Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility and Miscarriage
Conditions: Infertility and Miscarriage
Sponsor: St. Louis University

COVER PAGE
Study Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment for Infertility
and Miscarriage
NCT02925390
Responsible Party: Patrick Veung, MD
Documents: Study Protocol and Statistical Analysis Plan
Date of Study Protocol document: Submission date 12.102019 (printed 8.10.2020)

e-pRoyocct
PROTOCOL
Protocol # 26221
Biomedical Research
Date Printed: 08/10/2020
Saint Louis University
Continuing Review
1
Personnel Information
6
Subject Population
9
Study Location
g
General Checklist
10
Funding
10
Expedited Paragraphs
11
Background, Purpose, Study Procedures
13
Radioisotopes or Radiation Machines
19
Devices
20
Drugs, Reagents, Chemicals, or Biologic Products
20
Other Levels Of Review
21
Subject Population
22
Subject Population
24
Risks
25
Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy
28
Potential Conflict of Interest
32
Informed Consent
33
Assent
34
HIPAA
34

S-PROTOCOL
PROTOCOL
Protocol*26221
Biomedical Research
Date Printed: 08/10/2020
Saint Louis University
Attachments
37
P1 Obligations
38
Event History
39

e-pRoroccL
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of
Treatment
for Infertility and Miscarriage
Protocol Status:
APPROVED
Date Submitted:
12/10/2019
Approval Period:
0110912020-0111912021
Important Note:
This Print View may not reflect all comments and contingencies for approval.
Please check the comments section of the online protocol.
Questions that appear to not have been answered may not have been required
for this submission. Please see the system application for more details.
Continuing Review
* * *
Continuing Review Request
WHAT TO UPLOAD WITH YOUR CONTINUING REVIEW APPLICATION
For studies where research activities are limited to data analysis, upload subject safety
information and publications (e.g., manuscripts, abstracts) since the last IRS approval, if
applicable.
NOTE: if activities are limited to data analysis of de-identifled/anonymous data (data that
can no longer be linked to subject identifiers directly or through use of a code with master
list kept), the study can likely be closed via the Final Report Form. See the SLU IRS
Guidance for Closure of Human Subjects Research Studies.
For all other studies, upload:
Subject safety information including the most current Serious Adverse Event
(SAE) cumulative table and data safety monitoring reports since the last IRS
approval, if applicable.
Any publications (e.g., manuscripts, abstracts) since the last IRS approval.
Any changes, updated and/or new study materials should be uploaded and questions 19
-
24 of this form should be completed.
1.
Please indicate the status of the study:
a)
The study has not started but will become active.
Please explain why the study has not started.
b)
X
The study is ACTIVE (please check the appropriate box below):
Study is open to accrual.
Study is on hold or halted.
Please explain what needs to occur before accrual can resume.
X
Study is permanently dosed to accrual.
i.
Y
Have all subjects completed all research related
Page 1 of 44

e-pnoTocoL
PROTOCOL
Biomedical Research
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
Protocol ft 26221
Veung
activities/interventions?
U.
N
Will the research only remain active for long-term follow-up of
subjects?
iii.
Y
Are remaining research activities limited to data analysis only? (See
instructions above).
iv.
N
For studies that are closed to subject accrual, do any subjects need
to be re-consented (to inform them about changes to study
procedures, study risks, study personnel, etc.)?
For IRB office use: * may qualify for expedited review
The study has expired and needs to be re-initiated.
Explain any research activities occurring during lapse in IRB approval.
2.
Date the study was initially approved by the IRB:
3.
Approval date of previous continuing review:
4.
Total number of participants/records/specimens you are approved to
enroll.
5.
Total number Df subjects that have given consent (verbal or written) to
date.
6.
Total number of subjects that failed screening (if not applicable, state
N/A).
01/20/2016
01/08/2019
600 participants (300
women and 300 partners)
72 (45 women + 27 mare
partners)
0
7.
Total number of participants accrued since the beginning of the project.
72 (45 women + 27 male
partners)
8.
For multi-center studies, number of subjects approved for accrual study-
wide (SLU site plus all other sites).
9.
For multi-center studies, number of subjects enrolled study-wide (SLU
site plus other sites).
10.
Number of withdrawals from the research and explanation/reasons for withdrawals.
None
c)
N/A
N/A
Page 2 of 44

e-pRDTOCDL
Protocol Title:
PROTOCOL
Biomedical Research
Saint Louis University
Natural Procreative Technology Evaluation and Surveillance of Treatment
for lnfertiNty and Miscarriage
Protocol # 26221
Yeung
11.
Description and number ot
a)
b)
c)
Serious Adverse Events (SAEs) since the last approval date:Note: Information here should be
consistent with the cumulative table, which should also be attached in section #16.
None
Have there been any complaints about the research during the last year?
N
If yes, please describe.
Briefly describe the progress of the study to date. Provide a status of participants in study, for
example, where is the most recently accrued participant in terms of timeline in the study? If
participants are in long-term follow-up, explain what this consists of in terms of data collection
and/or intervention. Provide any new information in regard to risks. Summarize or attach
publications or presentations.
There has been no subject enrollment since last continuing review approval 1/19/2019. Follow up
‘completed. Data analysis and manuscript being done.
14.
Is there a Data Safety Monitoring (DSM) plan for this study?
V
No
Yes, a copy of the DSM report(s) for the last approval period is in the Attachments section.
Yes, but a copy of the DSM reports(s) for the last approval period is not attached. Please
explain below.
15.
FDA Regulated Studies
Is this a Food and Drug Administration (FDA) Regulated Study, (i.e., involves drugs,
N
devices, biologics)? If yes, please answer the following questions:
a)
Have there been any changes in the FDA status of any
drug or device used in the study?
If yes, please explain:
Reportable Protocol DeviationsNiolations since the last approval date:
None
I
Unanticipated Problems (UPs) since the last approval date:
None
I
12.
13.
Page 3 of 44

e-PROTOCOL
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and SureiIlance of Treatment
for Infertility and Miscarriage
b)
Have any of the investigational drugs or devices used in
this study received FDA approval?
If yes, please explain:
c)
Have any new alternative drugs or devices been approved
for treatment of the study condition that may affect subjects
willingness to participate?
If yes, please explain:
Have current subjects been notified? Please explain:
d)
Has there been a change in the standard care that may be
considered as an aLternative to the investigational drug or
device or that would affect the original study design?
If yes, please explain:
Have current subjects been notified? Please explain:
e)
Is there any new information that might affect the
risWbeneflt ratio and the willingness of current study
subjects to participate or to continue to participate in the
research?
If yes, please explain:
Have current subjects been notified? Please explain:
fl
Does the study include an investigator’s brochure (IS)?
If yes, what is the current version date?
(If study has multiple lBs. attach current versions in Attachments
section (#16))
16.
Provide a summary of any recent findings, literature, or other relevant information (especially
pertaining to risks), if applicable.
Page 4 of 44

e-pRDT000L
PROTOCOL
Protocol#26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
Oral presentation at international conference of American Association of Gynecologic
Laparoscopists (AGL) 2019 in Vancouver canada. Findings, no difference in abnormal pathology
of appendix.
17.
Have there been any significant amendments or revisions to the
N
protocol during the past approval period? (Significant amendments
include changes in study design or risk level including those that
resulted in a change in consent).
If yes, please briefly summarize the changes:
18.
N/A
The consent materials attached to this eIRB application (including consent documents, assent
documents, recruitment statements or other materials used to obtain consent) are the
versions being used in the conduct of this study and all enrolled subjects have signed consent
forms on file, if required. (If the requirement to obtain consent was waived or if no participants
have enrolled since last continuing review, check N/A).
NOTE: The IRS routinely monitors consent document usage and may request copies of
redacted participant consent forms.
19.
Ne any changes (amendments) requested with this Continuing Review?
Yes, please complete the remainder of this form.
Y
No, form is complete. Please submit.
20.
Summarize the proposed changes to the protocol in lay terms, including the type of change AND
what the change involves.
If this is a change in P1 a new Department Chair review is required. Please upload the signed
document in the Attachments section.
21.
Provide justification/explanation for the proposed changes.
22.
Will currently accrued subjects need to be notified of changes?
If no. please justify why not.
If yes, please explain how AND when notification or re-consenting will occur.
23.
Does the SLU IRB Protocol need to be modified?
24.
Are consent documents modified?
Page 5 of 44

e-PROTDCDL
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
Proceed to the appropriate section(s) of the protocol and make your changes. Also make necessary changes in
the Consent Form(s), Assent Form(s), Recruitment Statement, Questionnaire, or other attachments, as
applicable. Upload any revised IRS materials. Please provide the entire revised document (not just revised
pages). Use track changes or highlight (in yellow) changes to documents being revised. Please upload a
trackedlhighlighted copy of each revised document to be stamped upon IRS approval. NOTE: Upload a clean
copy (changes or highlights removed) of documents in file formats other than Microsoft Word (i.e., the IRS will
remove the tracked changes/highlights on uploaded Word documents).
-
NOTE: Protqcol amendments must receive IRS review and approval before they are implemented, unless an
immediate change is necessary to eliminate an apparent hazard to the subjects.
Sponsored Studies: Remember to update the Sponsor’s Protocol version number and date in the Funding section
of the protocol (this information will appear on the approval letter).
* * * Personnel Information
* * *
Study Personnel Roles:
-Principal Investigator: accepts responsibility for study, must sign obligations, can edit protocol and submit to IRB
-Administrative Contact: additional study contact, may or may not also be member of research team, can
ediVprepare protocol and submit to IRB
-Key Personnel (Research Team): SLU member of research team, can view protocol (not edit)
-Non-SLU Collaborator member of research team from another institution or organization outside of SLU, has no
access to system, must be provided with PDF of protocol. NOTE: SLUHJSSM employees who collaborate
regularly may obtain a guest SLU account if access to system is needed.
-Department Chair Official Department Chair, may or may not also be a member of research team, can view the
protocol (not edit). NOTE: a proxy may be listed if the Chair is the P1.
IMPORTANTNOTE: Human Subjects Protection Training Is mandatory for all research team personnel.
Principal Investigator (P1)
Mandatory
P1 must be SLU affiliate.
Name of Principal Investigator
Degree (MD/PhD)
Title
(Faculty, Staff or Student)
Yeung, Patrick
MD
Associate Professor
Email
Phone
Fax
pyeungl©slu.edu
(314) 781-8605
Department Name
Ob/Gyn-Minimally Invasive Gyn
Human Subjects Training Completed?
Y
WARNING: Proof of training must show below or the application will be
returned. If your training infDrmation isn’t shDwing, upload a copy in the
Attachments section.
Research Experience
Has over 8 years of research experience including design, implementing, data collection and analysis.
Research Team Member Duties PicHist
Page 6 of 44

