pregnancies (percent)

Unexplained infertility . . . . 796 247 31

Endometriosis . . . . . . . . . . . 413 132 32

Male factor . . . . . . . . . . . . . . 397 61 15

Tubo-peritoneal . . . . . . . . . . 210 61 29

Failed artificial

insemination by donor . . 160 66 41

Cervical . . . . . . . . . . . . . . . . . 68 19 28

Immunological . . . . . . . . . . . 30 5 10

Premature ovarian failure. . 18 10 56

Total . . . . . . . . . . . . . . . . . 2,092 601 29

aRe9ultS of a multinational cooperative Study.

bperCent of stimulation ~yCleS leadingto a clinical p~egnancy, As many as one in three such clinical pregnancies fails to go

to term.

SOURCE: R.H. Asch, UCUAMI Center for Reproductive Health, Garden Grove, CA, personal communication, December 1987.
298 ● Infertility: Medical and Social Choices

the fertilizing ability of sperm or oocytes that drawback is that, unlike IVF, gamete intrafallomight have been identified during IVF can go un - pian transfer usually requires the woman to unnoticed with gamete intrafallopian transfer, when dergo general anesthesia.

gametes are placed in the oviduct. An additional

UTERINE LAVAGE TO RETRIEVE A FERTILIZED OVUM

Since 1983, about a dozen viable pregnancies

have been reported as a result of flushing a preimplantation embryo (a fertilized ovum) from the

uterus of a fertile donor and transferring it to an

infertile recipient (8,9,16). This procedure initially

seemed promising, particularly for infertile recipients without ovaries or with premature ovarian

failure.

The future of this technique is uncertain (37).

First, the success of IVF and gamete intrafallopian

transfer, using multiple donor eggs, in treating

women with premature ovarian failure exceeds

that of fertilized ovum transfer where, to date,

only one fertilized ovum at a time is transferred.

Also, it remains to be shown that safe supranormal stimulation of the ovaries of ovum donors is

possible in the ovum transfer technique.

Second, active IVF or gamete intrafallopian

transfer programs, with sufficient patient popuFREEZING

Embryo freezing is an attractive adjunct to IVF

to conserve embryos, obviate the need for repeat

egg retrieval procedures, and reduce the risk of

multiple pregnancy when several embryos (i.e.,

more than three or four) are available for transfer. In Australia and Europe, about 60 children

have been born from the transfer of thawed embryos; the first such U.S. birth occurred in 1986.

Two dozen or more IVF programs in the United

States have stored frozen embryos, but the technique is still experimental and requires additional

research to improve success.

Initial research in France suggests that three

factors influence human embryo survival after

thawing: the developmental stage of the frozen

embryos, the appearance of the embryo at the

time of freezing, and the mode of ovarian stimu -

lations providing an abundance of extra donor

eggs and with a ready number of hormonally

receptive recipients, can more easily arrange for

donation of unused eggs. With increasing success

in freezing eggs in years down the road, however,

IVF and gamete intrafallopian transfer patients

who now donate may become reluctant to do so

when they themselves could receive the same eggs

at a later date. At the same time, efficient freezing would eliminate the need to synchronize donor

with recipient in the lavage procedure.

Third, certain risks to the fertile donor, such

as ectopic pregnancy, multiple pregnancy as a consequence of supranormal stimulation of ovulation,

and transmission of disease (e.g., acquired immunodeficiency syndrome) via semen, may render this technique impractical if not reduced to

negligible levels. Such risks may be unacceptable

for some in light of the suitability and success rates

of IVF and GIFT.

EMBRYOS

lation in the IVF cycle

optimal success was

(39). In the French study,

obtained by using programmed hormonal stimulation and selecting for

l-cell embryos or 2- and 4-cell embryos with a

favorable appearance. There was also a tendency

for better pregnancy rates if embryo storage did

not exceed 1 to 2 months.

Research with cryopreserved animal embryos

suggests that embryos frozen and stored in liquid nitrogen at – 1960 C remain viable for 10 years

or more, similar to cryopreserved sperm. Embryo

freezing technology is especially well developed

for laboratory mice and cattle; in farm animals

(cattle, sheep, goats, and horses) as a group, the

expected pregnancy rates from frozen-thawed embryos range from 35 to 55 percent (18). The farm

animal embryos that exhibit the best viability fol -
Ch. 15—Frontiers of Reproductive Technology . 299

lowing freezing are those frozen at the morula the stage (i.e., 1 to 8 cells) at which most human

or blastocyst stage of development, well beyond embryos have been frozen to date.

FREEZING EGGS

Three births have been recorded in Australia

and West Germany from eggs that were frozen

and thawed. The routine capability to freeze and

store eggs, in much the same manner that sperm

are frozen for later use, would obviate much of

the need to freeze embryos, thereby reducing the

ethical and legal dilemmas inherent in the cryopreservation of human embryos (see chs. 11 and

13). An egg’s chromosomes, however, are less

hardy than a sperm’s (which are highly condensed),

and their fragility may make them intolerant of the

rigors of freezing and thawing. The possibility of

developmental anomalies arising in offspring conceived from frozen eggs—a major unanswered

question—is cited as justification for chromosomal

analysis of such embryos before attempting transfer of other such embryos for pregnancy. As with

several of the technologies discussed in this chapter, this raises the issue of embryo use for research

rather than pregnancy (22).

The most pressing clinical applications for freezing eggs arise in situations where women face the

loss of fertility due to pelvic disease, surgery, or

imminent radiation or chemotherapy for ovarian

cancer or other malignancies. Patients could have

one or more cycles of ovarian hyperstimulation

so that oocytes could be collected and stored prior

to the fertility-threatening treatment (26).

Oocyte freezing and thawing is technically more

difficult and costly than embryo freezing and

thawing. First, unlike a multicellular embryo, an

egg consists of a single cell surrounded by a single membrane, damage to which kills the egg. Second, eggs must be frozen soon after retrieval, on

a daily basis in a laboratory, whereas embryos

can be maintained in culture and frozen in batches

every other day or so. Third, in order to ultimately

obtain a sufficient number of fertilized embryos,

extra eggs must be frozen and thawed to account

for the failure of some eggs to fertilize, For the

latter reason, cryopreservation of eggs would have

to be more successful than cryopreservation of

embryos in order to be competitive, Therefore,

in the near term, egg freezing is unlikely to surpass embryo freezing (40,41). With improved technology (2), however, and if chromosomal damage

is not a factor, egg freezing could take its place

alongside cryopreservation of sperm in the mainstream of reproductive technology.

MICROMANIPULATION OF SPERM INTO OVA

In animals, the microscopic surgical placement

of a single sperm into an egg can achieve fertilization and trigger cleavage, but there has been

little success in triggering embryonic development

and producing offspring. Establishing such a treatment for humans would permit infertile men who

either produce a reduced number of sperm (severe oligospermia), produce ejaculates with a large

percentage of abnormal sperm, or produce sperm

that are unable to fertilize their wives’ ova to attempt fertilization by means of IVF by sperm

micromanipulation (22)34). The ability to inject

sperm cells could also be useful in conjunction

with a reliable technique for separating X- and

Y-bearing sperm (discussed in next section), if that

technique had a low yield of viable sperm (15).

One type of micromanipulation of sperm involves insertion of a sperm under the egg’s outer

membrane, the zona pellucida, by using a fine glass

needle that mechanically breaches the membrane.

Successful fertilization of a human oocyte (but not

embryonic development) was reported with this

technique in Australia in 1987 (24). Another type

of micromanipulation, called “zona drilling, ” involves chemically etching the egg’s outer membrane to create an opening for sperm penetration. The egg is anchored into place on a dish and
300 ● Infertility: Medical and Social Choices

cessful human and domestic animal pregnancies

may be recorded before the next decade is out.

This technique is of potentially great value for

treating male factor infertility, most of which is

due to unexplained oligospermia. The technique

carries the risk, at least in theory, of fertilizing

an egg with a sperm that otherwise would have

been unable to fertilize the egg, with unknown

developmental consequences.

Micromanipulation of a different sort also lies

on the visible horizon—i.e., the multiplication of

genetically identical individuals through cloning.

Initial research in sheep and cattle indicates that

nuclei from multicellular embryos can be injected

into unfertilized, enucleated eggs and produce offspring of the same genotype (18)47). The research

necessary to develop such a technique in humans

is unlikely to soon be deemed ethically acceptable

in the United States for several reasons, not the

least of which is concern about deliberately creating genetically identical humans.

SEXING SPERM CELLS

The only established difference between female

(X-bearing) sperm and male (Y-bearing) sperm is

DNA mass, with Y-bearing sperm being about 3

percent lighter in weight than X-bearing sperm.

Many articles have appeared in the scientific literature on attempts to separate X- and Y-bearing

sperm. Most studies have been conducted on the

semen of laboratory animals, most often rabbits.

Methods evaluated over the years (1) include separation by mass, electric charge, or staining, and

sperm migration through cervical fluids. other

methods focus on manipulation of vaginal chemistry by diet or douching in order to select sperm.

Although individual experiments using some of

these approaches have been encouraging, usually

the results could not be replicated.

The most recent approach to sexing human

sperm cells involves the use of a protein solution,

bovine serum albumin, to separate X- and Ybearing sperm (13). According to the theory behind this procedure, Y-bearing sperm migrate

preferentially into the protein solution and can

then be washed and used for artificial insemination in an attempt to conceive a male. This method

is protected by patents in the United States and

abroad and has been used by some 50 clinics

worldwide to produce about 400 babies. Although

it is reported to tip the sex balance of offspring

from the norm of just over 50 percent males to

as high as 75 percent males, some members of

the scientific community remain skeptical of even

this degree of success attributed to semen sexing

technology. In 1986, the American Fertility Society stated that current techniques for separating

X- and Y-bearing sperm are not adequate to provide reasonable assurance of success (3).

Selection for X-bearing sperm has been attempted

with at least two methods. In one, X-bearing sperm

are separated from Y-bearing sperm using solutions with different densities (23). In another,

sperm are flushed through columns that preferentially retain Y-bearing sperm because of their

smaller size. The X-bearing sperm flow through

the column and can be used for insemination. Too

few births have been reported to date to adequately evaluate this technique for producing

females,
Ch. 15—Frontiers of Reproductive Technology . 301

It is noteworthy that the ability to sex semen

of farm animals and influence the sex ratio of animal progeny would be of great economic benefit

to commercial livestock producers. A male calf

of a dairy cow may be worth only $5o, for example, while a female calf may be worth 10 times

as much. The strong economic incentive in the

livestock industry for sex selection–as well as human interest in selecting the sex of children, in

some cases to avoid sex-linked genetic diseases—

will continue to drive research in sexing of sperm

for the foreseeable future.

In humans, there is likely an upper limit to the

popularity of sex selection by separation of X- and

Y-bearing sperm, should a reliable method become

available. The process requires artificial insemination of the woman once the sperm are separated, and the overwhelming majority of couples

are likely to prefer intercourse. Thus, the intrusive nature of artificial insemination will probably

limit the broad use of sex selection, regardless of

how reliable the selection of X- and Y-bearing

sperm becomes in the future.

SEXING EMBRYOS

Although sexing the human fetus by evaluating chromosomal spreads in embryonic cells (collected by chorionic villi sampling or amniocentesis) is a well-established clinical procedure, sexing

human embryos by such karyotyping has only recently been considered. Applying this procedure

involves doing a biopsy of the embryo to examine the sex chromosomes of one cell. Such karyotyping has been reported in mice and cattle, but

this method is unlikely to be developed for use

in humans unless there is a general acceptance

of human embryo biopsy. In such a case, embryonic cells would be evaluated from the biopsied

part of the embryo, and the embryo would be

made ready for transfer (18).

Researchers in the United Kingdom have demonstrated the identification of human male embryos using a commercially available DNA probe

for Y-chromosomal DNA (46). The embryos, created solely for research purposes, were at the 2-

cell through blastocyst stages. The DNA probe was

applied to whole embryos, not samples of cells;

it left the embryos unviable and the process took

4 to 8 days. Sexing embryos by this method will

ultimately require embryo splitting and, because

of the time required for the process, embryo freezing with later transfer. This is likely to become

technically feasible, but will remain a laboratory

technique without popular application for the

foreseeable future. Basic studies of nonhuman

preimplantation embryos may provide new approaches to embryo sexing.

GENETIC SCREENING OF GAMETE DONORS

It is impossible to exclude all sperm or egg

donors capable of transmitting genetic disorders.

Indeed, most couples conceiving a genetically abnormal child through intercourse show no characteristic that distinguishes them from couples

having genetically normal children. In fact, the

more severe an autosomal dominant trait, the

greater the likelihood that the trait will have arisen

in an affected individual as a result of a new

mutation—i.e., one arising in the egg or sperm responsible for fertilization. Likewise, there is usually no recorded history of exposure to deleterious agents, nor are there consistently identifiable

socioeconomic factors. The same can be expected

for IVF, gamete intrafallopian transfer, and artificial insemination (37). In practice, relatively few

prospective donors are excluded for genetic reasons (45).

Despite these limitations, some genetic screening is possible. A goal of excluding donors likely

to place a pregnancy at greater risk than the rate

of seriously anomalous offspring expected for the

general population–about 3 percent–has been

called realistic (36). No uniform criteria for such

screening exist, but various guidelines have been
302 ● Infertility: Medical and Social Choices

suggested. Some methods include lengthy and

often unwieldly donor screening forms for physicians to use while eliciting a complete history

and conducting a physical examination.

Guidelines proposed in 1986 by the American

Fertility Society (4) recommend that sperm donors:

have no malformations, have no nontrivial Mendelian disorder, have no adult-onset disease with

a genetic component (e.g., hypertension or epilepsy), not be a heterozygote for an autosomal

recessive gene known to be prevalent in the

donor’s ethnic group for which heterozygosity can

be determined, have no chromosomal rearrangement, be young, and have an Rh type compatible

with that of the prospective mother. Similar exclusions pertain to egg donors.

In addition, first degree relatives (i.e., parents

and offspring) of male and female gamete donors

should not have any nontrivial anomalies, autosomal dominant disorders of reduced penetrance

or late age of onset, or autosomal recessive disorders of a high frequency in the population. For

prospective female donors, those with heterozy -

gosity for an X-linked recessive disease are also

excluded.

The practical impact and uniform application

of these guidelines are today unknown. OTA surveyed practitioners of artificial insemination in

the United States, asking-among other questions

—if the practitioner uses professional society

guidelines and, if so, which ones (43). The guidelines are certain to assume increasing importance

with the continued practice of noncoital reproduction and as the capability to test for human

genetic disorders grows.

In recent years, the powerful techniques of

molecular biology have been used to locate genes

or chromosomal loci responsible for several inherited diseases, such as Huntington’s disease,

Duchenne’s muscular dystrophy, familial Alzhei -

mer’s disease, autosomal dominant manicdepres -

sive disease, myotonic dystrophy, and familial

amyloidotic polyneuropathy. Likely to be located

in the near future are genetic loci for neurofibro -

matosis, familial spastic paraparesis, and torsion

dystonia. Further in the future lies the possibility

of locating the gene for virtually any dominantly

inherited disorder, provided that sufficiently large

families with the disorder are available for analysis (27). With tests for a growing number of human genetic disorders likely to become available

through the next decade, diagnostic testing of gamete donors for a handful of genetic diseases may

become routine.

HEALTH OF INFANTS CONCEIVED BY IVF OR GIFT

Initial reports indicate that babies conceived in

the laboratory through IVF face the same low risk

of birth defects as babies conceived through intercourse. This finding comes from several studies,

including one of 164 babies conceived between

1983 and 1985, half by IVF and half by normal

means (48). A French study of 2,342 IVF pregnancies around the world found no significant increase in the rate of birth defects, once the data

were corrected for the risks of increased maternal age and multiple pregnancies (10). Among 574

live births following IVF at 41 U.S. clinics in 1985

and 1986, 18 chromosomal abnormalities or congenital anomalies were recorded (3 percent) (28).

In contrast, a study from North Carolina of 70

IVF pregnancies reports an excessively high 6

anomalies (30).

As with IVF, early indications are that gamete

intrafallopian transfer confers no risk of excessive congenital abnormalities. The first 800 GIFT

cases worldwide resulted in one chromosomal abnormality, a trisomy 21 (7).

Rigorous proof that neither IVF nor gamete intrafallopian transfer contributes to an increased

prevalence of anomalies in offspring is today

limited primarily by small numbers of potential

subjects (37). For example, a sample size of 1,151

IVF pregnancies and 1,151 controls would be required to exclude (with 95 percent certainty) a

threefold increase in chromosomal abnormalities

that have an incidence of 0.5 percent. To detect

a twofold increase, the required sample size would

be 4,668 in each group. A sample size of 244 IVF
Ch. 15–Frontiers of Reproductive Technology ● 303

pregnancies would be required to exclude a threefold increase in total congenital anomalies (3 percent incidence), whereas 748 would be necessary

to detect a doubled increase.

The IVF or gamete intrafallopian transfer population is also less than ideal to study because of

inherent limitations in sample characteristics. Pooling tabulated outcomes of IVF or gamete intrafal -

lopian transfer pregnancies—although fashionable—is hazardous because groups of women

achieving such pregnancies come from diverse

geographic areas and countries, with possible exposure to a host of potentially deleterious agents.

An even more important confounder is the varying history of infertility among pooled patients:

idiopathic infertility, for example, may be related

to (as yet undetectable) genetic abnormalities in

sperm or eggs. Finally, criteria for anomaly assessment are not standardized.

MATERNAL HEALTH CONSEQUENCES OF IVF AND GIFT

Women undergoing IVF or other forms of noncoital reproduction are not comparable to the general population. Their pregnancy outcomes, therefore, are not likely to be comparable. Inability to

have achieved pregnancy readily dictates that such

couples are older than the childbearing population at large. As a result, they are expected to be

at increased risk for a variety of age-related adverse perinatal outcomes (25). older women naturally have had a longer time to manifest certain

illnesses (e.g., chronic high blood pressure) that

might not have been evident had they been able

to achieve pregnancies earlier in life. Research

will be needed to verify the present thinking that

there is no apparent reason to suspect maternal

complications in excess of those found in a comparable age group.

Adequate studies of maternal health consequences are today lacking, and there are at least

two practical problems in conducting such research. First, the worldwide experience with IVF

totals about 5)

000 births; that of gamete intrafallopian transfer is about half that number, and fertilized ovum transfer far less. These numbers are

too small for statistically rigorous studies. Second,

IVF couples generally come from diverse geographic venues, even when treated at a given center. Successful pregnancies are usually delivered

in a couple’s local community, where outcomes

are not monitored in a consistent fashion.

In the United States, one report of maternal consequences of IVF consists of 125 pregnancies conceived between 1981 and 1984 (5). These resulted

in 100 deliveries, producing 115 babies. Only 12

deliveries actually happened at the IVF clinic (Norfolk, VA); 88 deliveries occurred elsewhere in the

United States and in three foreign countries. The

spontaneous clinical abortion rate (18.4 percent)

was slightly higher than that of the general popu -

Iation, but similar to that of women undergoing

ovulation induction. In 1986,485 clinical pregnancies among 41 U.S. IVF clinics resulted in 151 miscarriages (31 percent) (28). Another study reports

a spontaneous clinical abortion rate of 28 percent

among women 40 years and older undergoing IVF

(32).

A higher than normal rate of delivery by cesarean section—despite no indication of increased

likelihood of fetal distress-has been noted among

IVF pregnancies (5). The increased rate of cesarean section may be a consequence of high levels

of anxiety generated in physician and patient alike

by an IVF pregnancy. This leads to a tendency

to take every medical precaution at delivery, a

circumstance generally favoring cesarean rather

than vaginal delivery.

When ovarian stimulation with human menopausal gonadotropin or clomiphene citrate is undertaken prior to IVF or gamete intrafallopian

transfer, hyperstimulation can land the woman

in the hospital. Among IVF clinics, this has been

reported at the rate of 1.2 to 1.5 patients per 1,000

stimulation cycles (28).
304 . Infertility: Medical and Social Choices

PSYCHOLOGICAL EVALUATION OF PARTICIPANTS

IN NONCOITAL REPRODUCTION

The circle of participants in reproduction today

encompasses biological parents, legal parents, and

immediate family members of participants (e.g.,

siblings of a child conceived through assisted reproduction technology). It also includes medical

personnel who share responsibility for the successes and more numerous failures of the procedures, as well as those whose participation in

assisted reproduction was rejected (e.g., unsuitable gamete donors or surrogate mothers). Each

group of individuals is subjected to unique stimuli

and can be expected to exhibit a range of psychological responses. Yet few participants have been

systematically studied, and little is known about

the psychology of participants in assisted reproduction.

The intended child is the principal participant

in assisted reproduction and arguably the individual whose psychological status is of greatest

concern. Three major psychological questions regarding the child are:

●

●

●

What are the developmental sequelae, if any,

of prenatal procedures such as in vitro embryo culture or embryo cryopreservation?

In the case of surrogate motherhood, what

is the child’s relationship with his or her birth

mother (even if the relationship occurs only

in the child’s fantasy life)?

In the case of ovum donation or artificial insemination by donor, what is the child’s relationship to his or her genetic parent(s) (again,

even if this occurs only in the child’s fantasy

life)?

From the child’s perspective, ovum donation or

artificial insemination by donor may at times dif -

fer from adoption–with unknown psychological

consequences to the child. Adoption, for example, can involve parents giving up a child for the

child’s own good. In contrast, gamete donation

can involve parents giving up gametes with no

knowledge of the child to be born and at times

for the parent’s financial reward.

The major research question regarding participants in assisted reproduction is the descriptive

Photo credit: Martin Quigley

Identification of egg under microscope in

IVF laboratory

measurement of what happens to them psychologically from the first contact with infertility

evaluation and treatment through the years that

follow. This type of controlled, longitudinal research is essential. The National Institute of Child

Health and Human Development is moving toward

establishing a health surveillance system of women

undergoing treatment for infertility with IVF (44).

Similar systems would be useful for the children

so conceived, the genetic (donor) parents and

spouses, and spouses of those who underwent infertility treatment (who may themselves undergo

treatment),

Along with controlled, longitudinal research,

studies are needed of the baseline psychological

status of each group of participants. Such studies

are necessary both to quantify the subsequent psychological effects of assisted reproduction as well

as to assist in the selection of participants. Research is needed, for example, to determine

whether couples seeking assisted reproduction

have special psychological problems that would

render them unfit candidates for treatment.

No widely accepted psychological criteria currently exist that couples seeking a child must meet

before they can be considered as participants in
Ch. 15–Frontiers of Reproductive Technology ● 305

an assisted reproduction program. Neither, of

course, are there standard criteria for a couple

seeking a child by means of intercourse. Establishing criteria for couples desiring to undertake

assisted reproduction may permit caregivers to

impose their values on the selection process—

raising questions about who should be involved

in and responsible for developing such criteria

(17). Yet such criteria have been assessed as useful for helping to guide the behavior of the caregiver assisting a couple. Criteria could include the

following (14):

●

●

The presence of a stable psychosocial environment. An applicant couple on the brink

of divorce, for example, would be poor candidates. Likewise, applicants troubled by addictive behaviors (i.e., drug or alcohol abuse)

would be unsuitable.

Evidence of authentic motivation. Each spouse

should be participating because of the desire

to raise a child, and not, for example, under

the threat of divorce if he or she did not participate.

Research is needed on the predictive validity of

these criteria, as well as on useful criteria for other

participants in assisted reproduction, particularly

the genetic parents (the donors).

A final critical question is how an infertile couple resolve their childlessness if infertility persists

and adoption is rejected. What are the developmental factors, thought processes, or emotional

involvement necessary to accept childlessness?

What are the societal attitudes that affect a couple’s ability to live contently without children? It

is especially important to identify the treatment

strategies that mental health professionals can

bring to bear to assist a couple in the resolution

of this final stage of infertility.

SUMMARY AND CONCLUSIONS

Two reproductive technologies first applied to

humans within the past decade are today helping

a small, but measurable, fraction of infertile couples form families and will continue to do so for

the foreseeable future. The chances of achieving

a successful pregnancy in the hands of the most

expert practitioners are estimated to be about 15

to 20 percent for one completed IVF cycle and

about the same for one completed attempt at gamete intrafallopian transfer. The number of infertile couples offered these techniques is likely

to increase in the future as the techniques are

applied to infertility of more varied causes than

at present. The once-promising technique of uterine lavage to retrieve a fertilized ovum, followed

by embryo transfer, is unlikely to continue to be

offered to infertile couples.

The next decade will likely see the proliferation

of embryo freezing as an adjunct to IVF, although

early success with freezing eggs would likely preclude embryo freezing. Freezing eggs, however,

stands as a formidable technical task and may

involve an insurmountable biological obstacle—

damage to the fragile chromosomes of the oocyte.

Researchers seeking to examine fertilization of

human sperm and eggs, fertilized ova, or early

embryos face a de facto moratorium on funding

of such investigations by the Department of Health

and Human Services, unless the study is directly

related to IVF carried out as part of an infertile

couple’s routine clinical care. Research to study,

for example, why some sperm do not fertilize eggs,

or why some eggs are not fertilizable, is not funded

by the National Institutes of Health.

Successful pregnancies following microinjection

of a single sperm into an egg—recorded in neither animals nor humans, to date—would mark

dramatic progress in the treatment of male factor infertility, most of which is caused by too few

or abnormal sperm.

Reliable separation of X- and Y-bearing sperm

for sex selection remains elusive despite many

such attempts. When sex selection of sperm cells

becomes possible, its use will be limited by the

willingness of couples to undergo artificial insemination. The development and use of techniques

to sex human embryos is likely to be retarded because such techniques involve splitting embryos
306 . Infertility: Medical and Social Choices

into one part for sexing and another part for transfer. Research on nonhuman preimplantation embryos may lead to alternative approaches for the

sexing of embryos.

Techniques for screening sperm and ova donors

for a limited number of genetic anomalies lie in

the foreseeable future. The practical application

of genetic screening by practitioners of artificial

insemination is uncertain, however, and no amount

of screening will exclude all donors capable of

transmitting genetic disorders.

The health of infants conceived by IVF or by

gamete intrafallopian transfer and that of their

mothers does not appear to deviate from norms

for comparable populations. Because of the small

numbers of individuals that have used these techessarily preliminary, and ongoing surveillance

would be prudent. Similarly, studies of the psychology of participants in assisted reproduction—

particularly the children–are warranted.

This brief review of selected reproductive technologies and areas of reproductive research suggests that, while Aldous Huxley’s vision of a Brave

New World has not been realized, some frontiers

of reproductive technology have been broached

and others are being approached. As a result, infertile couples today have a wider range of options than before, and some of today’s babies already have a qualitatively different pedigree. One

noted science fiction writer recently offered his

view of what the pedigree of tomorrow’s babies

nologies to date, however, such estimates are nec - might look like (see box 15-B).

Box IS-B.—A Look Ahead

Commonwealth of California, Department of Health’s Vital Records

CERTIFICATE OF LIFE

subject: Baby Boy, Miller

Date of Conception: Nov. 15, 2018, 12:15 p.m.

Place: Comprehensive Fertility Institute, Beverly Hills, CA

Number of Parents: Three, including surrogate mother—mother donated egg, father sperm

Method of Conception: In vitro fertilization followed by embryo transfer. Mother’s body had rejected

her artificial fallopian tube. After 8 days on Pergonal, mother produced two

eggs. Both were removed during routine laparoscopy and screened for possible defects. Eggs united with father’s sperm. After 48 hours in incubator,

embryos were removed from growth medium and placed in surrogate’s

womb. Only one embryo attached itself to uterine wall.

Prenatal Care: Ultrasound at 3 months. Fetal surgery performed at 5 months.

Date/Time of Birth: Jason Lawrence Miller born July 20, 2019, 4:15 a.m.

Father: Jason L. Miller, Sr.

Mothers: Amy Wong (natural); Maribeth Rivers (surrogate)

Birth Method: Newly lifed in Morningstar Birthing Center, division of Humana Corporation.

Natural delivery after 5-hour labor. Labor pains controlled though acupuncture. Therapeutic touch used for last hour of labor. Child’s father, adopted

sister, and natural mother attended the delivery.

Weight/Length: 10 lb.; 25 in.

Eye Color: Green

Projected Life Span: 82 years

SOURCE. Adapted from .A C Clarke, h!! 20, 2019’ LIfk in the 21s1 Cemuq (New York N} Macmillan, 1$W3
Ch. 15–Frontiers of Reproductive Technology ● 307

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1987.

22. Hodgen, G. D., Scientific Director, Jones Institute

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21, 1987.

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24. Laws-King, A., Trounson, A., Sathananthan, H., et

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26

27

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tion of a Single Spermatozoon Under the Zona Pellucid,” Fertilit y and Sterilit.V 48:637-642, 1987.

Lehmann, D. K., and Chism, J., “Pregnancy Outcome in Medically Complicated and Uncomplicated

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1020, 1987.

28. Medical Research International and the American

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29. Meldrum, D. R., Chetkowski, R., Steingold, K. A., et

al., “Evolution of a Highly Successful In Vitro Fertilization-Embryo Transfer Program,” Fertility and

Sterility 48:86-93, 1987.

30. Nebel, L., Mashiach, S., Rudak, E., et al., “Congenital Anomalies and Neonates Following IVF-ER; Teratological Analysis,” presentation at Fifth World

Congress on In Vitro Fertilization and Embryo

Transfer, Norfolk, VA, Apr. 5-10, 1987.

31. Roh, S.1., Chin, N., Awadalla, S. G., et al., “In Vitro

Fertilization and Embryo Transfer: TreatmentDependent Versus -Independent Pregnancies,” Fertility and Sterility 48:982-986, 1987.

32. Romeu, A., Muasher, S. J., Acosta, A., et al., “Results of In Vitro Fertilization Attempts in Women

40 Years of Age and Older: The Norfolk Experience,” Fertility and Sterility 47:130-136, 1987.

33. Rosenwaks, Z., “Donor Eggs: Their Application in

Modern Reproductive Technologies, ” Fertility and

Sterility 47:895-909, 1987.

34. Schrader, S. M., Andrologist/Toxicologist, Experimental Toxicology Branch, National Institute for

Occupational Safety and Health, Cincinnati, OH,

personal communication, September 1987.

35. Sher, G., Director, Pacific Fertility Center, San Francisco, CA, persona] communication, Jan, 25, 1988.

36. Simpson, J. L., “Genetic Screening for Donors in

Artificial Insemination,” Fertility and Sterility 35:

395-396, 1981.

37. Simpson, J. L., Professor and Chairman, Department of Obstetrics and Gynecology, The Health Science Center, The University of Tennessee, Memphis,

TN, personal communications, June and August

1987.

38. Tesarik, J., “From the Cellular to the Molecular

Dimension: The Actual Challenge for Human Fertilization Research,” Gamete Research 13:47-89,

1986.

39. Testart, J., Lassalle, B,, Forman, R., et al., “Factors

Influencing the Success Rate of Human Embryo

Freezing in an In Vitro Fertilization and Embryo

Transfer Program,” Fertility and Sterility 48:107-

112, 1987.

40. Trounson, A., “Preservation of Human Eggs and

Embryos,” presentation at 42d Annual Meeting of

the American Fertility Society, Toronto, Ontario,

Sept. 29, 1986.

41. Trounson, A., “Preservation of Human Eggs and

Embryos,” Fertility and Sterility 46:1-12, 1986.

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VA: National Technical Information Service, 1982).

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Artificial Insemination: Medical and Social Issues,

forthcoming.

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1987.

45. Verp, M. S., Cohen, M. R., and Simpson, J. L., “Necessity of Formal Genetic Screening in Artificial Insemination by Donor,” Obstetrics and Gynecology

62:474-479, 1983,

46. West, J. D., Angell, R. R., Thatcher, S. S., et al., ‘(Sexing the Human Pre-Embryo by DNA-DNA In-Situ

Hybridisation, ’’Lancet, June 13, 1987, pp. 1345-1347.

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Embryos, “ Nature 320:63-65, 1986.

48. Wirth, F.H., Morin, N., Johnson, D., et al., “Followup

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10, 1987.
Appendices
Appendix A

Sites Offering IVF/GIFT

in the United States

The following 169 facilities in 41 States, Puerto Rico,

and the District of Columbia, are reported to be accepting referrals or are actively engaged in in vitro

fertilization (IVF) or gamete intrafallopian transfer

(GIFT) as of March 1988, according to the American

Fertility Society and other sources.

Alabama

IVF Australia at Birmingham

Women’s Medical Plaza, Suite 508

2006 Brookwood Medical Center Drive

Birmingham, AL 35209

205-870-978 4

University of Alabama-Birmingham Medical

Center

Laboratory for In Vitro Fertilization-Embryo

Transfer

547 Old Hillman Building, University Station

Birmingham, AL 35294

205-934-5631

IVF/GIFT Program

University of South Alabama

Room 326

Cancer Center Clinical Science Building

Mobile, AL 36688

205-460-7173

Arizona

Arizona Center for Fertility Studies

In vitro Fertilization Program

4614 E. Shea Boulevard, D-260

Phoenix, AZ 85028

602-996-7896

Arizona Fertility Institute

2850 N. 24th Street, Suite 500A

Phoenix, AZ 85008

602-468-3840

Phoenix Fertility Institute P.C.

Good Samaritan Hospital

1300 North 12th Street, Suite 522

Phoenix, AZ 85006

602-252-8628

The Reproductive Institute of Tucson

El Dorado Medical Center

Tucson Medical Center, Bldg. 800

.5200 East Grant Road

Tucson, AZ 85712

602-325-0802

California

Alta Bates Hospital

In Vitro Fertilization Program

3001 Colby Street

Berkeley, CA 94705

415-540-1416

Berkeley-East Bay Advanced Reproductive

Service

2999 Regent Street, Suite 201

Berkeley, CA 94705

415-841-5510

Central California In Vitro Fertilization Program

Fresno Community Hospital

P.O. B OX 1232

Fresno, CA 93715

209-439-1914

Fertility Institute of San Diego

Sharp/Children’s Medical Center

9834 Genessee Avenue, Suite 300

La Jolla, CA 92037

619-455-7520

Scripps Clinic and Research Foundation

10666 N. Torrey Pines Road

La Jolla, CA 92037

619-457-8680

University of California at Irvine Memorial

Hospital

2880 Atlantic Avenue, Suite 220

Long Beach, CA 90806

213-595-2229

California Reproductive Health Institute

Division of In Vitro Fertilization

California Medical Hospital

1338 S. Hope Street

Los Angeles, CA 90015

213-742-5970

311
312 Infertility: Medical and Social Choices

Cedars-Sinai Medical Center

444 San Vicente Boulevard, Suite 1101

Los Angeles, CA 90045

213-855-2150

Century City Hospital

2070 Century Park East

Los Angeles, CA 90067

213-201-6604

Southern California Fertility Institute

California Institute for In Vitro Fertilization,

Right to Parenthood Program

12301 Wilshire Boulevard, Suite 415

Los Angeles, CA 90025

213-820-3723

Tyler Medical Clinic

921 Westwood Boulevard

Los Angeles, CA 90024

213-208-6765

University of California—Los Angeles School

Medicine

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

Los Angeles, CA 90024

213-825-7755

University of California—Irvine

Department of Obstetrics and Gynecology

101 The City Drive

Orange, CA 92668

714-638-1500

South Bay-AMI Hospital

In Vitro Fertilization Center

415 North Prospect Avenue

Redondo Beach, CA 90277

213-318-4741

Northern California Fertility Center

87 Scripps Drive, Suite 202

Sacramento, CA 95825

916-929-3596

Pacific Fertility Center

2100 Webster Street, Suite 22o

San Francisco, CA 94120

415-923-3344

University of California, San Francisco

In Vitro Fertilization Program

Inc.

of

Department of Obstetrics and Gynecology and

Reproductive Sciences

Room M 1480

San Francisco, CA 94143

415-666-1824

Stanford University

Department of Obstetrics and Gynecology

S-385 Medical Center

Stanford, CA 94305

415-723-5251

Fertility Medical Group of the Valley

In Vitro Fertilization Program-Northridge

Hospital

18370 Burbank Boulevard, Suite 301

Tarzana, CA 91356

818-946-2289

John Muir Memorial Hospital

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

1601 Ygnacio Valley Road

Walnut Creek, CA 94598

415-937-6166

Whittier Hospital Medical Center

The Genesis Program for In Vitro Fertilization

Center for Human Development

15151 Janine Drive

Whittier, CA 90605

213-945-3561, ext. 549

Colorado

Reproductive Genetics In Vitro

455 South Hudson Street

Level Three

Denver, CO 80222

303-399-1464

University of Colorado Health Sciences Center

In Vitro Fertilization Program

4200 East 9th Avenue

B OX B19 8

Denver, CO 80262

303-394-8365

Connecticut

University of Connecticut Health Center

Division of Reproductive Endocrinology &

Infertility

Farmington, CT 06790

203-674-2110

Mount Sinai Hospital

Department of Obstetrics and Gynecology

Division of Reproductive Endocrinology and

Infertility

675 Tower Avenue

Hartford, CT 06112

203-242-6201
App. A—Sites Offering IVF/GIFT in the United States ● 313

Yale University Medical Center

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

333 Cedar Street

New Haven, CT 06510

203-785-4019, 785-4792

Delaware

The Medical Centre of Delaware

Reproductive Endocrine and Infertility Center

P.O. B OX 6001

4755 Stanton-Ogletown Road

Newark, DE 19718

302-733-2318

District of Columbia

Columbia Hospital for Women Medical Center

In Vitro Fertilization Program

2425 L Street, N.W.

Washington, DC 20037

202-293-6500

George Washington University Medical Center

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

901 23rd Street, N.W.

Washington, DC 20037

202-994-4614

Florida

Shands Hospital

University of Florida

In Vitro Fertilization Center

Gainesville, FL 32610

904-395-0454

Fertility Institute of Northwest Florida

Gulf Breeze Hospital

1110 Gulf Breeze Parkway, Suite 202

Gulf Breeze, FL 32561

904-934-3900

Memorial Medical Center of Jacksonville

In Vitro Fertilization Program

3343 University Boulevard South

Jacksonville, FL 32216

904-391-1149

IVF Florida

HCA Northwest Regional Hospital

5801 Colonial Drive

Margate, FL 33063

305-972-5001

Mount Sinai Medical Center

University of Miami

4300 Alton Road

Miami Beach, FL 33140

305-674-2139

University of Miami

Department of Obstetrics and Gynecology: D-5

P.O. B OX 016960

Miami, FL 33101

305-547-5818

Naples Life Program

775 First Avenue North

Naples, FL 33940

813-262-1653

Orlando Regional Medical Center

Sand Lake Hospital

94OO Turkey Lake Road

Orlando, FL 32819-8001

305-351-8537

Florida Fertility Institute

Palms of Pasadena Hospital

3451 66th Street, North

St. Petersburg, FL 33710

813-384-4000

Humana Women’s Hospital

University of South Florida

3030 West Buffalo Avenue

Tampa, FL 33607

813-872-2988

Georgia

Reproductive Biology Associates

993-D Johnson Ferry Road, N. E., Suite 330

Atlanta, GA 30342

404-843-3064

Augusta Reproductive Biology Associates

810-812 Chafee

Augusta, GA 30904

404-724-0228

Humana Hospital

2 East, 3651 Wheeler Rd.

Augusta, GA 30910

404-863-6234

Hawaii

Pacific In Vitro Fertilization Hospital

Kapiolani Women’s and Children’s Hospital

1319 Punahou Street, Suite 104o

Honolulu, HI 96826

808-946-2226

76-580 - 88 - 11 : (JL 3
314 “ Infertility: Medical and Social Choices

Kauai Medical Group, Inc.

