![](media/image1.png){width="5.96875in" height="0.41944444444444445in"}

Top of Form

## Complete Summary

#### GUIDELINE TITLE

Round spermatid nucleus injection (ROSNI).

#### BIBLIOGRAPHIC SOURCE(S)

Round spermatid nucleus injection (ROSNI). Fertil Steril 2003
Sep;80(3):687-9. \[29 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12969742)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Male infertility

#### GUIDELINE CATEGORY

Treatment

#### CLINICAL SPECIALTY

Family Practice\
Internal Medicine\
Medical Genetics\
Obstetrics and Gynecology\
Urology

#### INTENDED USERS

Physicians

#### GUIDELINE OBJECTIVE(S)

To present recommendations for the treatment of male infertility using
round spermatid nucleus injection (ROSNI)

#### TARGET POPULATION

Men who are infertile

#### INTERVENTIONS AND PRACTICES CONSIDERED

Round spermatid nucleus injection (ROSNI)

#### MAJOR OUTCOMES CONSIDERED

-   Fertilization rates

-   Adverse effects of procedure

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Not stated

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Not stated

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

This bulletin was approved by the Practice Committee of the American
Society for Reproductive Medicine and the Board of Directors of the
American Society of Reproductive Medicine.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

-   Round spermatid nucleus injection (ROSNI) is a method of assisted
    fertilization in which precursors of mature spermatozoa are injected
    into oocytes.

-   ROSNI should not be performed when more mature sperm forms
    (elongating spermatids or spermatozoa) can be identified and used
    for intracytoplasmic sperm injection (ICSI).

-   Patients who may be candidates for ROSNI should receive careful and
    thorough pretreatment counseling to ensure they are clearly informed
    of the limitations and potential risks of the procedure.

-   Application of ROSNI in clinical human in vitro fertilization (IVF)
    should be considered experimental and therefore requires approval
    and oversight by an appropriately constituted Institutional Review
    Board.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is not specifically stated for each
recommendation.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Effective treatment of male infertility using round spermatid nucleus
injection (ROSNI)

#### POTENTIAL HARMS

Offspring conceived via in vitro fertilization (IVF) with round
spermatid nucleus injection (ROSNI) may be at risk for infertility or
even more severe genetic defects.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   While this document reflects appropriate management of a problem
    encountered in the practice of reproductive medicine, it is not
    intended to be the only approved standard of practice or to dictate
    an exclusive course of treatment. Other plans of management may be
    appropriate, taking into account the needs of the individual
    patient, available resources and institutional or clinical practice
    limitations.

-   The Practice Committee recommends that round spermatid nucleus
    injection (RSNI) be considered an experimental procedure that should
    be applied only in the setting of a clinical trial approved and
    overseen by a properly constituted Institutional Review Board.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Round spermatid nucleus injection (ROSNI). Fertil Steril 2003
Sep;80(3):687-9. \[29 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12969742)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2003 Sep

#### GUIDELINE DEVELOPER(S)

American Society for Reproductive Medicine - Private Nonprofit
Organization

#### SOURCE(S) OF FUNDING

American Society for Reproductive Medicine

#### GUIDELINE COMMITTEE

Practice Committee of the American Society for Reproductive Medicine

Practice Committee of the Society for Assisted Reproductive Technology

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

Not stated

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Not stated

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [American Society for Reproductive
Medicine Web site](http://www.asrm.org/Media/Practice/practice.html).

Print copies: Available from American Society for Reproductive Medicine,
1209 Montgomery Highway, Birmingham, Alabama 35216-2809; Phone: (205)
978-5000; Fax: (205) 978-5005; E-mail: <asrm@asrm.org>; Web site:
[www.asrm.org](http://www.asrm.org/).

#### AVAILABILITY OF COMPANION DOCUMENTS

None available

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on August 23, 2004.

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
associations, public or private organizations, other government
agencies, health care organizations or plans, and similar entities.

Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
clinical practice guidelines and related materials represented on this
site. Moreover, the views and opinions of developers or authors of
guidelines represented on this site do not necessarily state or reflect
those of NGC, AHRQ, or its contractor ECRI Institute, and inclusion or
hosting of guidelines in NGC may not be used for advertising or
commercial endorsement purposes.

Readers with questions regarding guideline content are directed to
contact the guideline developer.

Bottom of Form

© 1998-2008 National Guideline Clearinghouse

Date Modified: 11/3/2008