e-p RD TO CO
Protocol Title:
PROTOCOL
Biomedical Research
Saint Louis University
Natura Procreative Technology Evalualion and Surveillance of Treatment
for Infertility and Miscarriage
Protocol # 26221
Yeung
I.
X
Recruitment
3.
X
Determine Subject Eligibility for Accrual
4b.
Follow-up Visits including physical
assessments
Ba.
Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
7.
Subject Randomization or Registiy
9,
X
Report Data (CRFs, e-CRFs, Spreadsheets)
11 a.
Review Adverse Events
12.
Other (Please insert explanation below.)
2.
X Obtains consent
4a.
Subject Physical Examinations
5.
Perform study procedures or Specimen
Collection
6b.
Receive, Store, Manipulate or Account for
Study Drugs, Biologics or Devices
8.
X
Collection of Subject Data
10.
- Data Analysis
11 b.
Treat and Classi5’ Adverse Events
UserIb
CourseComplellonDate
Course
pyeungl
11-08-2012
Good Clinical Practice (GCP)
pyeungl
08-1 1-2017
Good Clinical Practice (GCP)
Refresher
pyeungl
07-22-2009
ICITI/University of Miami Training
pyeungl
03-11-2013
rCITI Biomedical Research Refresher1
Training
Administrative Contact
Name of Administrative Contact
Degree
-
Title
Mathews, Katherine
MD
Associate Professor
Jamalabadi-Majidi, Shohreh
MPH, DMD
Research Coordinator
Key Personnel (Research Team)
Name of Key Personnel
Degree
Title
Department Name
(Research Team)
Treiman, Sierra
Medical Student
Student
Ob/Gyn/Women’s Health
Voltz, John
MD
Housestaff Resident
Ob/Gyn/Women’s Health
Department Chair Mandatory
The official Department Chair should be listed here. If the Department Chair is the P1, a proxy may be listed.
Name of Department Chair
Degree
Title
Page 7of44

e-PRDTCCDL
Protocol # 26221
Young
PROTOCOL
Biomedical Research
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
McLennan, Mary
MD
Professor
Email
Phone
Fax
mcIennan@slu.edu
(314) 781-1031
Department Name
Ob/Gyn-Ad ministration
Is this indMdual also a member of the research team?
N
Human Subjects Training Completed?
WARNING: Proof of training must show below or the application will be
returned. If your training information isn’t showing, upload a copy in the
Attachments section.
Research Experience
*?HELP?*
Research Team Member Duties Picklist
1.
Recruitment
3.
Determine Subject Eligibility for Accrual
4b.
Follow-up Visits including physical
assessments
6a.
Administer and/or Dispense Study Drugs,
Biologics or Devices (must be licensed)
7.
Subject Randomization or Registry
9.
Report Data (CRFs, e-CRFs, Spreadsheets)
11 a.
Review Adverse Events
12.
Other (Please insert explanation below.)
2.
Obtains consent
4a.
Subject Physical Examinations
5.
Perform study procedures or Specimen
Collection
6b.
Receive, Store, Manipulate or Account for
Study Drugs, Biologics or Devices
8.
Collection of Subject Data
10.
Data Analysis
11 b.
Treat and Classify Adverse Events
UserID
CourseComplefionDate
J Course
mclennan
01-26-2018
Good Clinical Practice (GCP)
mclennan
01-19-2018
CITI Biomedical Research Refresher
Training
mclennan
01-11-2001
Protecting Study Volunteers in
Research
Research Team Roles
Name(s), Degree
Department
Experience
Duties
Yeung, Patrick, MD
Ob/Gyn-Minimally
Has over 8 years of
Recruitment, Obtains
Invasive Gyn
research experience
consent, Determine
including design,
Subject Eligibility for
implementing, data
Accrual, Collection of
collection and analysis.
Subject Data, Report Data
(CRFs, e-CRFs,
Spreadsheets)
Treiman, Sierra, Medical
OblGyniWomen’s
limited research experience, Collection of Subject
Student
Health
but will be mentored by the
Data, Report Data (CRFs,
experienced staff
e-CRFs, Spreadsheets),
!
Data_Analysis
Page 8 of 44

e- PROTOCOL
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
Voltz, John, MD
Ob/Gyn/Women’s
conducted chart reviews on
Collection of Subject
Health
a several hundred patients
Data, Report Data (CRFs,
for a study on cesarean
e-CRFs, Spreadsheets),
sections. Limited research
Data Analysis
experience mentored by
experienced research team.
* “ Subject Population ** *
Subject Population(s) Checklist
Select All That Apply:
X
Adults
Cognitively Impaired Subjects
Employees (specifically targeted)
Fetuses
Minors (under 18)
Neonates
Non English Speaking Subjects
Pregnant Women
Prisoners
Students (specifically targeted)
Terminally Ill Subjects
-
Wards of the State
Other (any population that is not specified above)
* * * Study Location
*
Study Location(s) Checklist
Indicate where the study will be conducted. Select all that apply:
Saint Louis University, Medical Center Campus
Saint Louis University, Frost Campus
Saint Louis University, Madrid Campus
X
Saint Louis University, SLUCare Practice Locations
SSM STL (DePaul Hospital, St. Man/s Health Center, St. Joseph (St. Charles, Wentzville, Lake Saint
Louis), St. Clare)
Cardinal Glennon Childrens Medical Center
Saint Louis University Hospital (SSM Health- SLU Hospital)
SLU-SSM Cancer Center Research Alliance Sites
Other (In the box below, list any off-campus institutions or locations and describe the activities being
conducted there. Please provide letters of cooperation and/or IRB approvals from each location to
document support/approval of the study. You may provide such documentation as it becomes available, but
Page 9 of 44

e-pno-r000L
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and SuNeillance of Treatment
for Infertility and Miscarriage
you may not begin work at those sites until documentation of support is provided to the IRB.) Please refer
to the Guidance for involving non-SLU institutions in human subject research.
* *
General Checklist
* * *
General Checklist
Select All That Apply:
Collection of Specimens
X
Data collection via e-mail or the Internet
Deception/Incomplete Disclosure
Dietary Supplements, Vitamins, and Other Food Agents
FDA Approved Device
FDA approved drugs, reagents, other chemicals administered to subjects (even if they are not being
studied), or biologic products
Genetic Testing
HIV Testing
Human blood, cells, tissues, or body fluids
International Research or Research on International Populations
Investigational drugs, reagents, chemicals, or biologic products
Investigational Device
X
Investigator Initiated Study
*?HELP?*
X
Medical Records
Photography, Video, or Voice-Recording Subjects
X
Questionnaires and/or tests
Radioisotopes/radiation-producing machines, even if standard of care
rDNNGene Transfer Therapy
Registry(ies)
Specimens to be stored for future research projects (must be in consent form)
Study of existing data or specimens
X
University Indemnified Study (SLU is responsible for liability coverage)
?HELP?’
Other (clarify in text box to the right)
Single Use. Provide a brief summary and justification for the Single Use Therapy. Note: This application will
refer to research. For Single Use applications it is understood that ‘research’ will mean ‘therapy’.
* ** Funding
* **
Funding Checklist
Page 10of44

e-PRDT0CCL
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol TiDe:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
X
NONE
NOTE:
Applicable grant application, contract or subcontract, investigator’s brochure, and sponsors
protocol (fDr all industry sponsored clinical trials) must be attached. You will be prompted for these in
section #16 (Attachments).
*
* Expedited Paragraphs”
To request an Expedited Review, check the appropriate category(ies) below. Provide justification for your request
for Expedited Review.
To qualify for expedited review, research activities must (1) present no more than minimal risk to human subjects,
and (2) involve only procedures listed in one or more of the categories below.
1.
Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
a)
Research on drugs for which an investigational new drug application (21 CFR Part 31, 32) is not
required. (Note: Research on marketed drugs that significanDy increases the risks or decreases the
acceptability of the risks associated with the use of the product is not eligible for expedited review.)
b)
Research on medical devices for which
(i)
An investigational device exemption application (21 CFR Part 812) is not required; or
(ii)
The medical device is cleared/approved for marketing and the medical device is being used in
accordance with its cleared/approved labeling.
2.
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
a)
From healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts
drawn may not exceed 550 ml in an 8-week period and collection may not occur more ftequentiy
than 2 times per week; or
From other adults and children, considering the age, weight, and health of the subjects, the
Page 11 of44