University of Hawaii

G.N. Wilcox Memorial Hospital

Department of Obstetrics and Gynecology

3420-B Kuhio Highway

Lihue, HI 96766

Illinois

Michael Reese Hospital and Medical Center

In Vitro Fertilization-Embryo Transfer Program

31st Street at Lake Shore Drive

Chicago, IL 60616

312-791-4000

Mount Sinai Hospital Medical Center

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

California Avenue at 15th Street

Chicago, IL 60608

312-650-6727

Northwestern Memorial Hospital

In Vitro Fertilization Program

Prentice Womens Hospital

333 East Superior Street, Suite 454

Chicago, IL 60611

312-908-1364

Rush Medical College

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

600 South Paulina Street

Chicago, IL 60616

312-942-6609

University of Illinois College of Medicine

Department of Obstetrics and Gynecology

840 South Wood Street

Chicago, IL 60612

312-996-7430

The Glenbrook Hospital

Northwestern Univerity

In Vitro Fertilization Program

2100 Pfingsten Road

Glenview, IL 60025

312-729-6450

Indiana

Indiana University Medical Center

Department of Obstetrics and Gynecology–

Reproductive Endocrinology

926 West Michigan Street, N-262

Indianapolis, IN 46223

317-264-4057

Pregnancy Initiation Center

Humana Womens Hospital

8091 Township Line Road, Suite 110

Indianapolis, IN 46260

317-872-5103

Iowa

University of Iowa Hospitals and Clinics

IVF-ET GIFT Program

Iowa City, IA 52242

319-356-1767

Kansas

University of Kansas College of Health Sciences

Obstetrics and Gynecology Foundation

39th and Rainbow Boulevard

Kansas City, KS 66103

913-588-6246

Kentucky

University of Kentucky

Department of Obstetrics and Gynecology

Kentucky Center for Reproductive Medicine

Lexington, KY 40536

606-233-5410

Norton Hospital

In Vitro Fertilization Program

601 Floyd Street, Room 304

Louisville, KY 40202

502-562-8154

Louisiana

Fertility Center of Louisiana

St. Jude Medical Center

200 West Esplanade Drive

Kenner, LA 70065

504-464-8622

Omega Institute

Elmwood Medical Center

4425 Conlin Street, Suite 101

Metairie, LA 70006

800-535-4177

Fertility Institute of New Orleans

Humana Women’s Hospital

6020 Bullard Avenue

New Orleans, LA 70128

504-246-8971

Tulane Fertility Program

In Vitro Fertilization Program

1415 Tulane Avenue

New Orleans, LA 70112

504-587-2147
App. A—Sites Offering IVF/GIFT in the United States 315

Maryland

Baltimore In Vitro Fertilization Program

2435 West Belvedere Avenue, Suite 41

Baltimore, MD 21215

301-542-5115

Greater Baltimore Medical Center

Women’s Fertility Center

In Vitro Fertilization Program

6701 N. Charles Street

Baltimore, MD 21204

301-828-2484

The Johns Hopkins Hospital

Division of Reproductive Endocrinology

In Vitro Fertilization Program

600 N. Wolfe Street

Baltimore, MD 21205

301-955-2016

Union Memorial Hospital

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

201 E. University Parkway

Baltimore, MD 21218

301-235-5255

Genetic Consultants

Washington Adventist

5616 Shields Drive

Bethesda, MD 20817

301-530-6900

Hospital

Montgomery Fertility Institute

10215 Fernwood Road, Suite 303

Bethesda, MD 20817

301-897-8850

Massachusetts

Beth Israel Hospital

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

330 Brookline Avenue

Boston, MA 02215

617-732-5923

Brigham and Womens Hospital

In Vitro Fertilization Program

75 Francis Street

Boston, MA 02115

617-732-4239

In Vitro Fertilization Center of Boston

Boston University Medical Center

75 East Newton Street

Boston, MA 02118

617-247-5928

New England Medical Center Hospitals

Division of Reproductive Endocrinology

260 Tremont Street

Boston, MA 02111

617-956-6066

Boston IVF

25 Boylston Street

Chestnut Hill, MA 02167

617-735-9000

Greater Boston In Vitro Associates

Newton-Wellesley Hospital

2000 Washington Street, Suite 342

Newton, MA 02162

617-965-7270

Michigan

Hutzel Hospital

In Vitro Fertilization Program

Wayne State University

4707 St. Antoine

Detroit, MI 48201

313-494-7547

Blodgett Memorial Medical Center

In Vitro Fertilization Program

1900 Wealthy Street S. E., Suite 330

Grand Rapids, MI 49506

616-774-0700

William Beaumont Hospital

In Vitro Fertilization Program

3601 West 13 Mile Road

Royal Oak, MI 48072

313-288-2380

Saginaw General Hospital

In Vitro Fertilization Program

Saginaw, MI 48603

517-771-4562

Minnesota

University of Minnesota VIP Program

Department of Obstetrics and Gynecology

Mayo Memorial Building, Box 395

420 Delaware Street, S.E.

Minneapolis, MN 55455

612-373-7693

Mayo Clinic

Department of Reproductive Endocrinology and

Infertility

200 First Street, S.lV., W-10

Rochester, MN 55905

507-284-7367
316 ● lnferti/ity: Medical and Social Choices

Mississippi

University of Mississippi Medical Center

Department of obstetrics and Gynecology

In Vitro Fertilization Program

Jackson, MS 39216

601-984-5300

Missouri

St. Luke’s Hospital

In Vitro Fertilization, Gamete Intrafallopian

Transfer Program

44th and Wornall Road

Kansas City, MO 64111

816-756-0277

Jewish Hospital of St. Louis

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

216 S. Kingshighway

St. Louis, MO 63110

314-454-7834

Missouri Baptist Hospital

In Vitro Fertilization Program

3015 N. Ballas Road, Room 301

St. Louis, MO 63131

314-432-1212, ext. 5295

Silber and Cohen

224 South Woods Mill Road

Suite 730

St. Louis, MO 63017

314-576-1400

Nebraska

University of Nebraska Medical Center

Department of Obstetrics and Gynecology

42nd and Dewey Avenue

Omaha, NE 68105

402-559-4212

Nevada

Northern Nevada Fertility Clinic

350 West 6th Street

Reno, NV 89503

702-322-4521

New Jersey

UMDNJ-School of Osteopathic Medicine

In Vitro Fertilization Program

401 Hadden Avenue

Camden, NJ 08103

609-757-7730

UMDNJ-Robert Wood Johnson Medical School

Department of obstetrics and Gynecology

In Vitro Fertilization Program

1 Robert Wood Johnson Place, CN19

New Brunswick, NJ 08903

201-937-7627

UMDNJ-University Hospital

Center for Reproductive Medicine

100 Bergen Street

Newark, NJ 07103

.201 -456-6029

New Mexico

Presbyterian Hospital

In Vitro Fertilization Program

Cedar Street Southwest

Albuquerque, NM 87106

505-841-4214

New York

Childrens Hospital of Buffalo

Reproductive Endocrinology Unit

140 Hedge Avenue

Buffalo, NY 14222

716-878-7232

Albert Einstein College of Medicine

In Vitro Fertilization Center at Womens Medical

Pavilion

88 Ashford Avenue

Dobbs Ferry, NY 10522

914-693-8820

North Shore University Hospital

Division of Human Reproduction: In Vitro

Fertilization

300 Community Drive

Manhasset, NY 11030

516-562-4470

Advanced Fertility Services PC

1625 Third Avenue

iNew York, NY 10028

212-369-8700

Columbia-Presbyterian Medical Center

Presbyterian Hospital In Vitro Fertilization

Program

622 West 168th Street

New York, NY 10032

212-694-8013

Cornell University Medical College

In Vitro Fertilization Program

515 East 71st Street, 2nd Floor

New York, NY 10021

212-472-4693
App. A—Sites Offering IVF/GIFT in the United States ● 317

Mount Sinai Medical Center

In Vitro Fertilization Program

One Gustave Levy Place

Annenberg 20-60

New York, NY 10029

212-241-5927

St. Luke’s-Roosevelt Hospital Center

[n Vitro Fertilization-Embryo Transfer Program

1111 Amsterdam Avenue

New York, NY 10025

2 12-870-6603”

Wayne H. Decker In Vitro Fertilization Program

1430 Second Avenue, Suite 103

New York, NY 10021

212-744-5500

IVF Australia at United

406 Boston Post Road

Port Chester, NY 10573

914-934-7481

[University of Rochester

University of Rochester

601 Elmwood Avenue

Rochester, NY 14642

716-275-2384

North Carolina

Hospital

CARE Program

Medical Center

Chapel Hill Fertility Services

109 Conner Drive, Suite 2104

Chapel Hill, NC 27514

91 !3-968-4656

University of North Carolina Medical School

Fertility Center

Division of Endocrinology and Infertility

Department of Obstetrics and Gynecology: 226H

Chapel Hill, NC 27514

919-966-5282

Duke University Medical Center

Department of Obstetrics and Gynecology

P.O. Box 3143

Durham, NC 27710

919-684-5327

Ohio

Akron City Hospital

In Vitro Fertilization-Embryo Transfer Program

525 East Market Street

Akron, OH 44309

216-375-3585

Jewish Hospital of Cincinnati

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

3120 Burnet Avenue, Suite 204

Cincinnati, OH 45229

513-221-3062

University of Cincinnati Medical Center

Division of Reproductive Endocrinology

231 Bethesda Avenue, ML 526

Cincinnati, OH 45267

513-872-5046

Cleveland Clinic Foundation

In Vitro Fertilization Program

9500 Euclid Avenue

Cleveland, OH 44106

216-444-2240

MacDonald Hospital for Women

In Vitro Fertilization Program

2105 Adelbert Road

Cleveland, OH 44106

216-844-1514

Mount Sinai Medica] Center

LIFE Program

University Circle

Cleveland, OH 44106

216-421-5884

Infertility and Gynecology

St. Anthony Hospital

1492 E. Broad Street

Columbus, OH 43205

614-253-8383

Midwest Reproductive Institute

1409 Hawthorne Avenue

Columbus, OH

614-253-0003

University Reproductive Center

Ohio State University Hospitals

410 West l0th Avenue

Columbus, OH 43210

614-421-8937; 421-8511

Miami Valley Hospital

In Vitro Fertilization Program

1 Wyoming Street

Dayton, OH 45409

513-223-6192, ext 4066
318 . Infertility: Medical and Social Choices

Oklahoma

Henry G. Bennett Fertility Institute

Baptist Medical Center of Oklahoma

3433 NW 56th, Suite 200

Oklahoma City, OK 73112

405-949-6060

Oklahoma University Health Sciences Center

Section of Reproductive Endocrinology

P.O. B OX 26901, 4SP720

Oklahoma City, OK 73190

405-271-8700

Hillcrest Fertility Center

1145 South Utica, Suite 1209

Tulsa, OK 74104

918-584-2870

Oregon

Oregon Health Sciences University

Oregon Reproductive Research and Fertility

Program

3181 SW Sam Jackson Park Road

Portland, OR 97201

503-279-8449

Pennsylvania

Hospital of the University of Pennsylvania

Department of Obstetrics and Gynecology

34OO Spruce Street, Suite 106

Philadelphia, PA 19104

215-662-2981

The Pennsylvania Hospital

In Vitro Fertilization-Embryo Transfer Program

Eighth and Spruce Streets

Philadelphia, PA 19107

215-829-5018

Albert Einstein Medical Center

Department of Obstetrics and Gynecology

York and Tabor Roads

Philadelphia, PA 19141

215-456-7990

St. Luke’s Hospital

In Vitro Fertilization Program

801 Ostrum Street

Bethlehem, PA 18015

215-691-7323

Christian Fertility Institute

241 North 13th Street

Easton, PA 18042

215-250-9700

Women’s Clinic Ltd.

In Vitro Fertilization Program, Suite 385

301 S. 7th Avenue

W. Reading, PA 19611-1499

215-374-7797

Puerto Rico

Hospital San Pablo

Edificio Medico Santa Cruz

73 Santa Cruz, Suite 213

Bayamon, PR 00619

809-798-0100

Rhode Island

Women’s & Infant’s Hospital of Rhode Island

In Vitro Fertilization Program

Providence, RI 02905

401-274-1100

South Carolina

Medical University of South Carolina

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

171 Ashley Avenue

Charleston, SC 29425

803-792-2861

The Southeastern Fertility Center

Trident Regional Medical Center Hospital

315 Calhoun Street

Charleston, SC 29401

803-722-3294

Tennessee

East Tennessee State University

Department of Obstetrics and Gynecology

P.0. B OX 19570 A

Johnson City, TN 37614

615-928-6426, ext. 334

East Tennessee Baptist Hospital

Family Life Center

7A Office 715

Box 1788, Blount Avenue

Knoxville, TN 37901

615-632-5697

University of Tennessee

Center and Hospital

1924 Alcoa Highway

Knoxville, TN 37920

615-971-4958

Vanderbilt University

Memorial Research

In Vitro Fertilization Program

D-3200 Medical Center North

Nashville, TN 37232

615-322-6576
App. A—Sites Offering IVF/GIFT in the United States c 319

Texa s

St. David’s Community Hospital

In Vitro Fertilization-Embryo Transfer Program

P.O. Box 4039 (1302 West 38th Street)

Austin, TX 78765

512-451-0149

Texas Endocrine and Fertility Institute

Trinity Medical Center

4323 North Josey Lane, Suite 206

Carrollton, TX 75010

214-394-0114

Presbyterian Hospital of Dallas

P.O. Box 17 (8160 Walnut Hill Lane)

Dallas, TX 75231

214-891-2624

The University of Texas-SW Medical School

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

5323 Harry Hines Blvd

Dallas, TX 75230

214-688-2784

Fort Worth Infertility Center

Harris Institute

1325 Pennsylvania Avenue, Suite 750

Fort Worth, TX 76104

817-335-0909

Baylor College of Medicine

Department of Obstetrics and Gynecology

In Vitro Fertilization Program

1 Baylor Plaza

Houston, TX 77030

713-791-2033

Memorial Reproductive Services

7600 Beechnut

Houston, TX 77074

713-776-5514

Texas Woman’s Hospital

7600 Fannin

Houston, TX 77054

713-795-7257

University of Texas Health Science Center

Department of Reproductive Science

6431 Fannin, Suite 3204

Houston, TX 77030

713-792-5360

University of Texas Medical Branch

Department of Obstetrics and Gynecology:

In Vitro Fertilization Program

Galveston, TX 7755o

409-761-3985

The West Houston Fertility Center

Sam Houston Memorial Hospital

1615 Hillendahl Boulevard

P.O. Box 55130

Houston, TX 77055

713-932-5600

Texas Tech University Health Sciences Center

Department of Obstetrics and Gynecology

P. O. B OX 456 9

Lubbock, TX 79430

806-743-2335

Humana Women’s Hospital of South Texas

Division of Reproductive Endocrinology

Center for Reproductive Medicine

8109 Fredricksberg Road

San Antonio, TX 78229

512-692-8971

University of Texas Health Science Center

Department of Obstetrics and Gynecology

77o3 Floyd Curl Drive

San Antonio, TX 78284

512-567-4955

Utah

University of Utah

Division of Reproductive Endocrinology

50 Medical Drive North

Salt Lake City, UT 84132

801-581-4837

Vermont

University of Vermont College of Medicine

Department of Obstetrics and

Given Building

Burlington, VT 05405

802-656-2272

Virginia

University of Virginia Medical

Department of Obstetrics and

In Vitro Fertilization Program

Charlottesville, VA 22908

804-924-0312

Genetics and IVF Institute

Fairfax Hospital

3020 Javier Road

Fairfax, VA 22031

703-698-7355

Gynecology

Center

Gynecology

Eastern Virginia Medical School

Jones Institute for Reproductive Medicine

Hoffheimer Hall, 6th Floor

825 Fairfax Avenue

Norfolk, VA 23507

804-446-8935
320 “ Infertility: Medical and Social Choices

In Vitro Fertilization Program

Henrico Doctors Hospital

1602 Skipwith Road

Richmond, VA 23229

804-289-4315

Medical College of Virginia

In Vitro Fertilization Program

Box 34—MCV Station

Richmond, VA 23298

804-786-9638

Washington

Swedish Hospital Medical Center

Reproductive Genetics

747 Summit Avenue

Seattle, WA 98104

206-386-2483

University of Washington In Vitro Fertilization

Program

Department of obstetrics and Gynecology: RH20

Seattle, WA 98195

206-543-0670

Infertility and Reproductive Associates

West 104 5th Avenue, Room 410

Spokane, WA 99204

Fertility Center of Puget Sound

3rd Floor, Puget Sound Hospital

South 36th and Pacific Avenue

Tacoma, WA 98408

206-475-5433

Tacoma Fertility Clinic

1811 South K Street

Tacoma, WA 98405

206-627-6256

West Virginia

West Virginia University

Department of Obstetrics and Gynecology

3110 MacCorkle Avenue, SE

Charleston, WV 25304

304-347-1344

Wisconsin

Appleton Medical Center

Family Fertility Program

1818 Meade Street

Appleton, WI 54911

414-731-4101, ext. 3380

University of Wisconsin Clinics

In Vitro Fertilization Program

600 Highland Avenue, H4/630 CSC

Madison, WI 53792

608-263-1217

University of Wisconsin-Milwaukee Clinical

Campus

Department of Obstetrics and Gynecology

Mount Sinai Medical Center

950 North 12th, PO Box 342

Milwaukee, WI 53201

414-289-8609

Waukesha Memorial Hospital

In Vitro Fertilization Program

725 American Avenue

Waukesha, WI 53186

414-544-2722
Appendix B

Self-Administered

Preconception Questionnaire

The following reproductive health questionnaire, developed at an OTA workshop held in Seattle, WA, is

intended for self -administration by young adults. Each

question is accompanied by an informative response.

This particular questionnaire is presented solely for

illustrative purposes and has not been tested or validated. It is intended to illustrate the type of questionnaire that could identify men and women who may

have a problem that might render them infertile in

the future (l).

Questions for Men

Do you feel that having children is very important to

your goals in life?

If you do, you should develop S- and 10-year life

plans that will include the opportunity to conceive and have children.

Have you considered the role of children in a marriage

and, if you are in a long-term relationship, reached

an understanding regarding number of children and

when you plan to have them?

If you are involved in a significant relationship,

you should initiate discussion on these issues.

Have you had unprotected intercourse for more than

1 year without your partner becoming pregnant?

You or your partner may be infertile.

True (yes) or false (no), a woman is only fertile 1 day

a month?

If you answered no, you may misunderstand the

relationship between the timing of sex and pregnancy. Seek further information.

Have both of your testes been in your scrotum since

birth? If not, have you had surgery or hormonal

treatment?

Consult your physician.

Are you experiencing, or have you experienced, frequent urination or a discharge or burning during urination?

You may have an infection that could affect your

future fertility and that of women with whom

you have had sex. See your physician and tell

your sex partner(s) to see one also.

Is one of your testes significantly larger than the other?

You could have a low sperm count, Consult your

physician.

Have you ever had a lump in the groin, or significant

pain of the testes or scrotum?

This lump or pain may indicate that you may

have problems producing sperm. Consult your

physician.

Have you ever noticed an extra fullness or pressure

in the scrotum or been told that you have varicose veins

in the scrotum?

You could have a varicocele or varicose veins in

the scrotum. Consult your physician, who may

examine your scrotum and do a semen analysis

and sperm count.

Do you use alcohol, cigarettes, marijuana, cocaine, or

prescription drugs?

Use of these products may reduce-your fertility.

Seek further information regarding their poten -

tial effects on your fertility.

Have you been exposed to radiation, chemotherapy,

pesticides, or other chemicals, or to diethylstilbestrol

(DES) when your mother was pregnant with you?

You could have decreased sperm production as

a result of this exposure. Consult your physician,

who may do a semen analysis and sperm count.

Have you ever had an operation on your testes or hernia repairs in the lower abdominal region?

You may have reduced fertility. Consult your physician.

Do you have more than 10 alcoholic drinks per week?

You may have semen abnormalities. Consult your

physician, who may do a semen analysis and

sperm count.

Do you frequently take hot tubs or saunas, or have

other chronic heat exposure?

You may have reduced fertility.

Can you name all of your sexual partners?

Multiple sexual partners expose you to increased

risk of acquired immunodeficiency syndrome

(AIDS), gonorrhea, herpes, and other conditions

321
322 “ Infertility: Medical and Social Choices

that can lead to infertility, significant illness, or

even death. It is important to consider the consequences of your sexual activity.

Have you had difficulty in achieving or sustaining

penile erections (potency) or sexual arousal (libido)

sufficient to successfully initiate or complete sexual

intercourse?

You could have a problem with the functioning

of your testes.

Have you ever been treated for cancer or lymphoma?

You could have a low sperm count. Consult your

physician.

Following urination, do you continue to dribble a few

drops of urine or stain your underwear with urine?

This might affect your general health or your

potential fertility. You probably have an infection of the prostate gland. Consult with your physician, who will need to examine you and possibly prescribe antibiotics.

Do you know how to avoid getting a venereal disease?

Venereal disease can be minimized by limiting

the number of sexual partners and by using barrier methods of contraception (i.e., condom, dia -

hragm, or contraceptive sponge, in concert with

foams or jellies).

Questions for Women

Do you feel that having children is very important to

your goals in life?

If you do, you should develop 5- and 10-year life

plans that will include the opportunity to conceive and have children.

Have you considered the role of children in a marriage

and, if you are in a long-term relationship, reached

an understanding regarding number-of children and

when you plan to have them?

If you are involved in a significant relationship,

you should initiate discussion on these issues.

Have you had unprotected intercourse for more than

I year without becoming pregnant?

You or your partner may be infertile.

True (yes) or false (no), a woman is only fertile 1 day

a month?

If you answered no, you may misunderstand the

relationship between the timing of sex and pregnancy. Seek further information.

Have you had a ruptured appendix and an appendectomy?

You may have pelvic adhesions reducing your

fertility. Consult your physician.

Have you ever had profuse vaginal discharge associated with pelvic pain?

You may have a pelvic infection. Consult your

physician to evaluate this history of infection.

Have you been exposed to radiation, chemotherapy,

pesticides, or other chemicals, or to diethylstilbestrol

when your mother was pregnant with you?

You may have an increased risk of pregnancy

complications. Consult your physician for evaluation of DES exposure.

Is your weight significantly above or below what it

should be?

Your fertility may be compromised. Seek information regarding a program for weight management.

Do you have a significant amount of pain with your

periods or at the time of intercourse?

You may have endometriosis, a condition associated with infertility. Consult your physician.

Have you ever been treated for fallopian tube infection, fallopian tube inflammation (salpingitis), uterine

infection, or pelvic inflammatory disease?

Fallopian tube infection can cause blocked or

damaged fallopian tubes that prevent pregnancy.

Are you currently using an intrauterine device (IUD)

for contraception?

You are at increased risk of tubal infection, which

can cause infertility. If you are using the Dalkon

shield, have it removed. If you are using another

type of IUD, consult your physician.

Have you noticed any increase in the amount or thickness of hair on your face, chest, or abdomen?

You could have a common hormone imbalance

that might effect your general health or your potential fertility. Consult your physician who might

perform laboratory testing to identify a particular abnormality.

Have you ever had an episode of abdominal pain, abnormal vaginal discharge, fever, or bleeding within a

few weeks of an abortion or delivery?

You may have had a fallopian tube infection.

Do you have a white or milky discharge from your

nipples that can be increased with gentle pressure?

You may have an elevated prolactin level. Consult your physician for a simple blood test.

Can you name all of your sexual partners?

Multiple sexual partners expose you to increased
App. B—Self-Administered Preconception Questionnaire ● 323

risk of AIDS, gonorrhea, herpes, pelvic inflammatory disease, and other conditions that can

lead to infertility, significant illness, or even

death. It is important to consider the conse -

quence of your sexual activity.

Do you exercise vigorously (e.g., swimming, running,

bicycling) for more than 60 minutes daily?

You may be at risk for an ovulatory problem.

If you menstruate less frequently than once every

40 days, consult your physician.

Has a sexual partner ever complained of burning during urination or pain at the time of ejaculation?

Your partner may have had a sexually transmitted disease he could pass to you. Consult your

physician regarding evaluation for history of infection.

Do you smoke more than one pack of cigarettes per

day?

Smoking may be associated with difficult conceiving and carrying a successful pregnancy to

term. Stop smoking!

Have you ever had a pregnancy in the fallopian tube

(an ectopic pregnancy)?

You may have fallopian tube damage.

Are you considering postponing childbearing beyond

age 30 for work, school, or other personal reasons?

Fertility decreases with age. You might wish to

have children sooner.

Did you have your first menstrual period at the same

time as your classmates?

If you had a delay of several years in the time

of your first menstrual period, you are at risk

of having problems with ovulation.

Do your mother or sisters have endometriosis?

You also may have endometriosis, a condition

associated with infertility. Consult your physician

regarding evaluation for endometriosis and a discussion of future plans for pregnancy.

Did you begin intercourse before the age of 20, have

greater than 5 previous sexual partners, or a sexual

partner with a genital infection or discharge?

Some sexually transmitted infections can produce fallopian tube damage.

Have you had any operations on your cervix such as

cone biopsy, cervical freezing, or electrocauterv?

Your cervical mucus quality may be poor, which

may compromise your ability to get pregnant.

Consult your physician for evaluation of your cervical mucus.

Have you ever had sexual relations with a man who

you think might have been homosexual, bisexual, or

a drug user?

You are at increased risk for AIDS. Consult your

physician to decide whether you should have a

test for AIDS,

Did your mother experience menopause before the

age of 40?

You could also experience early menopause. Consult your physician.

Have you had two or more voluntary abortions?

Use effective birth control to prevent cervical injury uterine scarring, or pelvic infection from

repeated abortions.

Do your menstrual periods last longer than 6 days,

come more frequently than every 24 days, or require

the use of both a tampon and pad together to maintain cleanliness during your period?

These factors are associated with a lack of regular ovulation.

Do you know how to avoid getting a venereal disease?

Venereal disease can be minimized by limiting

the number of sexual partners and by using barrier methods of contraception (i.e., condom, diaphragm, or contraceptive sponge, in concert with

foams or jellies).

Of the following, which do you think may affect your

fertility: weight loss, weight gain, dieting, exercise, hormone pills, or stress?

All these factors can prevent regular ovulation.

1

Appendix B Reference

Soules, M. R., “A Report on a Proposed Method To Prevent

Infertility: Self-Identification of Risk for Infertility, ” prepared for the Office of Technology Assessment, U.S.

Congress, Washington, DC, September 1987.
Appendix C

Fetal Research Laws

Possibly Affecting IVF

ARIZONA: Arizona bans use of “any human fetus

or embryo” in nontherapeutic research, but specifies

that research on embryos “resulting from an induced

abortion” is at issue. Since preimplantation embryos

created in vitro do not result from “an induced abortion,” this statute probably does not apply to embryo

research designed to improve or extend in vitro fertilization (IVF). Artificial insemination followed by

lavage for fertilized ovum retrieval and transfer might

be covered.

CALIFORNIA California bans research on the “product of conception” but is specific that the “aborted product of conception” is at issue. Thus this statute would

not apply to preimplantation embryos that have not

been transferred and implanted, for they cannot yet

have been aborted. It is unclear whether it would apply to research on embryos created by artificial insemination and removed by lavage.

ILLINOIS: Illinois bans sale or experiments “upon

a fetus produced by the fertilization of a human ovum

by a human sperm unless such experimentation is therapeutic to the fetus thereby produced, ” making intentional violation of the section a misdemeanor. Yet,

another section specifies that it is not “intended to prohibit the performance of in vitro fertilization.”

Although this formulation leaves open several questions about what IVF activities might be allowed, the

proscriptions of the statute are elsewhere directed to

research activities with “fetuses .“ Since the preimplan -

tation embryo is not clearly a fetus under Illinois law,

the statute does not necessarily apply to embryo research.

LOUISIANA: Three statutes appear to apply to embryo research. First, Louisiana’s IVF law (see ch. 13)

specifically prohibits the use of IVF to create an embryo exclusively for the purpose of doing research.

By its terms, however, the statute does not cover embryos created by artificial insemination and then recovered by lavage prior to implantation. Nevertheless,

this statute is the most far-reaching with respect to

discouraging embryo research.

Another statute makes “human experimentation” a

crime, defining it to include “the conduct, on a human

embryo or fetus in utero, of any experimentation or

study except to preserve the life or to improve the

health of said human embryo or fetus.” This statute

could be read to require that the embryo in question

be in utero, which would exempt preimplantation embryos, for a subsequent section speaks of the “complete extraction or expulsion from its mother of a human embryo or fetus, irrespective of the duration of

pregnancy.”

The third statute bans experiments “on an unborn

child . . . unless the experimentation is therapeutic to

the unborn child.” If ‘(unborn child” is broadly construed, it could extend to preimplantation embryos.

Arguments about the scope of this statute are moot,

however, since it was struck down on vagueness

grounds (see ch. 13).

MAINE: The Maine statute against donating or selling “any product of conception considered live-born

for . . . any form of experimentation” is defined to

mean a “product of conception after complete expulsion from the mother, irrespective of the duration of

the pregnancy, which breathes or shows any other

evidence of life, etc. ” This statute does not appear to

refer to preimplantation embryos.

MASSACHUSETTS: The Massachusetts statute prohibits the use of “any live human fetus whether before or after expulsion from its mother’s womb, for

scientific, laboratory, research or other kind of experimentation.” Since a preimplantation embryo is not

easily defined as a “live human fetus,” the statute would

appear to place no barrier in the way of research with

unimplanted embryos. Another section defines “live

fetus” in terms of “the same medical standards as are

used in determining evidence of life in a spontaneously

aborted fetus at approximately the same stage of gesta -

tional development,” thus reinforcing the notion that

only embryos or fetuses that have implanted and initiated a pregnancy are subject to the statute’s prohibitions on research.

A subsection of this statute penalizes a person who

“shall knowingly sell, transfer, distribute or give away

any fetus in violation of the provisions of this section. ”

The next sentence reads: “For purposes of this section, the word ‘fetus’ shall include also an embryo or

neonate. ” The meaning of “section” in this sentence

is unclear. The most plausible reading is that it means

the “subsection” in which it appears, addressing the

sale and transfer of fetuses. It is also unclear whether

the term “embryo” refers to fertilized eggs and zygotes

or only to more fully developed embryos that have

implanted in the uterine wall. If this expansive defini -

324
App. C—Fetal Research Laws Possibly Affecting IVF ● 325

tion were taken to apply to every use of “fetus” in the

statute, it would ban all research with preimplanta -

tion embryos. This seems the less plausible interpretation, especially in a criminal statute that ordinarily

is narrowly construed.

MICHIGAN: Michigan bans use of a “live human embryo for nontherapeutic research if . . . the research

substantially jeopardizes the life or health of the embryo.” It also bans such use if the embryo is the subject of a planned abortion.

MINNESOTA: Minnesota makes it a gross misdemeanor to “use or permit the use of a living human

conceptus for any type of . . . research or experimentation except to protect the life or health of the concepts. ” However, it permits research “which verifiable scientific evidence has shown to be harmless to

the concepts. ”

Although this law appears explicit in its ban on research on embryos, it was passed in 1973 in reaction

to Roe v. Wade, before IVF was even possible. It is possible that research on an unimplanted embryo that is

not intended for implantation would be considered

“harmless. ”

NEW MEXICO: New Mexico’s statute on “Maternal,

Fetal and Infant Experimentation” defines regulated

research to include that involving IVF, but not IVF performed to treat infertility. This might seem to apply

to research on discarded or nontransferred embryos

or embryos created solely for research. Yet the operative section of the statute, which prohibits clinical research not meeting its provisions, applies only to clinical research “involving fetuses, live-born infants or

pregnant women. ” Thus the restrictions possibly may

not apply to extracorporeal embryo research, notwithstanding the broad definition of clinical research to

include IVF.

NORTH DAKOTA: The North Dakota fetal research

law is modeled on the Massachusetts law, with some

organizational differences. The section prohibiting "live

fetal experimentation” clearly does not apply to embryos that have not yet implanted.

A later section that prohibits the sale of fetuses also

defines fetus to include “embryo or neonate. ” However, it appears that this expansive definition applies

only to sales and transfers in violation of that section.

OHIO: Ohio prohibits “experiments upon the product of human conception which is aborted .“ Thus even

though a “product of conception” would include fertilized eggs and preimplantation embryos, the statute’s

prohibition applies only to “aborted” embryos. Since

embryos that have not yet been transferred to a uterus

and implanted arguably are not ‘(aborted, ” the most

likely reading of this statute is that it would not apply

to research on embryos in vitro. Its application to eggs

fertilized by artificial insemination and recovered by

lavage is unclear.

OKLAHOMA: Oklahoma also refers to use of an “unborn child” in research, but in language that clearly

refers to the results of an abortion. Once again, unless preimplantation embryos created by artificial insemination can be considered aborted because they

were recovered by lavage, the section would not apply.

RHODE ISLAND: Rhode Island’s statute is similar to

Massachusetts’ and thus raises the same issues of scope

and interpretation.

PENNSYLVANIA: Pennsylvania prohibits “any type

of nontherapeutic experimentation upon any unborn

child, ” making it a third degree felony. This would not

appear to prevent embryo transfer after IVF. The status of research on discarded or nontransferred embryos is less clear and depends on whether preimplantation embryos are considered “unborn children. ”

UTAH: Utah also prohibits experimentation on “live

unborn children .“ But the statute appears to be aimed

at abortion, since it is included under a heading of abortion laws. As in the Oklahoma law, the provision would

not likely apply to IVF embryos, and it is unclear if

it could apply to embryos recovered by lavage.
Appendix D

Feminist Views on

Reproductive Technologies

Feminist analyses largely consist of applying political, sociological, psychological, biological, and ethical

analysis to the role of women in society. Just as individuals differ in their preferred political and ethical

values, feminists differ in their analyses of women’s

roles, their approval or disapproval of those roles, and

their recommendations for changing those roles (I-19).

This diversity of views makes it impossible to state categorically that feminists as a group will approve or disapprove a particular application of a particular noncoital reproductive technique. Nevertheless, certain

broad areas of agreement exist among most feminists

(15), including the following:

● Women have been and are subordinated to men,

a phenomenon rooted in women’s roles as childbearers and childrearers. Subordination of certain

classes and races has also taken place. Subordination of any group based on such characteristics

is ethically undesirable. Feminists are particularly

sensitive to the interactions of class, race, and

gender in the exploitation of women.

Q Feminist values emphasize the importance of human relationships, rather than ownership or

traditional or legal kinship. A man does not own

his wife or any other woman, nor does he have

ownership rights over the children she bears. The

relations people freely form with each other are

to be valued and supported, whether or not they

conform to a traditional family form.

● Women have full rights of bodily autonomy.

Women have control over their bodies, gametes,

conceptuses, and fetuses through birth. This is

true whether or not there is a ‘(right” to have children that can be expressed by having a “right” to

medical services, gamete donation, surrogacy, or

financial assistance in order to be able to have children. Feminists are concerned with the medicalization of pregnancy and childbirth, and the potential subordination of pregnant women’s rights

to State intervention ostensibly on behalf of the

fetus. Further, the choice to prevent or allow conception and childbirth cannot be considered to be

freely made if political and economic institutions

make certain choices impractical or impossible.

Noncoital reproductive techniques pose a challenge

to feminist analyses. They offer new possibilities for

personal choice at the same time as they exacerbate

possibilities for exploiting some women or reinforcing societal attitudes concerning the imperative of biological parenthood. Many feminists fear that opening

reproductive options for some women may jeopardize women’s freedoms overall.

These techniques (gamete intrafallopian transfer, in

vitro fertilization (IVF), artificial insemination by donor,

surrogate mothering) increase opportunities for conceiving, circumventing male partner absence or sterility, and for bringing a baby to term. When chosen

freely, with accurate information about the likelihood

of success and an appreciation of the physical, legal,

and emotional risks, noncoital reproductive techniques

increase an individual’s opportunity to realize the goal

of genetic or gestational parenthood. Further, in light

of the difficulty of adopting a child, they may offer

the only hope of forming a family quickly. At the same

time, these techniques create new opportunities for

isolating and exploiting certain portions of the population, such as surrogate mothers or gamete donors.

Many feminists question how often the choice to have

children, and particularly biologically related children,

is genuinely free, in light of the cultural milieu in which

adult women in the United States have been raised.

The decision to seek out these techniques can be motivated by sincere, informed, and voluntary personal

desires or by considerations many feminists would like

to see deemphasized. The latter include views that

genetic linkages are essential to the creation of a genuine family, particularly for men, and that women must

bear or somehow provide children for their husbands

in order to experience their womanhood fully and meet

the societal expectations of marriage, even if at great

personal risk, inconvenience, or disinclination.

The development of these techniques entails research and experimentation that may ultimately increase options for procreation, such as making delayed

childbearing more feasible. It also invites, however,

extensive experimentation with women. Some assert

that careerism and a philosophy of “science for the

sake of science” encourage research and development

of infertility treatments that require women to undergo unpleasant or risky procedures. Many feminists assert that this is exacerbated by the fact that the majority

of the researchers and clinicians are male. The relative lack of research into the causes of male infertility,

and the resulting dearth of causes identified or treat326
App. D—Feminist Views on Reproduction Technologies . 327

ments offered, means that men are rarely subjected

to the same strains of diagnosis and treatment, and

so may lack the empathy necessary to appreciate fully

the intrusiveness and degradation of many of the procedures. This may lead to an inappropriate degree of

enthusiasm within the medical and scientific community for using these techniques. In addition, feminists

note that some earlier advances in the area of contraception have actually led to infertility, such as the

use of certain kinds of intrauterine devices. This history of interaction between medical advances and

women’s reproductive health leads many feminists to

be skeptical of the success claimed by researchers for

their techniques.

In addition, the use of these techniques usually involves medical personnel and procedures. Although

welcoming opportunities to enhance the safety of childbearing and the health of infants, many feminists note

that numerous physicians and hospitals have come to

treat pregnancy as an abnormal, highly dangerous

(almost diseased) state. On this basis, a number of hospitals and physicians have moved rapidly to introduce

medical interventions that regard the woman as separate from her fetus, that treat the fetus as a separate

patient with interests markedly different from and

often opposed to the mother’s, and that encourage invasive, painful, or dangerous procedures (e.g., internal fetal monitoring, in utero fetal therapy, or cesarean sections) that medicalize the process of birth. The

diminution of women’s authority to make decisions

about the conduct of their pregnancies and childbirths

concerns many feminists. This is a particularly sensitive point in the late 1980s, as the women’s health

movement finds itself just beginning to succeed in its

efforts to persuade pregnant women to question more

often the medical traditions surrounding childbirth,

such as specific birthing positions or indications for

fetal monitoring and cesarean section.