e-PROT000L
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
collection procedure, the amount of blood to be collected, and the frequency with which ft will be
collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per
kg in an 8-week period and collection may not occur more frequently than 2 times per week.
Children are “persons who have not attained the legal age for consent to treatments or
procedures involved in the research, under the applicable law of the jurisdiction in which
the research will be conducted.’
3.
Prospective collection of biological specimens for research purposes by non-invasive means.
EXAMPLES: (a) hair and nail dippings in a nondisfiguring manner (b) deciduous teeth at time of exfoliation or
if routine patient care indicates a need for extraction; (a) permanent teeth if routine patient cam indicates a
need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected
either in an unsfimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric
solution to the tongue; (fl placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the
membrane prior to or during labor; (h) supra-and subgingival dental plaque and calculus, provided the
collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is
accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by
buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulizabon.
4.
Collection of data through non-invasive procedures (not involving general anesthesia or sedation)
routinely employed in clinical practice, excluding procedures involving X-rays or microwaves. Where
medical devices are employed, they must be cleared/approved for marketing. (Studies intended to
evaluate the safety and effectiveness of the medical device are not generally eligible for expedited
review, including studies of cleared medical devices for new indications.)
EXAMPLES: (a) physical sensors that are applied either to the surface of the body or at a distance and do not
involve input of significant amounts of energy into the subject or an invasion of the subjects’ privacy; (b)
weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography,
electroencephalography, theunography, detection of naturally occurring radioactivity, electroretinography,
ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiology; (e) moderate exercise,
muscular strength testing, body composition assessment, and flexibility testing where appropriate given the
age, weight and health of the individual.
X
5.
Research involving materials (data, documents, records, or specimens) that have been collected, or
will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE:
Some research in this category may be exempt from the HHS regulations for the protection of human
subjects. 45CFR 46.101 (b)(4). This listing refers only to research that is not exempt.)
This is a prospective cohort observational study. Couples presenting for possible treatment with natural
procreative technology, or NPT will he recruited for participation in the study. Observation of the characteristics
of the couples, the nature of the NPT treatments, and the outcomes including live births will be followed for up to
• 3 years for each couple entering the study. Data will be collected from medical records from consent to 3
years of treatmentorfoNowp1 See data collection sheet in section 16.
6.
Collection of data from voice, video, digital, or image recordings made for research purposes.
X
7.
Research on individual or group characteristics or behavior (including, but not limited to. research on
Page 12of

e-pRoTo CDL
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and
social behavior) or research employing survey, interview, oral history, focus group, program
evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in
this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR
46.1O1(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
This is a prospective cohort observational study. couples presenting for possible treatment with natural
procreative technology, or NPT will be recruited for participation in the study. Observation of the characteristics
of the couples, the nature of the NPT treatments, and the outcomes including live births will be followed for up to
3 years for each couple entering the study. Participants will completed surveys at entry, childbirth, yearly time
Lpoints and ifjy exit the efore compjçjpgUne3 year foNow gi
-
8.
[FOR IRS use only]. Continuing review of research previously approved by a convened IRB only
when condition (a), (b), or (c) is met.
a)
Previously approved research where
(i)
The research is permanently closed to the enrollment of new subjects;
(H)
All subjects have completed all research-related interventions; and
(Hi)
The research remains active only for the long term follow-up of subjects.
b)
Previously approved research where no subjects have been enrolled and no additional
risks have been identified.
c)
Previously approved research where the remaining research activities are limited to data
analysis.
9.
[FOR IRS use only]. Continuing review or research not conducted under an investigational new drug
application or investigational drug exemption where expedited categories two (2) through eight(S) do
not apply but the IRS has determined and documented at a convened meeting that the research
involves no greater than minimal risk and no additional risks have been identified.
*
Background, Purpose, Study Procedures
* *
*
Title
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
Complete Sections 1 -16. In sections that allow reference to sponsor protocol or grant, clearly state section and
page numbers. Any inftunation that is different or specific to the local site should be in the SLU application.
Specify N/A as appropriate.
1. Background
-
Page numbers from a sponsors protocol/grant may be referenced in la and lb.
a)
Provide an introduction and background information. Describe past experimental and/or clinical
findings leading to the formulation of the study, if applicable. Investigator Initiated studies must
cite references in the response provided or attach a bibliography.
*?HELP?*
Page 13 of 44

e-PRDTOCDL
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol TdJe:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
cite references in the response provided or attach a bibhography.
?HELP?
Infertility is a common problem. While most of current clinical research of infertility focuses on in
vitro fertilization and related techniques of assisted reproductive technology (ART), some
couples do not wish to use in vitro fertilization, or cannot afford it. Natural procreative
technology (NPT) is a standardized approach to the treatment of infertility that does not involve
ART. NPT incorporates standard infertility treatments (such as clomiphene or progesterone)
within a set of standardized application protocols. The gOal of NPT is to identify abnormalities
of the woman’s reproductive cycle (menstrual cycle), and where possible, correct them by
medical intervention.(1, 2) An integral part of NPT is teaching women to observe and chart the
biomarkers of their fertility (menstrual) cycle, based on changes in vaginal discharge (resulting
from uterine bleeding and cervical mucus production). This charting of fertility biomarkers is
done according to the Creighton Model FertilityCare System (CrM). (3) The CrM has several
applications. First, the CrM chart alerts women when ovulation is approaching within the next
few days and therefore intercourse is most likely to result in pregnancy, even for subfertile
couples.(4, 5) Second, it also gives the physician a record that can be used as a standardized
basis for doing diagnostic tests timed in reference to ovulation. Third, the physician can also
employ standard medications to enhance ovulation, luteal hormonal production, or cervical
mucus production, and use the Crfvl chart to assess the immediate response of the woman to
treatment. Where appropriate, NPT may also include medical treatment for male factor
infertility, and for prior miscarriage. Formal evaluation of the outcomes of NPT in medical
!practice has been limited to a few studies based on single medical practices.(6-9) We plan to
conduct a prospective observational study to measure the generalizability of this program to
multiple populations and settings, and characteristics of patients that may correlate with the
likelihood of treatment success.
Please save frequently
b)
Describe any animal experimentation and findings leading to the formulation of the study, if
there is no supDortinp human data.
2. Purpose of the study
a)
Provide a brief lay summary of the project in <200 words. The lay summary should be readily
understandable to the general public.
This study involves research, and the purpose of this study is to evaluate live birth rates among
couples who are treated by Natural procreative technology, (NPT) for infertility and miscarriage.
Comparisons will be made to those declining NPT treatment, waiting for NPT treatment,
receiving other treatment, or stopping treatment. We seek to document specific pregnancy
rates for different factors such as age and type of infertility diagnosis. We will also assess
characteristics of environmental exposures that may be associated with infertility. Couples will
be followed for up to three years, regardless of when they begin NPT treatment, or whether
they continue treatment.
We are seeking the broadest possible participation from couples who
are considering NPT treatment. Data from all couples will be useful for this study, regardless of
Ltheir individual circumstances or actual treatment.
Page numbers from a sponsors protocol/grant may be referenced in 2b and 2c,
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e-PRCTDCOL
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Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
b)
List your research objectives (specific alms & hypotheses of the study).
This is an exploratory study rather than a hypothesis testing study. This study aims to
determine what the live birth rates are over time for patients who are treated with natural
procreative technology (NPT) for infertility or history of spontaneous abortion, and how the live
birth rate may vary by patient characteristics, especially the age of the woman, prior pregnancy,
and underlying diagnoses. Secondary analyses will explore outcomes of conceptions (live birth
versus other outcomes) and the association of environmental exposures with infertility. This is
an observational study: there will be no intervention. Patients will receive whatever care they
choose to receive. Couples receiving NPT treatment will be compared to those declining NPT
treatment! waiting for NPT treatment, receiving other treatment, or stopping treatment.
Interventions received! conceptions, and outcomes of conceptions will be followed for up to 3
years for each couple entering the study.
Please save frequently
c)
Describe the study design (e.g., single/double blind, parallel, crossover, control, experimental,
observational, etc.). If the study is investigator-initiated, a timeline for individual subject
recruitment, follow-up, and analysis for the study is required. Also, indicate if the subjects will be
randomized.
‘This is a prospective cohort observational study. Couples presenting for possible treatment with
NPT will be recruited for participation in the study. No randomization will occur. If a couple
agrees to participate, we will collect information in three ways:
1)Questionnaires. (This is standard of care) These will be done at entry (SOC) to the study, on
an annual basis for up to three years (research related), for any pregnancy, or whenever a
patient exits the study. Questionnaires may be done by mail, email! or telephone. Each
questionnaire has a woman’s and a man’s version, except the pregnancy questionnaire, which
only has a woman’s version. Each questionnaire will take approximately 3045 minutes to
complete.
2)The subject’s own Creighton Model fertility charts. (standard of care)
3)lnformation about NPT treatment and pregnancies from the medical records of their NPT
physician(s). (standard of care)
d)
If subjects will be given placebo, please justify placebo use.
?HELP?
NA
3. Study Procedures
.
-
a)
N
Is this project a multicenter study (i.e., same project is conducted elsewhere by a
different investigator) OR does this study involve conduct of research at multiple sites?
Is SLU acting as a coordinating center for other sites OR is the SLU P1 a direct recipient
of a federal grant for this research? If yes, complete and attach the Supplemental
Application for Coordinating Center Activities.
Will the SLU site be participating in all parts/procedures/arms of the study?
If No, explain what SLU will NOT participate in:
Please save frequently
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e-pRDTQC0L
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
Page numbers from a sponsor’s protocol/grant may be referenced in Sb, Sc, and 3d.
b)
Describe all the procedures, from screening through end-of-study, that the human subject must
undergo in the research project, including study visits, drug treatments, randomization and the
procedures that are part of standard of care. Specify which procedures are for research and
which are standard of care. Please note: The box below is for text only. If you would like to add
tables, charts, etc., attach those files in the Attachment section (#16).
The clinical care will be performed as usual, and will not be altered by this study.
If a couple agrees to participate, we will collect information from them in three ways:
1)
For women:
The Woman’s Entrance Questionnaire will be completed by the subject at the time of their initial
visit or as soon as possible per SOC. Following enrollment into the study, the subject will
complete the following questionnaires:
•Women’s Update Questionnaire on an annual basis (from the date of completion of the
Women’s entrance questionnaire) for up to 3 years (research related),
-Pregnancy Outcome Questionnaire for any pregnancy (research-related),
Women’s Exit Questionnaire whenever they exit the study (research-related).
Depending on the timing of subject enrollment, any follow-up questionnaire time point which
may have already occurred at the time of subject enrollment will be considered skipped.
Questionnaires may be done by mail, email or telephone. Each questionnaire will take
approximately 3045 minutes to complete.
For male partners:
The Men’s Entrance Questionnaire will be completed per SOC (may be completed before or
after enrollment into the study).
Following enrollment into the study, the subject will complete the following questionnaires:
‘Men’s Update Questionnaire on an annual basis (from the date the female partner completed
the Women’s entrance questionnaire) for up to 3 years (research-related),
-Men’s Exit Questionnaire whenever they exit the study (research-related).
Depending on the timing of subject enrollment, any follow-up questionnaire time point which
may have already occurred at the time of subject enrollment will be considered skipped.
Questionnaires may be done by mail, email, or telephone. Each questionnaire will take
approximately 30-45 minutes to complete.
2)The subjects own Creighton Model fertility charts.(The Creighton Model Fertility charts
teaches couples to recognize, understand, and record the changes that occur during the fertility
tmenstruall cycle. These changes [biomarkersi indicate whether the reproductive system is
functioning normally or not. It also identifies ovulation and other key events. It is completely
natural and cooperative with a woman’s fertility [menstrual] cycle).
3)lnformation about NPT treatment and pregnancies from the medical records of their NPT
physician(s) (prospective and/or retrospective, based on the timing of consent)..
This data collection will continue for up to three years after enrollment into the study (research
related).
We will keep track of all information, including information needed to contact the subject at the
Study Center at Saint Louis University. All information will be kept confidential. No personal
information will be released to anyone outside the study.
‘The study database has been constructed without any patient identifiers (no name, address,
phone number, or identification numbers other than study subject number). The subject’s
contact information will be kept separate from the study data.
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Protocol#26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
combined results will be used for the analysis in this study. It will be impossible to identify any
individual during the course of the analysis or in the reporting of the results.
couples presenting for possible treatment with NPT will be recruited for participation in the
study. Observation of the characteristics of the couples, the nature of the NPT treatments, and
the outcomes including live births will be followed for up to 3 years for each couple entering the
study.
The paper informed consent form will be reviewed with the couple in detail in the office.
Individuals will have the opportunity to ask questions before they consent.
Follow up Questionnaires may be completed per the patient’s preference, by e-mail, phone or in
person.
All data collected (no PHI) from the questionnaires and medical records will be entered into a
single secure database that will be kept at the Saint Louis University, Department of Ob, Gyn
and Women’s Health.
c)
If the proposed study is a clinical trial where a drug, vaccine, device or other treatment is
compared to a placebo group or comparison treatment group, what are the guidelines or
endpoints by which earty decisions regarding efficacy or lack of efficacy can be made? For
example, it may be reasonable to stop enrollment on a study when efficacy has already been
clearly demonstrated, to avoid unnecessary enrollments of additional subjects. Alternatively, it
may be reasonable to stop enrollment when it is clear that efficacy will never be demonstrated,
given the statistical power of the study as designed. Describe the guidelines that are in place to
assist in making these determinations, if relevant to the proposed study.
NA
d)
Describe how data analysis will be performed (statistical tests, methods of evaluating data) and
indicate the smallest grouplunft for which separate reporting will occur. For studies involving a
questionnaire, if data and reliability information are available, please describe or provide
references. For frill board, unfunded studies describe sample size determination and power
analysis. If none, please justify.
The database exists in Microsoft Access. Analyses will be done in Excel (for basis of
descriptions), SAS and/or SPSS statistical computer programs. As stated above, data used in
the analysis will be aggregate data, and will not contain any individual identifiers. Therefore,
there will be no possibility of identifying individual respondents during the analysis or in the
reporting of the final results.
Analysis of Main Outcome
The main outcome of this study is the proportion of subjects that had a live birth at various time
points up to five years after beginning treatment with NPT, compared to couples who do not
receive NPT treatment, or who cease to receive NPT treatment. This will be analyzed by
standard lifetable techniques to deal with censored data (i.e., couples for whom pregnancy
status cannot be ascertained beyond a certain time period). Cox proportional hazards
regression will be used in an exploratory manner to investigate demographic and medical
characteristics (particularly woman’s age, prior pregnancy, and associated medical diagnoses)
that may be associated with a greater likelihood of successful live birth. The same set of
analyses will be repeated for the secondary outcome of conception (clinical pregnancy).
Analysis of Secondary Outcomes
Initially, all secondary outcomes will be analyzed as simple proportions, e.g., of couples who
conceived, what proportion had a live birth, spontaneous abortion, or other pregnancy outcome.
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e-pROTDCOL
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
conceived, what proportion had a live birth, spontaneous abortion, or other pregnancy outcome.
Where indicated by the initial analysis, supplementary analyses using standard statistical
techniques may be employed (e.g., a logistic regression with the outcome of live birth versus
other pregnancy outcome).
Sample Size
The sample size is not exact since its size depends upon the total number of patients seen at
the participatingclinic. We do not have sufficiently reliable information to estimate the variance
of the predictor variables (age, prior pregnancy, associate medical diagnoses, and other
• characteristics) in predicting the primary outcome of live birth. Because this is an observational
g4y of existing treatment, we will conduct interim analyses yearly.
Please save frequently
e)
State if deception (including incomplete disclosure of study purpose/procedures) will be used. If
so, describe the nature of the deception and provide a rationale for its use. Also, describe
debriefing procedures or justify a waiver of the requirement to debrief. NOTE: for studies using
deception, an alteration of consent must be justified in the Informed Consent section of the
protocol (#13) and the debriefing script/statement must be uploaded in the Attachments section
(#16). See IRB Deception Guidelines.
t)
Is there an accepted standard of care and/or standard practice at SLU for the
Y
condition/disease/situation being studied? This information will assist in comparing
the risk/benefit ratio of study procedures relevant to usual care that would be
received outside of the research context *?HELP?*
If yes, please describe the standard of care and standard practice at SLU for the
condition/disease/situation being studied.
NPT incorporates standard infertility treatments (such as clomiphene or progesterone) within a
set of standardized application protocols. The goal of NPT is to identify abnormalities of the
woman’s reproductive cycle (menstrual cycle), and where possible, correct them by medical
intervention.(1 ;2) An integral part of NPT is teaching women to observe and chart the
biomarkers of their fertility (menstrual) cycle, based on changes in vaginal dischacge (resulting
from uterine bleeding and cervical mucus production). This charting of fertility biomarkers is
done according to the Creighton Model FertilityCare System (CrM). (3) The CrM has several