The developing techniques for infertility diagnosis

and treatment also have potential application in areas

that are quite troubling to many feminists. For example, artificial insemination allows manipulation of

sperm before insemination, making preconception sex

selection a possibility for the future. Given the fact that

many cultures express a strong preference for boys,

many feminists question whether sex selection should

be permitted. While enhancing personal choice for an

individual woman, it may have widespread implications for our perception of the relative values of a boy

or girl, and even demographic effects should the technique become reliable and widely used. In general,

feminists express great concern over the prospects for

genetic diagnosis, selection, and manipulation made

possible by the use of IVF and research on human

embryos.

Some feminists argue that commercializing noncoital

reproductive techniques makes them more available,

and thus increases access and personal choice for those

who can pay. For some women, they also create new

ways to earn money, by selling gametes or embryos,

or by gestating for a fee. A philosophy of mind-body

dualism (which to some extent encourages a view of

the body as an object, separate from the mind) supports the choice to use the body as an economic resource.

Other feminists, however, reject this dualism. They

fear that commercialization invites a view of gametes,

embryos, and even women as commodities to be

banked, bought, sold, and rented as a means to procreation. As property, they maybe subject to management,

such as governmental or contractual regulation of the

behavior of women who are pregnant for a fee. Commercializing embryos or pregnancy, so that custody

goes to someone other than the woman giving birth,

may exacerbate the view of the fetus and the woman

as separate individuals with opposing interests. This

in turn may further the view that the interests or bodily

integrity of one must be sacrificed to the other. Finally,

these techniques create one employment area, surrogacy, that will be exclusively occupied by women,

especially those without opportunities to earn money

in other ways. Thus what is viewed as an opportunity

by some feminists maybe viewed by others as an invitation to exploitation of poor or Third World women.

Overall, it is not possible to state whether feminists

will oppose or support any particular noncoital reproductive technique, as there are many feminist voices

and many motivations for the use of these techniques.

Yet feminists generally oppose developments that explicitly restrict bodily autonomy, that subordinate the

ties of pregnancy, childbirth, or childrearing to exclusively genetic or property claims, that limit use to certain classes of people or categories of family unit, or

that directly exploit women.

Further, many feminists advocate an effort to provide nontechnological solutions where possible. These

include making institutions more flexible in order to

allow increasing integration of family life and public

activities. This would allow both men and women to

participate in childrearing, making it possible to choose

to have children at a younger age. Nontechnological

solutions also include providing education to prevent

sexually transmitted diseases that lead to impaired fertility, helping people to adopt children of all races and

ages, and decreasing the social pressures that lead

many to feel unfulfilled if they do not or cannot have

biologically related children.
328 “ Infertility: Medical and Social Choices

1,

2.

3.

4.

5.

6.

7.

8,

9.

Appendix D References

Andrews, L. B., “Feminist Perspectives on Reproductive

Technologies,” paper presented at A Forum on Reproductive Law for the 1990’s, New York, NY, May 18, 1987.

Arditti, R., Duelli-Klein, R., and Minden, S. (eds.), Test

Tube Women: What Future for Motherhood? (Boston,

MA: Pandora Press, 1984).

Choderow, N., The Reproduction of Mothering (Berkeley,

CA: University of California Press, 1978).

Corea, G., The Hidden Malpractice: How American Medicine Mistreats Women, 2d ed. (New York, NY: Harper

& ROW, 1985).

Corea, G., The Mother Machine: Reproductive Technologies From Artificial Insemination to Artificial Wombs

(New York, NY: Harper & Row, 1985).

Gallagher, J., “Fetal Personhood and Women’s Policy,”

Women’s Biolo~ and Public Policy, V. Sapiro (cd.),

(Beverly Hills, CA: Sage, 1985).

Gilligan, C., Zn a Different Voice: Psychological Theory

and Women’s Development (Cambridge, MA: Harvard

University Press, 1982).

Hartsock, N.C.M., Money, Sex, and Power: Toward a Feminist Historical Maten”alism (New York, NY: Longman, Inc.,

1983).

Holmes, H. B., Hoskins, B., and Gross, M. (eds.), The Custom Made Child? (Clifton, NJ: Humana Press, 1981).

10. Hubbard, R., and Sanford, W., “New Reproductive Technologies, ” The New Our Bodies, Ourselves, The Boston

Women’s Health Book Collective (eds.) (New York, NY:

Simon & Schuster, 1984).

11. Jaggar, A. M., Feminist Politics and Human Nature

(Totowa, NJ: Rowman & Allanheld, 1983).

12. Rich, A., Of Woman Born (New York, NY: W.W. Norton

& co., 1977).

13. Rothman, B. K., In Labor: Women and Power in the Birthp]ace (New York, NY: W.W. Norton & Co., 1982).

14. Rothman, B. K., The Tentative Pregnancy: Prenatal Diagnosis and the Future of Motherhood (New York, NY: Viking Press, 1986).

15. Rothman, B.K., “Feminism and the New Reproductive

Technologies)” prepared for the Office of Technology

Assessment, U.S. Congress, June 1987.

16. Rothman, B. K., Recreating Motherhood (New York, NY:

W.W. Norton & Co., in press).

17. Ruzek, S. B., The Women’s Health Movement: Feminist

Alternatives to Medical Control (New York, NY: Praeger

Publishers, 1979).

18. Treblicott, J. (cd.), Mothering: Essays in Feminist Theory (Totowa, N.J.: Rowman & Allanheld, 1983).

19. Wikler, N., “Society’s Response to the New Reproductive

Technologies: The Feminist Perspectives,” Southern California Law Review 59:1043-1057, 1986.
Appendix E

International Developments

Major reports on the ethical and legal aspects of noncoital reproductive technologies have been issued by

governmental or nongovernmental bodies in Australia, Canada, the Federal Republic of Germany, France,

Israel, South Africa, Sweden, and the United Kingdom.

At least 33 other countries have had considerable

professional or public debate concerning these technologies.

Several international organizations are also considering the issues raised by reproductive technologies,

including the Council of Europe, the World Health

Organization, the European Parliament, and the Feminist International Network of Resistance to Reproductive and Genetic Engineering (FINRRAGE). This appendix surveys countries and organizations as follows:

Major National Efforts Regarding Noncoital

Reproduction

Australia . . . . . . . . . . . . . . . . . . . . . ............329

Canada . . . . . . . . . . . . . . . . . . . . . .............332

Federal Republic of Germany . ...............335

France . . . . . . . . . . . . . . . . . . . . . ..............338

Israel . . . . . . . . . . . . . . . . . . . . . ...............339

South Africa . . . . . . . . . . . . . . . . . . . . . .........341

Sweden . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..342

United Kingdom . . . . . . . . . . . . . . . . . . . . . . . . . ..343

Other National Efforts Regarding Noncoital

Reproduction

Argentina . . . . . . . . . . . . . . . . . . . . . ...........346

Austria . . . . . . . . . . . . . . . . . . . . . ..............346

Belgium . . . . . . . . . . . . . . . . . . . . . .............347

Brazil . . . . . . . . . . . . . . . . . . . . . . . . . . . . ........347

Bulgaria . . . . . . . . . . . . . . . . . . . . . .............347

Chile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ....347

Colombia . . . . . . . . . . . . . . . . . . . . . . ...........347

Cyprus. . . . . . . . . . . . . . . . . . . . . . .............347

Czechoslovakia . . . . . . . . . . . . . . . . . . . . . .......347

Denmark . . . . . . ...........................34 7

Egypt . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....348

Finland . . . . . . . . . . . . . . . . . . . . . . . ...........348

German Democratic Republic. . .

Greece . . . . . . . . . . . . . . . . . . . . . .

Hungary . . . . . . . . . . . . . . . . . . . .

Iceland . . . . . . . . . . . . . . . . . . . . . .

India . . . . . . . . . . . . . . . . . . . . . . .

Ireland . . . . . . . . . . . . . . . . . . . . . .

Italy . . . . . . . . . . . . . . . . . . . . . . . .

Japan . . . . . . . . . . . . . . . . . . . . . . .

Libya . . . . . . . . . . . . . . . . . . . . . . .

Luxembourg . . . . . . . . . . . . . . . . .

Mexico. . . . . . . . . . . . . . . . . . . . . .

Netherlands . . . . . . . . . . . . . . . . .

New Zealand.. . . . . . . . . . . . . . . .

Norway . . . . . . . . . . . . . . . . . . . . .

Philippines . . . . . . . . . . . . . . . . . .

Poland . . . . . . . . . . . . . . . . . . . . . .

Portugal . . . . . . . . . . . . . . . . . . . . .

Spain . . . . . . . . . . . . . . . . . . . . . . .

Switzerland. . . . . . . . . . . . . . . . . .

Turkey . . . . . . . . . . . . . . . . . . . . .

Yugoslavia . . . . . . . . . . . . . . . . . . .

International Organizations

Council of Europe . . . . . . . . . . . .

European Parliament. . . . . . . . . .

FINRRAGE . . . . . . . . . . . . . . . . . . .

World Health Organization. . . . .

. . . . . . . . . . . . . 348

. . . . . . . . . . . . . 348

. . . . . . . . . . . . . 348

. . . . . . . . . . . . . 349

. . . . . . . . . . . ,. 349

. . . . . . . . . . . . . 349

. . . . . . . . . . . . . 349

. . . . . . . . . . . . . 349

. . . . . . . . . . . . . 350

. . . . . . . . . . . . . 350

. . . . . . . . . . . . . 350

. . . . . . . . . . . . . 350

. . . . . . . . . . . . . 351

. . . . . . . . . . . . . 352

. . . . . . . . . . . . . 352

. . . . . . . . . . . . . 352

. . . . . . . . . . . ., 353

. . . . . . . . . . . . . 353

. . . . . . . . . . . . . 354

. . . . . . . . . . . . . 355

. . . . . . . . . . . . . 355

. . . . . . . . . . . . . 356

. . . . . . . . . . . . . 356

. . . . . . . . . . . . . 357

. . . . . . . . . . . . . 357

overall, the international trend is toward accepting

artificial insemination by husband and by donor. If artificial insemination by donor is used with a husband’s

consent, the child is generally considered his irrefutably legitimate offspring. In vitro fertilization (IVF) is

also widely accepted, if it is done for a married couple

and donor gametes are not used. Surrogate motherhood and ovum donation have achieved far less widespread acceptance, and, even where permitted, are

often not commercialized. Research on human embryos is neither universally accepted nor rejected; it

is often an item of disagreement within individual

countries.

MAJOR NATIONAL EFFORTS REGARDING

NONCOITAL REPRODUCTION

Australia Three reports have been published on the federal

level. In 1985, the Senate Standing Committee on ConThere has been considerable activity in Australia sur- stitutional and Legal Affairs published a report on lVF

rounding novel reproductive techniques, including fed- and the Status of Children (12), examining the lack of

eral and state reports, state legislation, and professional uniformity in previous legislation establishing the staself-regulation. tus of IVF children and evaluating the significance of

329
BO . Infertility: Medical and Social Choices

this lack. Also in 1985, the Family Law Council of the

Attorney-General’s Office published a report examining reproductive technology in Australia, entitled Creating Children: A Uniform Approach to the Law and

Practice of Reproductive Technology in Australia (9).

Both of these reports stated that there should be uniformity of law throughout Australia regarding the status of children born using donor gametes, and the Family Law Council further emphasized the need for

uniform regulation of reproductive technologies.

In the same year, a bill prohibiting experiments involving the use of IVF embryos (the Human Embryo

Experimentation Act, 1985) (7) was introduced to the

senate. The bill, which would have prohibited experimentation on embryos, sparked considerable controversy and was referred to a senate select committee

for deliberation. The committee solicited written submissions from a wide range of organizations and individuals with interest and expertise on the topic; it also

conducted public hearings all over the country, taking testimony from 64 witnesses. The submissions and

testimony are published in a series of volumes totaling

more than 2,000 pages (8). In 1986 the committee released its final report, Human Embryo Experimentation in Australia (11).

Considerable action has also taken place on the state

level regarding reproductive technology. In 1977, the

Australian Law Reform Commission completed a series of reports urging that legislation be considered concerning artificial insemination. In 1982, the Australian

states began taking independent action (10). Since then,

official inquiries and committees concerned with noncoital reproductive techniques have been set up in

every state, issuing numerous reports:

New South Wales, New South Wales Law Reform

Commission

—Artificial Conception Discussion Paper 1: Human

Artificial Insemination (November 1984) (84)

—Artificial Conception Report 1: Human Artificia/

Insemination (November 1986) (85)

—Artificial Conception Discussion Paper 2: In Vitro

Fertilization (July, 1987) (86)

Queensland, Report of the Special Committee Appointed by the Queensland Government to Enquire into the Laws Relating to Artificial Insemination, In Vitro Fertilization and Other Related

Matters (March 1984) (97)

South Australia, Report of the Working Party on

In Vitro Fertilization and Artificial Insemination

by Donor (January 1984) (114)

Tasmania, Committee to Investigate Artificial Conception and Related Matters

–Interim Report (December 1984)

–Final Report (June 1985) (124)

Victoria, Commission for the State of Victoria,

Committee to Consider the Social, Ethical, and Legal Issues Arising from In Vitro Fertilization (under the direction of Professor Louis Wailer)

–Interim Report (September 1982)

—Issues Paper on Donor Gametes in IVF (April

1983)

–Report on Donor Gametes in IVF (April 1983)

—Report on the Disposition of Embryos Produced

by In Vitro Fertilization (April 1984) (128)

Western Australia, Committee to Enquire into the

Social, Legal, and Ethical Issues Relating to In Vitro

Fertilization and Its Supervision

–Interim Report (August 1984) (135)

–Report (October 1986).

Most states have enacted uniform legislation clarifying the status of children born using donor gametes,

but Victoria’s action, in response to the Wailer Commission, is the most extensive, imposing statutory control on the practice of IVF and artificial insemination

by donor (85). In 1984, the Victorian legislature passed

the Status of Children (Amendment) Act and the Infertility (Medical Procedures) Act. The Status of Children Act states a child born following artificial insemination or in vitro fertilization with donor gametes is

the legitimate offspring of his or her mother and her

consenting husband.

The Infertility (Medical Procedures) Act (Nos. 10122-

10171, 1984) continues the Australian ban on sales of

human tissues, including sperm, ova, and embryos, and

outlaws cloning, fertilization of a human ovum with

an animal gamete, use of children’s gametes, mixing

donor’s and husband’s sperm in artificial insemination

by donor, and all commercial forms of surrogate

motherhood. It also sets up a system of state regulation for donor insemination, IVF, freezing and experimenting on embryos, participant counseling, and

recordkeeping. In addition, a Standing Review and

Advisory Committee was created to monitor the use

of experimental procedures and to study and report

to the Government about new developments in this

field. Most importantly, the act bans the production

of embryos for research purposes and allows research

on surplus embryos only if this has been approved by

the Standing Review and Advisory Committee. Legislation to amend the act, arising out of recommendations made by the Standing Review and Advisory Committee on Infertility, was introduced into the Victorian

Parliament in April 1987 and was scheduled for debate (133).

Australia has a national regulatory system concerned

with ethical aspects of research on humans. This system is guided by the National Health and Medical Research Council (NHMRC), a body charged with advis-
App. E—International Developments . 331

ing federal, state, and territory governments and the

Australian community on health-related matters (75).

The NHMRC’S regulatory system consists of two components, the Medical Research Ethics Committee

(MREC) and a network of Institutional Ethics Committees (IECS). The MREC was constituted in 1982 as an

advisory committee to the NHMRC, charged with recommending ethical principles to govern human experimentation and providing ethical guidelines for research in certain fields, supervising the work of the

IECS, and maintaining dialogue with the Commonwealth and state ministers of health and attorneys general and to the community. The IECS are in-house ethics

committees that have been established in all Australian

hospitals and other institutions conducting research

on humans (75).

The NHMRC guidelines consist of a general statement

on human experimentation and a series of supplementary notes addressing ethical aspects of research in

particular fields, each of which has been published

separately with numerous supporting documents. The

primary recommendation of the statement on human

experimentation was the establishment of an Institutional Ethics Committee in any institution in which human experimentation takes place. The guidelines as

a whole were published together in 1985 in the

NH&MRC Statement on Human Experimentation and

Supplementary Notes (82). The MREC continually reviews and updates the supplementary notes, in addition to preparing new reports on various topics. The

supplementary notes of particular interest for this report are number I, Institutional Ethics Committees,

and number 4, In-Vitro Fertilisation and Embryo Transfer, discussed in greater detail later in this section.

In 1987, some 116 institutions were stated to be conducting medical research; all of them already conformed to the NHMRC guidelines or were making adjustments to do so (75).

Artificial Insemination

In 1983, the Family Law Act of 1975 was amended

to state that a child conceived by a married woman

using donor sperm with the consent of her husband

is legitimate. In 1985, amendments to the Marriage of

1961 allowed recognition of this presumption of

legitimacy if each state enacted the necessary legislation. Thus, the initiative was left to the states (85).

New South Wales (in the Artificial Conception Act,

1984), Victoria (in the Status of Children Act, 1984),

South Australia (in the Family Relationships Amendment Act, 1984), Tasmania, Western Australia, the Australian Capital Territory, and the Northern Territory

have all enacted legislation stating that children resulting from artificial insemination or IVF with donor gametes are the legitimate offspring of the mother and

her consenting husband or partner (stable unmarried

couples are included in this legislation). Queensland

is in the process of enacting legislation related to artificial insemination (85).

The state committees and commissions listed earlier

agree that artificial insemination by donor is acceptable in principle, provided donor screening and donor

and recipient counseling are performed. All but the

Victorian committee agreed that couples in stable relationships as well as married couples should have access to this technique (134). All but one committee

specified that there should be a limit on the number

of donations allowed, and all but two specified that

payment should be limited to expenses. The committees were split on the issue of using known donors,

while most of them agreed that recipients and children of donor sperm should have access to nonidentifying information about the donor. All of them urged

proper recordkeeping at the institutional level, and

most even recommended varying types of central registries to record information about gamete donors and

children resulting from artificial insemination by donor

and IVF.

Oocyte Donation

All six state committees found egg donation permissible, provided that proper screening and counseling

are performed. All but two specified that payment for

donation of oocytes should not be allowed (excepting

reimbursement of expenses), and Victoria’s Infertility

(Medical Procedures) Act forbids the sale of human

gametes. The recommendations concerning number

of donations, anonymity, access to information, and

recordkeeping are identical to those for sperm donation (134).

The NHMRC guidelines state that ovum donation is

acceptable, provided proper consent is obtained and

no payment occurs (82).

In Vitro Fertilization

All the state committees considered IVF acceptable

in principle, both with and without donor gametes,

provided it is being used on medical grounds and the

coupIe receives counseling. All the committees agreed

that the procedure should be made available to couples only, but the Wailer Commission in Victoria further specified that marriage should be required (134).

Only the South Australia report forbade donation

of embryos (114), although the Western Australian

committee specified that embryo donation should be

used only in rare cases (135).

On the federal level, the Family Law Council’s recommendations were largely similar to those of the state
332 ● Infertility: Medical and Social Choices

reports-counseling should be required, adequate

records should be kept, and donated gametes are considered acceptable (subject to better standards and

guidelines). However, the Council did not approve the

use of known related donors; known unrelated donors

were considered acceptable. Furthermore, the Council recommended that children born from donor gametes have access to nonidentifying information about

their genetic parents before the age of 18 and identifying information after 18 (9).

The NHMRC guidelines on IVF also agree that IVF

is a justifiable means of treating infertility. However,

they state that much research still needs to be done,

and therefore certain rules should be followed. Most

importantly, every institution offering IVF should have

all aspects of the program approved by an institutional

ethics committee. These committees must include at

least five people—a laywoman, a layman, a minister,

a lawyer, and a medical graduate with research experience. This committee must ensure that proper

records are kept. Furthermore, the guidelines state

that IVF should normally involve the ova and sperm

of the partners (82).

In 1985, the MREC conducted a study of IVF centers

and found that they were following the NHMRC guidelines. The only exceptions were that several of the IECS

did not have proper lay representation (83).

Freezing and Storage of Human Sperm,

Oocytes, and Embryos

Cryopreservation of oocytes was not universally accepted by the state committees as it was considered

an experimental procedure. Legislation in Victoria forbids the procedure, as it would involve research on

the resulting embryos to determine any deleterious

effects (15). All the committees save the one in Western Australia, which did not resolve the issue (134),

considered freezing embryos acceptable in principle

but refrained from supporting oocyte freezing unconditionally until the technology improves. Only the commissions in Victoria and South Australian suggested

a time limit for storage of frozen embryos (114,134).

The NHMRC guidelines approve cryopreservation of

embryos, provided limits are set on the duration of

storage (82). During their discussion of research on

human embryos, the senate select committee on the

Human Embryo Experimentation Act, 1985, stated that

cryopreservation is acceptable if it maximizes the

chance that the embryo will be implanted and carried

to term (11).

Research on Preimplantation Embryos

Only the commissions in Victoria and Western Australia considered human embryo research acceptable

(128,135). They considered excess embryos (i.e., those,

left over from a therapeutic IVF attempt) to be the only

acceptable source of embryos for research, and they

set a time limit of 14 days on the duration of embryo

culture. In Victoria, the Infertility (Medical Procedures)

Act bans the production of embryos solely for research

and allows research on surplus embryos only if the

specific experiment has been approved by the Standing Review and Advisory Committee (134). At the federal level, the Family Law Council report opposed all

research on human embryos (9).

The NHMRC guidelines find research on embryos

acceptable up to the stage at which implantation would

normally occur, provided each experiment is approved

by the appropriate IEC. Cloning is rejected outright

(82).

In its 1986 report, the senate select committee on

the Human Embryo Experimentation Act, 1985, recommended that experiments designed to help an embryo be allowed but that all experiments resulting in

the destruction of an embryo be outlawed. The committee did not find the currently operating system of

IECS adequate, nor did it support the criminal law approach of the proposed bill. Instead, the committee

recommended an accreditation and licensing scheme

to assess each experiment on a case-by-case method.

A dissenting minority argued that embryo research

should not be restricted to therapeutic experimentation only (11).

Surrogate Mothers

Four of the state committees rejected surrogacy arrangements unconditionally—South Australia, Tasmania, Victoria, and Western Australia—and the Queensland report opposed commercial surrogacy and

suggested that legislation should ensure that the birth

mother remained the mother of the child

(97,114,124,134,135). The New South Wales Law Reform Commission has not yet addressed the question

of surrogacy, but the practice is effectively illegal in

New South Wales as it is illegal for a mother giving

up a baby for adoption to designate to whom the baby

should be given (105). Commercial forms of surrogacy

are also illegal under Victoria’s Infertility (Medical Procedures) Act.

The Family Law Council report stated that surrogacy

is contrary to the interests and welfare of the child

(9), and the NHMRC guidelines state that surrogacy is

not ethically acceptable (82).

Canada

Canada is a federation of 10 provinces and two territories. Under Canada’s federal system, provinces and

territories are responsible for the provision of health
App. E—International Developments ● 3 3 3

care. National health insurance is provided in Canada

through a series of interlocking provincial and territorial plans, sharing common elements. Insured serv -

ices vary from province to province, but a fairly comprehensive range is provided by all provinces (91).

To qualify for federal financial support, provincial

hospital and medical care insurance plans must meet

minimum criteria of federal legislation: comprehensiveness of coverage of services, portability of benefits, and nonprofit plan administration by a public

agency. The plans are designed to ensure that all residents of Canada have access, on a prepaid basis, to

needed medical and hospital care. In general, medical

and hospital services, diagnostic procedures to determine the incidence and etiology, and the surgical or

medical treatment of infertility are covered benefits

under provincial health insurance plans (91).

Although the federal government role in issues surrounding health care is limited, there are certain areas

that do fall under federal jurisdiction. For example,

the government has the authority to regulate medical

devices and the storage of sperm. Accordingly, in 1981,

an advisory committee to the Minister of National

Health and Welfare recommended guidelines concerning the storage and utilization of human sperm (29).

Although no federal action has been taken in response

to this report, several individual provinces have either

released reports or taken legislative action on various

aspects of this issue.

Currently, the Protection of Life Project of the Law

Reform Commission of Canada has established a working group to examine a number of issues, including

embryo experimentation and novel reproductive techniques, as they relate to the legal status of the fetus.

The report will be directed to federal law (e.g., criminal law) rather than those areas of law under provincial jurisdiction, and the commission will make recommendations to the federal Parliament (54).

Four provinces—Alberta (Status of Children) (l), British Columbia (Ninth Report of the Royal Commission

on Family and Children Law: Artificial Insemination)

(17), Ontario (Report on Human Artificial Reproduction and Related Matters) (90), and Saskatchewan

(Proposals for a Human Artificial Insemination Act)

(102)–have published reports addressing reproductive technologies. Only two, Quebec and the Yukon

Territory, have any legislation addressing these issues,

and that legislation deals only with artificial insemination by donor.

Of the provincial reports, the Ontario Law Reform

Commission’s report of 1985 is the most comprehensive (64). The other reports dealt only with artificial

insemination. The Ontario Law Reform Commission

made 67 specific recommendations, generally favoring noncoital reproduction “where medically necessary to circumvent the effects of infertility and genetic

impairment .“ It recommended that these procedures

be legislatively defined as the “practice of medicine.”

Access to them should be restricted to ‘(stable single

women and to stable men and stable women in stable

marital or nonmarital unions” (90).

In 1987, the Office of the Attorney General of Ontario organized an interdepartmental committee to

study artificial insemination, human embryo research,

and surrogate motherhood and to review’ the recommendations of the Ontario Law Reform Commission

report (61). There have been no decisions to date.

The Government of Quebec has a Council on the Status of Women that examines a number of topics relating to women’s rights. The Council has reviewed clinical and legislative developments with regard to certain

reproductive technologies, but its 1985 and 1986 series of studies made no specific recommendations for

action by the Quebec Government (92,93,94,95).

Artificial Insemination

The Minister of National Health and Welfare’s advisory committee on the storage and utilization of human

sperm released its report in 1981. Briefly, the committee recommended that there be provincial legislation

ensuring that a child conceived by donor insemination is considered the legitimate child of the mother

and her consenting husband; that federal regulations

govern standards for the acquisition, preservation, and

importation of sperm (the committee made specific recommendations for the standards themselves); and that

artificial insemination by donor be available only in

facilities where guidelines are met to safeguard the

donor, the recipient, and the resulting child (29).

Legislation relevant to artificial insemination exists

in two Canadian provinces. In Quebec, the Civil Code

provides that the child conceived by donor insemination is presumed to be the legitimate child of the consenting spouse. As of 1984, the Yukon Territory’s Children’s Act provides that the consenting husband or

cohabitant of a woman who undergoes artificial insemination is considered the legal father of the child,

and that the semen donor is not considered the legal

father (90).

All four of the provincial reports published to date

in Canada agreed that a child born to a married couple through artificial insemination by donor should be

considered their legitimate child if both gave written

consent. The British Columbia report further stated

that the husband should have all rights and duties to

the child, and the donor should remain anonymous

(17). The Law Reform Commission of Saskatchewan

actually proposed legislation to ensure the legitimacy

of the child, relieve anonymous donors from obliga -
334 ● Infertility: Medical and Social Choices

tions toward any resulting children, and provide extensive protection of the privacy of donors, recipients,

and children born as a result of artificial insemination

(102).

The Ontario Law Reform Commission recommended

that screening for infectious and genetic diseases

should be regulated by professional standards. Limits

on the number of times any one donor is used should

be left to the discretion of the medical profession.

Donors should be paid their reasonable expenses, but

no more. Anonymity of all parties should be maintained, although in the case of genetic disease the doctor should have a duty to disclose relevant information (90).

Quebec’s Council on the Status of Women reported

on feminist analyses of artificial insemination by donor,

noting the feminist criticism of attempts to medicalize

the procedure and to ban self-insemination (92,93,

94,95).

Oocyte Donation

The Ontario Law Reform Commission, in the only

Canadian report to date that has considered the issue,

considered oocyte donation permissible. Furthermore,

the commission stated that reimbursement of reasonable costs should be allowed, and that reimbursement

of ovum donors might be greater than that of sperm

donors as an invasive procedure is involved (90).

In Vitro Fertilization

The federal government of Canada currently maintains a registry to keep track of children conceived

by IVF (65), The Ontario Law Reform Commission considered IVF acceptable in principle, implicitly stating

that it should be used for medical reasons only (134).

Donation of eggs and embryos was considered acceptable (90). Quebec’s Council on the Status of Women

noted the feminist critique that insufficient experimentation had preceded introduction of IVF as a clinical

practice (92,93,95) and that insufficient efforts have

been made to guard against its use as a prelude to eugenic prenatal diagnosis (95).

The Ontario Law Reform Commission stated that

preconception sex selection in the context of IVF should

be discouraged but that any law prohibiting physicians

from telling a couple the sex of embryos is not desirable. The Council on the Status of Women in Quebec

made a stronger statement, urging that sex selection

of embryos or children should be forbidden (96).

IVF is provided as an insured service in Ontario, but

only at designated centers. Prince Edward Island covers IVF, with the exception of laboratory costs. Some

other provinces make the service available on an uninsured basis (9 I).

Freezing and Storage of Human Sperm,

Oocytes, and Embryos

The report of the advisory committee to the Minister of National Health and Welfare, Storage and Utilization of Human Sperm, stated that freezing sperm

should be allowed. Concerned about the quality of frozen sperm, the committee recommended that “until

regulations establishing federal standards of quality

are in effect for Canada, the importation of sperm from

commercial human sperm banks should be prohibited;

and no new human sperm bank should be allowed to

operate outside the jurisdiction of a university or other

publicly owned agency” (29). The British Columbia report recommended that sperm banking be allowed

only under professional and governmental surveillance

(17).

The Ontario Law Reform Commission suggested that

gamete banks that buy and sell sperm, ova, or embryos

should operate under federal license and should extract payment from users “to defray reasonable costs,

and perhaps, to provide a reasonable profit” (5). The

commission recommended limiting storage to no more

than 10 years, as well as permitting disposal of excess

embryos.

Research on Preimplantation Embryos

Two Canadian reports consider research on human

embryos. The Ontario Law Reform Commission found

embryo research acceptable in principle and approved

both surplus embryos and embryos created for research purposes as acceptable sources, with a time

limit of 14 days after fertilization.

In 1984, the Medical Research Council of Canada’s

Standing Committee on Ethics in Experimentation reviewed the adequacy and currency of the council’s

1978 guidelines for the protection of human subjects

in research. The committee published the revised

guidelines on research involving human subjects in

1987. With regard to research on human embryos, the

committee recommended that at first only research

“directed toward improvement of infertility management” should be allowed, using embryos up to no more

than 14 to 17 days. The committee opposed the creation of embryos for research purposes. Approval of

specific research proposals involving human embryos

should be made by local research ethics boards (30).

Surrogate Mothers

The Ontario Law Reform Commission recommended

that surrogate motherhood contracts be enforceable,

but only with the prior and continuing involvement

of a family law court. The commission felt that the

court should supervise the screening and counseling
App. E—International Developments “ 335

of the surrogate and the client, review the drafting

of the contract, and monitor the fee for the surrogate

(134).

Quebec’s Council on the Status of Women noted the

feminist criticism that the practice of surrogacy

threatens to destroy unified definitions of motherhood,

by dividing maternity into gestational, genetic, and social components (92,93,94), and threatens to compromise the autonomy of pregnant women by encouraging contractual or governmental restrictions on

their decisions concerning prenatal diagnosis and care

(94,9.5).

Federal Republic of Germany

No national organization in West Germany regularly

considers biomedical developments and ethical or political responses (103). Nor do hospitals have ethics committees or institutional review boards, unless they are teaching or research hospitals (104). However, a number of

private and governmental committees are considering guidelines for noncoital reproduction and embryo research. These

include the Bundesarztekammer’s Wissenschaftlicher Beirat

(Scientific Council of the German Medical Association),

which issued guidelines for professional standards on IVF

and embryo research (18, 19, 103). During their annual conventions in 1970 and 1985, West German physicians

passed resolutions concerning artificial insemination and

IVF, and subsequently issued guidelines related to IVF

(24). Membership in the organization is obligatory for any

practicing physician, and the association has a greater

ability to dictate policy and enforce its guidelines than

does any American association (67).

Another active group has been the Bundesministerium fur Forschung und Technologies (Federal

Ministry for Research and Technology), which initiated discussion of ethical implications of biotechnology (51, 103), as well as collaborated with the Ministry

of Justice to consider restrictions on noncoital reproduction (50). Their joint report, known as the Benda

Report, was completed in 1985 and recommended numerous restrictions on the use of noncoital reproductive techniques.

In 1987, an ad hoc commission to the German Parliament (known as the Enquete Commission) delivered

a report on biotechnology that recommended the

acceptance of reproductive and genetic technology

subject to strong legal regulation (52,67). Also in 1987,

the Federal-State Working Group on Reproductive

Medicine published an interim report, which is more

liberal in its proscriptions (48). This committee, consisting of representatives of the justice and health ministries of the federal government and of the states, was

created by mandate of the upper house of the German Parliament, and its report is expected to gather

wide political support (57). No action has been taken

yet on either report, although draft bills concerning

surrogacy and embryo management are now under

consideration by various ministries (57).

Artificial Insemination

In their resolution of 1970, the German Medical Association stated that donor insemination is not contrary

to professional ethics, but that it is so beset with

difficulties that they could not recommend the procedure (24). The Benda Report also expressed strong reservations about its use, noting concern about releasing the genetic father from responsibility for his child;

about selecting donors, both in terms of having a third

party select the father of a child and the possibility

of eugenic considerations playing a role; and about any

inbreeding that might result.

There is no statute in West Germany pertaining to

the legitimacy of a child conceived by donor insemination, but two cases in 1982 and 1985 addressed the

question. Under German law, any husband has the

right to contest paternity, within a specified period of

time. If successful, the child’s genetic father (even if

an anonymous sperm donor) may become legally responsible. The 1982 case allowed a paternity challenge

when a husband objected that the child his wife had

borne was conceived by extramarital intercourse

rather than by the artificial insemination attempts that

had been ongoing during this period.

A 1985 decision, on the other hand, ruled that if a

man has agreed to his wife’s use of donor semen and

has renounced his right to contest paternity, he may

not later challenge the legitimacy and paternity of the

resulting child, despite the fact that he was now leaving the marriage and joining another woman. At least

one commentator applauded the latter decision, noting that it is always possible to be certain of the paternity of a child, and that artificial insemination practice would become untenable if men could routinely

present postbirth objections to the paternity of a child,

despite their earlier agreement (81).

The Benda Report recommended that a child conceived by donor insemination should have free access

to the details of his or her parentage, stating that the

personal details of the donor be recorded and made

available to the child produced when he or she turns

16. Similar recommendations were made in a 1986 report by the national legal association (42). This, COUpled with sperm donors’ fears of future responsibility

toward the children, has made donor insemination

rather uncommon (103).

The Benda Report recommended that one sperm

donor be used for no more than 10 births. Beyond this
336 “ Infertility: Medical and Social Choices

it did not comment on screening sperm. As the German Medical Association, fearing commercial misuse

and involuntary incestual relationships, had previously

recommended that donor semen not be used, the

Benda Report generally did not address regulation of

semen donation, for the practice would probably not

be used extensively.

The report of the federal-state working group addressed artificial insemination by husband and by

donor separately. The report specified that insemination by a woman’s partner should be available to married or unmarried couples, but only if medically indicated. The written permission of the husband or

partner should be required, and sex selection and postmortem insemination should be forbidden (48).

The working group recommended that donor insemination be available only when the male has otherwise untreatable infertility. It should not be available

to unmarried couples or single women. Consultation

by a doctor should be required. The husband must

be a voluntary participant, as indicated by a notary

deed stating his intention to accept paternity. The man

thus loses his right to renounce his consent to the procedure; he cannot regain this right unless he obtains

another notary deed. All claims for support and inheritance between the donor and the resulting child

should be excluded, but a petition for a declaration

of fatherhood without these financial effects should

be possible.

As the working group, unlike the Benda commission,

did consider donor insemination a potentially widespread practice, their report addresses regulation of

semen donation. The recommendations state that one

donor should not be used for more than one live birth,

and mixing sperm should be forbidden. There should

be a central register of donor data that remains confidential, but the possibility of allowing the child to

learn his or her genetic heritage should remain open.

Doctors should be allowed to screen donors for health

and similarity to the recipient’s husband only, and payment of donors should be forbidden. Donor semen

should be screened before insemination and should

not be transferred from doctor to doctor. The use of

a deceased donor’s sperm is forbidden (48).

Oocyte Donation

Current legislation in West Germany does not cover

egg donation. The Benda Report recommended that

the woman who gives birth, rather than the genetic

mother, be initially regarded as the lawful mother, just

as the husband of an artificially inseminated woman

should initially be considered the lawful father, The

birth mother may not have any grounds to contest

legitimacy, as she has contributed substantially to the

birth by carrying the fetus. The legal position on this

point is unclear.

As with artificial insemination by donor, the Benda

Report did not address regulation of egg donation, as

the medical establishment does not condone the procedure. However, it maintained that the child resulting from ovum donation should have free access to

the details concerning his or her genetic mother.

Like the medical establishment, the federal-state

working group did not approve oocyte donation. However, the report did state that civil law should recognize the birth mother as the legal mother of any child

(48).

In Vitro Fertilization

The resolution of the 1985 physicians’ convention

concerning IVF stated that guidelines should ensure

the high medical quality of IVF facilities and personnel and that, in principle, IVF should only be offered

to married couples using their own sperm and eggs.

Exceptions are possible only after approval by a commission established by the German Medical Association (44). Since the publication of the Benda Report,

the German Medical Association’s statements have

tended to be more restrictive, insisting that IVF be

strictly limited to married couples using their own gametes (67). Guidelines concerning the conditions under which IVF and embryo transfer should be carried

out have also been issued by the organization (18,24).

The Benda Report recommended that legislation be

enacted restricting the use of IVF techniques to medical establishments that satisfy certain safety requirements to be specified by law. Although it considered

nationwide legislation desirable, it recognized that the

federal legislature may not have the constitutional authority to pass the legislative measures called for, and

thus they recommended to the representative body

of the German states (the Lander) that they work out

regulations free of inconsistencies. The medical profession opposes legislation, insisting on the sufficiency of

self-regulation (67,103,104).

According to the Benda Report, the genetic parents

of an embryo created in vitro have a limited right to

determine the use or disposal of the embryo. If, in the

course of treatment, embryos are created that cannot, for whatever reason, be transferred, a mother

cannot be forced to allow implantation into another

woman to ensure that the embryo develops. Embryo

donation is only justified when it is voluntary, it allows an embryo to develop, and a married couple is

willing to accept the child as their own.