applications. First, the CrM chart alerts women when ovulation is approaching within the next
few days and therefore intercourse is most likely to result in pregnancy, even for subfertile
couples.(4, 5) Second, it also gives the physician a record that can be used as a standardized
basis for doing diagnostic tests timed in reference to ovulation. Third, the physician can also
employ standard medications to enhance ovulation, luteal hormonal production, or cervical
mucus production, and use the CrM chart to assess the immediate response of the woman to
treatment. Where appropriate, NPT may also include medical treatment for male factor
infertility, and for prior miscarriage.
g)
Does this study involve any diagnostic imaging, labwork or genetic testing that could N
result in clinical discovery (diagnoses, genetic mutations, etc.)? Note that this could
include discovery that is expected (related to the research) or incidental (not related
to research aims, but possible, like a mass/shadow found in imaging despite not
looking for it).
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e-pnoToccL
Protocol Title:
PROTOCOL
Biomedical Research
Saint Louis University
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
Protocol # 26221
Yeung
If yes, please describe and include whether there are plans to share findings with study
participants.
h)
Is this study subject to the NIH Genomic Data Sharing Policy?
The NIH GDS policyapplies to all NIH-funded research that generates large-scale
human genomic data as well as the use of these data for subsequent research and
includes: genome-wide association studies (GWAS), single nudeotide
polymorphisms (SNP) arrays, and genome sequence, transcriptomic,
metagenomics, epigenomic and gene expression data, irrespective of NIH funding
mechanism. Click here for more specific examples.
* * * Radioisotopes or Radiation Machines
* * *
N
You have not selected the Radioisotopes option in the General Checklist. If you would like to add Radioisotopes
information, please select the option to enable this section.
4. Radioisotopes or Radiation Machines
In this section, investigators must enter all radiation usage associated with the protocol.
Important: Protocols that involve non-standard of care radioactive materials (which includes the terms
-
“radioisotopes”, “radionuclides”, “radiopharmaceuticals”, and “nuclear medicine studies”, e.g., “PET”, “MUGA”,
“Zevalin”, and/or specific radionuclides such as “F-is’, “Tc-99m”, “Th-201”, “1-131”, “Ra-233”, “V-go”, etc.) will
receive review by the Radiation Safety Officer (RSO) and/or Radiation Safety Committee (RSC). In these cases,
submission to the RSD/RSC should occur after the RB staff has drafted the informed consent radiation exposure
risk statement, or verified the statement that was drafted by the research team (as noted below). For more
information on how to submit for radiation safety review, see RSC instructions or contact the Radiation Safety
Officer at 977-6895.
(1) It is the responsibility of the P1 to assure the accuracy and completeness of the data submitted in this section,
consistent with guidelines provided below. (2) For projects requiring radiation procedures, please refer to this
guidance.
a)
If applicable, list and quantify the radiographic diagnostic and therapeutic procedures associated with
this protocol by clicidng-TMAdd” and adding to Table I below. (Includes X-ray, fluoroscopy; CT,
radioactive materials, nuclear medicine, PET-CT, radiation oncology, accelerator, Cyber Knife
procedures, etc.)
b)
Total estimated research radiation dose *
* Calculate from the table above by adding the Effective Dose Subtotals for all procedures.
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e-PPDT000L
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
NOTE: Informed Consent Radiation Exposure Risk Statement- The appropriate Informed Consent Radiation
Exposure Risk Statement template language must be inserted into the SW IRS Informed Consent, inclusive of
applying the total estimated research radiation dose specified in item b) from the table above, as instructed in the
SLU IRB Informed consent Template. Per IRB Guidelines, the language will either be drafted by the IRS staff or
drafted by the research team and then verified by IRS staff prior to submission to the RSC for review. Contact the
lAB Office at 977-7744 or ith@slu.edu with any questions.
* ** Devices ** *
5. Devices
a) Please list in the space below all investigational devices to be used on subjects during this study..
b) Please list in the space below all FDA approved devices to be used on subjects during this study.
* * * Drugs, Reagents, Chemicals, or Biologic Products
* * *
6. Drugs, Reagents, Chemicals, Biologic Products, or Dietary Supplements, Vitamins, and Other Food Agents
Pilot
Phase
I
Phase II
Phase III
Phase IV
X
Not Phased
List placebo if it is considered a drug (contains more than inactive ingredients). For example, normal saline
is considered a drug that should be listed, whereas placebo tablets are usually inert ingredients that do not
need to be listed.
b)
Please list in the space below all investigational drugs, reagents or chemicals to be administered to
subjects during this study. Attach all applicable Investigator Brochures in section #16 (Attachments).
c)
Please list in the space below all FDA approved drugs, reagents, chemicals to be administered to subjects
during this study. Attach all applicable package inserts in section #16 (Attachments)..
d)
Please list in the space below all dietary supplements, vitamins, minerals, or foods to be administered to
subjects during this study.
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e-pRoToccL
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
* *
* Other Levels Of Review
* * *
7. Other Levels Of Review
1. University Radiation Safety
Protocols that involve non-standard of care radioactive materials (which includes the terms
“radioisotopes”, “radionuclides”, “radiopharmaceuticals”, and “nuclear medicine studies”, e.g
“PET”,
“MUGA”, “Zevalin”, and/or specific radionuclides such as “F-iS”, “Tc-99m”, “Th-201”, “1-131”, “Ra-223”
“Y-90”,%tc.) will receive review by the Radiation Safety Officer (RSO) an’d/or Radiation Safety
Committee (RSC). For information on how to submit for radiation safety review, see RSC <a
requiring-rsc-review-instructions-for-coordinators.pdf target=...blank> instructions or contact the
Radiation Safety Officer at 977-6895.
X
Not Applicable
Yes, study involves radioactive materials
2. Institutional Biosafety
Experiments involving the deliberate transfer of Recombinant or Synthetic Nucleic Acid Molecules (e.g.,
Gene Transfer), or DNA or RNA derived from Recombinant or Synthetic Nucleic Acid Molecules, or
Microorganisms containing Recombinant or Synthetic Nucleic Acid Molecules and/or infectious agents
(including select agents and toxins as defined by CDC and/or Animal and Plant Health Inspection
Service (APHIS)) into one or more human research participants must be reviewed by the SLU Biological
Safety Officer. Most of these protocols also require review and approval by the SLU Institutional
Biosafety Committee (IBC). Please contact the SLU Biological Safety Officer at 977-6888 for more
information.
X
Not Applicable
Yes, study requires Institutional Biosafety review
3. Pharmacy, Therapeutics, Nutrition, and Transfusion (PTNT) Committee
Saint Louis University Hospital requires that all research involving the administration of medications
within the hospital (including outpatient areas such as the Emergency Department, Outpatient Center,
Saint Louis University Hospital-South Campus, etc.) be reviewed and approved by the Pharmacy,
Therapeutics, Nutrition, and Transfusion (PTNT) Committee and that study drugs are received, stored,
prepared, and dispensed by the Hospital’s Department of Pharmacy Services. Please contact the
Investigational Drug Services Clinical Pharmacist at 268-7156 or SLUH-IDS@ssmhealth.com for more
information.
X
Not Applicable
Yes, study requires PTNT review
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e-pporo CDL
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
4. Saint Louis University Hospital
All research involving Saint Louis University Hospital, including the Emergency Department, inpatient or
outpatient services (including outpatient surgery at SLUH South Campus and the infusion center at the
DOB) and medical record access, requires Research Business Review (RBR) and approval prior to
study initiation. This process is designed to facilitate compliance with state and federal regulations as
they pertain to research in hospitals and clinical research billing. While researchers can begin to
complete the SSM RBR form at anytime, the form should not be submitted until the RB and the Clinical
Trials Office (CTO) have approved the study. Please contact the Research Compliance Office at 577-
6113 or sluh-research@ssmhealth.com or the CTO at 977-6335 or clinical-trials-office@health.slu.edu
for more information.
.
.
-
X
Not Applicable
Yes, study requires Saint Louis University Hospital review
5. SSMSL
All research involving SSMSL locations (including Cardinal Glennon), including inpatient or outpatient
services and medical record access, requires approval from the SSM STL or SSM Cardinal Glennon
Research Business Review (RBR) prior to study initiation. This process is designed to facilitate
compliance with state and federal regulations as they pertain t research in hospitals and clinical
research billing. While researchers can begin to complete the SSM RBR form at anytime, the form
should not be submitted until the IRB and the CTO have approved the study. Please contact the SSMSL
Office at 989-2058 or Marcy.Young©ssmhealth.com for more information.
X
Not Applicable
Yes, study requires RBR review
-
6.
&nbsp&nbsp&nbspDoes this project require registration on Clinicalmals.gov, and/or is
V
this project subject to the NIH GCP Training Requirement? (Select “Yes’ if either apply)
Registration may be required if any of the following apply: 1) The project meets the
FDAAA definition of an ‘Applicable Clinical Trial’, which requires registration on
ClinicalThals.gov. 2) As of January 1,2017,2 new NIH policy mandated biomedical and
behavioral ‘Clinical Trials’ to be registered on Clinicaffdals.gov. In addition, NIH policies
require personnel on NIH ‘Clinical Trials’ to lake GCP training every three years. 3)
Registering may be required for Journal Publication (ICMJE). Please review relevant
definitions here. Contact the CTO at clinical-tdals-oftce@slu.edu with questions about
registering on ClinicalTrials.gov and refer to the training page of the RB website for
information on NIH GCP Training requirements.
*
* Subject Population
*
8. Subject Population - In the space below, please detail the participants that you are requesting to recruit
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e-pRoT000L.
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Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
(include description of each group requested)
a)
Expected age range of subjects. (For example
18 yrs to 90 yrs).
18-5byrs of age
b)
Number of evaluable subjects to be accrued at SLU or SLU site (this includes all [participants (300
sites under the direction of the SW RI).
women and 300 partners)
Exceeding the number listed here is a protocol violation. Prior IRB approval is required if additional
participants are to be accrued. If applicable, this number should be consistent with your power analysis
described in 3d.
c)
Number of evaluable subjects to be accrued study wide. *?HELP?*
[äparticipants (300
Iwomen and 300 partners)
d)
If including vulnerable populations (minors, pregnant women and fetuses, neonates, non-English speaking,
economically or educationally disadvantaged, prisoners, adults temporarily or permanently unable to
consent for themselves): 1) provide the rationale for the importance of including this population in the
research, and 2) specify the measures being taken to minimize risks to potentially vulnerable subjects.
Click on hyperlinks to access SW Guidelines containing additional considerations and strategies for
mitigating nsks.
NA
e)
If women, minorities, or minors are not included, a dear compelling rationale must be provided unless not
applicable. Examples for not including mLnors: disease does not occur in children; drug or device would
interfere with normal growth and development etc. If federally funded reference appropriate section of the
sponsors protocol/grant. *?HELP?S
Women and minorities are included. Usually minors are not seen for infertility
I)
If any specifically targeted subjects are students, employees, or laboratory personnel, specify the measures
being taken to minimize the risks and the chance of harm to these potentially vulnerable subjects. See SLU
Guidelines for additional considerations and strategies for mitigating risks.
g)
Describe (labeled a-c): a) who you are recruiting hr this study (e.g.. your patients/students/colleagues,
those in existing database or registry, the general public), and b) how you are recruiting (flyers,
advertisements, direct call/mailing, membership networks, in-person recwthnent in clinic, classroom, public
locations, etc.). For secondary data analysis or specimen studies, state how you have access to materials.
Importantly: do not contact participants prior to obtaining IRS approval for your study.
c) Also indicate whether or not you plan to obtain personal/private information or biospecimens for the
purpose of screening, recruiting, or determining eligibility of prospective subjects prior to obtaining informed
consent and how (obtained by communicating with prospective subjects or obtained by accessing records
or stored biospedmens). Note: if you are accessing medical records other than those of your own patients
or those in your immediate department, you will need to submit a <a hrefr
https:I/www.slu.edWresearch/facufty-resource&research-integrity-safetyñnstitutional-review-board
ithfith_assets/prep_tojesearch_form.doc target_blank>HIPAA Preparatory to Research form and submit
to the SLU Privacy Officer PRIOR to accessing records.
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PROTOCOL
Protocol Title:
PROTOCOL
Biomedical Research
Saint Louis University
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
Protocol # 26221
Yeung
Please refer to the <a href=hftpsi/www.slu.edu/research/ftculty-resources/research-integrity
safetyrinstitutional-review-board-irbIirb_assets/guidelines_subject_recwitmentdoc target=_blank>SLU IRB
Recruitment Guidelines when designing recruitment strategies and upload recruitment materials to the
Attachments page for lRB review. You are expected to obtain permission for individuals/organizations that
assist with recruitment, and whenever possible, those assisting should share your materials with potential
participants on your behalf rather than providing you with private contact information.
Couples seeking NPT treatment or consultation to achieve pregnancy, to maintain pregnancy, or for
fertility-related health issues will recruited from our practice.
Providers will present the study information
Ito the patients at any visit. Women and their partner do not have to be consented at the same vlsi/on the
same date. No recruitment by phone or maiIwiII be done.
8. Subject Population (continued)
* *
* Subject Population
* *
Page numbers from a sponsor’s protocol/grant may Pe referenced in Bh.
h)
Inclusion and Exclusion Criteria.
0
j)
k)
IdentiN inclusion criteria.
Identifr exclusion criteria.
Estimate the probable duration of the entire study including data analysis and publication. This estimate
should include the total time each subject is to be involved and the duration the data about the subject is to
be collected. If the study is Investigator-initiated, a timeline for individual subject recruitment, follow-up,
total time for subied accrual, and data analysis for the study is required.
Annual questionnaires will be sent out to consented participants yearly for 3 years
We anticipate keeping the study open for up to 10 years for enrollment.
Couple/Female involvement 3 years
Data collection per couple 3 years
Analysis and publication 3 years
Total duration of study 19 years
I Couple or women, seeking NPT treatment or consultation to achieve pregnancy, to maintain
pregnancy, or for fertility-related health issues.
2.Couple or women who is seeking pregnancy WITHIN the coming year.