The Benda Report also approved IVF using the husband’s sperm as a means of treating sterility. IVF should

in principle be offered only to married couples. Only
App. E—International Developments . 337

in exceptional cases should cohabiting couples be

offered IVF, and the procedure should not be offered

to single persons. The resulting child, if the procedure

were allowed in these cases, would be illegitimate. A

child resulting from embryo donation to a married couple is legitimate under the section of the German Civil

Code that states that a child born in the course of a

marriage is always regarded as legitimate, although

the law at present makes no special provision in this

case. The question of the right to dispute legitimacy

is particularly complicated in the case of embryo donation, as both parents might have grounds for dispute.

The federal-state working group recommended that

IVF be available to married couples using their own

gametes and only when medically indicated. The physician must perform a comprehensive medical and psychological exam, which must be documented. Doctors

should only fertilize as many eggs as can be transferred

at that time, and donation of superfluous IVF embryos

or embryos flushed from a woman’s body should be

forbidden. Finally, the report addresses gamete intrafallopian transfer, stating that it should be subject

to the same regulations as IVF (48).

Freezing and Storage of Human Sperm,

Oocytes, and Embryos

Freezing embryos and sperm troubled members of

the Benda Commission, who feared that a person conceived by such techniques might become confused

about his or her identity; family relationships, for example, might be confused if gametes are frozen for

an extended period of time and then allowed to

develop.

Thus the Benda Report states that cryopreservation

of human embryos can only be considered when embryo transfer is not possible for some time and cryopreservation provides an opportunity for transfer

within the next 2 years, or when the embryo is to be

transferred during one of the woman’s following cycles in order to improve the embryo’s prospect of implantation. The German Medical Association similarly

states in its guidelines that cryopreservation for a

limited time is permitted if it improves the embryo’s

chances for implantation or represents a temporary

measure until another opportunity for transfer arises

(24).

The federal-state working group recommended that

the cryopreservation of sperm and oocytes occur only

in officially regulated facilities and be limited to 2 years.

The freezing of embryos and fertilized eggs should be

forbidden except when the woman’s condition does not

permit transfer at the time and she desires cryopreservation (48).

Research on Preimplantation Embryos

The majority view presented in the Benda Report

stated that, as a matter of principle, creating human

embryos for research, without intending to implant

them, cannot be justified. Experiments with human

embryos are justifiable only if they assist in diagnosing, preventing, or curing a disease that the embryo

in question is suffering from or if they “help to obtain

specific medical findings of great value” and are reviewed by both a local and a central ethics committee

(50). Consistent with this was the 1985 German Medical Association resolution stating that “embryos

produced in vitro must, on principle, be implanted as

part of the particular infertility treatment being carried out, Experiments with embryos must, on principle, be rejected insofar as they do not serve the improvement of clinical method or the well-being of the

child” (24).

Embryo research was also identified in the joint Ministry of Justice and Ministry of Research and Technology report as harmful to human dignity (50,103), and

the Ministry of Justice followed up on the report by

drafting restrictive legislation (49). The Ministry of Justice draft proposed penalties of up to 5 years imprisonment for engaging in embryo research without permission of the genetic parents, especially if severe

damage or loss of embryos ensues. Also penalized

would be performing IVF without an intent to implant

the resulting embryos, maintaining in vitro embryos

beyond the normal point of implantation, artificially

maintaining nonviable embryos, creating chimeras, or

cloning (49, 103). Resistance to this particular proposal

has been vehement, particularly from the German

Medical Association and research funding organizations (57,67,103). Commentators note the inconsistency

between German law allowing abortion during the first

trimester and the near total ban on embryo research

during that same period (103).

The federal-state working group report, published

after the draft legislation, also stated that creating embryos or fertilized eggs for research purposes should

be a criminal offense. Research on superfluous embryos should be forbidden, as should altering the

genetic makeup of an individual, splitting embryos, creating chimeras or hybrids, and cloning (48).

Surrogate Mothers

Any commitment a woman makes to carry a child

for another couple is legally unenforceable in Germany.

Two German courts dealt with surrogate contracts in

1985. One determined that the child’s custody could

not be supplanted by a prebirth agreement by the
338 ● Infertility: Medical and Social Choices

mother to give up custody, and the other ruled that

the contract was void (47).

The Benda Report opposed any form of surrogacy,

and furthermore interpreted surrogacy as unconstitutional, as it fails to respect the dignity of the child. Participants at the 1985 convention of physicians also opposed any form of surrogacy, stating in a resolution

that “in view of the possible disadvantages for the child,

and given the danger of in vitro fertilization and embryo transfer being commercialized, recourse to the

services of ‘surrogate mothers’ must be rejected” (5o).

The national legal organization recommended in

1986 that ordinary surrogacy, i .e., where the surrogate

is the genetic and gestational mother of the child, is

not inherently immoral, but that the legislature nevertheless could and should outlaw the practice (42). With

regard to gestational surrogacy, the association went

further, stating “it does not take into account that the

development in the uterus is part of the personal development of the child and violates the human dignity

of the female who has been made an instrument . . .“

(104).

The federal-state working group recommended in

1987 that medical participation in surrogacy be forid -

den, that contracts for surrogacy be unenforceable,

and that commercial surrogacy and advertisement be

forbidden (48).

Recently, a US. commercial surrogate motherhood

agency opened an office in Frankfurt to match West

Germans with American surrogates. The magistrate

of Frankfurt announced that the agency must be

closed, if necessary by compulsory measures, but the

agency refused (132). The conflict went to the courts,

and in early 1988 a West German state court ruled

that the agency must close as it violated West Germany’s adoption laws (6).

France

The French national debate on the use of noncoital

reproductive technologies is still quite lively. In 1986,

the Comite' Consultatif National d’Ethique (CCNE) held

public hearings in Paris and Lyons (34), to follow up

on its previous work (33). The CCNE has no legal authority. Its initial purpose was to pave the way for subsequent legislation, but nothing has followed thus far

(71). The Ministry of Justice prepared a 30-country review of regulatory and ethical developments with respect to all forms of medically assisted reproduction

(24), and the Conseil d’Etat is preparing a report to

the Prime Minister dealing with the need for statutes

in this field (23).

Since 1978, the French Public Health Code has provided regulations requiring the funding of artificial insemination and IVF by the National Health Service (23).

Artificial Insemination

Ninety percent of artificial insemination by donor

recipients in France order their sperm from one of

France’s 23 sperm banks, called the centers for the

study and preservation of semen (CECOS). Policies

governing artificial insemination by donor are thus

mostly designed by the physicians running CECOS after a discussion in a CECOS National Commission, and

the restrictions are quite rigid. Other institutions and

private practices have more flexible rules (89).

The CECOS have developed an artificial insemination by donor program with the Statistical Research

Unit of the National Institute of Health and Medical

Research (INSERM). The established regulations require that sperm donors be married and of proven

fertility and that the donor’s wife give her permission

for the procedure. Donors are screened for sexually

transmitted diseases (including acquired immunodeficiency syndrome) and genetic problems, and karyotypes are routinely performed. Semen is provided only

to stable couples, and only if the male partner is sterile or carries a hereditary disorder (2). Donors are

anonymous and unpaid, and donor semen is available

at no cost to infertile couples in France.

In one case regarding artificial insemination by husband, a French widow was successful in her suit to

obtain her late husband’s sperm in order to bear his

posthumous child. Her attorney argued that “a deceased man has the right to breath life into the womb

of his wife and prove that love is stronger than death”

(74). The court did not consider the sperm as property. Its reasoning was based on the fact that the widow

proved that her husband stored his sperm with the

strong desire to beget a child by her (23).

In Vitro Fertilization

Over 100 IVF centers existed in France as of December 1985 (2). Quality of practice, restrictions on eligibility, and profitability vary enormously. Only a certain number follow the suggestions of CCNE, which

recommended that centers be nonprofit and that a central organization be designed to pass on questions of

gamete donation. However, legislation has been introduced that would restrict IVF to a limited number of

centers that will be licensed only if they conform to

strict technical requirements (53). Although IVF does

not usually require egg or embryo donations, a few

large and experienced centers do provide this service
App. E—International Developments ● 339

(46). The CCNE recommended that legal rules be developed before embryo donation be allowed (22). An

independent society named FIV-NAT has been created

to centralize data concerning IVF (32).

Freezing and Storage of Human Sperm

and Embryos

From the beginning, the CECOS have always frozen

sperm because insemination is done outside the hospitals by a local gynecologist. CCNE considers embryo

freezing an experimental procedure that should be performed only under strict conditions (for example, the

first implantation should occur after no longer than

6 months and excess embryos should not be kept more

than 1 year) (23), but the majority of CECOS do perform embryo freezing. Cryopreservation is now being performed in many centers not related to the

CECOS as well (32).

Research on Preimplantation Embryos

After CCNE was created in 1983, it established several working groups that published reports on issues

related to noncoital reproductive techniques. In 1986,

CCNE published a long report on the ethical acceptability of research on human embryos, recommending that embryos not be created for research purposes,

that IVF be carried out only in centers approved by

public authorities, and that research aimed at making

a genetic diagnosis prior to implantation undergo a

3-year moratorium (34,46). In spite of the dissenting

opinion of some members, CCNE did not forbid all research on in vitro embryos, provided that embryos

are not kept beyond 7 days. Furthermore, the committee did not forbid the use of surplus embryos for

research (23).

Surrogate Mothers

Surrogacy contracts appear to be unenforceable because of a French adoption law prohibiting babyselling. In addition, under French law, agencies and

individuals who use the agencies’ services to effect surrogate parenting arrangements are subject to prosecution. The Ministry of Health dissolved the three agencies facilitating commercial surrogacy agreements and

they are now illegal (32).

Israel

General laws in Israel are secular and are legislated

by the Knesset (the Israeli Parliament); matters concerning marriage, divorce, paternity, legitimacy, and

bastardy are adjudicated according to the Jewish reli -

gious laws as determined by the Rabbinical courts. The

practice of the new reproductive technologies thus

must be supported by religious authorities (106). Although large sectors of the Israeli population will be

guided by religious laws concerning the new reproductive technologies, this section will deal exclusively

with the Government regulations. Religious views concerning these technologies, which sometimes differ

from but do not necessarily conflict with secular laws,

are covered in appendix F.

In 1980, the Director General of the Ministry of

Health promulgated Public Health Regulations (Human

Experimentation), 1980, in an effort to devise a supervisory mechanism in the field of biomedical research

involving human subjects. These regulations state that

medical experiments on humans, may only be conducted in a hospital if authorized by the Director General and if in accord with the provisions of the Regulations and of the Helsinki Declaration on Human Rights.

Before the Director General can authorize a medical

experiment involving humans, it must be approved by

what in Israel is called a Helsinki Committee, and the

Director General must obtain an opinion from the

Drugs and Food Administration of the Ministry of

Health or from the Supreme Helsinki Committee for

Medical Experiments on Humans. One of the areas for

which the Supreme Helsinki Committee is responsible is experiments involving the artificial fertilization

of a woman (108),

From 1981 to 1987 the Knesset did not enact legislation to deal with many matters concerned with artificial reproduction (106). However, the Ministry of

Health attempted to regulate these issues by means

of secondary legislation. The Director General of the

Ministry of Health sent a circular to all hospital directors spelling out rules for the regulation of sperm banks

and artificial insemination. The legal authority for

promulgating this secondary legislation was tenuous

(110). In 1986 the Ministry of Health published draft

regulations dealing with various aspects of artificial

reproduction, The Supreme Helsinki Committee discussed these regulations a month later, offering several revisions. The draft was revised and the formal

declaration of the regulations was made in 1987 (109).

In 1987, the Knesset approved the Ministry of

Health’s new Public Health (Extracorporeal Fertilization) Regulations (60), which adopted the 1979 regulations on artificial insemination, and adopted new regulations concerning IVF and ovum donation. The 1987

regulations continue to ban surrogacy in any form.

Artificial Insemination

The Ministry of Health regulations pertaining to artificial insemination by donor were signed in 1979 and

readopted under the 1987 regulations. They state that
340 ● Infertility: Medical and Social Choices

artificial insemination by donor may only be performed

by a licensed obstetrician or gynecologist after examination of both the wife and the husband, (72).

According to the regulations, only a doctor may

choose the sperm to be used in donor insemination.

The blood type of the donor must have the same Rh

factor as that of the husband, and the number of times

that a donor may donate sperm is limited (72). The

donor must have a medical examination and be free

of certain ailments and of exposure to the human immunodeficiency virus (107,109). Mixing of the donor’s

sperm and the husband’s sperm is to be done as much

as possible (108), and Regulation 15 states that the

donor shall remain anonymous (60).

The regulations dictate that strict records must be

kept of both the sperm donor (to regulate how many

times one man donates) and the sperm itself (to record specifics such as blood type, skin color, hair color,

and Rh factor, but not the personal identity of the

donor). However, access to these records in sperm

banks is strictly limited, and the identity of the donor

and of the wife and husband may not be revealed to

anyone, including the parties themselves. The written consent of both the husband and the wife are required (108).

The regulations also state that the sperm donor is

required to give his written consent to the use of his

sperm for the purpose of artificial insemination. Presumably in doing so he gives up all rights and duties

to the child. The regulations further state that the husband should declare that the child will be considered

his own natural child for all purposes (108).

In Jewish law, there is controversy over whether

a child conceived by donor insemination is illegitimate.

Secular law does not directly address the issue of

legitimacy, but as a secular system will probably consider the welfare of the child to be the most important

consideration, a child conceived by donor insemination is probably considered legitimate (110).

[n 1979, the Israeli Supreme Court had its first encounter with artificial insemination when a man refused to pay support for a child born to his wife after

donor insemination. The court dismissed his contention that he had not agreed to the artificial insemination, and thus ruled that he must pay, whether divorced

or not. Because the Supreme Court recognized the

agreement, it may be assumed that it does not condemn artificial insemination by donor, at least when

a woman is married and her husband consents (110).

Oocyte Donation

The Supreme Helsinki Committee and the regulations

of the Ministry of Health both state that ova may be

recovered for purposes of donation only from women

themselves undergoing infertility treatment and during the course of such treatment. In other words,

women may not undergo the invasive procedure

necessary to retrieve eggs simply for the purpose of

donating them to another or for donating them to a

laboratory (60). The Supreme Helsinki Committee recommends that an egg donor should be limited to donating to one recipient (108), and, as with sperm donation, the egg donor should remain anonymous, with

all her rights and obligations to the child cut off under

Regulation 15. Oocyte cryopreservation is permitted,

and post-mortem donation of an egg is permitted if

the genetic mother was single and if she left written

evidence of permission.

Only married women intending to raise the resulting child may accept donated eggs, thus ruling out

gestational surrogacy. The recipient also may not be

related to the egg donor. Related, under Regulation

12, includes parent, child, grandparent, sibling, aunt,

or first cousin. women accepting a donated egg must

use their husband’s sperm for fertilization, as contrasted with those receiving IVF using their own eggs,

in which case donor sperm may be substituted. The

net result is that a couple cannot gestate and rear a

child to whom neither parent is genetically related.

Upon birth of the child, the recipient of a donated ovum

must take steps to formally adopt the child, thus implying that under Israeli law, maternity will follow the

paternity model, and will be based upon genetic rather

than gestational connection.

The Ministry of Health regulations recommend that

a woman only receive an ovum from someone of the

same national origin. This restriction derives from the

traditional Jewish religious law that states that a Jew.

is someone born to a Jewish mother. Recognizing that

a child resulting from the implantation of a n ovum

from a non-Jewish woman in a Jewish woman could

create considerable inconvenience for the child, who

might not be considered Jewish, the regulations suggest that ovum donation not be made across religious

or national differences, but do not prohibit the practice (108).

In Vitro Fertilization

Regulation 4 permits IVF only if a woman is infertile

and her physician recommends the procedure (107,

109). Regulation 8 further states that single women

may be eligible for IVF, provided that a social worker

certifies that the woman is psychologically and economically capable of raising a child (60). Retrieval and

donation of ova and freezing and implantation of fertilized eggs are permitted only in a hospital authorized by the Director General of the Health Ministry

to carry out these procedures. Authorization is granted
App. E—International Developments “ 341

after inspection for the adequacy of personnel, clinical and laboratory equipment, recordkeeping, and attent ion to ethical problems, and authorization may be

revoked if the standards do not continue to be met.

Both members of the couple undergoing IVF (or the

woman, if she is single) must give written consent to

the procedure. Donor sperm may be used, provided

that the woman is using her own egg. Single women

must use their own eggs, as egg donation to single

women is not permitted.

Freezing of fertilized eggs is permitted, but is limited

to a period of 5 years, unless special consent is obtained to extend that period to 10 years (60,107,109).

A frozen fertilized ovum may not be implanted in a

woman in the following instances: if the woman is

divorced and the egg was fertilized by her former hus -

band's sperm, unless the latter consents to the implantation; if hot h genetic parents are dead; or if the woman

is a widow, except when a year has already elapsed

since her husband’s death and a written report has

been made by a hospital’s social worker that the widow

is psychologically and economical}’ capable of raising

a child (60). No use maybe made of a frozen fertilized

egg if its genetic mother has died.

Research on Preimplantation Embryos

The 1987 regulations permit egg retrieval only for

the purpose of fertilization and implantation. This may

operate as a ban on experimentation with embryos,

as no embryo may be deliberately formed for the purpose of experimentation. It is not clear, however,

whether the genetic parents of a frozen embryo may

donate it to a laboratory for experimentation purposes

if they no longer wish to try implantation and gestation for themselves.

Surrogate Mothers

After the practice of IVF became established and egg

donation received a qualified endorsement, the Supreme Helsinki Committee was asked to approve IVF

with subsequent embryo transfer to a “host ,“ or gesta -

tional, mother. However, the Committee dismissed surrogacy. The regulations of the Ministry of Health also

ban implantation of a fertilized egg in a woman not

planning to be the child’s mother (60).

After studying the issue of surrogacy for a considerable amount of time, the Health Minister and Attorney Genera] decided to publish regulations that would

outlaw the practice of surrogacy in Israel (4).

South Africa

In 1986, pursuant to the Human Tissues Act of 1983

and the recommendations of a working committee

(113), South Africa’s Department of National Health

and Population Development issued regulations

governing the physician licensing and gamete donation associated with IVF and artificial insemination

(112).

Artificial Insemination

The 1986 regulations specify that artificial insemination by donor may only be performed by a physician who has been registered and approved by the Director General of the Department of National Health

and Population Development. Physicians must maintain detailed records of each donor and recipient, of

the transfer of gametes, and of the health of the children born by donor insemination. These records form

the basis of an annual report to the Director-General,

who maintains a central registry of gamete donation,

and help to ensure strict compliance with the limit of

five children per donor. If the physician does not attend the birth of the child, the mother must within

30 days of the birth report on the health of the child.

Any evidence of a hereditary disorder must be fol -

lowed by an inquiry into the mother’s and donor’s

genetic health.

The regulations require that a donor be screened

for sexually transmitted diseases, fertility, and general

health. The records maintained, to which the recipient may have access, note the donor’s age, height,

weight, eye and hair color, complexion, “population

group,” nationality, religion, occupation, education, and

interests. The donor’s spouse must agree to the use

of his sperm for donor insemination, and the donor

may limit the use of his sperm to recipients of specified religion and population groups.

Donor insemination is available only to married

women. Recipients are screened for all of the same

conditions as the donor, as well as to ensure that they

are “biologically, physically, socially, and mentally suited

for artificial insemination. ” Records are maintained

with “particular reference to possible genetic conditions and mental disorders. ” Recipients and their husbands must be advised by the physician of the psychological and legal risks of donor insemination, and must

receive counseling if the recipient appears to be a carrier for any heritable disorders.

The 1986 regulations do not address the legal status

of the resulting child. In 1979 a South African court
342 ● infertility: Medical and Social Choices

ruled that a child conceived by donor insemination was

illegitimate. The judge, however, did not declare the

procedure unlawful or ethically undesirable, and

urged the legislature to legitimize children conceived

by donor insemination (118).

Oocyte Donatio n

Oocyte donation is allowed in South Africa, and

screening of the donor and recipients is subject to precisely the same provisions as screening for donor insemination.

In Vitro Fertilization

The 1986 regulations do not address IVF except with

regard to licensing physicians and regulating the use

of donor gametes. The working committee did, however, consider a number of additional points. Most

members of the working committee whose recommendations formed the basis of the 1986 regulations had

no fundamental objections to IVF. They approved IVF

with the gametes of the infertile couple as well as with

donor gametes or donor embryos.

According to the 1986 regulations, IVF may only be

performed on licensed premises by registered gynecologists and these facilities must be centralized and

their number restricted. Later implantation for the

same couple was acceptable to the majority of the committee and, as far as is known, to the majority of the

community as well. The committee stated that embryos

may be donated to other infertile couples only if the

second infertile couple cannot overcome the infertility in any other way or may transmit serious hereditary disorders. Donated gametes may not be used unless each donor has given explicit written consent for

the use of their gametes to form an embryo. When

an embryo has been donated, it must be used for the

selected participants.

Research on Preimplantation Embryos

The committee stated that research on preimplantation embryos should be allowed under strict conditions approved by the responsible research controlling

body for a period up to 14 days after fertilization. The

committee further concluded that embryo flushing is

still an experimental procedure and thus it should not

at present be part of an IVF program.

Freezing and Storage of Human Sperm,

Oocytes, and Embryo s

The committee recognized the benefits of embryo

freezing for an IVF program, and suggested that the

participants in the program should be able to indicate

how they want excess embryos handled. Freezing and

storage of human embryos is allowed with the consent of the participants of the IVF program or the

donors of the gametes used to form the embryo. A

bank of frozen embryos is not to be allowed; each frozen embryo must be retained for participants, and if

donated must be used for the selected participants.

Donors must consent to freezing and storage of an

embryo formed from their gametes. Furthermore,

donors may decide the manner in which a stored embryo is to be used—whether it is to be donated to other

participants in the IVF program, whether it can be

made available for research, or whether storage is to

cease. Conditions governing use of the embryos shall

be incorporated as part of the consent document.

Surrogate Mothers

The working committee considered commercial surrogacy ethically unacceptable. It stated that surrogacy

contracts are unenforceable and that volunteer surrogacy should not be included in the IVF program, The

medical profession in South Africa also opposes surrogate motherhood. The Medical Association of South

Africa declared it “undesirable)” and the head of the

country’s leading IVF laboratory has also expressed

disapproval (16).

One unusual surrogate motherhood case has drawn

international attention to South Africa. In 1987, a 48-

year-old grandmother bore triplets conceived in vitro

from her daughter’s ova and her son-in-law’s sperm

(45). Experts disagree on the legal status of the children; one law professor said that the daughter might

have to adopt the children to protect her rights, while

another claimed that since the surrogacy was not part

of a commercial arrangement there should be no legal problems for the family. A third stated that under

common law the children will be legitimate, as they

were conceived with the gametes of a married couple

(16).

Sweden

In 1981, the Swedish Government formed a committee that is currently investigating most of the issues

surrounding noncoital reproductive techniques, The

Insemination Committee has published two reports,

one in 1983 concerning artificial insemination (121) and

one in 1985 concerning IVF and surrogate motherhood

(122). Some of the recommendations of the 1983 report became law in March 1985.

Artificial Insemination

Artificial insemination, both by husband and by

donor, has been carried out in Sweden since the 1920s.
App. E—International Developments ● 343

In 1983, the Government committee published Children Conceived by Artificial Insemination. This report

stated that there is “no specific protection for the AID

[artificial insemination by donor] child, judicially or in

any other respect” (121). The committee’s general point

of departure was therefore “that the needs and interests of the prospective child be satisfied and safeguarded in a satisfactory way.” The committee found

“strong reasons in favor of drawing parallels between

adoption and AID” (121).

These recommendations resulted in a 1985 artificial

insemination law (119). According to this law only

women married or cohabiting with a man under circumstances of marital character should be allowed insemination treatment; insemination requires a written consent by the husband or cohabitant, who will,

by this act, be regarded as the legal father of the child

born following the treatment; artificial insemination

by donor should only be undertaken in general hospitals under the supervision of a physician specialized

in obstetrics and gynecology, and the sperm donor

should be chosen by the physician; information about

the donor of sperm should be kept in a special hospital record for at least 70 years; when a child conceived

by donor insemination is mature enough, he or she

has a right to obtain information about the identity

of the natural father, information that is kept in the

special hospital record; and, when requested, the public welfare committee is duty bound to assist the child

in retrieving this information (119). The question of

contact between the donor and child is not regulated.

The National Board of Health and Welfare has stated

that such contacts sometimes can be of great value

to the child, but must be voluntary on all sides. The

parents are not obligated to tell the child of the use

of donor insemination for his or her conception, but

are encouraged by the board to do so (58,66).

The physician performing artificial insemination by

donor should examine the suitability of the technique

with respect to the medical, psychological, and social

circumstances of the prospective parents. Finally, the

insemination should only be undertaken if the circumstances of the prospective parents are of a character

enabling the child to grow up under favorable conditions (119).

Oocyte Donatio n

The Government committee recommended that egg

donation be prohibited in Sweden (122).

In Vitro Fertilization

IVF is not regulated in Sweden, although legislative

work is in progress (73). The Government committee

proposed that IVF treatment be restricted to women

married or cohabiting under marital circumstances,

that the implantation of the fertilized egg requires a

written consent by the husband or cohabitant, and that

without the permission of the National Board of Health

and Welfare, IVF may only be undertaken in general

hospitals. Regarding donor gametes in IVF, the committee further suggested that an in vitro fertilized egg

should only be implanted in the woman from whom

the ovum was recovered and that the egg should only

be fertilized by the semen of the husband or cohabitant (122).

Research on Preimplantation Embryo s

In 1982 the Swedish Government appointed a different committee to study the ethical, humanitarian, and

social issues arising from the use of genetic engineering. The Committee on Genetic Integrity published a

report, Genetisk lntegritet (Genetic Integrity), in 1984

(120). It did not propose a limit on human embryo experimentation but instead suggested a number of ethical norms to be followed. Regarding research on embryos, the committee recommended that “research and

experiments on zygots and embryos are acceptable

provided they are medically well-founded, that they

are performed within 14 days after fertilization (freezing time not counted), and that the donor of eggs and

sperm has given her/his free and informed consent”

and that “human zygots and embryos exposed to experiments must not be implanted and developed in

vivo” (120). They further recommended that any experiments proposing to violate these guidelines must

come under severe ethical examination. Legislative

work on this issue has not been completed (73).

Surrogate Mother s

The Insemination Committee regarded surrogate

motherhood as indefensible due to the risk of children

becoming objects of financial bargaining. The procedure would require extensive changes within the legal system, which the committee saw no reason to consider (122).

United Kingdom

In 1984, the Government-sponsored Warnock Committee (named after its chairperson, Dame Mary Warnock) made 63 specific recommendations concerning

noncoital reproductive techniques and reproductive

research (125). The Warnock report has been influential in the United Kingdom and elsewhere, as it was

one of the first national committees to address the ethical, legal, and social implications of the new reproductive technologies (64). The ethical and social delibera-
344 ● Infertility: Medical and Social Choices

tions have been discussed in chapter 11; this section

covers the legal issues.

The Government’s first response to the Warnock Report was to introduce legislation in 1985 banning commercial surrogacy. Regarding other issues surrounding infertility treatment, the Government decided

further consultation was needed. Thus, in 1986, the

Department of Health and Social Security released a

Consultation Paper, Legislation on Human Infertility

Services and Embryo Research (126). The document

encouraged further discussion on the following questions: the need for a statutory licensing authority for

infertility treatment, the need to counsel infertile couples, the legal status of children resulting from techniques that use donated gametes, the definition of

mother and father in cases of egg or embryo donation, the enforceability of surrogacy contracts, storage and disposal of human embryos, and research on

human embryos (126).

The consultation period ended in June 1987, and in

November 1987 the Government issued a White Paper that should be the basis for future regulation (127).

The proposals generally followed the recommendations of the report, unless otherwise noted. The most

notable deviation is the presence of alternative clauses

on embryo research; the Government is leaving this

decision to free vote by the Members of Parliament.

The Warnock Committee recommended that a statutory licensing authority be established to regulate certain infertility services and related research. As an interim measure, the Medical Research Council and the

Royal College of obstetricians and Gynecologists

formed a Voluntary Licencing Authority (VLA) to regulate the clinical practice of IVF and embryology. The

guidelines published in the VLA’S first two reports are

consistent with the recommendations made by the

Warnock Committee (130,131). The Government’s

White Paper of 1987 then proposed a Statutory Licenc -

ing Authority (SLA) that would oversee the following

areas: any treatment (or research, if approved) involving human embryos created in vitro or taken from the

womb of a woman (e.g., by lavage); treatments involving donated gametes or donated embryos; the storage

of human gametes or embryos for later use (by

cryopreservation); and the use of diagnostic tests involving fertilization of an animal ovum by human

sperm. The SLA will be responsible, among other

items, for licensing and collecting data on facilities

offering these techniques. The White Paper states that

the use of these techniques without the appropriate

license is a criminal offense.

Artificial Inseminatio n

Section 27 of the Family Law Reform Act 1987 follows the Warnock recommendation that a child conceived with donor semen is the legitimate child of the

mother and her husband, provided both have consented to the procedure. The White Paper states that

legislation will establish that the sperm donor will have

no parental rights or duties to the child.

The White Paper proposes that the SLA keep a central record of all gamete and embryo donations and

births resulting from these donations. All adults over

the age of 18 conceived by gamete or embryo donation should have a legal right to find out how they were

conceived and to obtain certain nonidentifying information about the donor. The Government plans to construct the bill so that this provision can be amended

and the possibility of granting access to identifying information remain open. This measure would be made

retroactive,

Although the White Paper recognized that limiting

the number of donations from any one donor is desirable, it did not propose stating a limit within future legislation. Instead, it proposed that the SLA set and regulate this limit. It also stated that the SLA will be

responsible for making sure that any financial transactions are for the recovery of reasonable costs only.

Oocyte Donatio n

The White Paper proposes that the provisions of section 27 of the Family Law Reform Act 1987 be extended

to children born following egg and embryo donation,

so that any child born to a couple using donated gametes or a donated embryo be considered the legitimate child of that couple, provided the husband and

wife both consented. The White Paper also states that

legislation will make clear that where a child is conceived with donated gametes or embryos, the birth

mother shall be regarded in law as the child’s mother.

Furthermore, the donor(s) will have no parental rights

or duties to the child.

In Vitro Fertilization

The Warnock Committee proposed that IVF be available to all couples, whether married or not, but the

Government White Paper did not specifically mention

whether marriage should be a prerequisite, According to the White Paper, artificial insemination by husband or by donor, egg donation, and embryo donation in conjunction with IVF should continue to be

available, subject to the recommended licensing and

inspection. The Warnock Committee did not recommend the use of embryo donation by lavage because

the technique was not known to be safe, and the White

Paper fails to specifically mention this technique.

The guidelines published in the VLA report state that

clinical and research facilities carrying out IVF must

have access to an ethics committee, keep detailed
App. E—international Developments ● 345

records, and have appropriately trained staff. No more

than three embryos, or four in exceptional circumstances, should be transferred to a woman (129). The

VLA visited IVF centers and evaluated them; 30 IVF

clinics had been approved and licensed by the VLA

as of 1987 (131).

The proposed SLA will similarly oversee facilities

offering the regulated infertility treatments. The White

Paper states that the SLA will ensure there is adequate

staffing, quality facilities, recordkeeping, screening and

assessment procedures, and arrangements for storage

and disposal of gametes and embryos.

Freezing and Storage of Human Sperm,

Oocytes, and Embryos

Although the Warnock Committee considered freezing sperm acceptable, it stated that freezing oocytes

would be acceptable only if the technology improved.

Embryo cryopreservation was considered acceptable

as an experimental technique.

The White Paper stated that cryopreservation of human gametes and embryos should be permitted, but

only under license from the SLA and subject to certain conditions regarding maximum storage times. According to the Government, gametes may be stored

for a maximum of 10 years, while embryos may be

stored for a maximum of 5 years.

The White Paper also states that storage of gametes

and embryos can only take place with the written consent of donors. The donor’s wishes should be followed

during the period during which embryos or gametes

may be stored; when this period expires, they may be

used by the licensed storage facility for other purposes

only if the donor gave consent for such use. Concerning embryos, all possible uses (implantation into

another women, research, destruction) must be approved by both donors. If disagreement exists, the embryo must be left in storage until the end of the storage

period, then discarded.

Research on Preimplantation Embryos

The majority of the Warnock Committee members

recommended that research on embryos be allowed

for up to 14 days after fertilization but only under license, and whenever possible with the informed consent of the couple from whom the embryo was

generated. (Nine of the sixteen members recommended this course of action; three were opposed to all experimentation on embryos; and four were opposed to

experimentation on embryos created solely for the

purpose of research.) The current VLA guidelines follow the committee’s suggestions, allowing research on

embryos up to 14 days with the consent of both donors

only if the information needed cannot be obtained by

research on other species.

There has been considerable controversy in the

United Kingdom concerning embryo research. Three

bills were introduced by members of Parliament to

ban such research, all of which have been defeated.

The British Medical Association, the Royal College of

Obstetricians and Gynecologists, and the Medical Research Council all favor carefully regulated research

on early embryos (55).

The Government White Paper did not follow the recommendations of the Warnock Committee on this issue; it proposed alternative draft clauses to be voted

on by Members of Parliament. One clause forbids any

research on human embryos not aimed at preparing

the embryo for transfer to the uterus of a woman; the

other permits any project specifically licensed by the

SLA. Regardless of which clause is used, any genetic

manipulation of the embryo, creation of hybrids, or

trans-species fertilization (except when fertilization of

the egg of another species with human sperm is used

for diagnosis of subfertility) is forbidden.

Surrogate Mothers

The recommendations of the Warnock Committee

to forbid surrogacy agencies led to the passage of the

Surrogacy Arrangements Act in 1985, which banned

commercial surrogacy in the United Kingdom. The act

has accomplished the purpose of suppressing surrogacy agencies; such arrangements will likely continue to occur, however, as surrogates and commissioning parents are exempt from criminal liability, and

private surrogacy arrangements are not prohibited.

The White Paper decided against licensing noncommercial surrogacy services and emphasized that any

contract drawn up as part of a surrogacy arrangement

will be unenforceable in the United Kingdom courts.

76-580 - 88 - 12 : QL 3
346 “ Infertility: Medical and Social Choices

OTHER NATIONAL EFFORTS REGARDING NONCOITAL

REPRODUCTION

Argentina

Five centers for infertility treatment in Argentina

offer artificial insemination, IVF, and gamete intrafallopian transfer. None of these procedures is currently regulated by law, but legislators are examining the

relevant issues (76).

Infertility treatment is covered by health insurance

and is offered throughout the country in specialized

hospitals; however, artificial insemination must be

paid for by the patient. Ethics committees function in

some of these hospitals (76).

Austria

In 1986, two studies were published in Austria, one

a national enquiry on family policy and the new reproductive technologies and the other a report of the

Ministry of Science and Research on the fundamental

aspects of genetics and reproductive biology (13). The

Department of Justice is now preparing a bill that will

regulate artificial procreation; of particular interest,

it will allow posthumous insemination and surrogacy

(23).

Artificial Insemination

Infertility treatment and artificial insemination are

not currently regulated in Austria. Artificial insemination is not offered widely throughout the country,

although some specialized hospitals and private physicians provide it. Infertility treatment in general is covered by health insurance but artificial insemination

must be paid for by the patient (79).

The Ministry of Science and Research report recommended that donor sperm be used in artificial insemination and IVF only if the husband or partner is

sterile and the woman and her husband or partner

give informed consent to the procedure. If he has consented, the husband or partner cannot contest paternity, and the donor should have no legal rights to any

resulting child.

The report recommended that the doctor be responsible for screening donors, keeping confidential

records of the physical examination and the identity

of the donor, and, if necessary, revealing medical facts

to the recipients and the resulting children. These criteria should be applied to egg donation as well. Mixing sperm should be forbidden, and the use of frozen

sperm by a widow should be allowed only within 10

months after her husband’s death. Finally, no more

than 10 conceptions should be allowed with any one

donor’s sperm.

In Vitro Fertilization

The Ministry of Science and Research report recommended that IVF only be used to ameliorate infertility after other treatments have failed, or when medical treatment is too risky or without hope. There must

be reasonable hope for success, and precautions must

be taken to ensure that there is no risk to the mother

or child. The procedure should only be offered to couples who are married or in a stable relationship and

who show that they would offer a satisfactory home

for a child.

A couple can accept a donated egg or embryo if all

other treatment possibilities have been exhausted, if

the husband (or partner) agrees, if the egg has been

fertilized in vivo or in vitro with the husband’s sperm,

and if the woman is younger than 45 years old. The

report specified that doctors should not fertilize more

eggs than they intend to transfer back to the woman;

if more embryos are created, however, freezing them

is allowed. Frozen embryos should be used by the couple from whom the gametes originated. If not, they

can be donated. If no infertile couples need the embryos, then they may be used for research, provided

the parents give permission. In no case should embryos

be implanted after they have been frozen for 3 years.

Research on Preimplantation Embryos

The report states that research should be performed

only on embryos that have no hope of implantation.

Before the research commences, the researchers must

show that medical progress can be made from this experimentation and must check with their local Institutional Review Board. Experimentation is expressly prohibited if the possibility for animal research is not

exhausted; if the embryo is more than 14 days old;

if the embryo is used for routine experiments; if researchers are attempting to create clones, chimeras,

or human/animal hybrids; or if the point of the experiment is not to prevent or cure disease but to create

humans with special characteristics.

Surrogate Mothers

Surrogate motherhood should not be allowed,

according to the Ministry of Science and Research

report.
App. E—International Developments . 347

Belgium

Currently artificial insemination by donor is dealt

with mainly by the courts in Belgium, It can only be

used for sterility or hereditary disease, payment of

donors is not allowed, and the identity of the donor

can only be revealed by court if necessary (24). The

consent of the woman, her husband, and the donor

is required. Absolute secrecy must be maintained. In

1987 a law was passed stating that a child born from

artificial insemination by donor with the consent of

the husband is legitimate and that the consenting husband cannot challenge paternity (23,35).

IVF is regularly practiced in the obstetrics departments of all medical schools and in a number of other

centers (53). In 1987, the Government organized two

colloquia dealing with reproductive techniques, one

dealing mainly with judicial problems and the other

with ethical and medical matters (23). Sharp differences between those who share the views of the Roman Catholic Church and others prevented these colloquia from reaching conclusions acceptable to a

substantial,majority, although a report (Collogue Alational de Reflexion Scientifique) was presented to the

Belgian Secretary on the State of Health and Bioethics

in the 1990s (2 I). This deadlock and the technological

advances that constantly modify the practical problems encouraged governmental circles to postpone definite legislative proposals in this field (53).

Brazil

According to Brazil’s 1957 Code of Medical Rules (Article 53), artificial insemination by donor is prohibited

and artificial insemination by husband may be performed only with the consent of both spouses (24).

Bulgaria

Article 31 of Bulgaria’s Family Code deals with artificial reproduction, It states that motherhood is determined through birth, regardless of the origin of the

genetic material, and that the husband of a woman

who undergoes artificial insemination by donor or accepts an oocyte donation cannot contest paternity if

he consented to the procedure (24).

Chile

There is no specific legislation in Chile regarding noncoital reproduction. However, the Chilean Fertility Society and the Chilean Society of Obstetrics and Gynecology have developed guidelines concerning IVF. The

two societies consider the procedure ethical if used

for a married couple using their own gametes (37).

Colombia

Colombia’s criminal code states that artificially inseminating a woman without her consent is a crime

punishable by imprisonment (117).

Cyprus

There is no legal regulation of infertility treatment

in Cyprus. The Government medical services provide

limited facilities for infertility treatment but none for

artificial insemination. Some private gynecologists offer artificial insemination at high costs (79).

Czechoslovakia

Czechoslovakian federal legislation (Family Law, Article 52-2, 1982) states that the consenting husband of

a woman undergoing donor insemination may not contest paternity if the child was born between 6 and 10

months after artificial insemination was administered,

unless it can be proved that the mother of the child

became pregnant by means other than artificial insemination (24).

Two Czechoslovakian republics, the Czech Socialist

republic and the Slovak Socialist republic, have passed

legislation based on the 1982 federal legislation. They

state that artificial insemination may be performed

only when health reasons exist for such an intervention; that a medical examination must be performed

on the parties involved; that written permission must

be obtained for the procedure by both husband and

wife; that donors must be healthy, without evident

genetic defect; that the couple and donor may not learn

each other’s identities; and that all circumstances involved with artificial insemination must be kept confidential (24). The legislation does not explicitly state

that the couple must be married, but in the legislation

they are always referred to as husband and wife.

Denmark

Currently no regulations cover infertility treatment

in Denmark, but artificial insemination by donor is performed only in public hospitals (79). In 1953 a Commission appointed by the Danish Ministry of Justice

issued a report recommending a law on artificial insemination. No legislative action was taken in response.

However, the report recommended that physicians

performing donor insemination choose the donor and

keep the identity of both the donor and the couple

confidential, and these rules are generally followed

in current practice (68). Oocyte donation and surrogate

motherhood have not been accepted in Denmark (69).
348 ● Infertility: Medical and Social Choices

A committee under the Danish Government published a report on Ethical Problems with Egg Transplantation, AID and Research on Embryos in 1984. The

conclusion of this report was that legislation concerning these techniques was unnecessary but that a standing review and advisory ethics committee should supervise their use. This committee will begin to function

in 1988 (69).

In 1987a law was passed forbidding all research on

human embryos until a National Ethics Committee proposes guidelines for such research to Parliament (23).

Egypt

Artificial insemination by husband is allowed in

Egypt, while artificial insemination by donor is not.

One center offering artificial insemination by husband

and IVF reports that these technologies are accepted

on a social level in Egypt but are still resisted by some

doctors. A number of other centers are developing

slowly.

The use of IVF on infertile couples is permissible under Islam if the couple is married, the gametes come

from the couple, and the embryo is implanted into the

wife. Cryopreservation of sperm, oocytes, and embryos

is not clearly addressed by religious

rogate motherhood is forbidden by

tions (63).

authorities. Surreligious regulaFinland

There are no regulations specifically covering infertility treatment in Finland, but treatment is available

from hospitals and the Finnish family planning agencies free of charge (79).

German Democratic Republic

Artificial insemination by donor and IVF are considered ethically acceptable in East Germany. Artificial

insemination by donor is offered through special

centers, following the written agreement of the infertile couple that any resulting child will be regarded

as legitimate (79). oocyte and embryo donation are also

accepted, with the informed consent of the genetic parents. The sale and purchase of human gametes or embryos is forbidden, as is surrogacy. The transfer of frozen embryos is discouraged until there is no risk

involved in the procedure (137). However, there are

no regulations governing infertility treatments.

Greece

There are five IVF centers and one frozen sperm

bank in operation in Greece, and artificial insemination by donor has been practiced there for the last

23 years. Article 1 471/2-2 of Greek Civil Code, Law

1329, of February 1983, states that a husband who has

consented to his wife undergoing artificial insemination by donor cannot disavow his paternity regarding

the resulting child (24).

IVF, frozen and fresh sperm banks, surrogate

mothering, and embryo freezing are all illegal in

Greece. Thus, although these medical procedures are

carried out, they are in essence being done illegally.

The Greek Orthodox Church also opposes surrogate

motherhood (78).

Hungary

Two pieces of legislation relate to infertility treatment in Hungary. Ordinance No. 12 of the Ministry

of Health states that artificial insemination maybe carried out on any woman under 40 who resides in Hungary; is in full possession of her physical and mental

faculties; and is unlikely, according to medical opinion, to conceive naturally. Artificial insemination is normally carried out using the husband’s semen. The use

of donor sperm may only be considered if insemination using the husband’s semen is unlikely, according

to medical opinion, to result in the birth of a healthy

child. A donor must not be suffering from any hereditary disease, and physicians must observe strict confidentiality regarding the identity of the donor (24).

The National Institute of Obstetrics and Gynecology

and the National Institute of Urology issued a circular

pursuant to Ordinance No. 12. The circular states that

potential sperm donors must be healthy, intelligent,

and free of hereditary disease. Furthermore, potential donors must undergo the following tests: a genetic

examination, determination of blood group and Rh factor, a psychological examination, and a test to detect

the presence of sexually transmitted diseases. The physician carrying out the insemination and the personnel of the establishment in which it is carried out are

required to keep the identity of the donor and the procedure confidential (117).

Article 38-1 of the Law on Marriage, Family, and the

Care of Children (1974) states that except when the

husband or partner of a woman undergoing artificial
App. E—International Developments ● 349

insemination recognizes paternity of the resulting

child, paternity can only be determined in court, However, the court cannot establish paternity when artificial insemination has been used. These provisions ensure that the sperm donor will have no rights or duties

to the resulting child. The presumption of paternity

can be contested if the husband can prove that he did

not have sexual relations with the woman at the time

of conception or if he did not consent to his spouse’s

artificial insemination (24).

Iceland

More than 50 children have been conceived by artificial insemination since 1979. Donor sperm comes

from Denmark to avoid problems of consanguinity due

to the small size of the population. Artificial insemination by donor is the only method of noncoital reproduction currently used in Iceland (24).

During the 1985/86 parliamentary session, Parliament passed a resolution asking the Ministry of Justice to form a study commission to look at the legal

aspects of artificial insemination (24), as there currently

is no legislation on any aspect of noncoital reproduction.

India

IVF is now officially encouraged as a treatment for

infertility, despite India’s overall objective of slowing

population growth. The Indian Council for Medical Research first sanctioned IVF in 1983 and began a research program at the Institute for Research in Reproduction in Bombay. There is now considerable

public interest in IVF. Many private clinics as well as

Government-run facilities offer the procedure (62).

Ireland

Artificial insemination by donor and IVF are performed in Ireland. In 1985 the Medical Council of Ireland approved guidelines promulgated by the Institute

of Obstetricians and Gynecologists. Therapeutic application of IVF is authorized provided the couple is

married, no donor gametes are used, and all embryos

created are placed into the woman undergoing the procedure. Experimentation on and freezing of embryos

is considered unacceptable (23).

Italy

In 1984, the Minister of Health appointed the Commission Ministerale per una Specifica Normatica in

Terma di Fecondazione Artificial Umana to study reproductive technologies. The resulting document, the

Santosuosso Report (published in 1985), proposed two

bills-one dealing with artificial insemination and the

other with artificial insemination by donor, surrogacy,

and other issues—and included two introductory essays (80).

No legislation has been passed as yet in response to

the Santosuosso Report. The report proposed that artificial insemination by husband and donor be permitted,

but be limited to married couples, and that donor insemination be available only when adoption is not

granted within 6 months of application (136). In 1987,

the Italian Government issued a regulation requiring

that all donors undergo tests for hepatitis and sexually transmitted diseases. Furthermore, the Ministry

of Health is preparing a registry listing all public and

private centers where artificial insemination is practiced and plans to create a data bank on the results

of the procedures (136).

IVF has been the subject of considerable discussion

during the past several years in Italy. Six bills have been

proposed, but none has been debated in Parliament

(80). In 1984, a group of gynecologists and researchers

the

●

●

●

●

●

●

●

●

in Italy made the following recommendations for

practice of IVF:

IVF is justified only when other therapeutic techniques have been unsuccessful or have no possibility of success, or when alternative therapeutic

techniques are too risky;

the couple must be married and be adequately informed about the technique and related risks;

embryos should be reimplanted, whenever

possible;

donor eggs and sperm are acceptable in principle, but IVF embryos should not be donated from

one couple to another;

research on embryos for commercial purposes

should not be allowed;

manipulation on the genotype of germ cells should

not be allowed;

IVF must be carried out under the direction of

a physician in a facility authorized by the Ministry of Public Health; and

a national ethics committee should be established

to formulate guidelines (24).

Japan

Japanese attitudes concerning noncoital reproductive technologies are divided. Currently no law deals

with any of the technologies, but various professional

organizations have issued relevant guidelines (14), such

as the 1985 guidelines issued by the Japanese Obstetrics and Gynecology Society (21).
350 “ Infertility: Medical and Social Choices

Only one hospital offers artificial insemination by

donor in Japan at the moment, and no sperm bank

facilities exist. Sperm donors are paid, and they are

usually medical students or others with some affiliation to the hospital. Estimates indicate that approximately 10,000 children have been born in Japan as a

result of donor insemination (14). The medical profession in Japan preserves the anonymity of sperm

donors; records are kept but no information is made

available to recipients of sperm (14).

No law establishes the status of these children. However, many legal scholars have construed existing law

to presume that the child of a married woman conceived by donor insemination is the legitimate child

of her husband, provided the procedure is carried out

according to current practice (14).

The first IVF baby in Japan was born in 1983, and

currently about 30 institutions perform the procedure.

The guidelines of the Japanese Obstetrics and Gynecological Society state that IVF must be limited to married couples. Oocyte donation and surrogate motherhood are not practiced in Japan (14).

The Japanese obstetrics and Gynecology Society has

also recommended that a fertilized egg can be used

for experimentation up to 14 days, with the consent

of the donors (14).

Libya

Artificial insemination by donor is criminal in Libya.

Libya’s criminal code (articles 304A and B) states that

anyone who artificially inseminates a woman by force,

threat, or deceit is to be punished by imprisonment.

Furthermore, a woman who consents to artificial insemination or who attempts to artificially inseminate

herself is to be punished with imprisonment. The husband is also punished if the insemination took place

with his consent. It is not clear if these prohibitions

extend to artificial insemination with the husband’s

sperm (24).

Luxembourg

An official committee under the Director of the National Laboratory of Health has been charged with

proposing guidelines for the use of medically assisted

procreation. Its report was submitted to the Government in 1986 (24).

Mexico

There is no legislation regarding reproductive technology in Mexico, nor are there published reports

studying the relevant issues. Infertility programs are

available, however, for couples desiring to have children. Due to the expense involved with such programs,

they are offered primarily by Government institutions.

The procedures available are IVF and gamete intrafallopian transfer, using only gametes of the couple.

Mexicans have not used donated gametes or surrogate

mothers to date. Cryopreservation of embryos is currently available at one program (111).

Although there are no national regulations related

to reproductive technologies, the Government institutes have adopted the declarations of the American

Fertility Society and the Queen Victoria Medical Center from Melbourne, Australia, as a basis for selfregulation. To accept a couple for treatment, the institutions require that the woman be 20 to 35 years

old; that ovulation occur; that the infertility be caused

by a tubal factor, perineal factor, immunologic factor,

or another kind of undetermined infertility; and that

the couple have no more than one child already (111).

The Netherlands

All noncoital reproductive technologies are available

in Holland, and research on the embryo is being discussed, In 1986, the independent Health Council of the

Netherlands submitted a report on reproductive technologies to the Minister and State Secretary of Health

(43). The report discusses the technical, psychosocial,

and ethical aspects of noncoital reproduction, in particular artificial insemination by donor, IVF, egg donation, and surrogacy.

Artificial Insemination

The use of artificial insemination by donor is fairly

common in the Netherlands, resulting in the birth of

approximately 1,000 children per year (43). Holland’s

Civil Code denies the husband of a woman undergoing donor insemination the right to contest the paternity of any resulting child if he has consented to the

procedure (24). General agreement exists that sperm

donors have no responsibility for children resulting

from their sperm (7o). A working group of the Association of Family and Youth recently recommended

that legislation ensure this situation (43).

The Health Council of the Netherlands considered

the use of donor insemination or IVF by a woman without a male partner acceptable in certain circumstances.

It recommended that prospective sperm donors be

screened for heightened genetic risks and infectious

diseases, A sperm bank should only be allowed to reject a donor on these grounds. Only frozen sperm

should be used, and sperm from different donors

should not be mixed. The Council recommended that
App. E—International Developments ● 351

children conceived by donor insemination be informed

about their manner of conception and relevant genetic

information but not about the identity of the donor.

The number of inseminations allowed per donor

should be limited. Finally, donors should not be paid

for their sperm, only their travel expenses (99).

Oocyte Donation

The Health Council also considered noncommercial

egg donation acceptable. They recommended that

more detailed legislation is needed regarding the right

of ownership of human egg and sperm cells. Recipients of donor eggs should also sign informed consent

statements. Regarding donated gametes generally, the

Council felt that parents should be encouraged to inform their children of the nature of their origin but

should have the freedom to decide how and when to

inform the child (99)

In Vitro Fertilization

IVF is available in the Netherlands. In 1985, however, the Minister of Health decided that for the time

being IVF would not be covered routinely by the sickness funds, a public health insurance system that covers people whose yearly income is below fl. 50,000

(about $20,000) (43).

The Health Council report concluded that the results

of IVF in relation to the costs have roughly come to

match those of tubal surgery, so IVF should no longer

be limited on medical grounds. IVF centers should be

subject to certain requirements that would ensure high

quality care and adequate ethical review. As with artificial insemination by donor, the couple undergoing

treatment must give written informed consent, indicating at the same time what should be done with any

excess embryos. Cryopreservation of embryos was also

found acceptable, within certain time limits (99).

Research on Preimplantation Embryos

The Health Council stated that preimplantation embryos should be approved for research provided “that

major interests of a large number of people are at stake;

that the data could not be obtained by different means;

that both partners have given their consent; and that

the research proposal has been vetted and approved

not just by the medical ethics committee of the hospital in question but also by a national committee” (99).

Furthermore, they recommended that the legal status

of the preimplantation embryo, the authority over the

embryo by its genetic parents, and the functioning of

embryo banks should be regulated by law. Selling embryos should be prohibited (99). No general agreement

exists in the Netherlands concerning this research (70).

Surrogate Mothers

The Health Council considered noncommercial surrogacy arrangements acceptable for medical reasons

only and stated that commercial surrogacy should be

forbidden by law. Their report recommended that a

Government-supervised body (resembling an adoption

agency) should be responsible for supervising surrogate arrangements.

The Council proposed that in principle a surrogate

mother should part with the child right after birth.

However, the surrogate mother should be allowed to

claim a 3-month period to reconsider the transaction.

The “claim” should be made (and granted) prior to the

child being given up. Once the child has been handed

over to the adoptive parents, a claim should be considered invalid (99).

New Zealand

In 1985, the Law Reform Division of New Zealand’s

Department of Justice published a comprehensive issues paper specifically to encourage “informed public

debate” on new developments in reproductive technology (87). Twenty-one months later the Division published an extensive summary of the submissions it had

received (88).

New Zealanders hold a variety of opinions concerning these technologies, with no one view favored by

a clear majority (41,88). There are religious objections

to every procedure, feminist objections, strong advocacy views from infertility associations, and various

intermediate positions.

In 1986 the Government introduced to Parliament

a bill to amend the Status of Children Act 1969. The

purpose of the bill was to clarify the legal status of

children conceived through the use of donated sperm,

donated ova, or donated embryos using the techniques

of artificial insemination by donor, IVF, or gamete intrafallopian transfer. Not all these techniques are currently available in New Zealand. The bill, known as

the Status of Children Amendment Act 1987, provides

that the consenting husband of a woman receiving

donor insemination is the legal father of the child. The

husband’s consent is presumed unless evidence indicates otherwise. When oocyte donation occurs, the

birth mother is the child’s legal mother. Sperm and

ova donors lose all rights and responsibilities of parenthood. If the husband does not consent to the procedure or if the mother is single, the donor is the legal

father, but he holds no rights or responsibilities regarding the child unless he marries the mother. The

bill does not discuss a child’s access to information

about his or her genetic parentage because there is

no statutory prohibition on the release of such information.
352 ● Infertility: Medical and Social Choices

In 1986, the Minister of Justice set up a threemember committee to “monitor the issues associated

with alternative methods of reproduction and to advise the government as required, ” with one member

each from the Ministry of Women’s Affairs, the Department of Health, and the Department of Justice

(loo).

Artificial Insemination

During the past 10 years, artificial insemination by

donor has been performed at major centers in Auckland, Wellington, Christchurch, and Dunedin; in

smaller centers in Hamilton, Napier, and New

Plymouth; and by some individual physicians. Some

of these clinics do not operate continuously; some close

temporarily, usually for lack of donors. One 1987 estimate stated that one child a week is born as a result

of artificial insemination by donor (100). Currently all

the centers freeze semen for 3 months to test donors

for acquired immunodeficiency syndrome. Policies

vary from center to center regarding the age of wife,

husband, and donor; the screening, recruitment, and

reimbursement of donors; and recordkeeping (87).

In Vitro Fertilization

There is one state-funded IVF program in New

Zealand, located in Auckland, which produced its first

baby in 1984. As of November 1986,28 IVF babies had

been born (100). The IVF program uses no donor gametes. A private clinic was setup in Auckland in 1987

that offers gamete intrafallopian transfer and transvaginal ultrasonically directed oocyte retrieval. Because

of the limited facilities and long waiting lists, many infertile New Zealanders go to Australia for IVF (59).

Norway

Two groups in Norway have addressed issues raised

by novel reproductive techniques. In 1983, the Council of Medical Research issued ethical directives for artificial insemination and IVF (40). In 1986 a group of

ministers proposed a law on both procedures (24),

which the Norwegian Parliament adopted in 1987 (Act

No. 68 of June 12, 1987).

The 1983 directives stated that artificial insemination and IVF should be limited to married couples or

unmarried couples in a stable relationship. There

should be uniform law concerning the anonymity of

donors, and any children conceived with donated gametes should be considered legitimate. Sperm banks

should be regulated by public law. A registration for

donors should be instituted for eggs and sperm not

immediately used in artificial insemination and IVF.

The recipient of donated gametes and any resulting

child should have access to medical information about

the donor. Finally, research on sperm, eggs, and embryos should be reviewed by medical ethics committees.

The 1987 law states that artificial insemination and

IVF are available only to married couples or couples

in a stable relationship, that written consent must be

obtained, and that the doctor must perform a medical

and psychosocial evaluation. Artificial insemination by

donor may only take place if the husband is infertile

or the carrier of a grave hereditary disease, and IVF

may only take place if the woman is otherwise sterile.

The doctor must choose the donor, who remains anonymous. The donor may not be given identifying information about the couple or the resulting child. For IVF,

the couple’s own gametes must be used, and the intended rearing mother must carry the child; gestational

surrogacy is not allowed. An Amendment to the Children Act, passed on the same day, states that the consenting husband of a woman using donor sperm should

be considered the legitimate father of the child, and

that the donor has no legitimate claim to the child.

The 1987 law states that artificial insemination and

IVF must take place only in designated hospitals under special authorization by the Ministry of Social Affairs and under the direction of specialists. Cryopreservation of sperm and embryos is allowed, but only at

the designated hospitals. Embryos may not be stored

for more than 12 months. By virtue of limits on the

use of artificial insemination by donor and IVF, surrogacy is illegal in Norway.

Philippines

Although a small number of physicians perform artificial insemination or gamete intrafallopian transfer,

the use of reproductive technology is not common in

the Philippines. More governmental emphasis is placed

on controlling the birth rate than on alleviating infertility (3).

Poland

There are no statutes concerning artificial insemination or IVF in Poland. However, a Supreme Court

decision in 1984 stated that the consenting husband

of a woman using donor sperm cannot contest paternity of the resulting child (24). Concerning IVF, several clinics have attempted the procedure with no

apparent success so far. The state has no objections

to the procedure, although the Church disapproves

of it(123).
App. E—International Developments “ 353

Portugal

A 1984 Portuguese law on sex education and family

planning mentions infertility explicitly, stating that the

state must encourage its treatment by facilitating the

creation of artificial insemination centers and specialized centers for prenatal diagnostics (24).

Since 1985, frozen sperm has been available through

the University of Porto, and in 1986 Portugal’s first

sperm bank was created. Also in 1986, sperm banks

became subject to licensing regulation; the regulations

state that the donor should not be paid, should remain

anonymous, should be within a certain age range, and

should have had children previously. Furthermore, the

collection, manipulation, and conservation of sperm

must be done only by publicly created centers or private doctors specially licensed by the Ministry of Health

(24).

According to Portugal’s penal code (article 214), artificially inseminating a woman without her consent

is punishable by imprisonment (24). Under the Civil

Code (article 1839), as amended in 1977, a husband

who has consented to donor insemination cannot deny

paternity (117). The Department of Justice has setup

a “committee for the regulation of new reproductive

technologies” that will soon submit a bill concerning

these technologies to the Parliament (23).

Spain

The first human sperm bank in Spain was set up

in Barcelona in 1978 (77). Efforts to address the legal

and ethical issues raised by artificial insemination and

IVF increased with the 1986 reports of the Ministry

of Justice (116) and the parliamentary commission for

the Study of Human In Vitro Fertilization and Artificial Insemination (115). The commission presented 155

recommendations for legislative and regulatory action,

covering diverse topics such as quality assurance for

medical clinics and personnel offering noncoital reproductive techniques, national and regional recordkeeping of use of donor gametes, criteria for embryo

donation and experimentation, screening for gamete

donors and recipients, and regularization of the legal

rights of gamete donors, rearing parents, and children

conceived by noncoital means.

The special commission generally recommended that

artificial insemination and IVF be available to married

or stable unmarried heterosexual couples, but specifically suggested that homosexual couples be banned

from their use. Use of a deceased partner’s sperm, eggs,

or embryo was specifically endorsed, although the resulting children should not inherit from the deceased

genetic parent. Donor gametes should be made available to overcome sterility, and their collection and

screening should be managed on a strictly noncommercial basis by licensed gamete banks. The commission also recommended that legislation be passed to

ensure confidentiality of any individual’s infertility, donation of gametes, use of donor gametes, or conception by noncoital means. Finally, limited forms of embryo experimentation were approved.

The special commission recommended the formation of a national commission (Comisision Nacional de

Fecundacion Asistida, or CNFA) with separate committees on artificial insemination, IVF, and public policy

to issue interim regulations governing relevant medical practice and embryo research, pending legislative

action. The CNFA could also review medical findings

and approve use of new techniques, such as oocyte

freezing or genetic therapy on embryos, as they become nonexperimental. The special commission suggested that regional commissions should be set up as

well (115).

The Socialist wing in Parliament has proposed two

pieces of legislation that address these issues. The first

preserves donor anonymity and limits the number of

donations per donor to six, and the second forbids the

conception or abortion of embryos exclusively for donation and forbids commercial traffic in human embryo tissue (101).

Artificial Insemination

The special commission recommended that artificial

insemination be performed at authorized health clinics,

some of which would also operate as sperm and embryo banks, and as ova banks when that technology

improves sufficiently. Donation should only be accepted from those in good medical and genetic health,

as demonstrated by a physical examination and a

karyotype, and could only be made with permission

from the donor’s spouse or partner after warning that

children conceived by donor insemination might yet

seek to challenge the constitutionality of limitations

on their right to know their genetic parents. Donors

would have to be warned that they may not seek parental rights to the children conceived with their gametes,

and will not be told the identity or even number of

children born to them, although they will be asked

to discontinue participation after six children have

been born (115).

Recipients would also be screened for general health,

fertility, and freedom from infectious diseases. Single

women could receive donor gametes for artificial insemination or IVF (although not at public expense) provided they could demonstrate the ability to provide

an adequate home. Selection of a donor would be made

by the bank, and not by the recipient. Every effort

should be made to match the physical appearance of
354 ● Infertility: Medical and Social Choices

the recipient’s partner, and he would be able to renounce paternity only if he could show that he never

consented or that his consent was seriously uninformed. Recipients and offspring would have the right

to obtain nonidentifying information about the donor

(1 15).

In Vitro Fertilization

The special commission recommended that IVF be

available only to overcome infertility or to avoid a grave

hereditary disorder, but went on to say that should

other uses be made legal, they ought not to be paid

for by public funds. The commission especially noted

that, as with artificial insemination, the technique

should not be used for sex selection. The recommendations state that only seemingly healthy embryos

should be implanted, and that no more than the optimal number for a safe, live birth should be implanted.

Extra embryos could be frozen for their own future

use, be donated by the genetic parents to transfer

banks for distribution to other couples, or be given

to laboratories for experimentation. The commission

suggested a storage limit of 5 years for frozen embryos,

subject to new technical developments. Genetic parents could express in writing their wishes regarding

disposal of an embryo in the event of death, disease,

or divorce (115).

Research on Preimplantation Embryos

With regard to embryo research, the special commission suggested that embryos might be donated by

couples not wishing to use them for IVF, but that embryos ought not to be created solely for the purpose

of doing research. A time limit of 14 days (not counting time frozen) was recommended. Research would

have to be approved by tile CNFA and found to have

“positive” goals for individuals or society, such as

broadening knowledge on the process of fertilization,

causes of infertility and cancer, and techniques for contraception. Research on a particular embryo would

only be allowed with permission of the genetic parents, and after they had been informed of the goals

of the particular experiment. The commission noted

that no research ought to be allowed that involves mixing human and other animal genes, that is performed

on embryos or fetuses in utero, or that takes place

on an embryo destined to be implanted. Genetic therapy for embryos would be permitted if it could be

shown that the embryo exhibited traits for an identifiable and serious disorder, that no other medical or

surgical therapy would be effective, and that genetic

therapy has a reasonable chance of success (115).

Surrogate Mothers

Surrogate motherhood, whether paid or unpaid, was

found unacceptable by the commission. It recommended that any health center offering surrogate

matching should lose its authorization to offer IVF and

artificial insemination, and that all parties to a surrogacy contract, including the lawyers, agencies, and

physicians, should be subject to criminal penalties (115).

Switzerland

There is no legislation in Switzerland pertaining to

infertility except that regarding paternity in cases of

donor insemination. However, the individual cantons

(the Swiss equivalent of states) are now making their

own laws, based on the 1985 Swiss Academy of Medical Sciences’ directives concerning IVF and 1981 directives on artificial insemination. In Switzerland, most

areas of public health are under the authority of the

cantons.

one referendum on public demand suggested that

the Swiss Government amend the federal constitution

to allow regulation of reproductive manipulation and

research in human genetics. In response, a federal commission was formed in 1986 to study problems associated with noncoital reproduction and human genetic

research. The commission’s report is expected in mid1988 (25,98). The Government will formulate an opinion based on the report. At this point, a procedure of

consultation will be carried out, involving all interested

parties. The result of the consultation, the referendum,

and the Government opinion will be submitted to

Parliament for debate and to formulate recommendations (139).

Artificial Insemination

Six centers in Switzerland currently provide artificial insemination by donor in public gynecological

clinics (in Bern, Lausanne, Liestal, Locarno, St. Gallen,

and Schaffhausen) (25). There are also private gynecologists in Zurich, Bern, and Geneva who provide insemination services. All six insemination centers and

the private gynecologists performing the service belong to the Swiss Work Group for Artificial Insemination founded in 1977 to coordinate the activities of the

centers, standardize working methods, and carry out

scientific programs on a joint basis (25,28). The Swiss

Work Group for Artificial Insemination has been subsumed in the Swiss Society of Fertility and Sterility,

but the original directives are still in operation.

Donors at the six donor insemination centers are

selected by physicians, and all centers apply the fol-
App. E—International Developments “ 355

lowing criteria for acceptance of donors: social motivation for donating semen, normal psycho-intellectual

state, normal genetic screen, normal clinical and laboratory tests, adequate sperm counts, and age between

20 and 40. One controversial point centers on the use

of karyotyping (28). The work group is not concerned

with inbreeding, as a given donor usually does not give

semen for more than a year and as a significant proportion of the couples requesting artificial insemination

by donor come from other countries; thus the number of children fathered by one donor is not regulated.

The identity of the donor is never mentioned on the

insemination record (26,28), but the 1985 referendum

suggested that keeping the genetic parentage of a child

hidden from that child should be forbidden, unless the

law states that such information should not be available (24). With regard to the child’s status, article 256-

3 of the Swiss Civil Code (June 1975) states that a husband who has consented to artificial insemination by

donor cannot contest the paternity of any resulting

child (24).

In Vitro Fertilization

As of January 1988, there were four public centers

(in Basel, Lausanne, Locarno, and Zurich) and two private clinics (in Geneva and Lausanne) providing IVF

services in Switzerland (25,27).

Within the framework of the law on public health,

the Canton of Geneva issued regulations based on the

directives of the academy of Medical Sciences on IVF.

The academy stated that IVF and embryo transfer must

be conducted by a physician, and that the IVF team

must follow the academy’s guidelines. Both IVF and

embryo transfer for a couple with sperm and ova from

that couple are allowed. IVF using donor gametes is

not allowed, according to the academy directives. In

addition, the transfer of embryos from one woman

to another is banned by the academy (31), and the the

referendum also suggested that the creation of embryo reserves for donation to other couples should be

forbidden.

Research on Preimplantation Embryos

The academy directives state that embryos may be

kept alive only during the course of treatment, and

that research on human embryos must not be allowed

(31). The 1985 referendum proposed that research

toward extrauterine pregnancy, cloning, and chimeras

should be forbidden, and that the manipulation of embryos or human fetuses such that their development

is interrupted should not be allowed. Finally, the

referendum disapproved of the commercialization of

embryos (24).

Surrogate Mothers

The academy directives and the referendum both

agree that IVF and embryo transfer must not be used

to initiate surrogate motherhood (24,31).

Turkey

No legal regulation in Turkey covers infertility treatment, but it is generally provided in hospitals as part

of standard medical treatment (79).

Yugoslavia

Two of Yugoslavia’s republics, Croatia and Slovenia,

have enacted laws concerning the right to medically

assisted conception. These laws state that women and

men have the right to diagnosis of the fertility problem and the right to attempt a remedy. Low fertility,

according to the legislation, will be remedied by

treatment—such as professional counseling, medication, or surgical procedure—and by artificial insemination (24).

Artificial insemination by husband is not only legal

in Yugoslavia but is also a right of any infertile couple.

Artificial insemination by donor is permitted in all the

republics and provinces of Yugoslavia. In Croatia and

Slovenia, where current law outlines the practice of

artificial insemination by donor in more detail, the procedure must be performed by specified medical organizations, and it may only be performed when the

spouses cannot fulfill their desire for children any

other way. Legislation in Croatia and Slovenia states

that artificial insemination may be performed upon

any healthy adult woman of childbearing age (1 17).

Legislation in Croatia and Slovenia also states that

the semen donor must be healthy. The donor is not

entitled to any compensation for his semen. Slovenian

law further specifies that a woman may not be artificially inseminated with the semen of a man who could

not legally marry her for reasons of consanguinity. Legislation in both Croatia and Slovenia requires that the

identities of the semen donor, the inseminated woman,

and her husband be kept confidential (24).

In Croatia, legislation explicitly requires the consent

of the recipient’s husband. Other republics, lacking an

explicit consent requirement, nonetheless state that

lack of consent means that a husband can contest paternity of a child conceived by donor insemination. These

republics include Slovenia, Bosnia, Hercegovina, KosoVO, Macedonia, Montenegro, Serbia, and Vojvodina

(117).
356 . Infertility: Medical and Social Choices

INTERNATIONAL ORGANIZATIONS

Council of Europe

In 1987 the Council of Europe’s Ad Hoc Committee

of Experts on Progress in the Biomedical Sciences

(CAHBI) submitted proposed principles (38) on the use

of noncoital reproductive techniques to the Council

of Europe’s Committee of Ministers (20). These principles were the subject of a 1986 hearing in Trieste,

Italy, that included nongovernmental international organizations. The principles are now being finalized.

The Parliamentary Assembly of the Council of Europe

also contributed recommendations to the Committee

of Ministers (39) concerning the use of human embryos and fetuses for diagnostic, therapeutic, scientific, industrial, and commercial purposes. The Ad Hoc

Committee’s principles do not currently represent the

official position of either the Council of Europe or the

member states; the Committee of Ministers of the

Council of Europe will decide whether the proposed

guidelines should be adopted (23).

CAHBI concerned itself with “artificial procreation, ”

defined to include artificial insemination; in vitro fertilization; methods involving donation of semen, ova,

and embryos; and certain procedures carried out on

embryos. CAHBI concluded that the availability of artificial procreation techniques should be limited to heterosexual couples with a medical need (defined as

infertility or disease that would result in the child’s

early death or having a severe handicap, such as Huntington’s chorea). Selecting sex or special characteristics through artificial procreation is explicitly

prohibited.

Noncoital reproduction may only be used if the persons involved have freely given informed consent expressed in writing. Furthermore, it is the physician’s

responsibility to ensure that the participants receive

appropriate information and counseling about possible medical, legal, and social implications of the treatment. only licensed physicians can perform these

techniques, and both physicians and clinics must

screen donors for hereditary and infectious disease.

CAHBI stated that the number of children born from

the gametes of any one donor should be limited and

that the donor (as well as any organization authorized

to offer gametes for artificial procreation or research)

should not receive any profit. Gametes stored for the

future use of the donor must be destroyed if the donor

dies or cannot be located when the storage term

expires.

If donor gametes are used, the provisions state that

the woman who gives birth to the child shall be considered the legal mother and her husband or partner

will be considered the legal father, provided he has

given his consent. The donor will have no rights or

responsibilities to the child. CAHBI did not reach any

conclusions concerning the anonymity of donors and

the right of the child to gain access to information

about the donor, choosing to leave this decision to the

member countries.

In principle, CAHBI felt that IVF should be performed only with the original couple’s gametes; in exceptional cases, however, donated gametes and even

donated embryos (only surplus embryos from another

couple’s IVF procedure) may be used.

CAHBI provisions state that the creation of embryos

for research purposes is forbidden, and that research

on embryos is only allowed if it benefits the embryo

or is an observational study that does the embryo no

harm. If the member countries do allow other

research, however, the following strict conditions

should be observed: the research must have preventive, diagnostic, or therapeutic purposes for grave diseases of the embryo; other methods of achieving the

purpose of the research must have been exhausted;

no embryo should be used later than 14 days after fertilization; the consent of the donating couple must be

obtained; and a multidisciplinary ethics committee

must approve the proposed research.

The Parliamentary Assembly submitted a formal recommendation to the Committee of Ministers, in general stating that no diagnostic or therapeutic intervention should be allowed on an embryo in vivo or in vitro

except for the well-being of the child; that embryos

should not be created for purposes of research; and

that certain techniques, such as cloning or producing

chimeras, should be forbidden altogether (39).

The CAHBI provisions state that contracts for surrogate motherhood should be unenforceable, and intermediaries and advertising should be forbidden. Surrogate motherhood should be allowed only if the

surrogate does not receive material compensation.

European Parliament

The European Parliament has various committees

looking at the problems surrounding noncoital reproduction, including its Committee on Legal Affairs and

Citizens’ Rights. No formal statement has been issued

to date.

Since 1984, however, five bills have been proposed

in the Parliament concerning reproductive technologies. These include:

● A resolution proposed in February 1985 by Marshal condemning “mechanical adultery” and sur-
App. E—International Developments . 357

rogate motherhood. The resolution encouraged

member states to facilitate adoption, discourage

abortion, and pass legislation making surrogate

motherhood criminal.

A resolution proposed in October 1984 by the

Christian Democratic Party suggesting that the

member states introduce legislation regulating experiments concerning human genetics and work

toward harmonizing the laws of the various member states. They recommended setting up a commission to study the relevant issues.

A resolution proposed in October 1984 by the Socialist Party asking for a commission to study the

problems surrounding all the reproductive technologies, including eugenics and sex selection.

A resolution proposed in September 1984 by Lizin

asking for a general code on artificial insemination for the European Community.

A resolution proposed in August 1984 by Habsburg and others urging that embryos be given the

rights of children, that the scientific use of embryos be forbidden, and that all forms of experimentation on human embryos be ended (24).

None of these bills were ever approved by the European Parliament.

Feminist International Network of

Resistance to Reproductive and

Genetic Engineering

FINRRAGE is an organization of feminists concerned

with the effects of reproductive technology and genetic

engineering on the social position and biological integrity of women. The organization has held several

conferences dealing with these issues, including one

in Brussels in 1986. (A general discussion of feminist

views on reproductive technologies can be found in

app. D.)

The main conclusion of the Women’s Hearing on

Genetic Engineering and Reproductive Technologies

at the European Parliament in Brussels (attended by

more than 140 women from 10 member states of the

European Community) was a consensus that “the approach by official committees, doctors’ associations,

churches, etc. (and the Legal Affairs Committee of the

European Parliament ) was less than satisfactory” (56).

The women felt that the prevailing view centers on

the fetus and ignores women’s interests. A summary

of the proceedings ended with the following “conclusions and demands, ” quoted verbatim from the text:

FINRRAGE demands:

● research into the (complex) causes of sterility and reduced fertility (for example post-appendicitis infections,

hormone treatments, intra-uterine pessaries, environ-

●

●

●

●

●

●

●

●

●

mental influences etc.) and promotion and development

of alternative methods of treatment.

comprehensive information on the risks, possible longterm effects and minimal prospects of success of IVF

treatment.

creation of an autonomous women’s research and information center on reproductive and genetic engineering.

political and financial support for autonomous women’s

groups working the fields of reproductive and genetic

engineering, pharmacology and health.

resumption of the discussion in official committees and

ethical committees taking account of the above views

and with effective participation by women initiatives

which for a long time have been carrying out excellent

research and information work in this field.

rejection of any compulsory counseling and examination.

repudiation of legislative measures which would block

access by certain groups of the population (for example single or lesbian women) to methods such as artificial insemination by donors.

an immediate ban on the use of medicaments which can

be proved to have harmful effects or involve risks.

no delay until the possible later harmful effects of IVF

treatment are revealed for women and children but a

reversal of the burden of proof particularly as regards

long-term effects (the decision by the cabinet of the Land

Government in the Saarland providing for an interim

ban on IVF treatment is significant in this context).

recognition that only women have a legislative right to

decide on whether to make use of antenatal examinations (amniocentesis, chorionic villus sampling, etc.) or

not or whether to terminate a pregnancy or not (56).

World Health Organization

The World Health Organization held a meeting in

Copenhagen in 1985 to discuss infertility and the various reproductive technologies that have been developed. Participants of the meeting made seven recommendations, which are summarized here.

A report should be prepared on the medical, psychosocial, demographic, economic, ethical, and legal aspects of the latest developments in noncoital reproductive techniques.

A study should be prepared and implemented in

selected member states on public knowledge,

needs, and attitudes concerting infertility and reproductive technologies.

The above two reports should be disseminated to

relevant Government agencies, professional organizations, the media, consumer groups, and the

general public.

Guidelines for clinical and research applications

of noncoital reproductive techniques need to be

developed.
358 ● Infertility: Medical and Social Choices

s The activities of ethics committees in member

states need to be tracked and Governments should

be encouraged to establish such committees.