1 .Couple or women is not a candidate for NPT for pregnancy (for example, couple or women is
medically sterile or medically too high risk for pregnancy).
2.Couple or women is notable to provide informed consent (for example, language barriers).
Compensation. Explain the amount and schedule of compensation, if any, that will be paid for participation
in the study. Include provisions for prorating payment.
No compensation will be paid
Describe who will cover study related costs. Explain any costs that will be charged to the subject.
Neither the subject or their insurance company will be billed for any study related procedures.
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PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
***Risks***
9. Risks
There is no research that can be considered totally risk free (e.g., a potential risk of breach of
confidentiality). Therefore, when describing the risk, the lowest level of risk is “no more than minimal risk”.
Page numbers from a sponso?s protocol/grant may be referenced in 9.1, 9.2, 9.3, and 9.4.
1.
Use of investigational devices. Please include the clinical adverse events (AEs) associated with each
of the devices with an indication of frequency, severity and reversibility. This information can often be
found in the Investigator(s) brochure. NOTE: Include any likely adverse effects associated with
procedures that subjects may experience while in the study.
2.
Use of investigational drugs. Please include the clinical AEs associated with each of the drugs with an
indication of frequency, severity and reversibility. This information can often be found in the
Investigator(s) brochure. NOTE: Include any likely adverse effects associated with placebos or
washout periods that subjects may experience while in the study.
3.
Use of FDA approved drugs, reagents, chemicals, or biologic products. Please include the clinical AEs
associated with each of the drugs with an indication of frequency, severity and reversibility. This
information can often be found in the package insert provided by the manufacturer. NOTE: Include any
likely adverse effects associated with placebos or washout periods that subjects may experience while
in the study.
4.
Use of FDA approved devices. Please include the clinical adverse events (AE5) associated with each
of the devices with an indication of frequency, severity and reversibility. This information can often be
found in the Investigator(s) bmchure. NOTE: Include any likely adverse effects associated with
procedures that subjects may experience while in the study.
5.
Describe any risks related to performing study procedures. Please include all investigational, non-
investigational, and non-invasive procedures (e.g., surgery, blood draws, treadmill tests).
There is the risk of loss of confidentiality.
____
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e-pROT000L
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
6.
Describe any risks related to the use of radioisotopeslradiation-producing machines (e.g., X-rays, CT
scans, fluoroscopy).
7.
Describe why this investigational compound/drug/device/procedure’s risks/benefits are potentially
better than standard of care or other common alternatives. Any standard treatment that is being
withheld must be disclosed and the information must be included in the consent form. *?HELP?*
This Study is solely observational— it evaluates clinical treatment that is being provided already and
involves no additional drugs or interventions. No care or treatment is being withheld.
8.
Describe any psychological, social, or legal risks the subject may experience.
?HELP?t
There are certain risks and discomforts that may occur if a patient takes part in this research study.
These include the potential risk of loss of confidentiality. Every effort will be made to keep the
information confidential, however, this cannot be guaranteed.
Some of the questions on the questionnaire may make participants feel uncomfortable. They may
refuse to answer (skip) any guesUons.
Page numbers from a sponsors protocol/grant may be referenced in 9.9 and 9.10.
9.
Special Precautions. Describe the planned procedures for protecting against or minimizing potential
risks. If appropriate, include the standards for termination of the participation of the individual subject.
Discuss plans for ensuring necessary medical or professional intervention in the event of adverse
effects to the subjects.
Data collected will be coded, stored in a locked suite, on a password protected computer. The master
list will be kept separately from the data collected.
PHI information will be stored with the coded study information. Documents such as the consent
(name) Demographic sheets from the SOC contains PHI. All study related documents will be stored in
a locked cabinet (only the data manager has the key) in a locked suite.
The subject couple information will be entered into the database housed by the Department of Ob,
Gyn and Women’s Health at Saint Louis University
The study database will be constructed without any patient identifiers (no name, address, phone
number, or identification numbers other than study subject number). Study subject numbers will be
linkable to individual patients only at Saint Louis University. The data file will be password protected,
and located on a password-protected computer in a locked research area of the Department of 08,
GYN and Women’s Health.
Combined results will be used for the analysis in this study. It will be
impossible to identify any individual during the course of the analysis or in the reporting of the results.
10.
Reproductive Risks.
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S-PROTOCOL
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
a.
Please list the pregnancy category of any drugs or N/A.
na
b. Please describe any reproductive risk associated with any pad of the research study. Include any data
from other studies (animal or human).
na
11.
Data Safety Monitoring
Federal regulations require that when appropriate, the research protocol makes adequate provisions
for monitoring the data to ensure the safety of participants. Monitoring should be commensurate with
risks and with the size and complexity of the research, and could range from no plan needed to an
independent data safety monitoring board. Please refer to SLU Guidelines for Data and Safety
Monitoring as you complete the questions below.
a.
Is there a Data Monitoring committee (DMC) or Board (DSMB)?
N
If yes, please provide the following information (labeled a-g): a) the composition of the board
(degrees/qualifications of members), b) whether the board is independent from the sponsor and
research team or not, c) frequency of meetings and issuance of reports to sites, d) assurance that
the board is reviewing aggregate safety data and making recommendations regarding study
continuance, e) provisions for ad hoc meetings if needed, f) who is reviewing SABs in real time (MD
or DO), and g) stopping/halting rules (if any exist).
A DSM charter can be referenced for all items except for “f) who is reviewing SAEs in real time.”
If no, please justify why not.
Not needed, this is an observational study
Is there a Data Safety Monitoring Plan (DSMP)?
N
b.
Note, if all relevant plan information is included in DSMB question above, select ‘Yes’ and state “see
above’ in the answer box.
If yes, provide details (labeled a-e) including: a) what types of data or events are captured and how are
they documented, b) who is monitoring data, their independence/affiliation with the research and their
degrees/qualifications, c) frequency of aggregate data review, d) who is reviewing SAEs in real time
(MD or DO), and e) stopping/halting rules (if any exist).
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e-PROT000L
PROTOCOL
Protocol#26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
If no, please justify why not.
[Not needed, this is an observational study
12.
In case of international research (research outside of the U.S. or research on international
populations (non-U.S.)), describe qualifications/preparations that enable you to evaluate cultural
appropriateness and estimate/minimize risks to subjects. Include whether research is sensitive given
cultural norms.
a.
State any local laws/regulations governing Human Subjects Research in the countiy(ies) you will
conduct the research and attach any relevant approvals. If none, state N/A.
b.
Will there be language barriers and if so, how will they be addressed?
Note: If materials are to be distributed to subjects in their native language, please follow SLU’s
Guidance For Studies Involving Non-English Speaking Subjects.
&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbspNOTE: Exiort control laws include the transfer of
technical information and data, as well as information
&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbspand technology to foreign nationals. If this study
has international components, contact the SLU Export
&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbsp&nbspControl Officer for direction on whether export
control policies apply.
-.
* * * Benefits/Alternatives, Procedures to Maintain Confidentiality and Privacy
* *
*
10. Benefits/Alternatives
a)
Benefits. Describe the potential benefit(s) to be gained by the subjects and how the results of the study
may benefit future subjects and/or society in general. Indicate if there is no direct benefit to the
participants.
I Subject participation may not benefit them but may help generate information about specific pregnancy
[rates and outcomes that will benefit future couples considering NPT treatment.
b)
Alternatives. Describe any alternative treatments and procedures available to the subjects should they
choose not to participate in the study. If no such alternatives exist, please state that the alternative is
nonparticipation. For some studies, such as record reviews, a description of alternatives would not be
applicable.
The alternative to participating in this study is not to participate. Whether or not subjects enroll in this study
will not change the NPT treatment that they receive, or choice to pursue any other treatment
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&PROTD CDL
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
11. Procedures to Maintain Confidentiality and Privacy
Federal regulations require that research materials be kept for a minimum of three (3) years and HIPAA
documents be kept for a minimum of six (6) yearn after the closure of the study. For FDA-regulated or
sponsored projects, the P1 may be required to keep the data and documents for a longer time period.
Confidentiality
To determine whether adequate provisions for confidentiality of data are in place, the lR8 must ensure that
research materials are stored in appropriate locations throughout the study (during collection,
transport/transmission, analysis and long term storage). Research information must be protected using
appropriate safeguards based on identifiability of the data and risk associated with the study (See SLU IRB
Confidentiality Guidelines).
For the questions below, please use the following definitions:
Anonymous/De-identified: data contain no identifiers, including code numbers that investigators can link to
individual identities;
Coded: data in which (1) identifying information, such as name or social security number, has been
replaced with a number, letter, symbol, or combination thereof (i.e., the code), and (2) a key to decipher the
code exists enabling linkage of data to identifying information (e.g., a master list), and (3) the key (master
list) is kept separately from coded data; AND/OR
Identifiable: data that includes personal identifiers (e.g., name, social security number), such that
information could be readily connected to respective individuals.
a)
Electronic (Computer) Data
Click Ad& to enter data security information for each type of electronic data that will be created in the
study: anonymous/de-identified, coded, and/or identifiable (see definitions above).
To properly address this question, there should only be one listing of each type of data in the table.
Depending on your project, you could have up to three types of data. See the SLU ITS Sensitive Data Guide
for acceptable data security methods.
Not Applicable, No Electronic (Computer) Data
X
Study IRS-approved Prior to New Question (Question N/A- Grandfathered)
b)
Hardcopy (Paper) Data
Click AddM to enter information for each type of hardcopy (paper) data that will be created in the study:
anonymous/de-identified, coded, and/or identifiable (see definitions above).
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e-pRomo CDL
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
To properly address this question, there should only be one listing of each type of data in the table.
Depending on your project, you could have up to three types of data.
Not Applicable, No Hardcopy (Paper) Data
X
Study IRB-approved Prior to New Question (Question N/A- Grandftthered)
c)
If a master list is used in this study (linking study codes to subject identifiers), explain: a) how and where
you will secure the master list, b) how long ft will be kept/when it will be destroyed, and c) provide a sample
of the code.
Data will be stored on a secure, password-protected server or computer. The informed consent will be
stored in a locked file cabinet, behind locked doors in the Research Unit.
A master list will be kept separately from the data. The master list is necessary in the event that data
collected needs to be confirmed or is questioned and to correlate reports to the correct subjects and to
contact subjects for annual questionnaires. It will be kept until study is complete and results published then
it will be destroyed.
d)
If data or specimens are being shared outside of the research team, indicate who will receive the material,
specifically what they will receive (data or specimens), and if an agreement has been signed to cover the
transfer. Note: unless covered under a Clinical Trial or other agreement, the transfer of data or specimens
to an external entity will require an agreement. For the transfer of materials (specimens), a Materials
Transfer Agreement (MTA) is used; for the transfer of data, a bata Use or Data Transfer Agreement is
used. Please contact the Research Innovation Group at 314-925-3027 for assistance.
•
na
e)
If samples or data will be provided to SLU from an outside source, indicate whether you will have access
to identifiers, and if so, how identifiable information is protected. Note: unless covered under another
agreement (e.g., Clinical Trial Agreement or subcontract), the transfer of data or specimens from an
external enbty to SLU may require an agreement. For the transfer of materials (specimens), a Materials
Transfer Agreement (MTA) may be required; for the transfer of data, a Data Use or Data Transfer
Agreement may be required. Please contact the Research Innovation Group at 314-925-3027 for
assistance.
f)
If data will be collected via e-mail or the Internet, how will anonymity or confidentiality be affected?
Describe how data will be recorded (i.e., will internet protocol (IP) addresses and/or e-mail addresses be
removed from data?).
Each participant will have their own usemame and password if they choose to complete the questionnaire
on line.
If they choose to have the questionnaire mailed to them, a stamp returned envelope will be provided with
the participant’s code number noted on the questionnaire.
If they wish to complete the questionnaire over the phone an approved member of the research team will
contact them and complete the questionnaire with a code number identifying the participant.
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e-PR0TOCDL
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
g)
If you will be audio/video recording or photographing subjects, provide a rationale as voiceprints and
images of faces/unique body markings are considered identifiers. Describe confidentiality procedures,
including any restricted access to images and/or the final disposition of the recordings/photos (destruction,
archiving, etc.).
h)
Describe any study-specific (non standard of care) information or documentation that will be put in the
participants’ medical records for this research (e.g., study visit notes, lab results, etc.). If none, state not
applicable”. NOTE; documentation of research in Epic should be done in accordance with the SLUCare