● The teaching of ethics as part of health professional training should be encouraged.

● It is necessary to promote the establishment of

national registers to monitor the use and outcome

of noncoital reproductive techniques (138).

World Medical Association

In Brussels in 1985, the 372d Congress of the World

Medical Association adopted a resolution calling for

all physicians to abide by a uniform set of principles

of ethical practice with regard to IVF. It urged physicians to briefly explain to their patients the purpose,

risks, inconveniences, and failures of IVF therapy.

When donor sperm, eggs, or embryos are used, physicians should clearly explain the risks associated with

these procedures as well, particularly risks associated

with freezing embryos. When the donors are not the

intended rearing parents, the physician should explain

to the donors the consequence of their intentions to

relinquish all claims to the resulting child, and to the

recipients that they will be responsible for the child

regardless of its health. It also called on physicians to

refrain from reimplanting any embryos used for experimentation, and stated that the Helsinki Declaration on the protection of human research subjects

should apply to embryo research as well. With regard

to commercialized surrogate motherhood, the World

Medical Association found the practice unethical (35).

SUMMARY AND CONCLUSIONS

In general, artificial insemination by husband and

donor are considered acceptable techniques worldwide. Several countries have adopted legislation stating a child conceived from donor insemination is the

legitimate child of his or her mother and her consenting husband. IVF is also generally considered acceptable, provided it is used only when medically necessary.

The use of artificial insemination and IVF for unmarried couples, homosexual couples, and single men and

women is more controversial. The use of donor gametes in IVF is not universally accepted either. Oocyte

donation is not as widely accepted as sperm donation,

largely because the technology involved is considered

experimental. Acceptance of embryo donation also

varies widely.

Most controversial, however, are the topics of research on human embryos and surrogate motherhood.

Countries that do approve embryo research often

stipulate that the embryos used must have been left

over from therapeutic IVF attempts, not deliberately

created for research, and they often impose a time limit

after which research must end. Surrogate motherhood

has achieved little acceptance, and several countries

have taken positive steps to ban the practice, especially

its commercial use.

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der Gentechnologie (Risk Assessment of Genetic

En@”neering) (Bonn, West Germany: Wolf-Michael

Catenhausen, Hanna Neumeister, 1987).

Firket, H., Professor, Biologic G~n~rale, Institut

de Pathologic, Universit& de Libge, Belgium, personal communication, Dec. 17, 1987.

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1987.

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Hirsch, G. E., Doctor of Jurisprudence, Augsburg,

West Germany, personal communication, Jan. 11,

1988.

H@berg, S., Science Counselor, Swedish Embassy

to the United States, personal communication,

Dec. 22, 1987.

Holmes, H., Amherst, MA, personal communication, Oct. 8, 1987.

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Jarrell, J., Associate Professor, Department of Obstetrics and Gynecology, McMaster University,

Hamilton, Canada, personal communication, Nov.

17, 1987.

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App. E—International Developments ● 361

65

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66. Knoppers, B. M., University of Montreal, Canada,

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67. Kottow, M. H., Stuttgart, Federal Republic of Germany, personal communication, Oct. 10, 1987.

68. Lebech, P. E., “Present Status of AID and Sperm

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69. Lebech, P., Frederiksberg Hospital, Frederiksberg,

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70. Leenen, H. J. J., Professor, Instituut Voor Sociale

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71. Lefevre, C., Director, Centre d’Ethique Medicale,

Federation Universitaire et Polytechnique de Line,

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72. Levin, Z., Israeli Ministry of Health, personal communication, Dec. 8, 1986.

73. Lindahl, B. I., Department of Social Medicine,

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76. Mainetti, J. A., MD, Ph.D, Fundaci6n J. M. Mainetti,

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19, 1985).

90. Ontario Law Reform Commission, Report on Human Artificial Reproduction and Related Matters

(Toronto, Canada: Ministry of the Attorney General, 1985).

91. Paltiel, F., Senior Adviser, Status of Women,

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Technologies de la Reproduction: Questions
362 . Infertility: Medical and Social Choices

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NOV. 4, 1987.

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760, 1987.

108. Shapira, A., Kalman Lubowski Chair in Law and

Biomedical Ethics, Tel Aviv University, personal

communication, November 1986.

109. Shapira, A., Kalman Lubowski Chair in Law and

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communication, Oct. 25, 1987.

110. Shifman, P., “First Encounter of Israeli Law with

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259, 1981.

111. Simpkins, R., Science Counselor, Embassy of the

112,

113.

114.

LJnited States of America, Mexico City, Mexico,

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1986.

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115. Spain, Congreso de 10S Diputados, Comisi6n Es116

117,

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App. E—International Developments “ 363

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Office, 1984).

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Paper (London, United Kingdom: Her Majesty’s

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132. Wagner, W., Medical Director, Duphar Pharma,

Hamover, Federal Republic of Germany, personal

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133. Wailer, L., Professor of Law, Monash University,

Victoria, Australia, personal communication, Aug.

28, 1987.

134. Walters, L., “Ethics and New Reproductive Technologies: An International Review of Committee

Statements, ’’Hastings Center Report 17(Supp.):3-

9, 1987,

135. Western Australia, Committee to Enquire into the

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Fertilization and Its Supervision, Interim Report

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136. Whitman, G.J., Counselor for Scientific and Technological Affairs, Embassy of the United States

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Oct. 7, 1987.

137. Wilken, H., “Ethical Positions in Reproductive

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138. World Health Organization, “Report on a Consultation and Research Findings. World Health Organization, Copenhagen 28-29 March 1985, ” Human

Reproduction 2:169-172, 1987.

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zerland, personal communication, Nov. 5, 1987.
Appendix F

Religious Perspectives

It is estimated that about 60 percent of Americans,

or 140 million people, belong to some established religious community. Table F-1 provides a membership

estimate for the major religious groups in the United

States. Table F-2 provides an overview of judgments

about the licitness of reproductive technologies from

the standpoint of each tradition.

This appendix both surveys these viewpoints and attempts to predict their present and future impacts on

Table F= I.—Membership Estimates,

Selected Religious Groups in the United States

Denomination Membership

Roman Catholic Church , . . . . . . . . . . . . . . . 52,393,000

Southern Baptist Convention . . . . . . . . . . . . 14,178,000

United Methodist Church . . . . . . . . . . . . . . . 9,405,000

Lutheran Churches. . . . . . . . . . . . . . . . . . . . . 7,877,000

Jewish . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5,027,000

Mormon Churches . . . . . . . . . . . . . . . . . . . . . 3,602,000

Presbyterian Churches (Reformed) . . . . . . . 3,122,000

Episcopal Church . . . . . . . . . . . . . . . . . . . . . . 2,795,000

Muslims . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2,000,000

Greek Orthodox Church . . . . . . . . . . . . . . . . 1,950,000

United Church of Christ . . . . . . . . . . . . . . . . 1,702,000

Jehovah’s Witnesses . . . . . . . . . . . . . . . . . . . 650,000

Seventh Day Adventists . . . . . . . . . . . . . . . . 624,000

Mennonite Churches . . . . . . . . . . . . . . . . . . . 110,000

SOURCE: U.S. Department of Commerce, StatkWca/Abstracf of the United Sfates,

106th ed. (Washington, DC: 19S5).

Table F-2.–Summary Table

individual choices and on community policy formulation (3).

At least three factors help determine the influence

of religious viewpoints: the size of the relevant community, the authority of the current viewpoints within

the community, and the unanimity and diversity of

opinion in the relevant community.

The larger the community, all other things being

equal, the more infertile couples there will be whose

individual treatment decisions are influenced by the

community’s viewpoints and the more adherents there

will be who address public policy formulation in light

of those views. By the same token, the weight and authority of specific religious viewpoints will influence

the number of adherents who draw on these views

in considering public policy issues.

At one extreme are communities that emphasize the

importance of individual judgments. These include religious communities such as the Baptists and the Evangelical. At the other extreme are traditions with centralized teaching authorities, such as the Roman

Catholic Church. In between are communities that formulate general policies at organized centralized meetings but that see these policies as reflections of current thinking rather than as authoritative teachings.

These include the decisions of the General Convenof Religious Perspectives

Traditional IVF with spousal

infertility gamete and no IVF with no Surrogate

workups AIH embryo wastage AID restrictions motherhood

Roman Catholic . . . . . . . . . . . . . . . . . . No No No No No No

Eastern Orthodox . . . . . . . . . . . . . . . . Yes Yes No No No No

Anglican . . . . . . . . . . . . . . . . . . . . ., . . Yes Yes Yes ● ● No

Lutheran . . . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes No No No

Reformed . . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes ● ● No

Methodist . . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes No No No

Mennonite. . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes ● ● ●

Baptist. . . . . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes ● ● ●

Evangelical . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes No No No

Adventist. . . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes ● ● No

Christian Scientist. . . . . . . . . . . . . . . . No Yes No Yes No Yes

Jehovah’s Witness . . . . . . . . . . . . . . . Yes Yes Yes No No No

Mormon . . . . . . . . . . . . . . . . . . . . . . . . . Yes Yes Yes ● No No

Orthodox Jewish ., . . . . . . . . . . . . . . . Yes Yes Yes No No No

Conservative Jewish . . . . . . . . . . . . . . Yes Yes Yes Yes Yes ●

Reform Jewish . . . . . . . . . . . . . . . . . . . Yes Yes Yes Yes Yes Yes

Muslim . . . . . . . . . . . . . . . . . . . . ... , . Yes Yes Yes No No No

Abbreviations: AlH—artificial insemination by husband, lVF—in vitro fertilization, AlD—artificial insemination by donor.

Yes = Accepted as licit.

No = Illicit.

● = Controversial or dependent licitness.

SOURCE: Office of Technology Assessment, 19SS.

364
App. F—Religious Perspectives ● 365

tion of the Episcopalian Church, the General Assembly of the Presbyterian Church, and the General Conference of the United Methodist Church. Also in

between are communities that emphasize the authority of leading religious scholars, while recognizing that

these scholars may disagree. These include the Muslim community and the Jewish community.

The final factor to consider is the unanimity and

diversity of opinion in the relevant community. The

greater the diversity of opinion, the less constrained

individual infertile couples will feel when confronting

choices about particular treatment decisions, and the

less the community in question will be able to influence public policy decisions (3).

Roman Catholic

Interventions designed to augment the possibility of

procreation through normal conjugal relations are

morally licit (e.g., gamete intrafallopian transfer). Infertility workups that involve masturbation are morally

dubious. All forms of artificial insemination, in vitro

fertilization (IVF), and surrogate motherhood are rejected as morally illicit. The desire to procreate does

not justify what is morally illicit (7,21-23).

Eastern Orthodox

Infertility workups and medical and surgical treatments of infertility for married couples are advisable

because of the significance of procreation. Artificial

insemination by husband is morally acceptable and

may even be advisable if needed, although artificial

insemination by donor is rejected as a form of adultery.

IVF is absolutely rejected when it involves the destruction of zygotes and is not recommended even if only

one egg is fertilized. Surrogate motherhood is rejected.

This teaching applies to the case when both gametes

come from the married couple (who would also be the

social parents) (9,16).

Interdenominational Protestant

The significance of procreation in the life of the community and in the life of individuals who want children leads to the appropriateness of society supporting the treatment of infertility for married couples so

long as the treatment does not lead to a dehumanization of procreation or to a violation of covenantal relations. The most acceptable treatments of infertility are

the traditional medical and surgical interventions and

artificial insemination by husband. IVF using gametes

from a married couple and avoiding harm to any

zygotes is probably also acceptable. Artificial insemination by donor, IVF that does not meet the stipulated

requirements, and all forms of surrogate motherhood

are at best morally questionable and at worst morally

illicit (12,24,34,40).

These stipulations do not apply to a number of

major Protestant denominations. The Pentecostalist

churches, particularly the Assemblies of God, have specifically chosen not to address what they take to be

social issues, such as questions surrounding the new

reproductive technologies. There is no material available from such diverse groups as the Churches of

Christ/Disciples of Christ, the Quakers, and the Unitarian-Universalists.

Anglican

Artificial insemination by husband and IVF using gametes from a married couple (who will also be the social parents) are morally licit. There seems to be no

concern over the disposition of unused embryos in IVF.

Considerable controversy surrounds the use of sperm

from someone other than the husband in artificial insemination by donor and in IVF, and that issue will

continue to be controversial in the near future. There

is general opposition to surrogate motherhood on

grounds relating to the resulting depersonalization of

motherhood and to potential exploitation. This opposition would apply whether or not the surrogate

mother donated the gamete or carried an implanted

embryo to term (8,15,36).

Lutheran

Procreation within marriage is viewed as a positive

blessing as well as a divine commandment, so the treatment of infertility is strongly encouraged. Procreative

actions that take place within the general setting of

a loving marital relation, even though the actual act

of conception is divorced from it, are morally licit.

Therefore, there is no objection to artificial insemination by husband or to IVF when it uses gametes and

the womb of the married woman, and when all embryos are implanted (6,10).

Reformed (Presbyterian and United

Church of Christ)

Responsible intentional procreation within marriage

is viewed as religiously significant; thus medical and

surgical interventions to treat infertility are generally

encouraged, while contraception to avoid unintended

procreation is also encouraged. There are no significant moral objections to the use of artificial insemination by husband and IVF using gametes from a mar-
366 ● Infertility: Medical and Social Choices

ried couple (regardless of whether some embryos are

not used). Artificial insemination by donor and IVF

using donor gametes are more controversial, but will

probably be treated as morally acceptable in the context of an infertile married couple mutually and freely

choosing them. Surrogate motherhood will probably

be treated as illicit, in part because of psychological

and relational issues and in part because of fear of

abuses (26,29,30).

Methodist

Methodists insist on the connection between procreation and conjugal sexuality only in that procreation

is supposed to grow out of the physical and emotional

union of a married couple. Therefore, they approve

of artificial insemination by husband and IVF using

gametes from a married couple, especially when all

embryos are implanted. They are concerned that IVF

not be used for sex selection or for the creation of experimental subjects. They are opposed to artificial insemination by donor, in vitro fertilization using donor

gametes, and surrogate motherhood (25,37).

Mennonite

Both the single life and married life without children

are religiously acceptable lifestyles, so there is no compelling religious need for infertile couples to pursue

treatment of infertility. Such treatments are appropriate, however, if they strengthen the marital relationship and marital intimacy. Since there need be no connection between acts of conjugal sexuality and

reproduction, artificial insemination by husband and

IVF are acceptable. Artificial insemination by donor

and (presumably) surrogate motherhood are acceptable, so long as they strengthen the marital relation

and marital intimacy (14,27).

Baptist

There is no necessary connection between individual procreative acts and individual acts of conjugal sexuality. Procreation is a blessing, and a biblical attitude

approves of artificial attempts to make procreation possible. This justifies traditional infertility workups and

treatments. It also justifies artificial insemination by

husband, artificial insemination by donor, and IVF.

Some Southern Baptists may, however, oppose the use

of techniques involving donor gametes. Since fetuses,

especially at the earliest stages, only have anticipatory

personhood, abortion concerns are irrelevant to the

new reproductive technologies. In light of recent

Southern Baptist statements, however, some Southern

Baptists may prefer limiting IVF to cases in which all

embryos are transferred (5,35).

Evangelical-Fundamentalist

Although there is no absolute commandment on each

individual couple to procreate, infertility is viewed in

the Bible as a burden to overcome. This leads to a positive evaluation of infertility workups and treatments.

In particular, because individual acts of procreation

can be separated from each other, there are no moral

objections to artificial insemination by husband or to

IVF using gametes from a married couple. There is

considerable controversy over artificial insemination

by donor, IVF using donor gametes, and surrogate

motherhood. Many oppose these techniques although

they do not see them as adulterous. Others find them

to be contemporary improvements over Biblical ana -

logues. Recent Evangelical treatments support the

former position (13,18).

Adventist

Given the legitimacy of separating individual acts of

conjugal sexuality from individual acts of procreation,

there are no moral objections to traditional workups

and treatments of infertility and to artificial insemination by husband or IVF using gametes from a married

couple. Artificial insemination by donor and IVF using

donor gametes are more controversial, with some Adventists opposing them while Adventist institutions are

using them. There is little support for commercialized

surrogacy (19,31,32).

Christian Science

The best treatment for infertility is prayer that dispels the illusions that are the source of the problem.

Individuals may choose to supplement that with techniques (e.g., artificial insemination) that employ neither drugs nor surgery, but techniques that do (including IVF) are inconsistent with the basic Christian

Scientist viewpoint (38).

Jehovah’s Witness

Infertility workups and traditional medical and surgical interventions are morally licit but are neither encouraged nor discouraged because no particular moral

significance is ascribed to parenthood. Artificial insemination by husband is morally licit, as is IVF providing

that the gametes come from the married couple, no

zygotes are destroyed, and no blood products are used.

Artificial insemination by donor, surrogate mother-
App. F—Religious Perspectives ● 367

hood, and IVF (if the above conditions are not satisfied) are serious violations of some of God’s fundamental laws (39).

Mormon Church

Because of their great emphasis on procreation, Mormons encourage infertility workups, traditional medical and surgical interventions, and accept artificial insemination and IVF using gametes from the married

couple. While not encouraged, artificial insemination

by donor is left as an option for couples. Surrogate

motherhood and artificial insemination of single

women are opposed. Though not explicitly addressed,

the disposal of nonimplanted embryos in IVF would

be problematic for many Mormons, as potentially a

form of abortion (4,28).

Jewish

Because of the religious and personal significance

of procreation, traditional infertility workups and

treatments are encouraged, subject to the constraint

of minimizing the use of masturbation. Artificial insemination by husband is acceptable, as is IVF when

it uses gametes from a married couple and when all

embryos are implanted. Artificial insemination by

donor and IVF using gametes from a third party are

more controversial. They are acceptable to Reform

Judaism and are increasingly acceptable as a last alternative to Conservative Judaism, but are rejected by

Orthodox Judaism (2,11,17,20).

Islamic

Because of the great significance of reproduction,

Islam welcomes effective infertility workups and treat -

ments and would not be troubled by use of masturbation. Muslims would have no problems with artificial

insemination by husband and with IVF when both gametes come from a married couple and when all embryos are implanted. Artificial insemination by donor

and IVF using donor sperm would be rejected on the

grounds that they confuse lineage, and they might also

be rejected as forms of adultery. A failure to implant

all embryos in IVF might be prohibited (although not

strongly) as a form of early abortion (1,33).

Other Religious Traditions

An increasing number of Asian-Americans have

viewpoints rooted in such religions as Hinduism, Buddhism, and Confucianism. These are old and rich traditions, with extensive views on human sexuality, reproduction, nature, and technology. There is no

evidence, however, that contemporary scholars in

these traditions are attempting to apply their views

to the topic of reproductive technologies.

A great many religious communities in the United

States grow out of the Afro-American experience. They

range in size from major segments of the Methodist

and Baptist traditions to santeria and voodoo centers.

No written material is available on what these religious

groups think about the new reproductive technologies.

In particular, it is not clear whether general Methodist and Baptist viewpoints would be equally shared

by the major black Methodist and Baptist churches.

Appendix F References

1. A1-Qaradawi, Y., The Lawful and the Prohibited in Islam

(Indianapolis, IN: American Trust Publications, undated).

2. Bleich, J.D., Judaism and Healing (New York, NY: Katav,

1981).

3. Brody, B. A., “Religious and Secular Perspectives About

Infertility Prevention and Treatment ,“ prepared for the

Office of Technology Assessment, U.S. Congress, Washington, DC, May 1987.

4. Bush, L., “Ethical Issues in Reproductive Medicine: A Mormon Perspective, ” Dialogue: A Journal of Alormon

Thought 18(2):41-66, summer 1985.

5. Christian Life Commission, Southern Baptist Convention,

Issues and Answers: Biomedical Ethics (Nash\~ille, TN:

1981).

6. Commission on Theolo&v and Church Relations, Lutheran

Church-Missouri Synod, Human Sexualit~~: A Theological Perspecti\7e (St. Louis, MO: Social Concerns Committee, 1981).

7. Congregation for the Doctrine of the Faith, Instruction

on Respect for Human Life in Its Origin and on the Dignity of Procreation (Vatican City: 1987).

8. Creighton, P., Artificial Insemination b-v Donor (Toronto,

Ontario: Anglican Book Center, 1977).

9. Department of Church and Society, Greek Orthodox Archdiocese of North and South America, Statements on Aloral

and Social Concerns (New York, NY: undated).

10. Division of Theological Studies, Lutheran Council in the

U. S., In Vitro Fertilization (New York, NY: 1983).

11. Feldman, D. M., and Rosner, F., Compendium on Medical

Ethics, 6th ed. (New York, NY: Federation of Jewish

Philanthropies of New York, 1984).

12, Fletcher, J., Morals and Medicine (Boston, MA: Bacon

Press, 1960).

13. Geisler, N. L., Ethics: AkernatitJes and Issues (Grand

Rapids, MI: Zondervan Publishing House, 1971).

14. General Conference, Mennonite Church, “Resolution on

Sexuality” (adopted in 1985).

15. General Convention of the Episcopal Church, Statements

on Abortion, In \’itro Fertilization, Control of Conception, and Genetic Engineering (obtainable from the Episcopal Church Center, New York, NY).

16. Harakas, S., Contemporarwv Moral Issues Facing the Or-
368 “ Infertility: Medical and Social Choices

thodox Christian (Minneapolis, MN: Light& Life Publishing Co., 1982).

17. Jacob, W., American Reform Responsa (New York, NY:

Central Conference of American Rabbis, 1983).

18. Jones, D.G., Brave New People (Leicester, England: Inter

Varsity Press, 1984).

19. Larson, D., Center for Christian Bioethics, Loma Linda

University, personal communication, Mar. 16, 1987.

20. Lubow, A., Secretary, Law Committee, Rabbinic Assembly, personal communication, May 5, 1987.

21. McCormick, R., Notes on Moral Theolo@: 1.965-80 (Wash22.

23,

24,

25.

26.

27.

28,

29.

ington, DC: University Press of America, 1981).

McCormick, R., Notes on Moral Theolo@: 1981-84 (Washington, DC: University Press of America, 1985).

Monks of St. Solesmes, The Human Boo’y: Papal Teachhgs (Boston, MA: Daughters of St. Paul, 1960).

National Council of the Churches of Christ in the U. S. A.,

Genetic Sciences for Human Benefit (New York, NY: National Council, 1986).

Neaves, W. B,, and Neaves, P., “Moral Dimensions of In

Vitro Fertilization,” Perkins Journal, winter 1986, pp.

10-23.

Nelson, J., and Rohricht, J. A. S., Human Mediche (Minneapolis, MN: Augsburg Publishing House, 1984).

North, W., and Preheim, V., Human Sexuality jn the Christian Life (Newton, KS, and Scottdale, PA: Faith & Life

Press and Mennonite Publishing House, 1985).

Numbers, R., and Amundsen, R., Caring and Curing (New

York, NY: Macmillan, 1986).

Office of the General Assembly, Presbyterian Church,

Covenant and Creation (New York, NY: Office of the General Assembly, 1983).

30. Office of the General Assembly, Presbyterian Church,

The Covenant of Life and the Caring Community (New

York, NY: Office of the General Assembly, 1983).

31. Provonsha, J., “Some Ethical Issues in the Newer Reproductive Techniques” (Loma Linda, CA: an unpublished

lecture made available by the Center for Christian Bioethics, Loma Linda University).

32. Provonsha, J., “Surrogate Procreation—An Ethical Dilemma” (Loma Linda, CA: an unpublished lecture made available by the Center for Christian Bioethics, Loma Linda

University).

33. Rahman, F., Health and Medicine in the Islamic Tradition (New York, NY: Crossroad, 1987).

34. Ramsey, P., Fabricated Man (New Haven, CT: Yale University Press, 1970).

35, Simmons, P.D., Birth and Death: Bioethical Decision Making (Philadelphia, PA: Westminster, 1983).

36. Smith, D., Health and Medicine in the Anglican Tradition (New York, NY: Crossroad Publishing Co., 1986).

37, Smith, H., Ethics and the New Medicine (Nashville, TN:

Abingdon Press, 1970).

38. Talbot, N. A., Manager, Committees on Publication, First

Church of Christ Scientist, personal communication, Mar.

11, 1987.

39. Watchtower Bible and Tract Society, True Peace and

Security: How Can You Find It? (Brooklyn, NY: 1986).

40. World Council of Churches, Faith and Science in an Unjust World, vol. 2 (Philadelphia, PA: Fortress Press, 1983).
Appendix G

OTA Survey of Surrogate Mother

Matching Services

As part of this assessment, OTA identified the following surrogate mothering matching services around the

country (see box 14-B):

California

Hilary Hanafin and William Handel

Center for Surrogate Parenting

8383 Wilshire Boulevard

Beverly Hills, CA 90211

Nina Kellogg

Surrogate Parent Program

11110 Ohio Avenue, Suite 202

Los Angeles, CA 90025

Bruce Rappaport

Center for Reproductive Alternatives of

Northern California

3313 Vincent Road, Suite 222

Pleasant Hills, CA 94523

Bernard A. Sherwyn

10880 Wilshire Boulevard

Suite 614

Los Angeles, CA 90024

Katherine Wycoff

Center for Reproductive Alternatives

727 Via Otono

San Clemente, CA 92672

Georgia

Debra A. Patton

Infertility Alternatives

P.O. BOX 1084

Snellville, GA 30278

Indiana

Steven Litz

Surrogate Mothers, Inc.

2612 McLeay Drive

Indianapolis, Indiana 46220

Kansas

Beth Bacon

Hagar Institute

1015 Buchanan

Topeka, KS 66604

Kentucky

Katie Marie Brophy

Surrogate Family Services Inc.

713 W. Main Street

Suite 400

Louisville, KY 40202

Richard Levin

Surrogate Parenting Associates

250 East Liberty Street, Suite 222

Louisville, KY 40202

Maryland

Harriet Blankfeld

Infertility Associates International

5530 Wisconsin Avenue, Suite 940

Chevy Chase, MD 20815

Michigan

Noel Keane

930 Mason

Dearborn, MI 48124

Nevada

Juanita Lewis

Surrogate Mother, Inc.

620 Lander Street, Suite 2A

Reno, NV 89509

New York

Betsy Aigen

Surrogate Mother Program

Suite 3D

640 West End Avenue

New York, NY 10024

Ada D. Greenberg

Surrogate Pregnancy Consultations

P.O. BOX 52

Jamaica, NY 11415-6052

Infertility Center of New York

14 East 60th Street, Suite 1204

New York, NY 10022

369
370 ● Infertility: Medical and Social Choices

Oregon

Norma Thorsen

Surrogate Foundation, Inc.

P.O. BOX 6545

Portland, OR 97206

Of 27 services contacted, 5 were no longer in business, 5 had moved with no forwarding address, 4

failed to respond, and 13 returned completed questionnaires. For the 2 nonrespondents, data were collected by examining the contracts they have used in the past, the testimony of their directors at congressional hearings, in their own published writings, and their interviews with the press.

The following are the questions asked on the survey questionnaire. For the purposes of this survey,

“client” referred to the person who wishes to hire a surrogate mother. “Client’s spouse/partner” referred

to the person with whom the client intends to rear the child. “Surrogate mother” referred to a woman

who is artificially inseminated with the intention of relinquishing custody upon birth to the genetic father.

With the exception of question (27), this survey did not concern “surrogate gestational mothers,” i.e. women

who bear children to whom they are not genetically related.
NATIONAL SURVEY OF SURROGATE MOTHER MATCHING SERVICES

OPTIONAL IDENTIFICATION

Your completio n of this page allows us to know which organization have responded

to the survey.

Please detach this page and return it separately, so that your agency~name cannot

be matched to your response. A self addressed, postage paid envelope is enclosed for

your convenience.

Of course, we are also happy to receive your response to the survey without your

having completed this section at all.

Organizatio n . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Address . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

TELEPHONE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

NATIONAL SURVEY OF SURVEY MOTHER MATCHING SERVICES

This is a survey of surrogate match services in the United States. The results of

this survey will be used in the assessment Infertility Prevention and Treatment, being

prepared by the Office Of Technology & Assessment The request of Congress your

participation is greatly appreciated.

For the purposes of this survey, “client's spouse/partner"

surrogate mother. “Client's spouse/partner" refers to the person with whom the client

intends to rear the child. P1ease answer all questions concerning demographics by

reference to the Client and not the client’s spouse or partner. "Surrogate mother

to a woman who is artificially inseminated with the inseminated with the intent of relinquishing custody

Upon birth to the genetic father. With the exception of question (27), this Survey does

not concern “surrogate gestations mothers," i.e. women who bear children to whom they

are not genetically related,

DEMOGRAPHICS OF YOUR AGENCY

1. Location:

major metropolitan area .

.

smaller city

— suburb

— rural area

2. Size and professional quaIification of staff:

3. Are you affiliated with:

Yes No

a hospital?

a physician’s practice? —

.

an infertility clinic? — —

a law firm? — .

other? — .

(specify)

4. Year of first matching arrangement:

5. How many matches have you made:

Since you opened?

In 1986?

—

in 1987?

—

I
372 . Infertility: Medical and Social Choices

I

I

I

I

I

I

I

I

I

I

I

I

I I I

I

I

I

I

I

I

I

I

I

I

I

;.-

1

I

I

I

I

I

I

I

I

c

Q

.

C-i

I

I

I

I

Ill II

.
SCREENING SURROGATES

15. Which of the following do you require of the person seeking to be a surrogate 19,

mother?

a)

b)

c)

d)

e)

f)

g)

h)

i)

j)

k)

—

Yes No

be heterosexual

be in a stable relationship

— —

be married

—

be in good health

—

have a prior conception

have a prior birth

— —

have previously given up a

— —

child for adoption 20.

have previously given up a

— —

child as a surrogate mother

be within a certain age range (specify)

—

have a minimum income (specify)

—

.

other (specify) 21.

16. Do you require that surrogates and their partners undergo:

Surrogate Surrogate’s Partner

Yes No Yes No

a) Home review

b) Physical examination

.

c) Psychological examination

— —

— If yes: what type? 22.

by whom?

where are professional services obtained?

d) Other exam

17. Do you allow clients to choose a surrogate mother on the basis of:

a) physical characteristics

b) ethnic origin

c) race

d) religion

Yes No

—

— —

—

—

18. Do you allow clients and surrogates to:

[f yes, when?

Yes No (before or after

conception, birth)

a) know each other’s names and

addresses?

b) meet each other? — c) have periodic contact during

pregnancy?

d) have contact after birth?

23.

USE OF PROFESSIONALS

Where do surrogates and clients obtain legal advice?

Surrogates Clients

Yes No Yes No

a) We have in-house attorneys

b) We refer to attorneys

— — — —

c) Must obtain attorneys

— —

on their own — — —

Does the same attorney ever represent both parties? Yes — No —

[f yes, under what circumstances?

Where do surrogates and clients obtain psychological advice?

surrogates

Yes No

a) We have in-house mental

health professionals

b) We refer to mental health

—

professionals — c) Must obtain mental health

professionals on their own — —

Is the use of mental health professionals or other support groups:

Surrogates

a) mandatory before signing

a contract?

b) mandatory during pregnancy? —

— c) mandatory after the birth? —

Where do surrogates and clients obtain medical services?

Surrogates

Yes No

a) We have in-house physicians — b) We refer to physicians — c) .Must obtain physicians

on their own

d) Client obtains physician

— —

for surrogate — —

Clients

Yes No

— —

—

— —

Clients

—

—

Clients

Yes No

— —

—

— —
CONTRACTS

24. Do you provide a standard contract? Yes — No —

25. What are your most typical contract provisions? Please comment on the following

possible provisions and any others not mentioned. If you have a standard contract,

please enter its provisions. If not, enter those which are most typical. We would

appreciate receiving a copy of the typical contract(s) if possible.

a) Does the contract provide that the client has any authority to make decisions

concerning:

Yes No

(1) a chorionic villus biopsy?

(2) an amniocentesis?

— —

(3) termination of pregnancy?

. .

(4) prenatal care?

—

(5) use of prescription medicine?

—

—

b) Are any of the following prescribed or proscribed in the contract:

(1) Diet?

(2) Exercise?

(3) Cigarettes?

(4) Alcohol?

(5) Marijuana?

(6) Other illegal drugs?

(7) Surrogate agrees to

follow doctor’s orders?

(7) Other (please specify)?

Prescribed

—

—

—

—

Proscribed

—

—

—

—

—

—

—

No mention

—

—

—

—

—

c) Does your contract state that:

(1) the surrogate will relinquish custody

at birth?

(2) the surrogate will terminate her

parental rights prior to birth?

(3) the surrogate will terminate her

parental rights upon birth?

(4) the client will accept the child

regardless of gender?

(S) the client will accept the child

regardless of health?

(6) the client will accept the child

regardless of health unless the problem

is due to surrogate’s carelessness or

breach of contract?

(7) the client’s partner will accept the

child if the client fails ill or dies?

Yes No

d) What remedies are listed in the contract in the event that:

(1) the surrogate fails to abide by a life-style restriction?

(2) the surrogate fails to follow her doctor’s advice?

(3) the surrogate fails to relinquish custody?

(4) the surrogate fails to relinquish parental rights?

(5) the client fails to accept the child?

(6) the client fails to pay?

(7) the client and partner die before birth or finalization of adoption?

e) What are the fees paid to the surrogate in the event of:

(1)

(2)

(3)

(4)

(5)

(6)

failure to become pregnant?

miscarriage?

terminated pregnancy?

stillbirth?

birth of child with health problems?

birth of healthy child?

f) What other fees and deposits are specified?

How much?

(1) Fees to attorneys

Paid by whom? Paid when?

(2) Fees to psychiatrists

(3) Fees to physicians

for prenatal care

(4) Fees to your agency —

(5) Deposits in escrow

accounts

(6) Other (specify)
26. Have your agency, your clients, or your surrogates ever been threatened with

litigation? [f yes, please give an estimate of the number of cases dropped, settled,

or pending.

DEMOGRAPHICS OF CLIENTS

(if no precise data, use best guess)

OTHER SERVICES

27.

a) Do you offer preconception sex selection?

b) Do You offer surrogate embrvo transfer?

Yes No

—

c) Do you offer artificial insemination by donor?

—

d) Do you match clients and surrogate gestational

—

mothers, i.e. women who carry a child to whom they

are not genetically related? —

If the answer to (d) is yes, are any of the above screening, counseling,

contract or fee provisions different? Please specify.

28.

29.

30.

31.

32.

33.

34.

35.

36.

Age: Range Average (best estimate) —

Marital status:

Married: percent

Unmarried couple: percent

Single: percent

Sexual orientation:

Heterosexual: percent

Homosexual: percent

Bisexual: percent

Religion (please give best estimate of percentages, or rank in perceived frequency):

Catholic

Protestant (fundamentalist)

Protestant (ail other)

Jewish

Muslim

Other

Unknown

Race (please give best estimate of percentages, or rank in perceived frequency):

White

Black

Asian

Other

How many already have a child?

Reasons clients cite for seeking a surrogate mother (please rank in order of

frequency):

Economic statue of those seeking a surrogate mother (please give best estimate of

percentages, or rank in perceived frequency):

family income below $15,000:

between 15,000 and 30,000: —

between 30,000 and 50,000:

above 50,000:

Educational status:

High school:

College:

Graduate degree:

percent

percent

percent
DEMOGRAPHICS OF SURROGATES OPINION

37.

38.

39.

40.

41.

42.

43.

44.

45.

Age: Range Average (best estimate)

Marital status:

Married: percent

Unmarried couple: percent

Single: percent

Sexual orientation:

Heterosexual: percent

Homosexual: percent

Bisexual: percent

Religion (please give best estimate of percentages, or rank in perceived frequency):

Catholic

protestant (fundamentalist) —

Protestant (all other)

Jewish

Muslim

Other

Unknown

Race (please give best estimate of percentages, or rank in perceived frequency):

White

Black

Asian

Other

Economic status of those offering to be a surrogate mother (please give best

estimate of percentage, or rank in perceived frequency):

family income below S15,000: —

between 15,000 and 30,000:

between 30,000 and 50,000:

above 50,000:

46. What do you think of the Baby M decision?

Reasons cited for seeking to be a surrogate mother (please rank in order of

frequency):

Educational status:

High school: percent

College: percent

Graduate degree: percent

Percentage who:

47. Do you think there is any role for professional societies with respect to surrogate

mothering practice? Yes — No —

If not, why not?

If so, precisely what would you like to see done?

48. Do you think there is any role for state government with respect to surrogate

mothering practice? Yes — No —

a) have had a prior pregnancy:

b) have had a miscarriage:

c) have had an abortion:

d) have relinquished a previous

child for adoption:

eJ have relinqulshed a child

as a surrogate:

f) are themselves adopted:

If not, why not?

If so, precisely what would you like to see done?

49. Do you think there is any role for the federal government with respect to surrogate

mothering practice? Yes — No —

If not, why not?

[f so, precisely what would you like to see done? I

Please feel free to attach further comments.

●
Appendix H

List of Contractor Documents

For this assessment, OTA commissioned reports on various topics concerning infertility prevention and treatment. The manuscripts of 10 of these contractor documents are available in

four volumes from the National Technical Information Service, 5285 Port Royal Road, Springfield, VA, 22161; (703) 487-4650.

Volume I: Research

“Animal Reproductive Technologies and Their Potential Applications for Human Fertility Problems: A Review,” Robert A. Godke, Department of Animal Science, Louisiana State University,

Baton Rouge, LA.

‘

(

Frontiers of Reproductive Research,” Richard P. Marrs, Division of Reproductive Endocrinology and Infertility, Cedars-Sinai Medical Center, Los Angeles, CA.

Volume 11: Prevention of Infertility

“A Report on a Proposed Method To Prevent Infertility: Self-Identification of Risk for Infertility,”

Michael R. Soules, Division of Reproductive Endocrinology, Department of Obstetrics and Gynecology, University of Washington, Seattle, WA.

“Prevention of Infertility,” James A. McGregor, Department of Obstetrics and Gynecology, University of Colorado Health Sciences Center, Denver, CO.

Volume 111: Economics of Infertility

“Economic Considerations for Infertility: Third Party Coverage of Infertility Treatments, ” Charles

P. Hall, Jr., and Arnold Raphaelson, School of Business and Management, Temple University,

Philadelphia, PA.

“Expenditures on Infertility Treatment,” Emanuel Thorne and Gilah Langner, Washington, DC.

Volume IV: Social and Medical Concerns

“Psychological Aspects of Being Infertile, ” Constance H. Shapiro, Department of Human Service

Studies, New York State College of Human Ecology, Cornell University, Ithaca, NY.

“Religious and Secular Perspectives About Infertility Prevention and Treatment ,“ Baruch A. Brody,

Baylor College of Medicine, Center for Ethics, Medicine, and Public Issues, Houston, TX.

“Risks of Infertility and Diagnosis and Treatment, ” Helen Bequaert Holmes, Women’s Research

College, Hartford College, Amherst, MA.

“Risks of Infertility Diagnosis and Treatment ,“ Anthony R. Scialli, Reproductive Toxicology Center, Columbia Hospital for Women, Washington, DC.

377
Appendix I

Acknowledgments

OTA would like to thank the members of the advisory panel who commented on drafts of this report, the

contractors who provided material for this assessment, and the many individuals and organizations that supplied

information for the study. In addition, OTA acknowledges the following individuals for their review of drafts

of this report:

C.F.D. Ackman

Montreal, Canada

G. David Adamson

Palo Alto, CA

Angeles Tan A]ora

University of the Philippines

Cynthia Alpert

Arlington, VA

Donna Day Baird

National Institute of Environmental Health Sciences

Phil Bannister

Health and Welfare Services, Canada

Ditta Bartels

University of New South Wales, Australia

Jonathan Van Blerkom

University of Colorado at Boulder

Baruch A. Brody

Baylor College of Medicine

Kathy J. Bryant

American College of obstetricians and

Gynecologists

Martin Buechi

Embassy of Switzerland

Lester Bush

Gaithersburg, MD

Maria Bustillo

Fairfax-Northern Virginia Genetics and IVF

Institute

M. Christian Byk

Ministere la Justice, France

A. Campana

Ospedale Distrettuale (La Carita), Switzerland

Willard Cates, Jr.

Centers for Disease Control

Paolo Cattorini

Milano, Italy

Wendy Chavkin

New York City Department of Health

J. Cohen

Clinique Marignan, Paris, France

Glinda S. Cooper

Uniformed Services University of the Health

Sciences

A. Costoya

Army Hospital, Santiago, Chile

Carolyn B. Coulam

Methodist Center for Reproduction and

Transplantation Immunology

B. Courvoisier

Swiss Academy of Medical Science

Thomas Vincent Daly

St. Vincent’s Bioethics Center, Australia

Marian D. Damewood

The Johns Hopkins Hospital

Ken Daniels

University of Canterbury, New Zealand

Miriam Davis

U.S. Department of Health and Human Services

David M. de Kretser

Monash University, Australia

Bernard M. Dickens

University of Toronto

Laneta J. Dorflinger

U.S. Agency for International Development

Richard J. Dowling

Maryland Catholic Conference

Rebecca S. Dresser

Baylor College of Medicine

Michel Falise

Federation Universitaire et PoIytechnique, Line,

France

378
App. l—Acknowledgments “ 379

H. Firket

Universit; de Liege, Belgium

Alan Ford

Embassy of Ireland

Jacqueline Darroch Forrest

Alan Guttmacher Institute

Nlark S. Frankel

American Association for the Advancement of

Science

Beverly Freeman

Resolve, Inc.

Richard Getzinger

U.S. Science Counselor in Japan

J.R. Gilhooly

Law Reform Commission of Canada

Allan R. Glass

Walter Reed Army Medical Center

Rachel Benson Gold

Alan Guttmacher Institute

Cynthia P. Green

Bethesda, MD

Arthur F. Haney

Duke University Medical Center

Jalna Hanmer

University of Bradford, England

Stanley K. Henshaw

Alan Guttmacher Institute

Gunter E. Hirsch

Augsburg, Federal Republic of Germany

S. Hogberg

Swedish Embassy to the United States

Angela R. Holder

Yale University School of Medicine

Helen Bequaert Holmes

Amherst, NIA

Neil A. Hohzman

The Johns Hopkins University

Frits Hondius

Council of Europe, Strasbourg, France

Stuart S. Howards

University of ~’irginia School of Medicine

Ruth Hubbard

Harvard University

Cathy James

Medical College of

Robert Jansen

Sydney, Australia

John F. Jarrell

Virginia

McMaster University IVF Program, Canada

Mohsen Ahmed Khairy

Benha Faculty of Medicine, Cairo

Francis Kinnelly

U.S. Embassy to Canada

Bartha M; Knoppers

University de Montr~al, Qu~bec

Michael Kottow

Stuttgart, Federal Republic of Germany

J. Lansac

Tours, France

Sylvia A. Law

New York University School of Law

Paul E. Lebech

Frederiksberg Hospital, Copenhagen

H.J.J. Leenen

University of Amsterdam

Charles Lefevre

Federation Universitaire et Polytechnique, Line,

France

Sandra R. Leiblum

University of Medicine and Dentistry of New

Jersey

B. Ingemar B. Lindahl

Karolinska Institute, Sweden

Larry I. Lipshultz

Baylor College of Medicine

Per-Erik Liss

Linkoping University, Sweden

Jos~ Alberto Mainetti

Fundaci6n Jose Maria Mainetti, Argentina

Richard P. Marrs

Cedars-Sinai Medical Center

Dennis Matt

Medical College of Virginia

John D. McConnell

University of Texas Health Science Center at

Dallas
—

380 “ Infertility: Medical and Social Choices

S. Ahmed Meer

U.S. Science Counselor in India

John Mendeloff

University of California, La Jolla

Bert Metz

Attach: for Health and the Environment, Royal

Netherlands Embassy

Edmund Meuwissen

Stichting Benovelentia, Amsterdam

Virginia Michaels

Mayo Clinic

Jon Miller

Northern Illinois University

Kamran S. Moghissi

Wayne State University School of Medicine

William D. Mosher

National Center for Health Statistics

Beth Mueller

Fred Hutchinson Cancer Research Center

W. Muller-Hartburg

Verlag Arzt und Christ, Austria

Randy J. Nelson

The Johns Hopkins University

N.C. Nielsen

Bispebjerg Hospital, Copenhagen

Margaret Nixon

Department of Justice, Wellington, New Zealand

Lennart Nordenfelt

Linkoping University, Sweden

H.J. odendaal

University of Stellenbosch, South Africa

Sharon M. Oster

Yale School of Organization and Management

James W. Overstreet

University of California, Davis

Freda L. Paltiel

Commission on the Status of Women, Canada

Lynn M. Pahrow

American Civil Liberties Union Foundation

Berit Pettersen

Secretary of the Royal Norwegian Embassy

Stephen R. Plymate

Madigan Army Medical Center

Ruth Richards

Mailman Research Center, Belmont, MA

Maithreyi K. Raj

Women’s University of Bombay, India

Henk Rigter

Netherlands’ Health Council

Jacques E. Rioux

Le Centre Hospitalier de l’University Laval, Canada

John A. Robertson

University of Texas at Austin

Robert C. Robinson

National Conference of Commissioners on Uniform

State Laws

Robyn Rowland

Deakin University, Australia

Suzanne Sangree

American Civil Liberties Union Foundation

Hans-Martin Sass

Ruhr University, Federal Republic of Germany

D.M. Saunders

Royal North Shore Hospital, Australia

Phillip E. Schambra

U.S. Science Attach~ in India

J.G. Schenker

Hadassah University Hospital, Jerusalem

Steven M. Schrader

National Institute for Occupational Safety and

Health

Amos Shapira

Tel-Aviv University

Yashuko Shirai

Shinsu University, Japan

Roy Simpkins

U.S. Science Counselor, Mexico

Peter Singer

Monash University, Australia

Susheela Singh

Alan Guttmacher Institute

Cheryl L. Sisk

Michigan State University

Margaret A. Somerville

McGill University, Qu~bec
App. l—Acknowledgments “ 381

Leon Speroff

University Hospitals of Clet~eland

Kenneth A. Steingold

Medical College of \’irginia

Robert N. Swidler

JNetv York State Task Force on Life and the Law

Richard J. Tasca

National Institutes of Health

Nadine Taub

Rutgers Law School

Datrid C. Thomasma

Loyola University Medical Center

Ian Tulloch

National Health and I$ledical Research Council,

Australia

Wolfgang Wagner

Duphar Pharma, Federal Republic of Germany

LeRoy Walters

Georgetown University

Anne Colston Wentz

J’anderbilt University Medical Center

Gerald J. Whitman

U.S. Science Counselor, Rome

Norma Wikler

University of California, Santa Cruz

Linda Williams

Trent University, Canada

Doug J. Yarrow

Embassy of Great Britain

S. Zobrist

Federal Office of Public Health, Switzerland

Gregor Zore

Embassy of the Socialist Federal Republic of

Yugoslavia

Louis Wailer

Monash Uni\7ersity, Australia
Appendix J

Glossary of Acronyms and Terms

AATB

ACOG

AFDC

AFS

AGI

AI

AIDS

AMA

BBT

BC/BS

CAHBI

c c

CCNE

CDC

CECOS

CFR

Glossary of Acronyms

—American Association of Tissue

Banks

—American College of obstetricians

and Gynecologists

—Aid to Families with Dependent

Children (DHHS)

—American Fertility Society

—Alan Guttmacher Institute

—artificial insemination

—acquired immunodeficiency

syndrome

—American Medical Association

—basal body temperature

—Blue Cross/Blue Shield Associations

—Ad Hoc Committee of Experts on

Progress in the Biomedical Sciences

(Council of Europe)

-clomiphene citrate

-Comite' Consultatif National d’Ethique

(National Advisory Ethics Cmmnittee)

(France)

-Centers for Disease Control (PHS,

DHHS)

-Centres d’Etude et de la

Conservation du Sperme (Centers for

the Study and Conservation of

Sperm) (France)

-Code of Federal Regulations

CHAMPUS -Civilian Health and Medical Program

of the Uniformed Services (U.S.

Department of Defense)

CHAMPVA -Civilian Health and Medical Program

of the Veterans’ Administration (VA)

CMV -cytomegalovirus

CNFA -Comisi6n Nacional de Fecundacibn

Asistida (National Commission on

Assisted Reproduction) (Spain)

CON -certificate of need

DES -diethylstilbestrol

DHHS —U.S. Department of Health and

Human Services

DNA -deoxyribonucleic acid

EAB —Ethics Advisory Board

FDA –Food and Drug Administration (PHS,

DHHS)

FEHB —Federal Employees Health Benefits

Plan

FINRRAGE –Feminist International Network of

FSH

FTC

GIFT

GnRH

hCG

HIV

hMG

HMO

HSG

IEC

INSERM

IRB

IUD

IVF

JCAHO

LH

LH-RH

LPD

MREC

NCHS

NHMRC

NIH

NMCUES

NPT

NSFG

OHSS

OHTA

OTA

PHS

PID

POD

ProPAC

PTSD

PVA

Resistance to Reproductive and

Genetic Engineering

–follicle-stimulating hormone

—U.S. Federal Trade Commission

–gamete intrafallopian transfer

–gonadotropin releasing hormone

—human chorionic gonadotropin

—human immunodeficiency virus

—human menopausal gonadotropin

—health maintenance organization

–hysterosalpingogram

—Institutional Ethics Committee

(Australia)

—Institut National de la Sant6 et de la

Recherche M&dicale (National Health

and Medical Research Institute)

(France)

—Institutional Review Board

—intrauterine device

—in vitro fertilization

–Joint Commission on Accreditation of

Healthcare Organizations

—luteinizing hormone

–luteinizing hormone-releasing

hormone

—luteal phase defect

—Medical Research Ethics Committee

(Australia)

—National Center for Health Statistics

(DHHS)

–National Health and Medical

Research Council (Australia)

–National Institutes of Health (PHS,

DHHS)

—National Medical Care Utilization and

Expenditure Survey

—nocturnal penile tumescence

–National Survey on Family Growth

(NCHS, DHHS)

—ovarian hyperstimulation syndrome

–Office of Health Technology

Assessment (PHS, DHHS)

--Office of Technology Assessment

–U.S. Public Health Service (DHHS)

—pelvic inflammatory disease

–polycystic ovarian disease

—Prospective Payment Assessment

Commission (U.S. Congress)

–post-traumatic stress disorder

—Paralyzed Veterans of America

382
App. J—Glossary and Acronyms and Terms . 383

SLA –Statutory Licencing Authority (U. K.)

STD —sexually transmitted disease

TEC —Technology Evaluation and Coverage

Program (BC/BS)

Ucc —Uniform Commercial Code

VA —U.S. Veterans’ Administration

VLA –Voluntary Licencing Authority (U. K.)

Glossary of Terms

Adhesions: Rubbery bands of scar tissue (usually

caused by previous infections or surgery) attached

to organ surfaces, capable of connecting, covering,

or distorting organs such as the fallopian tubes, ovaries, or bowel. Adhesions in the fallopian tubes and

ovaries obstruct the movement of sperm and oocytes.

Agglutinization of sperm: The binding together of

sperm in clumps.

Amenorrhea: The absence of menstruation.

Anovulation: The absence of ovulation.

Antibody: A blood protein (immunoglobin) produced

by white blood cells in response to the presence of

a specific foreign substance (antigen) in the body,

with which it fights or otherwise interacts. Antibodies to sperm, if present, can impair fertility by causing agglutination of sperm.

Artificial insemination (AI): The introduction of

sperm into a woman’s vagina or uterus by noncoital methods, for the purpose of conception.

Azoospermia: The absence of sperm in the semen.

Basal body temperature (BBT): A woman’s resting

temperature upon awakening in the morning before any activity; the temperature rises slightly when

ovulation occurs and remains at the higher level until

the next menstruation. Recording and charting BBT

is one of the oldest and most popular methods for

predicting ovulation.

Blastocyst: A fluid-filled sphere of cells developed

from a zygote. The embryo develops from a small

cluster of cells in the center of the sphere, and the

outer wall of the sphere becomes the placenta. The

blastocyst, also called a preimplantation embryo, begins to implant into the lining of the uterus 6 to 7

days after fertilization.

Breach of contract: A party’s failure to perform a contractually agreed-upon act.

Bromocriptine: A synthetic compound that interferes

with the pituitary gland’s ability to secrete prolactin. Bromocriptine is often prescribed for hyperprolactinemia.

Certificate of need (CON): A regulatory planning measure established by the National Health Planning Resources Development Act of 1974 to help State and

local health planning agencies review capital expenditure applications from institutions, and to explore

other ways of reducing medical costs.

Cervical mucus: Mucus produced by the cervix that

undergoes complex changes in its physical properties in response to changing hormone levels during

the reproductive cycle. These changes assist the survival and transport of sperm.

Chimera: An individual consisting of cells or tissues

of diverse genetic constitution (e.g., from different

species).

Chlamydia: An STD caused by the bacteria Chlamydia

trachomatis. In women, chlamydial infection accounts for 25 to 50 percent of the pelvic inflammatory disease cases seen each year. Chlamydia is the

most common STD in the United States today.

Choice-of-law: Body of law by which a court determines which State or country’s laws ought to apply

to the case before the court.

Chromosomal abnormalities: Genetic mutations involving changes in the number and structure of

chromosomes. This can affect fertility through early

fetal loss caused by genetic factors, impairment in

the reproductive function in an adult caused by chromosomal abnormalities already present, or by genetic predisposition toward certain diseases, such

as endometriosis.

Chromosome A rod-shaped body in a cell nucleus that

carries the genes that convey hereditary characteristics.

Cleavage: The stage of cell division that takes place

immediately after fertilization and that lasts until

the cells begin to segregate and differentiate and

to develop into a blastocyst.

Clomiphene citrate: A nonsteroidal estrogen-like

compound that binds to estrogen receptors in the

body. CC is a commonly prescribed fertility drug,

primarily used in patients with oligomenorrhea to

promote increased gonadotropin secretion and

stimulation of the ovary.

Conceptus: The mass of cells resulting from the earliest stages of cell division of a zygote.

Confidentiality: A fundamental component of the

physician-patient relationship, stemming primarily

from the Hippocratic oath, in which the physician

has the duty to keep confidential all that is confided

by the patient.

Consensus conference A meeting of experts held under the auspices of the NIH Consensus Development

Program (established in 1977), to develop consensus

on the clinical application of new medical findings.

Corpus luteum: A gland that forms on the surface of

the ovary at the site of ovulation and produces

progesterone during the second half of the menstrual cycle, in order to prepare the uterus for a
384 . Infertility: Medical and Social Choices

possible pregnancy. The corpus Iuteum regresses

if pregnancy does not occur.

Cryopreservation: The preservation of sperm, embryos, and oocytes by freezing them at extremely

low temperatures.

Cryptorchidism: Undescended testes.

Damages: Monetary compensation that the law

awards to a person who has been injured by the

actions of another.

Danazol: A synthetic derivative of testosterone used

in the treatment of endometriosis.

Diagnostic tests: Tests performed to evaluate reproductive health. In women, this can involve indirect

indicators (menstrual irregularity, hormone levels,

cervical mucus) and direct ones (tissue biopsy,

laparoscopy, ultrasound). In men, tests include semen analysis, endocrine evaluation, testicular biopsy,

and evaluation of sexual dysfunction.

Dictum (pi. dicta): A statement or observation in a judicial opinion that is not necessary for the decision

on the case. Dictum differs from a “holding” in that

it is not binding on the courts in subsequent cases.

Deoxyribonucleic acid (DNA): The nucleic acid in

chromosomes that codes for genetic information.

Donor gametes: Eggs or sperm donated by individuals for medically assisted conception,

Ectopic pregnancy: A pregnancy that occurs outside

the uterus, usually in a fallopian tube.

Ejaculation: A two-part spinal reflex that involves

emission, when the semen moves into the urethra,

and ejaculation proper, when it is propelled out of

the urethra at the time of orgasm,

Electroejaculation: Electrical stimulation of the nerve

that controls ejaculation, used to obtain semen from

men with spinal cord injuries.

Embryo: Term used to describe the stages of growth

from the second to the ninth week following conception. During this period cell differentiation proceeds rapidly and the brain, eyes, heart, upper and

lower limbs, and other organs are formed.

Embryo donation: The transfer from one woman to

another of an embryo obtained by artificial insemination and lavage or, more commonly, by WF.

Embryo lavage: A flushing of the uterus to recover

a preimplantation embryo.

Embryo transfer: The transfer of an in vitro fertilized

egg from its laboratory dish into the uterus of a

woman.

Endometrial biopsy: The microscopic examination of

a sample of cells, obtained from the lining of the

uterus between days 22 and 25 of a normal 28-day

menstrual cycle, in order to evaluate ovulatory

function.

Endometriosis: The presence of endometrial tissue

(the normal uterine lining) in abnormal locations

such as the fallopian tubes, ovaries, or the peritoneal

cavity. Endometriosis can interfere with nearly every

phase of the reproductive cycle and is a leading contributor to infertility in women. The causes and

development of endometriosis are incompletely understood.

Endometrium The tissue lining the uterus.

Epididymis: A coiled tubular structure in the male

that receives sperm moving from the testis to the

vas deferens. Sperm are stored and matured for a

period of several weeks in the epididymis.

Epididymitis: Infection of the epididymis, usually

from an STD, such as gonorrhea, that can impair

fertility during the course of the infection, as well

as causing scarring that can partially or completely

block sperm transport.

Estrogen: A class of steroid hormones, produced

mainly by the ovaries from puberty to menopause.

Ethics Advisory Board Established within the Department of Health, Education, and Welfare to review

proposals for Federal funding of research involving

IVF. The Ethics Advisory Board ceased to function

in 1980.

Experimental technology or treatment: A technology or treatment the safety and efficacy of which

has not been established.

Extracorporeal embryo: An embryo maintained outside the body.

Fallopian tube: Either of a pair of tubes that conduct

the egg from the ovary to the uterus. Fertilization

normally occurs within this structure. Blocked or

scarred fallopian tubes are a leading source of infertility in women.

Fecund: Able to conceive. A characterization used by

demographers to identify couples who have no

known physical problem that prevents conception.

Fern test: Evaluation of fern-like pattern of dried cervical mucus. As ovulation approaches, more ferning can be observed.

Fertility drugs Compounds used to treat ovulatory

dysfunction. These include clomiphene citrate, human gonadotropins, bromocriptine, glucocorticoids,

and progesterone.

Fertilization: The penetration of an oocyte by a sperm

and subsequent combining of maternal and paternal DNA.

Fetus: The embryo becomes a fetus after approximately 9 weeks in the uterus. This stage of development lasts from 9 weeks until birth and is marked

by the growth and specialization of organ function.

Fimbria: The fringed entrance to the fallopian tubes.

Fimbrioplasty: A surgical procedure to correct partial restriction of the fallopian tube.
App. J—Glossary and Acronyms and Terms ● 385

First Amendment: The First Amendment to the U.S.

Constitution. It guarantees freedom of speech, press,

assembly, petition, and exercise of religion.

Follicle: The structure on the ovary surface that nurtures a ripening oocyte. At ovulation the follicle ruptures and the oocyte is released. The follicle produces estrogen until the oocyte is released, after

which it becomes a yellowish protrusion on the

ovary called the corpus luteum.

Follicle stimulating hormone (FSH): A pituitary hormone, also known as a gonadotropin, that along with

other hormones stimulates hormone and gamete

production by the testes and ovaries.

Fourteenth Amendment: The Fourteenth Amendment to the U.S. Constitution. It guarantees due process of law and equal protection of the law. The latter has come to mean that the States and Federal

Government may not discriminate without at least

a rational purpose and, at times, without a compelling purpose.

Fundamental right: A right not enumerated in the

U.S. Constitution but deemed so apparent from examination of the Constitution and Declaration of Independence or other sources that it is protected

from undue interference by Federal or State action.

The right to marry, for example, has been deemed

a fundamental right.

Gamete A reproductive cell. In a man, the gametes

are sperm; in a woman, they are eggs, or ova.

Gamete intrafallopian transfer (GIFT): A technique

of medically assisted conception in which mature

oocytes are surgically removed from a woman’s body

and then reintroduced, together with sperm,

through a catheter threaded into the fallopian tubes,

where it is hoped fertilization will take place.

Gene: The portion of a DNA molecule that consists of

an ordered sequence of nucleotide bases and constitutes the basic unit of heredity.

Glucocorticoids: Hormones naturally produced by the

adrenal glands. Synthetic glucocorticoids are used

to treat ovulatory dysfunction caused by adrenal disorders.

Gonad: Ovary or testis.

Gonadotropin: Hormone that stimulates the testes or

ovaries. Examples are follicle-stimulating hormone,

human chorionic gonadotropin, human menopausal

gonadotropin, and Iuteinizing hormone. These can

be administered in cases of ovulatory dysfunction

to directly stimulate the ovary.

Gonadotropin releasing hormone (GnRH): The hormone released from the hypothalamus that causes

secretion of gonadotropin from the pituitary gland.

Gonorrhea: An STD caused by the bacteria Alesseria

gonorrhea. If the infection is not treated in women,

it can spread to the uterus and the fallopian tubes,

causing PID. In men, it can cause epididymitis and

can affect semen quality.

Hamster~oocyte penetration test: A test that evaluates the ability of human sperm to penetrate an

ovum by incubating sperm with hamster oocytes

that have had their outer layer removed. Normal

sperm will penetrate the eggs. The reliability and

significance of this test are controversial.

Health maintenance organization (HMO): A health

care organization that serves as both insurer and

provider of comprehensive but specified medical

services, provided by a defined group of physicians

to an enrolled, fee-paying population.

Human chorionic gonadotropin (hCG): A hormone

secreted by the embryo that maintains the corpus

Iuteum when pregnancy occurs. This hormone can

be extracted from the urine of pregnant women and

can be injected to stimulate ovaries and testes.

Human menopausal gonadotropin (hMG): Hormone

that can be extracted from the urine of menopausal

women and injected to stimulate ovaries and testes.

Hyperprolactinemia: The overproduction of the pituitary hormone prolactin, which can contribute to

infertility. The causes of this condition are diverse

and poorly understood. It can be treated with

bromocriptine.

Hypospadias: A structural abnormality of the penis

caused by an opening on the underside.

Hypothalamus: A structure at the base of the brain

that controls (among other things) the action of the

pituitary gland. By secreting and releasing hormones, the hypothalamus orchestrates the body’s

reproductive function in both men and women.

Hysterosalpingogram: An x-ray study of the female

reproductive tract in which dye is injected into the

uterus while x rays are taken showing the outline

of the uterus and the degree of openness of the fallopian tubes.

Hysteroscopy: Direct visualization of the interior of

the uterus in order to evaluate any abnormalities

that may be present. This is done by inserting a hys -

teroscope (a long, narrow, illuminated tube) through

the cervix into the expanded uterus. Surgical procedures may also be performed using this method.

Iatrogenic Resulting from the action of physicians.

The term is commonly applied to diseases or disabilities caused by medical care.

Idiopathic Of unknown origin.

Impaired fecundity: Categorization of infertility used

by demographers to describe couples who are nonsurgically sterile, or for whom it would be difficult

or dangerous to have a baby.

Impotence: The inability to achieve or maintain an
366 . Infertility: Medical and Social Choices

erection.

Implantation The process by which the fertilized oo -

cyte (zygote) becomes attached to the wall of the

uterus (endometrium).

In vitro: Literally “in glass”; pertaining to a biological

process or reaction taking place in an artificial environment, usually a laboratory.

In vitro fertilization (IVF): A technique of medically

assisted conception (sometimes referred to as “test

tube” fertilization) in which mature oocytes are removed from a woman’s ovary and fertilized with

sperm in a laboratory. (See embryo transfer.)

In vivo: Literally “in the living”; pertaining to a biological process or reaction taking place in a living

cell or organism.

In vivo fertilization: The fertilization of an egg by a

sperm within a woman’s body. The sperm may be

introduced by artificial insemination or by coitus.

Infertility: Inability of a couple to conceive after 12

months of intercourse without contraception.

Intracervical insemination: Artificial insemination

technique in which sperm are placed in or near the

cervical canal of the female reproductive tract, using

a syringe or a catheter, for the purpose of conception.

Intraperitoneal insemination An artificial insemination technique in which sperm are introduced into

the body cavity between the uterus and the rectum,

after ovulation has been induced, for the purpose

of conception.

Intrauterine device (IUD): Contraceptive device inserted through the cervix into the uterine cavity.

Intrauterine insemination: Artificial insemination

technique in which sperm are deposited directly in

the uterine cavity.

Karyotype: A photographic display of an individual’s

chromosomes that shows the number, size, and

shape of each chromosome.

Laparoscopy: Direct visualization of the ovaries and

the exterior of the fallopian tubes and uterus by

means of a laparoscope (a long, narrow, illuminated

instrument) introduced through a small surgical incision below the navel, to evaluate any abnormalities, Surgical procedures may also be performed

using this method.

Laparotomy: A surgical incision through the abdominal wall, larger than that used in a laparoscopy, to

allow visualization of reproductive structures for

evaluation or surgery.

Liberty right: The natural right of a human being, capable of choice, to undertake an action freely and

without interference, as long as it does not restrain

or injure other persons,

Luteal phase defect (LPD): Failure of the endometrial

lining of the uterus to develop properly after ovulation. This condition can be treated with progesterone.

Luteinizing hormone: A gonadotropin that along

with FSH stimulates and directs hormone and gamete production of the testes and ovaries.

Luteinizing hormone-releasing hormone (LH-RH):

A hormone secreted by the hypothalamus that acts

on the pituitary to promote secretions of gonadotropin that in turn direct hormone and gamete production by the ovaries and testes.

Menopause: The cessation of the menstrual cycle,

which occurs when the ovary is virtually depleted

of oocytes.

Menstrual cycle: The process of ovulation in which

an oocyte matures each month in a follicle produced

on the surface of the ovary. At ovulation, the follicle

ruptures and the oocyte is released into the body

cavity and enters the fallopian tube. If fertilization

and implantation do not occur, the uterine lining

is sloughed off, producing menstrual flow. The normal menstrual cycle is about 28 days.

Microsurgery Fine, delicate surgical procedures performed with the aid of a microscope or other magnifying apparatus. In cases of infertility, microsurgery is used to repair fallopian tubes in women and

blockages of the reproductive tract in men.

Mycoplasma: A micro-organism similar to bacteria,

but lacking a rigid cell wall. Mycoplasma is associated with reproductive tract infections.

National Survey of Family Growth: A survey conducted periodically (1976, 1982, and 1988) by the

National Center for Health Statistics (part of DHHS)

to collect data on fertility, family planning, and related aspects of maternal and child health.

Negligence: Failure to exercise reasonable care.

Nocturnal penile tumescence (NPT): The occurrence

of erections during sleep.

Noncoital reproduction: Reproduction other than by

sexual intercourse.

Oligomenorrhea: Scanty or infrequent menstruation,

a problem found in about 20 percent of infertile

women.

Oligospermia: Scarcity of sperm in the semen.

Oocyte: The female egg or ovum, formed in an ovary.

Ovaries: Paired female sex glands in which ova are

developed and stored and the hormones estrogen

and progesterone are produced.

Oviduct: Fallopian tube.

Ovulation: The discharge of an oocyte from a woman’s

ovary, generally around the midpoint of the menstrual cycle.

Ovulation induction: Treatment of ovulation dysfunction caused by such disorders as amenorrhea, oligo -

menorrhea, and LPD, using drugs that induce ovu-
App. J—Glossary and Acronyms and Terms “ 387

lation. These so-called fertility drugs include CC and

gonadotropins. ovulation induction is also used as

part of the AI, IVF, and GIFT techniques.

Ovulation prediction kits Over-the-counter hormone

monitoring kits that employ the enzyme-linked immunosorbent assay procedure to measure the midcycle increase in LH that indicates ovulation is taking place.

Ovum (pi. ova): The female egg or oocyte, formed in

an ovary.

Ovum donor: A woman who donates an ovum or ova

to another woman.

Paternity suit: A legal action to determine the father

of a child.

Pelvic inflammatory disease (PID): Inflammatory disease of the pelvis, often caused by an untreated STD.

Bacteria that cause gonorrhea, chlamydia, or other

infections can ascend from the lower genital tract

through the endometrium (causing endometriosis),

to the fallopian tubes (causing salpingitis), and pOSsibly to the ovaries (causing oophritis).

Peritoneal cavity: The abdominal cavity.

Pituitary: A gland at the base of the brain that secretes

a number of hormones related to fertility.

Polycystic ovarian disease (POD): A disease of the

ovaries caused by malfunction of the hormonal system that results in ovaries clogged with cysts, making ovulation almost impossible. The reasons this occurs are unclear.

Post-coital test: Microscopic analysis of cervical mucus within a few hours of timed intercourse in order to observe and evaluate the interaction of sperm,

semen, and cervical mucus. The oldest and most

widely practiced post-coital test is the Sims-Huhner

test.

post-traumatic stress disorder (PTSD): An anxiety

disorder involving the development of characteristic symptoms (including sexual dysfunction) following a psychologically traumatic event that is generally outside the range of normal human experience.

Preimplantation embryo: The mass of dividing cells

of the zygote and the blastocyst that develop in the

first 6 to 7 days after fertilization.

Preovulation: The first 14 days of a woman’s menstrual cycle, when estrogen levels are rising before

ovulation takes place.

Primary infertility: Infertility in those who have never

had children.

Progesterone: A steroid hormone secreted by the

ovary after ovulation; it may be used to treat LPD.

Prolactin: A hormone secreted by the pituitary that

stimulates breast milk production and supports

gonadal function.

Prostate gland: Male gland that supplies part of the

fluid of the semen.

Reasonable care: The degree of care that under the

circumstances would ordinarily be exercised or be

expected from the ordinary prudent person; in a

professional setting, that care ordinarily exercised

or expected from the ordinary prudent professional.

Regulation: A rule issued by an administrative agency

pursuant to authority granted to the agency by

statute.

Retrograde ejaculation: Discharge of semen backward into the bladder, rather than out through the

penis.

Retrograde menstruation: Menstruation that flows

backwards through the fallopian tubes.

Salpingitis: Inflammation of the fallopian tubes, sometimes caused by PID.

Salpingostomy A surgical attempt to recreate the normal fallopian opening and fimbria function in cases

of complete occlusion of the fallopian tubes.

Secondary infertility: Infertility in those who have

previously been fertile.

Semen: A fluid consisting of secretions from the male’s

seminal vesicles, prostate, and from the glands adjacent to the urethra. Semen carries sperm and is

ejaculated during intercourse.

Semen analysis: Evaluation of the basic characteristics of sperm and semen, such as appearance, volume, liquefaction and viscosity, and sperm concentration and motility. The presence of bacterial

infection and immunological disorders can also be

determined by semen analysis. It is the fundamental diagnostic method used to evaluate male infertility.

Sexual dysfunction: The inability to achieve normal

sexual intercourse for reasons such as impotence,

premature ejaculation, and retrograde ejaculation

in the man or of vaginismus in the woman.

Sexually transmitted diseases (STDS): Infectious diseases transmitted primarily by sexual contact, including syphilis, gonorrhea, chlamydia, herpes, and

acquired immunodeficiency syndrome.

Specific performance: A remedy for breach of contract in which the court orders that the precise terms

of the contract be fulfilled, rather than ordering that

monetary damages be paid.

Sperm The male reproductive cell, or gamete. Normal sperm have symmetrically oval heads, stout midsections, and long tapering tails.

Sperm bank: A place in which sperm are stored by

cryopreservation for future use in artificial insemination.

Sperm motility: The ability of a sperm to move

normally.

Sperm washing: The dilution of a semen sample with
3# ● lnfertility: Medical and Social Choices

various tissue culture media in order to separate viable sperm from the other components of semen.

Spinal cord injuries Injury to the spinal cord causes

fertility problems in paraplegic and quadriplegic

men, although not generally in women. Because of

these conditions sperm quantity and quality may be

decreased, there may be erection and ejaculation

dysfunction, and infections of the reproductive tract

may occur.

Statute: Legislation enacted by a legislature.

Surgically sterile Surgically rendered unable to conceive or to carry to term by techniques including

vasectomy, tubal ligation, and hysterectomy.

Surrogate gestational mother A woman who gestates

and carries to term an embryo to which she is not

genetically related, with the intention of relinquishing the child at birth.

Surrogate mother A woman who is artificially inseminated and carries an embryo to term, with the intention of relinquishing the child at birth.

Testes: Also known as the testicles, the paired male

sex glands in which sperm and the steroid hormone

testosterone are produced,

Testicular biopsy: The excision of a small sample of

testicular tissue for microscopic evaluation to determine sperm production.

Testosterone: A steroid hormone, or androgen, produced in the testes that affects sperm production

and male sex characteristics.

Tort: A private or civil wrong resulting from a breach

of a legal duty that exists by virtue of society’s legal

expectations regarding interpersonal conduct,

rather than by virtue of a contractual agreement.

Tubal ligation: The sterilization of a woman by surgical excision of a small section of each fallopian tube,

Ultrasound: The use of high-frequency sound waves

focused on the body to obtain a video image of internal tissues, organs, and structures. Ultrasound

is particularly useful for in utero examinations of

a developing fetus, for evaluation of the development of ovarian follicles, and for the guided retrieval

of oocytes for IVF and GIFT.

Unconstitutional Conflicting with the provisions of

a constitution, usually the U.S. Constitution. Statutory provisions or particular applications of a statutory provision found unconstitutional are thereby

rendered void.

Uniform laws: Model laws approved by the Commissioners on Uniform Laws and proposed to all the

State legislatures for their consideration. Uniform

laws have no force or effect unless adopted by a

State legislature. The UCC (Uniform Commercial

Code) is a uniform law that has been the basis for

almost all State commercial codes in the United

States.

Uterine lavage: A flushing of the uterus to recover

a preimplantation embryo.

Vaginismus: Involuntary contraction of the muscles

around the outer third of the vagina, prohibiting

penile entry.

Varicocele: An abnormal twisting or dilation of the

vein that carries blood from the testes back to the

heart; a varicose vein of the testis, It occurs most

commonly on the left side.

Vas deferens: The convoluted duct that carries sperm

from the testis to the ejaculatory duct of the penis.

Vasectomy: Sterilization of a man by surgical excision

of a part of the vas deferens.

Lasography: An x-ray examination of the vas deferens by injection of dye through a small incision. X

rays are taken giving an outline of the sperm transport system.

Void: Unenforceable and having no legal effect.

Voidable: A valid act that may later be rendered unenforceable and without legal effect.

Welfare right: A claim asserted by an individual that

requires a corresponding response, obligation, or

duty on the part of others to provide some benefit.

Zygote: A fertilized oocyte formed by the fusion of

egg and sperm, containing DNA from both.

Index

Italicized page numbers indicate table or figure references.

Access

to infertility services, 145-146, 173

policj~ options concerning infertilitj~ service, 20-22

of ifeterans to infertility treatment, 23-24, 192-193,

195-197, 198

Acquired immunodeficiency syndrome (AIDS), infertility

prevention and, 6, 56, 85, 89

Aetna, 156

Age

chromosomal abnormalities and, 71

infertility and maternal, 4, 4, 6, 51-52, 88, 92

relationship between oocyte number, menopause, and,

40, 41

Agent Orange, effects on fertility of, 191-192

Alabama

adoption law in, 281

artificial insemination statutes in, 243, 246

IVF statutes in, 251

proposed surrogacy law in, 288

status of infertility insurance coverage in, 152

surrogacy advertising in, 271

Alan Guttrnacher Institute (AGI), infertility survey data

by, 49, 53, 54, 145-146, 147-148

Alaska

adoption law in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

I\’F statutes in, 251

Alcohol

infertility risk from oI~eruse of, 69

prohibition of use of, in surrogacy contracts, 277

American Association of Tissue Banks (AATB), infertility

treatment and research quality assurance by, 9,

165, 167, 248

American College of Obstetricians and Gynecologists

(ACOG)

infertility treatment and research quality assurance, 9,

150, 151, 165, 166-167, 168, 170, 173, 175, 203,

248

membership increase in, 5

American College of Physicians, 171-172

American Fertility Society (AFS)

ethical position on use of reproductive technologies,

203, 206, 208-209

infertility treatment and research quality assurance by,

9, 10, 150, 151, 157, 165, 167-168, 168-169, 170,

173, 175, 248-249, 257, 302

membership increase in, 5

registry establishment for IVF and GIFT programs, 165

American Legion, 198

American Medical Association (AMA)

I\’F research guidelines and, 178

policy on reproductive technology use, 203

technology assessment by, 17:

American Urological Association, membership increase

in, 5

American Veterans of WWII, Korea, and \’ietnam

(AMVETS), 198

Argentina, efforts regarding noncoital reproduction in,

346

Arizona

adoption law in, 281

artificial insemination statutes in, 243

fetal research laws affecting I\TF in, 324

infertility insurance coverage in, 152

IvF ]aW, in, 176, 2,51

Arkansas

adoption law in, 281, 286

artificial insemination statutes in, 243

IVF statutes in, 251

status of infertility insurance coverage in, 10, 151,

152, 152

surrogate motherhood law in, 13, 275, 279, 282, 285

Artificial insemination

device used for, 126, 126

legal issues involving, 241-250

private physician-provided, 53, 244

risks of, 130

screening donor sperm intended for, 169-170

sperm washing and swim-up techniques, 127

State statutes covering, 242-244, 243

techniques used for, 126-127, 128

see also Technologies, reproductive

Attorneys, surrogacy arrangement involvement by,

272-273

Australia

births from frozen oocytes in, 128, 299

infection from artificial insemination in, 170

infertility research in, 207, 208, 209

noncoital reproduction debate in, 13, 329-332

Austria, efforts regarding noncoital reproduction in, 346

Baby M, 35, 225, 226, 230-231

media coverage of, 12, 267-268

surrogacy contract for, 276, 278, 279, 280, 286

Basal body temperature (BBT), ovulation prediction

using, 102-103, 117

Belgium, efforts regarding noncoital reproduction in,

347

Biopsy

endometrial, 104-105, 110, 117

testicular, 109, 111

Birth control. See Contraception

Blue Cross/Blue Shield Association

infertility treatment reimbursement policy of, 149,

150, 153

Medical Necessities Program of, 172

Technolo&v Evaluation and Coverage (TEC) Program

of, 169, 172

391
392 . Infertility: Medical and Social Choices

Bowers v. Hardwick (1986), 220-221

Brazil, efforts regarding noncoital reproduction in, 347

Bromocriptine, 119

Buck v. Bell (1927), 219

Bulgaria, efforts regarding noncoital reproduction in,

347

California

adoption law in, 281

artificial insemination statutes in, 243, 246

embryo transfer research in, 178

fetal research laws affecting IVF in, 324

infertility insurance coverage in, 152

IVF statutes in, 251

California, University of (San Francisco), 172

Canada

efforts regarding noncoital reproduction in, 332-335

noncoital reproduction debate in, 13

Cancer, fertility impairment from, 72-73

Center for Population Research (NIH), 296

Centers for Disease Control (CDC)

HIV monitoring authority of, 181

infertility study by, 35

semen donor guidelines developed by, 170

STD control strategy of, 88, 89

Certificate-of-need laws, 174

Chemicals, fertility impairment from exposure to, 63,

69-71

Chile, efforts regarding noncoital reproduction in, 347

Chlamydia. See Sexually transmitted diseases (STDS)

Choice-of-law provisions, 278-279

Chromosomes, See Genetics

Clayton Act (1914), 181

Clomiphene citrate (CC), 117-118

risks of using, 128-129, 303

Cloning, future developments in, 300

C.M. V. C.C. (1979), 247

Colombia, efforts regarding noncoital reproduction in,

347

Colorado

adoption law in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

Commercialization

policy options concerning human gamete and embryo

transfer, 24-25

policy options involving regulation of surrogate

motherhood, 26-28

of reproductive technologies, 205, 206, 208, 228-233,

259-262, 270-271, 273-284

of surrogacy, 12-13, 26-28

Competency, State regulation of physician, 173-174

Complications. See Medical impacts; Psychological

impacts

Confidentiality, 11

of artificial insemination records, 249-250

Federal Government’s power to forbid, 181

in patient-doctor relationship, 21 I-212

policy options concerning infertility recordkeeping,

25-26

of surrogacy records, 275

Congress, U.S.