Epic Research Charting Policy and Clinical Workfiow: Documenting Research Encounters in Epic.
Nothing will be recorded
i)
Are there any information security requirements identified in the project’s
N
REP/Award Notice/Contract? This could include data security, technical
safeguards, security controls, NIST, FISMA, CFR, etc.
If yes, SLU ITS approval is required. Contact lnfoSecufltyTeam©slu.edu to start
the approval process.
Privacy
Privacy refers to persons having control over the sharing of oneself with others.
j)
Please indicate how participant privacy will be protected in this study (select all that apply):
X
Discussion of health related and/or personal information in a private roomlarea
X
Research interactions/interventions are conducted in a private mom/area
Use of drapes or other privacy measures
X
Collection of sensitive/identifiable information is limited to the minimum necessary to achieve
the aims of the research
X
Access to study information is limited to the minimum amount of persons necessary to achieve
the aims of the research (e.g., access restricted to research team members only)
Consideration of parental inclusionfabsence for studies involving minors
Other (please explain):
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e-PPQT0COL
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
* *
* Potential Conflict of Interest * * *
12. Potential Conflict of Interest
Indicate whether you, your spouse or dependent children, have, or anticipate having, any income
from or financial interest in a sponsor, device or drug manufacturer of this protocol, or a company
that owns/licenses the technology being studied. Please remember that you are responding for you
and any other investigator partidpating in the study. Financial Interest includes but is not limited to:
consulting; speaking or other fees; honoraria; gifts; licensing revenues; equity interests (including
stock, stock options, warrants, partnership and other equitable ownership interests). For questions
regarding Conflict of Interest consuft the Conflict of Interest in Research Policy.
Check one of the following (please remember that you are responding for yourself, your spouse, dependent
children and any investigator, investigator’s spouse and dependent children participating in the study):
1)
X
No equity interest and/or Financial Interest less than or equal to $5K
2)
Any equity interest and/or Financial Interest exceeding $5K but not exceeding $25K in the past
year or expected in the current year
3)
Financial Interest exceeding $25K in the past year or expected in the current year
Check all those that apply:
Consulting
Speaking Fees or Honoraria
Gifts
Licensing agreement or royally income
Equity interests, (including stock, stock options, warrants, partnership or equitable ownership
interests), or serving on a sdenbfic advisory board or board of directors
Other fees/compensation
If you have marked #2 or #3, please contact coi@slu.edu to initiate review of this study and provide the
following information:
1.
A Conflict of Interest Management Plan.
has been approved for all investigators for this study
is pending
has not been initiated
2.
Describe who has, and briefly explain, the conflict of interest and indicate specific amounts for
each subcategory checked:
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e-PROTDCCL
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
Note to Investigator(s) Reporting a Potential Conflict of Interest
Investigator(s) must have:
1.
Current1 up-to-date Conflict of Interest Disclosure Form on file with the SLU Conflict of Interest
in Research Committee (COIRC) that describes any financial relationship indicated aboye.
This information must be disclosed on the SLU confidential Conflict of Interest
Disclosure Form and reviewed by the COIRC before accruing research subjects in this
study. If your current Disclosure Form does not contain this information, you are
required to submit an updated Disclosure Form to the COIRC.
2.
You may not begin your study until your disclosure form has been reviewed and any required
management plan has been approved by the COIRC for this study. To initiate COIRC review of
your study, please contact coi@slu.edu.
* * * Informed Consent * * *
13. Informed Consent
Federal regulations require that informed consent be obtained from individuals prior to their participation in
research unless the RB grants a waiver of consent. Answer the questions, below, then click Add to provide
the necessary consent documents and information regarding subject consent. Multiple consents/waivers
may be added, but they must be uploaded one at a time.
NOTE: You may refer to the SLU IRB Guidance for Obtaining Informed Consent for considerations
regarding the consent/assent process.
State N/A if not applicable.
1)
How is consent being obtained? When and where will the discussion take place? If the study involves
a Non-English Speaking participant/population, please include details about plans for translated
consent materials and interpreters to be used (see SLU Guidelines for Involving Non-English
SpeakingyjectsformoredetaiIs).
Consent will be obtained by a member of the research team at the time the subject is evaluated at
their initial consultation or at any subsequent visit. If consent is obtained by a non-medical member
of the research team, a medical member of the team will be available to answer the subject’s
medically related questions
2)
If the study involves adults unable to consent for themselves (whether diminished capacity to consent
is temporary, permanent, progressive or fluctuating), please address the following: a) how is capacity
to provide consent being assessed (initially and throughout study, if applicable); b) if unable to
provide consent, how is LAIR being determined (See SLU LAR Guidelines); c) if unable to provide
consent, will assent be obtained and if not, why not?; d) if unable to provide assent, will dissent be
honored and if not, why not? Note: participants initially unable to provide consent for themselves are
expected to be given an opportunity to provide consent once capacity is gained. See SLU Guidelines
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e-PRDTCCOL
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
for Adults Unable to Provide Consent for additional detail.
NA
Note: Any assent documents which will be used per the Adults Unable to Prdvide Consent guidance, should be
appropriately named and uploaded using the Add button and the Consent drop down menu selection.
Informed Consent
This
Consent Type
Attached Date
Approved_ Marked Main CF
Consent
01/19/2016
VersionS CR 2017 16-JA...
**
* Assent **
14. Assent
Complete this section if your study includes minors. The Assent Form Templates (For
children and For adolescents) provide guidelines for writing the assent document.
1.
Will minors be asked to give assent, then consent once they reach adulthood? If not, please justify. If
not capable to provide assent initially, please address whether assent will be obtained as the minor
gains capacity. Note: children who reach the age of adulthood during participation should be given
the opportunity to provide consent as parent/guardian consent no longer applies. If obtaining consent
would be impracticable (e.g., this is a registry with dat&specimen obtained long ago), a waiver of
consent should be added for IRB review. See SLU Guidelines for Research Involving Minors for
additional detail.
2.
If minors are asked to assent and do not wish to participate, will they still be accrued in the study? If
yes, justify.
3.
How will the minor’s ability to give assent be assessed? (Consider the age and mtuhty of the minors
as well as their physical or mental condition). If capacity is fluctuating, please explain how capacity
will be assessed throughout the study.
Note: For studies that require a discussion about reproductive risks, note that the conversation with the
minor should take place separately from the parents. Also, if a minor will reach adulthood (18 in Missouri)
during the course of the study, they will need to be asked to consent as an adult at that time to continue in
the study.
* * * HIPAA * * *
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e-pROTOCDL
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
15. HIPM
Studies that access, receive or collect protected health information (PHI) are subject to HIPAA regulations.
PHI is health information with one or more personal identifiers,
For more information refer to the SLU IRB
HIPAA Guidance.
1. Will health information be accessed, received or collected?
No health information. HIPM does not apply.
X
Yes (continue to question 2).
2. Which personal identifiers Will be received or collectedlrecorded?
No identifiers.
I certify that no identifiers from the list below will be received or collected and
linked to health information. (Skip remainder of page).
Limited identifiers will be received or collected/recorded (study will likely require a data use
agreement). Select Data Use Agreement- INTERNAL or Data Use Agreement- EXTERNAL as
appropriate, below.
City/State/Zip codes
Person-specific dates (e.g., date of birth, dates of service, admission/discharge dates,
etc.)
Age (if subjects are 90+ years)
At least one direct identifier will be received or collected/recorded.
X
Names
Social Security numbers
X
-
Telephone numbers
Linkable code or any other unique identifying number (note this does not mean the unique
code assigned by the Investigator(s) to code the research data)
X
All geographic subdivisions smaller than a State, including street address, city, county,
precinct, zip code, and their equivalent geocodes, except for the initial three digits of a zip
code, if, according to the current publicly available data from the Bureau of the Census:
(1) The geographic unit formed by combining all zip codes with the same three initial digits
contains more than 20,000 people; and (2) The initial three digits of a zip code for all such
geographic units containing 20,000 or fewer people is changed to 000
X
All elements of dates (except year) for dates directly related to an individual, including
birth date, admission date, discharge date, date of death; and all ages over 89 and all
elements of dates (including year) indicative of such age, except that such ages and
elements may be aggregated into a single category of age 90 or older
Fax numbers
X
Electronic mail addresses
Medical record numbers
Health plan beneficiary numbers
Account numbers
Certificate/hcense numbers
vehicle identifiers and serial numbers, including license plate numbers
Device identifiers and serial numbers
Web Universal Resource Locations (URL5)
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e- PRDTD CDL
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
Internet Protocol (IP) address numbers
Biometric identifiers, including finger and voice prints
Full face photographic images and any comparable images
If you are receiving or collecting/recording health information and at least one personal identifier, please
continue to complete the sections, below.
3. Sources of Protected Health Information:
X
Hospital/medical records for in or out patients
X
Physician/clinic records
X
Laboratory, pathology and/or radiology results
Biological samples
X
Interviews or questionnaires/health histories
Mental health records
Data previously collected for research purposes
-
Billing records
Other
Please describe:
4. If data will be shared outside the research team and the study involves PHI indicate how the research
team will share the information.
Not applicable (continue to question 5).
Only linkable code that can link data to the identity of the subject. A code access agreement or
business associate agreement may be needed when data are shared with other non-SLU
entities. If necessary, the agreement can be added and uploaded in item #5, below.
Limited identifiers: Zip codes, dates of birth, or other dates only. The study qualifies as a Limited
Data Set. A data use agreement may be needed when data are shared with other non-SLU
entities.
If necessary, the agreement can be added and uploaded in item #5, below, using DUA
external option.
X
With unlimited identifiers. The consent document and HIPAA Authorization form must describe
how the information will be disclosed.
5. HIPA4 Documentation is required for this study. Use the table below to add HIPA4 Documents for
your study.
HIPM Documents
HIPAA Documents
Tftle
Aft5e(J
HIPAA Authorization
Approved_HIPAA Ver 2
02/1 7/2016
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e-pR0TOCDL
PROTOCOL
Protocol# 26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
* * * Attachments
* * *
16. Attachments
In this section, please upload additional documents associated with your protocol. Failure to attach files
associated with the protocol may result in the protocol being returned to you.
Possible documents for this protocol could include:
•
Bibliography
•
Cooperating Institution’s IRB Approval
•
Data Collection Sheet
•
Debriefing Script
•
Device Information/Documentation
•
Grant Proposal/Sub-Contract
•
Human Subjects Training Certificate/Proof of Training
•
Information Sheet/Brochure
•
Interview/Focus Group Questions
•
Investigator’s Brochure
•
Letter of Agreement/Cooperation
•
IND Application Letter
•
Package Insert
•
Patient Diary Form
•
Questionnaire/Survey
•
Recruitment Material (e.g., flyers, ads, e-mail text)
•
Safety Information (DSM Information)
•
ScientifldPPC Review or Department Chair Review
•
Sponsor’s Protocol
•
Sponsor’s Protocol Amendment
•
Study Design Chart/Table
•
Other files associated with the protocol (most standard formats accepted: pdf, jpg, tiff, mp3, wmv,
etc.)
To update or revise any attachments, please delete the existing attachment and upload the revised
document to replace it.
Document Type
Document Name
Attached Date
Submitted Date
Bibliography
References
01/13/2016
01/13/2016
Data Collection Sheet
Approved_Pregnancy
02/17/2016
02/17/2016
Outcome collection sheet
Data Collection Sheet
Approved_Chart
02/17/2016
02)17/2016
Abstraction Forms vio
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e-PROT000L
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title;
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
Other
Approved_e-mail
02/1 7/2016
02/17/2016
Other
Approved_Mail letter
02/17/2016
02/17/2016
Phone Script
Approved_Phone script
02/17/2016
02/17/2016
Questionnaire/Survey
Approved_NPT Men’s
02/17/2016
02/17/2016
Exit v2
Questionnaire/Survey
Approved_NPT
-
02/17/2016
02/17/2016
MensEntQnaire v2
Questionnaire/Survey
Approved_NPT
02/1 7/2016
02/17/2016
MensUpdate v2-
Questionnaire/Survey
Approved_NPT
02/17/2016
02/17/2016
WomenExitV6 v2
Questionnaire/Survey
Approved_NPT Womens- 02/17/2016
02/17/2016
EntQnaire v2
Questionnaire/Survey
Approved_NPT
02/17/2016
02/17/2016
WomenUpdate v2
Questionnaire/Survey
Approved_Preg_outcome :02/17/2016
02/17/2016
s v2
Other
26221 NPT Consent
01/04/2018
01/09/2018
Review 20-JUN-2017 To
I RB
Other
Letter IRB# 26221 and
01/04/2018
01/09/2018
2090023 JUN 2017-1
Human Subjects Training
Treiman, Sierra
01/04/2019
01/04/2019
Certificate/Proof of
Training
Human Subjects Training
Voltz, John_biomedical
01/04/2019
01/04/2019
Certificate/Proof of
Training
.1
* * * P1 Obligations
* * *
P1 Obligations
By clicking the box below you indicate that you accept responsibility for and will follow the ethical guidelines set
forth by the Belmont Report, Declaration of Helsinki,the Nuremberg Code, and the Ethical Principles of the
American Psychological Association (if applicable) for the research described. It also indicates that you have the
requisite funding, credentials, training, and any necessary hospital privileges, if needed, to carry out all
procedures and treatments involved in the protocol.
Clicking the box also affirms that the activities involving human subjects will not begin without prior review and
approval by the Institutional Review Board, and that all activities will be performed in accordance with state and
federal regulations and Saint Louis University’s assurance with the Department of Health and Human Services.
The P1 assures that if members of the SLU research team access protected health information (PHI) from a
covered entity in order to seek consent/authorization for research or to conduct research, such access is
necessary for the research, is solely for that purpose, and the information will not be removed from the covered
Page 38 of 44