Biomedical Ethics Board authorized by, 30, 179

money appropriation right of, 177

policy issues and options for, 15-31

see also Government, Federal; Legislation

Connecticut

adoption law in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

proposed surrogacy law in, 288

Consensus Development Program (NIH), 171

Contraception

as factor in long-term, unintentional infertility, 51,

66-68

BBT measurement method of, 103

surgical, 3, 4, 5, 50, 51, 52, 54, 67, 85-86

costs

of infertility treatment services, 9, 10-11, 139-144, 141,

142, 143, 196-197

of opening IVF/infertility clinic, 159-160

of surrogate motherhood arrangement, 275-277

treatment classification and success rate’s effects on,

169

see also Expenditures; Funding

Council of Europe, efforts regarding noncoital reproduction in, 329, 356

Counseling

of infertility patients, 7-9, 8, 157, 159

mechanism and setting for infertility treatment, 97, 99

see also Psychological impacts

Courts. See Litigation

Cryopreservation. See Technologies, reproductive

Cystic fibrosis, 71-72

Cytomegalovirus (CMV), 248, 249

CUE Fertility Monitor, 104

Cyprus, efforts regarding noncoital reproduction in, 347

Czechoslovakia, efforts regarding noncoital reproduction

in, 347

Data

CDC infertility, 35

collection and dissemination by IVF/infertility clinics,

167-168

collection of patient history as diagnostic tool in infertility treatment, 98-100

contraception discontinuance-related infertility, 67-68

evaluation for development of infertility treatment

protocols, 170

infertility access, 145-146

infertility demographic, 3-5, 53-56

infertility treatment effectiveness, 146, 211

NSFG infertility, 49-53, 54

policy options ensuring availability of infertility service, 20-22
Index c 393

policy options involving Federal collection of reproductive health care, 15-16

on veterans with infertility problems, 189-191

Delaware

adoption law in, 281

artificial insemination statutes in, 243

I\’F statutes in, 251

status of infertility insurance coverage in, 149-150, 152

Demographics

of infertility, 3-5, 4, 5, 49-56

of surrogate motherhood, 273, 274

of U.S. veterans, 189-190

Denmark

efforts regarding noncoital reproduction in, 347-348

medical developments, recommendation and review in,

171

Department of Defense (DOD)

JVF procedures in facilities Of, 156

personnel exposed to radiation estimate of, 192

Department of Health and Human Services, U.S. (DHHS),

172

authority delegation to JCAHO for facility certification

for Medicare reimbursement, 174

see also Funding; Government, Federal

Depression. See Psychological impacts

Development

of reversible methods of sterilization and long-term

contraception, 90

stages of embryonic and fetal, 40-42, 42

Diagnosis

of infertility, 6, 97-112

risks from procedures involved in infertility, 110-112

scenarios of infertility treatment and, 139-144, 142,

143

of STD, 61

Diagnosis-related groups (DRGs), 171

Direct intraperitoneal insemination, 127

Disease

fertility impairment resulting from, 61-62, 71-73, 75,

85, 87-88

infertility characterized as, 36-37

see also Sexually transmitted diseases (STDS); individual disease names

District of Columbia

adoption law in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152, 156

IVF statutes in, 251, 261, 262

proposed surrogacy law in, 286

Doctors. See Health care practitioners; Physicians

Doe v. Kelley (1981), 225, 230

Doppler test, 109

Drugs

artificial insemination sperm treatment with, 127

fertility impairment from use of, 69, 70, 72-73

infertility prevention from correct dosage of, 89

prohibition on use of, in surrogacy contract, 277

risks of infertility treatment with, 128-130

use of fertility, to treat ovulatory dysfunction, 117-120

Ectopic pregnancy, 62, 67, 129

Education

infertility prevention through use of, 6, 87, 88, 89-90,

92

infertility’s relationship with, 51

infertility service access and, 145

limitations on sexual behavior modification of, 89-90

medical professional society required, 166, 177

role of, in STD prevention, 6, 87, 89

see also Training

Egalitarianism, 207

Eggs. See Oocytes

Egypt, efforts regarding noncoital reproduction in, 348

Eisenstadt v. Baird (1972), 220

Electroejaculation procedures, devices used in, 193-194,

194

Embryo lavage, 124-125, 298

Embryos

chromosomal abnormalities in human, 71

control over disposition of, 250-252

cryopreservation of, 87, 126, 128, 298-299

fertilization and early stages of development of, 40-42,

42, 208

future developments in sexing, 301

juridical status of extracorporeal, 253

legal issues involving transfer of, 255-259

moral status of, 11, 207-209

multicellular, 123, 124

policy options concerning regulation of commercial

transfer of, 24-25

protecting extracorporeal, 176, 224-225

storage of, for later implantation, 253-254

time line of loss of, 41, 42

Emotional impact. See Psychological impact

Endometriosis

drug therapy to treat, 119-120

fertility impairment from, 6, 65-66, 75

prevention of, 6, 85, 87, 90

England. See United Kingdom

Environment, fertility impairment and, 51, 69-71, 121

Epidemiology

Federal authorization of infertility studies of, 170

of infertility, 35, 49

research on infertility, 90

studies involving smoking and fertility impairment,

70-71

Epididymitis, fertility impairment from, 61

Estates, IVF use and inheritance of, 254-255

Ethical considerations

involving reproductive technologies, 11, 38, 177-179,

203-214

professional medical societies’ addressing of, 167, 168-

169, 203, 206, 208-209

of reproductive technologies’ assistance for unmarried

persons, 173, 204, 205, 206, 210

of reproductive technologies’ commercialization, 205,

206, 208

Ethics Advisory Board, U.S. (EAB)

human embryo research standards of, 207
394 . Infertility: Medical and Social Choices

reproductive technologies use, opinions of, 203

role in moratorium on Federal funding of IVF research, 178, 179, 296, 297

European Parliament, noncoital reproduction policy of,

329, 356-357

Exercise

fertility impairment from, 63-64

provision for, in surrogacy contract, 277

Expenditures

infertility, by source of payment, 147

IVF, 148

non-IVF, 146-148

see aho Costs; Funding

Families. See Parent~child bonding

Federal Employee Health Benefits Program (FEHBP), infertility coverage of, 10-11, 150, 153, 156-157

Federal Trade Commission (FTC)

medical technology advice and, 172

regulation of “unfair practices” by, 181

Federal Trade Commission Act (1914), 181

Federation of State Medical Boards of the United States,

173

Feminist International Network of Resistance to Reproductive and Genetic Engineering (FINRRAGE), noncoital reproduction policy of, 329, 357

Fertilization. See Technologies, reproductive; individual

types of

Finland, efforts regarding noncoital reproduction in, 348

Florida

adoption law in, 281

artificial insemination statutes in, 243, 244

embryo commercialization statute in, 12, 176, 228, 259

infertility insurance coverage in, 152

IVF statutes in, 251

proposed surrogacy law in, 287

Follicle-stimulating hormone (FSH), 103, 109, 118

Food and Drug Administration, U.S. (FDA)

Gn-RH proposed approval by, 119

IUD approval by, 68

IVF regulations on human research adopted by, 178

regulating authority of, 181-183, 260

sperm donor standards of, 170

treatment procedure classification used by, 169

France

embryo research in, 298

IVF birth defect study in, 302

noncoital reproduction debate in, 13, 338-339

French National Ethics Advisory Committee (CCNE), 203

Funding

ethics of Federal reproductive technologies, 206-207

Federal, for CON and Section 1122 program, 174

Federal biomedical research, 293

Federal infertility treatment, 223

Federal moratorium on IVF research, 178, 179, 210,

296, 297, 305

models of infertility, 179-180

reproductive health care education and research, 89

sources for IVF/infertility centers, 158

see also Costs; Expenditures

Gallup poll, 89

Gamete intrafallopian transfer (GIFT)

future developments in, 297-298

health of infants conceived by, 302-303

]egal issues involving, 255

success rate of, 7, 297, 297

treatment procedure, 123-124

see also Technologies, reproductive

Genetics

abnormalities in, and infertility, 71-72

future developments in screening, 301-302

Georgia

adoption law in, 281

artificial insemination statutes in, 243, 244

infertility insurance coverage in, 152

IVF statutes in, 251

surrogacy advertising in, 271

German Democratic Republic (GDR), efforts regarding

noncoital reproduction in, 348

Germany, Federal Republic of

noncoital reproduction debate in, 13, 335-338

oocyte freezing research in, 128, 299

Glucocorticoids, 119, 120-121

Gonadotropin releasing hormone (Gn-RH), 119, 129

Gonadotropins, 118-119

Gonorrhea. See Sexually transmitted diseases (STDS)

Government, Federal

ethics of funding reproductive technologies by,

206-207

funding infertility treatment by, 223

infertility data collection by, 49-53, 54

infertility treatment and research regulation by, 165-

166, 169, 176-183

moratorium on IVF research funding, 15, 178, 179,

210, 296, 297, 305

nonregulatory protection of research subjects and patients by, 10, 170-172, 241, 260

“research” definition of, 169

Government, State

infertility treatment and research regulation by, 10,

166, 172-176, 240-241, 324-325

interference with reproductive technique choice,

222-226

interference with right of reproduction, 219-222

models of surrogacy policy, 285-288

status of infertility insurance coverage by, 149-151,

152

surrogacy arrangements regulation by, 225-226, 227-

233, 273-275

Great Britain. See United Kingdom

Greece

abortion/infertility study in, 68

efforts regarding noncoital reproduction in, 348

Griswold v. Connecticut (1965), 220

Guidelines

for quality care in noncoital reproductive techniques,

175

Public Health Service Act infertility service, 54

see also Regulation; Standards

GynoPharma Inc., 68
Index ● 3 9 5

Hawaii

adoption law in, 281

artificial insemination statutes in, 243

IVF statutes in, 251

status of infertility insurance coverage in, 10, 150-151,

152

Health care facilities

infertility treatment in VA, 192-194

State licensing of, 174

see a/so Hospitals; I\’ F/infertility centers

Health Care Financing Administration (HCFA). See Department of Health and Human Services, U.S.

(DHHS)

Health care practitioners

fertility-threatening disease recognition and treatment

education for, 89, 92

State licensing of, 172-174

see also Physicians

Health maintenance organizations (HMOs), 149, 153, 172

Hegel, G.W.F., 213

Hill Burton Act (1946), 174

Hormones

fertility tests evaluating, 102-103, 104, 105, 110, 117

male infertility treatment using, 121

malfunction of, and infertility, 63-64

monitoring levels of, 103

responsibility of, in reproductive process, 38, 39-40,

41-42, 63, 117, 121

Hospitals

infertility service payment to, 147, 147

infertility service provision by, 54

State licensing of, 174

see also Health care facilities; I\’ F/infertility centers

Human chorionic gonadotropin (hCG), 119, 121, 123,

124, 129

Human immunodeficiency virus (HIV), transmission of,

in artificial insemination-intended semen, 170

Human menopausal gonadotropin (hMG), 118, 121, 129

Hungary, efforts regarding noncoital reproduction in,

348-349

Hyperprolactinemia, 63

Hysterosalpingogram (HSG), 105, 106, 110-111

Hysteroscopy, 105, 111

Iatrogenic infertility

factors causing, 73-74

prevention of, 88-89

Iceland, efforts regarding noncoital reproduction in, 349

Idaho

adoption law in, 281

artificial insemination statutes in, 243, 244, 248

infertility insurance coverage in, 252

IVF statutes in, 251

Idiopathic infertility, 75

reactions to diagnosis of, 100, 1 0 1

stress-related, 64

Illinois

adoption law in, 281

artificial insemination statutes in, 243, 246

fetal research laws affecting IVF in, 324

infertility insurance coverage in, 152

1VF laws in, 176, 251, 252

proposed surrogacy law in, 287, 288

Immunologic infertility

factors contributing to, 74-75

see also Sperm, antibodies; Infections

Impotence

related to PTSD, 191

techniques for diagnosing, 110

treatment of, 121, 121-122

see also Reproduction; Spinal cord injury

India, efforts regarding noncoital reproduction in, 349

Indiana

adoption law in, 276, 277, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

Infection

as contributing factor to infertility, 61-62

prevention of fertility impairing, 87-88, 89

semen analysis for, 108-109

treatment for reproductive tract, 120, 121

see also Disease; Sexually transmitted disease

Informed consent of research subjects, 169, 210-211

Institute of Medicine, 172

Institutional Review Boards (IRBs)

research subjects’ risks review by, 177-178

treatment classification determination by, 169

Insurance, private health

affordability analysis of infertility services to couples

with, 144-145, 145

infertility expenditures by, 147, 147

recent and future developments in, 149-155

State-mandated IVF coverage, 180

treatment type and reimbursement by, 10, 168, 169

see also individual carrier names

Intergenerational responsibilities, ethical considerations

of reproductive technologies and, 11, 212-213

International Classification of Diseases Code, 147

Interstate commerce, Federal Government’s use of, to influence infertility treatment, 180, 181-183

Intracervical insemination, 126-27

Intrauterine devices (IUDS), fertility impairment from

use of, 67-68

Intrauterine insemination, 127

In vitro fertilization (IVF)

classification of, by treatment type, 168-169

costs of, 141, 142, 143, 143

Federal Government’s moratorium on research funding for, 178, 179, 210, 296, 297, 305

future developments in, 293-297

health of infants conceived by, 302-303

lack of protocol in United States for, 178-179

legal issues involving, 250-255

legislation affecting fetal research, 324-325

risks of using, 130-131, 146

success rates of, 7-9, 146, 181, 182, 211, 293, 295

treatment procedure, 123

ultrasonography use in, 105

see also Technologies, reproductive
3 S ● Infertility: Medical and Social Choices

Iowa

adoption law in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 25 I

Ireland, efforts regarding noncoital reproduction in, 349

Israel, 171

noncoital reproduction debate in, 13, 339-34 I

Italy, efforts regarding noncoital reproduction in, 349

IVF/infertility centers

characteristics of, 157

components of comprehensive, 97, 157, 159

data collection and dissemination by, 167-168

demographic data on, 54

expansion of number and future of, 159-160

list of (by State), 311-320

statistical profile of an expert, 295, 295

success rate claims by, 146, 211

see also Health care facilities

Japan, efforts regarding noncoital reproduction in,

349-350

Jewish Chronic Disease Hospital case, 177

Jhordan C. v. Mary K. (1986), 244

Joint Commission on Accreditation of Healthcare Organizations (JCAHO), 174

Kaiser Permanence, technology assessment program of,

172

Kansas

adoption law in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

surrogate motherhood law in, 13, 271, 276, 285

Kentucky

adoption law in, 277, 281, 285

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF law in, 176, 251, 252, 256

surrogacy recognition in, 271

Kremer, J., 106, 107

Laparoscopy

as diagnostic technique, 105-106, 111

use in IVF and GIFT procedures, 106

Legislation

antitrust, 181

certificate-of-need, 174

Federal, influencing infertility treatment and research,

166, 169, 174, 176-183

State infertility treatment and research, 166, 167,

172-176

see also Congress, U. S.; Government, Federal; Goverment, State; Regulation

Libertarianism, 206, 207

Liberty rights, 204, 205, 211

Libya, efforts regarding noncoital reproduction in, 3s0

Litigation

involving reproductive technology ethics, 208, 209

medical malpractice, 175-176

right to reproduce, 219-226

surrogacy, 270, 284

Louisiana

adoption law in, 281

AFS- and ACOG-influenced legislation in, 167

artificial insemination statutes in, 242, 243

embryo sales prohibition in, 228, 256, 259

fetal research laws affecting IVF in, 324

infertility insurance coverage in, 152

IVF statute in, 12, 173, 176, 250, 251, 252, 253, 254,

255, 259, 261, 272

surrogate motherhood law in, 13, 271, 285, 288

Lochner v. New York (1905), 231

Luteal phase defects (LPD), 117

Luteinizing hormone (LH), 103

hCG’s mimicking of, 119, 123

Luxembourg, efforts regarding noncoital reproduction

in, 350

Maine

adoption laws in, 281

artificial insemination statutes in, 243

fetal research law affecting IVF in, 324

infertility insurance coverage in, 152

IVF statutes in, 251

Malpractice. See Litigation

“Managed care” plans, 149, 156

Margaret S. v. Edwards, 176

Marital status

of artificial insemination recipients, 246, 247-248

ethical acceptance of IVF and artificial insemination

use according to, 173, 204, 205, 206, 210

freedom to procreate and, 220-222

infertility services access and, 145

Maryland

adoption laws in, 281

artificial insemination statutes in, 243

fetal research laws affecting IVF in, 324-325

IVF statutes in, 251

status of infertility insurance coverage in, 10, 150, 152

Massachusetts

adoption laws in, 281

artificial insemination statutes in, 243

fetal research laws affecting IVF in, 324-326

IVF laws in, 176, 251

RESOLVE national clearinghouse in, 98

status of infertility insurance coverage in, 151, 152

Massachusetts Board of Registration in Medicine, 173

Maximim, 207

Medicaid

infertility treatment coverage by, 145, 150, 153

see also Reimbursement

Medical impacts

of infertility on a couple, 37, 111-112

of IVF and GIFT on women undergoing, 303

see also Psychological impacts

Medicare

infertility treatment reimbursement by, 153

JCAHO facility certification for reimbursement by, 174
Index ● 3 9 7

prospective payment system, 171

see also Reimbursement

Men

components of physical examination in infertility treatment for, 100

conventional medical infertility treatments for, 121-122

diagnostic technologies available to, IO7-11O

infertility prevention strategies for, 85, 86, 88-89, 90,

91

infertility treatment risks to, 129-130, 130

sample reproductive health questionnaire for, 321-322

STD’S infertility risk to, 61

surgical infertility treatments for, 125

veterans with infertility problems, 190

Menning, Barbara, 98

Menopause

premature, 73, 75

process of, 40

relationship between age, oocyte number, and, 40, 41

smoking and, 70

Mexico, efforts regarding noncoital reproduction in, 350

Michigan

adoption law in, 276-277, 281

artificial insemination statutes in, 243

fetal research laws affecting IVF in, 325

infertility insurance coverage in, 152

IVF law in, 176, 251

proposed surrogacy law in, 286, 288

surrogacy litigation in, 225, 230, 284

Microsurgery

use of, in infertility treatment, 122-123, 125

see also Sterilization, reversal of surgical

Minnesota

adoption laws in, 281

artificial insemination statutes in, 243

fetal research laws affecting IVF in, 325

infertility insurance coverage in, 152

IVF statutes in, 251

proposed surrogacy law in, 288

Minorities

ethical acceptance of 1VF and artificial insemination

use for, 173

infertility rates and, 4, 51, 52

infertility service access by, 145

infertility service use by, 54

Mississippi

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

Missouri

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF law in, 176, 2.51

Montana

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

Mycoplasmal infection, as infertility factor, 61, 62

National Academy of Sciences (NAS), 172

National Ambulatory Medical Care Survey (1980-81), 53

National Association of Radiation Survivors, 192

National Cancer Institute, testicular shield development

by, 72, 73

National Center for Health Statistics (NCHS), infertility

surveys by, 3-5, 4, 5, 51

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research,

177-178

National Conference of Commissioners on Uniform State

Laws, 287

National Fertility Study, 1965 (NFS), 49, 52

National Health Planning and Resource Development Act

(1974), Certificate-of-Need (CON) program established under, 174

National Institute of Child Health and Human Development, 304-305

National Institutes of Health (NIH)

Center for Population Research, 296

Consensus Development Program of, 171

research grants from, 178, 293

National Medical Care Utilization and Expenditure Survey (NMCUES), 147

National Organ Transplant Act (1984), 260

National Research Award Act (1974), 177

National Surveys of Family Growth (NSFG), 49-.53, 54,

139

Nebraska

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

proposed surrogacy law in, 286

Netherlands, the, 171

efforts regarding noncoital reproduction in, 350

noncoital reproduction debate in, 13, 3.50

Nevada

adoption law in, 277, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

surrogate motherhood law in, 13, 271, 285, 286, 288

New Hampshire

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

proposed surrogacy law in, 288

New Jersey

adoption laws in, 276, 277, 281

artificial insemination statutes in, 243, 248

infertility insurance coverage in, 152

IVF statutes in, 251

proposed surrogacy law in, 287

surrogacy litigation in, 225, 226, 230-231, 232, 267-

268, 276, 278, 279, 280, 286

New Mexico

adoption laws in, 281

artificial insemination statutes in, 243, 248

fetal research laws affecting IVF in, 325
398 ● Infertility: Medical and Social Choices

infertility insurance coverage in, 152

IVF law in, 251, 252

proposed surrogacy law in, 288

New York (State)

adoption law in, 277, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

proposed surrogacy law in, 288

surrogacy advertising in, 271

New Zealand, efforts regarding noncoital reproduction

in, 351-352

Nocturnal penile tumescence (NPT), 110

North Carolina

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF birth defect study in, 302

IVF statutes in, 251

preconceptional health questionnaire used in, 91

proposed surrogacy law in, 288

surrogacy advertising in, 271

North Dakota

adoption laws in, 281

artificial insemination statutes in, 243

fetal research laws affecting IVF in, 325

infertility insurance coverage in, 152

IVF law in, 176, 251

Norway, 171, 352

Nuremberg Code, 177

Nutrition

fertility impairment from poor, 64

provision for adequate, in surrogacy contract, 277

Office of the Actuary, U.S. Government, 156

Office of Health Technology Assessment (OHTA), 171

Office of Technology Assessment (OTA), 43

infertility service cost estimate by, 196, 197, 199

infertility service expenditure estimates by, 148

survey of surrogate mother matching services, 269,

270, 272, 273, 275, 369-376

Ohio

adoption laws in, 281

artificial insemination statutes in, 243, 244, 246, 248

fetal research laws affecting IVF in, 325

infertility insurance coverage in, 152

IVF law in, 176, 251

surrogacy agency licensing in, 271

Oklahoma

adoption laws in, 281

artificial insemination statutes in, 243

fetal research laws affecting IVF in, 325

infertility insurance coverage in, 152

IVF statutes in, 251

surrogacy advertising in, 271

Oocytes

cryopreservation of, 128, 299

hamster penetration test, 109

number, age, and menopause relationship, 40, 41

Oregon

adoption laws in, 281

artificial insemination statutes in, 243, 248

infertility insurance coverage in, 152

IVF statutes in, 251

proposed surrogacy legislation in, 286

Ovarian hyperstimulation syndrome (OHSS), 129

Paralyzed Veterans of America (PVA), Title 38 changes

advocated by, 197-198

Parent-Child bonding, 38

reproductive technologies’ effect on, 11, 209-210

Patent Office, U. S., process patent issuance by, 183

Patents, 183

Pelvic inflammatory disease (PID)

IUD-related, 51, 68

STD-caused, 61-62

see also Disease; Infections

Pennsylvania

adoption laws in, 281

artificial insemination statutes in, 243

fetal research laws affecting IVF in, 325

infertility insurance coverage in, 152

IVF law in, 251, 252

Philippines, efforts regarding noncoital reproduction in,

352

Philosophy of Right, The, 213

Physicians

donor insemination procedure performance restriction

to, 172-173, 244

infertility prevention education for, 88, 89, 92, 288-289

infertility service payment to, 147, 147

infertility treatment by private, 5, 5, 53, 55, 56

reimbursement policies of, 145, 211-212

surrogacy arrangement involvement by, 271-272

Planned Parenthood, 54

Poland, efforts regarding noncoital reproduction in, 352

Policy

Blue Cross/Blue Shield infertility treatment, 149, 150,

153

Federal Goverment insurance programs infertility

treatment, 145, 150, 153, 156-157

HMO infertility treatment, 149, 153

issues and options for Congress, 15-31

“managed care” plans infertility treatment coverage,

149, 156

models of State noncoital reproduction, 261-262

models of State surrogacy, 285-288

VA infertility treatment, 192, 195-196

Polycystic ovarian disease (POD), 63

Population Council, IUD development by, 68

Portable infusion pump, Gn-RN administration using,

119

Portugal, efforts regarding noncoital reproduction in,

353

Post-traumatic stress disorder (PTSD), 191

Preferred provider organizations, 149

President’s Commission for the Study of Ethical Prob-
Index . 399

lems in Medicine and Biomedical and Behavioral

Research, 178

Prevention

characteristics needed for an effective infertility strategy for, 91

physician education for infertility, 88, 89, 92

policy options relating to infertility, 17-18

strategies for infertility, 6-7, 7, 85, 86, 87, 88

Primary infertility

demographics of, 4, 50-51, 54, 55, 56

service use by women with, 145

Procreation. See Reproduction

Professional medical societies

ethical position on use of reproductive technologies,

167, 168-169, 203, 206, 208-209, 302

membership increase in, 5

membership qualifications of, 166, 167, 168

quality assurance role of, 166-168, 302

see also individual society names

Progesterone. See Hormones

Prospective Payment Assessment Commission (ProPAC),

171

Prospective payment system (Medicare), 171

Prudential, medical insurance programs, 151

Psychological impacts

causing infertility, 64

of idiopathic infertility diagnosis, 100, 101

of infertility on a couple, 37, 111-112

of undergoing infertility treatment, 118, 304-305

see also Medical impacts

Public Health Service, U.S. (PHS), 89

Public Health Services Act

HHS/CDC regulatory power derived from, 181

infertility service guidelines of, 54

Public opinion

confusion concerning professional society membership

and infertility treatment qualification, 168

of high school students on STD risk, 89

on reproduction-related facts, 43

on reproductive technologies use, 203-204

Puerto Rico, infertility insurance coverage in, 152

Quality assurance

infertility research and treatment, 9-10, 165-183,

210-211

see also Guidelines; Legislation; Regulations; Standards

Radiation, infertility caused by exposure to, 192

Radiography, 109

Regulations

Federal infertility treatment and research, 176-183

of gamete and embryo sales, 259-260

of infertility treatment-related products, 181-183

policy options involving human gametes and embryo

transfer, 24-26

State infertility treatment and research, 10, 166, 172-

176, 240-241, 324-325

see also Legislation; Standards

Reimbursement

improvement in third-party, and increased service use,

152-153

JCAHO facility certification for Medicare, 174

physician policies for third-party, 145, 211-212

third-party infertility service, 10, 148-155

treatment type and insurance, 168, 169, 171

see also Insurance, private health; individual reimbursement sources

Religion

ethical traditions and views on noncoital reproduction

of, 11, 204, 208, 364-367

U.S. membership of organized (by denomination), 364

Reproduction

factors contributing to failure in, 6, 61-76

impact of failure in, 37, 111-112

international developments in noncoital, 329-358

process of human, 38-42

prohibiting commercialization of noncoital, 228-233

public understanding of, 43

restrictions on choosing noncoital techniques of,

222-228

right to, 11, 205-207, 219-222

time line of embryonic loss in, 41, 42

see also Technologies, reproductive

Research

electroejaculation for spinal cord injured patients, 193,

194

Federal Government’s definition of, 169

Federal Government’s use of funding to influence infertility, 177-179

Federal moratorium on funding of IVF, 178, 179, 210,

296, 297, 305

history of reproductive, 294

human embryo, 176, 207

IVF byproducts use in, 295, 296

needs for infertility prevention strategy implementation, 6, 90

nonregulatory protection of subjects, 170-172, 210-211

policy options involving reproductive, 29-31

psychological evaluation of participants in noncoital reproduction, 304-305

quality assurance, 165-183, 210-211

State regulation of treatment and, 10, 166, 172-176,

240-241, 324-325

STD prevention, 6, 87, 88, 90

treatment patients as subjects of, 11, 210-211

Resolve, Inc., 9, 97, 98

Rhode Island

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF law in, 176, 251, 325

proposed surrogacy law in, 286, 288

Rios, Elsa and Mario, 209

Roberts v. United States Jaycees (1984), 221-222

Roe L. Wade (1973), 224, 253

Secondary infertility

demographics of, 4, 50, 51, 54

reactions to diagnosis of, 101

service use by women with, 145

Semen. See Sperm
400 ● /nfertility: Medical and Social Choices

Services, infertility

access to artificial insemination and IVF, 5, 173, 145-

146, 204, 205, 206, 210

affordability of, 144-145, 145

costs of, for proposed VA-provided, 196-197

demand for, 54-56, 158-159

demographic data on, 5, 5, 53-56

estimated costs of, 139-144, 141, 142, 143, 144,

196-197

list of surrogate mother matching (by State), 369-376

policy options ensuring information availability for

choosing, 18-20

policy options for providing access to, 20-22

surrogate mother matching, 13, 269, 270-271, 283,

369-376

U.S. expenditures on, 146-148, 147, 148

see also Treatment

Sexually transmitted diseases (STDS)

as factor contributing to infertility, 4, 6, 7, 61-62

prevention of fertility impairing, 87-88, 89

screening donor sperm for, 169-170

see also Infections

Sherman Antitrust Act (1890), 181

Sims-Huhner test, 106

Skinner v. Oklahoma (1942), 219-220, 222

Smoking

fertility impairment from, 70-71

prohibition of, in surrogacy contracts, 277

Social Security Act Amendments of 1972

medical care cost control authorized by (Section 1122

program), 174

ProPAC establishment by, 171

South Africa

efforts regarding noncoital reproduction in, 341-342

surrogate motherhood use in, 268

South Carolina

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

proposed surrogacy law in, 287

South Dakota

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

Spain, efforts regarding noncoital reproduction in,

353-354

Spallanzani, 127

Sperm

analysis of, in infertility treatment, 6, 107-109

antibodies, 74, 107, 109, 120-121

cryopreservation for artificial insemination, 127-128

future of micromanipulation of, 299-300

future of sexing, 300-301

infection’s effects on, 61, 62

legal issues involving improper handling of, 241-242

preparation for artificial insemination, 127

production, 40

screening of, for artificial insemination use, 169-170,

248-249

testing of cervical mucus interaction with, 106-107

Spinal cord injury

fertility impairment resulting from, 13, 71

treatment of impotence in patients with, 121-122

treatment of veterans with, 13, 193-194, 194

Standards

human embryo research, 207

medical professional society care, 9-10, 150, 151, 157,

166-168, 170, 173, 175, 248-249, 257

sperm donation (for artificial insemination), 170

subjective nature of “normal” sperm/semen diagnostic,

107-109

Sterilization

as birth control technique, 67, 85-86

court-ordered, 219-220

demographic data on surgical, 3, 4, 5, 50, 51, 52, 54

reversal of surgical, 10, 67, 88-89, 90

Stern, Elizabeth and William, 268

Stress

fertility impairment from, 64

see also Psychological impacts

Surgery

demographic data on sterilization by, 3, 50, 51, 52, 54

infertility diagnosis using minor, 105, 106, 109, 110,

111

infertility resulting from, 73-74, 88-89

infertility treatment using, 122-125

risks of infertility, 130

sterilization by, 3, 4, 5, 50, 51, 52, 54, 67, 85-86, 90

Surrogate motherhood

commercialization of, 13, 230-233, 270-271, 273-284

contract provisions for, 13, 275-282

ethical and religious opposition to, 11, 203-204

legal issues involving, 12-13, 267-288

list of matching services for, 369-376

policy options involving, 26-28

regulating, 225-226

Surrogate Parenting Association v. Commonwealth of

Kentucky v ex. rel. Armstrong, 256, 285

Sweden, 171

noncoital reproduction debate in, 13, 342-343

Switzerland, efforts regarding noncoital reproduction in,

354-355

Taxes, 177

Technologies, reproductive

access to, 145-146, 173

difficulty in maintaining confidentiality when using,

211-212

ethical considerations of using, 11, 203-214

feminist views on, 326-327

future of, 14-15, 14, 239-262

landmarks in, 36

legal issues involving, 12, 267-288

policy options for confidentiality in records involving,

25-26
Index ● 4 0 1

policy options involving supporting additional research

in, 29-31

protection of children conceived by noncoital, 226-228

sites offering (by State), 311-320

status evaluation of, 100-112

success rates of, 7-9, 146, 181, 182, 211, 293, 295, 297,

297

see also Treatment; individual technologies

Technology Evaluation and Coverage (TEC) Program

(Blue Cross/Blue Shield), 169, 172

Tennessee

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

I\’F statutes in, 251

Tests

cervical mucus evaluation, 104

hamster-oocyte penetration, 109

home pregnancy/hormone diagnostic, 103

in vitro post-coital, 106-107

in vivo post-coital, 106

ovulation prediction, 102-104

post-coital fertility evaluation, 106-107

standard infertility diagnostic procedures and, 101-

110, 101

STD detection, 170

Texas

adoption laws in, 281

artificial insemination statutes in, 243

GIFT tests in, 178

infertility insurance coverage in, 10, 151, 152

IVF statutes in, 251

Tobacco. See Smoking

Tort law. See Litigation

Training

health care practitioners to recognize surgery risk, 88,

89

physician, and treatment procedure risks, 111-112, 123

see also Education

Transient rights, 208

Treatment

affordability of scenarios for infertility, 144-145, 145

costs of, 9, 10-11, 139-144, 141, 142, 143, 196-197

defining experimental, 165, 167, 168-169, 210-211

factors contributing to increase in infertility, 4, 5, 55-

56, 56

fertility impairment from cancer, 72-73

motivation for seeking, 37-38

procedure classification, 165, 167, 168-169, 170

provision of, 53-54

psychological effects of undergoing infertility, 109

quality assurance for, 9-10, 165-183, 210-211

risks of infertility drug, 128-130

scenarios of infertility diagnosis and, 139-144, 142, 143

standard medical, 7, 53-54, 117-122

surgicai, 7-9, 54, 122-125

veterans’ patient advocacy groups and, 197-198

Veterans’ Administration infertility, 192-194

when to stop, 9, 131-132

see also Services, infertility; Technologies, reproductive

Trusts

illegality of, 181

IVF use and, 254-255

Tubal ligation. See Contraception; Sterilization, surgical

Tubal ovum transfer, 124

Turkey, efforts regarding noncoital reproduction in, 355

Tuskegee syphilis study, 177

Ultrasound

follicle development monitoring using, 123, 123

use in infertility evaluation, 105, 109, 110

Unexplained infertility. See Idiopathic infertility

Uniform Commercial Code (UCC), 259-260

Uniform Parentage Act, State artificial insemination statutes modeled after, 242-244

United Kingdom

infertility research in, 207, 301

medical innovations application review in, 171

noncoital reproduction debate in, 13, 343-345

Utah

adoption laws in, 281

artificial insemination statutes in, 243

fetal research laws affecting IVF in, 325

infertility insurance coverage in, 152

IVF law in, 176, 251

Utilitarianism, 206, 207

Varicocele, 66

radiographic tests used to diagnose, 109

repair of, 125

smoking and, 70

Vasectomy. See Contraception; Sterilization

Vasogram, 109, 109

Vermont

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

Veterans

eligibility of, for health care, 195-196

factors contributing to infertility problems of, 190-192

policy options concerning reproductive health of,

22-24

population of male, with service-connected infertility

conditions, 189, 190

reproductive health of, 189-199

with service-connected conditions related to infertility,

13, 190-191, 191

Veterans’ Administration (VA)

infertility-related procedures performed by, 13, 156,

192-194, 193

infertility treatment policy of, 192, 195-196

policy issues and options concerning infertility diagnosis and treatment by, 22-24

special considerations related to infertility treatment

for, 198

Spinal Cord Injury Centers, 13, 193

Veterans of Foreign Wars of the United States, 198

Victoria Medical Center (Australia), IVF program at, 209

Virginia

adoption laws in, 281
402 ● Infertility: Medical and Social Choices

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

presumption of paternity litigation in, 258

Waller Committee (Australia), 207

Warnock Committee (United Kingdom), 207

Washington

adoption laws in, 281

artificial insemination statutes in, 243, 248

infertility insurance coverage in, 152

IVF statutes in, 251

surrogacy litigation in, 270

Welfare rights, 204, 206, 209-210

West Germany. See Germany, Federal Republic of

West Virginia

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

Whitehead, Mary Beth, 268

Wisconsin

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

Women

characteristics of, becoming surrogate mothers, 273,

274

components of physical examination in infertility treatment for, 100

conventional medical infertility treatments for, 117-121

diagnostic technologies available to, 102-107

infertility prevention strategies for, 85, 86, 87-88, 89,

90, 92

infertility treatment risks to, 128-129, 130, 302

sample reproductive health questionnaire for, 322-323

STD’S infertility risk to, 61-62

surgical infertility treatments for, 122-125

veterans with infertility problems, 190

working Party (South Australia), 203

Workplace

fertility hazards in, 51, 69-70

infertility risks to women entering, 88

World Health Organization (WHO), noncoital reproduction policy of, 329, 357-358

World Medical Organization, noncoital reproduction

policy of, 358

Wyoming

adoption laws in, 281

artificial insemination statutes in, 243

infertility insurance coverage in, 152

IVF statutes in, 251

Yates v, Huber (1988), 279

Yugoslavia, efforts regarding noncoital reproduction in,

355

Zetek, Inc., 104

Zona drilling, 299-300

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