e-pRom000L
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatmenl
for Infertility and Miscarriage
entity without IRS authorization or approved waiver. P1 further assures that the SLU research team will comply
with the terms of a Data Use Agreement to PHI (if any).
1)
Have you completed the annual Conflict of Interest in Research Disclosure Form?
Y
You can only select N/A if you are not currently listed on any externally
funded research projects nor listed on any proposals
for externally funded research support.
NOTE: An annual disclosure must be completed by all faculty! staff and students involved in the design,
conduct or reporting of externally funded research applications and awards.
2)
Have your financial interests changed significantly since you completed the annual
N
disclosure form?
The PRINCIPAL INVESTIGATOR certifies that he/she has read the University’s Conflict of Interest Research
Policy and has checked the appropriate box in the ‘Potential Conflict of Interest’ section of the application. In
addition, the PRINCIPAL INVESTIGATOR certifies that, to the best of his/her knowledge, no person working on
this project at SLU has a conflict of interest or if a conflict of interest does exist, that an appropriate management
plan is in place.
According to the Saint Louis University Conflict of Interest in Research Policy, as P1, it is your responsibility to
inform co-investigators, staff, or students involved in the design, conduct, or reporting of externally sponsored
research of their requirement to complete a Conflict of Interest in Research Disclosure Form.
X
I accept this responsibility.
X
The Principal Investigator has read and agrees to the above certifications and will abide
by the above obligations.
* * * Event History
* * *
Event History
Date
Status
View Attachments
Letters
01/13/2020
CONTINUING REVIEW 4
Y
V
FORM APPROVED
Page 39 of 44

e-pnomoccL
PROTOCOL
Protocol#26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
0110812020
CONTINUING REVIEW 4
FORM REVIEWER(S)
ASSIGNED
12/10/2019
CONTINUING REVIEW 4
Y
FORM SUBMITTED
12/03/2019
CONTINUING REVIEW 4
FORM CREATED
10/21/2019
AMENDMENT 11 FORM
Y
Y
APPROVED
10/19/2019
AMENDMENT 11 FORM
REVIEWER(S)
ASSIGNED
10/14/2019
AMENDMENT ii FORM
Y
SUBMITTED
10/14/2019
AMENDMENT ii FORM
-
CREATED
01/10/2019
CONTINUING REVIEW 3
V
V
FORM APPROVED
01/08/2019
CONTINUING REVIEW 3
FORM REVIEWER(S)
ASSIGNED
01/07/2019
CONTINUING REVIEW 3
FORM PANEL
REASSIGNED
01/04/2019
CONTINUING REVIEWS
V
FORM SUBMITTED
12/20/2018
CONTINUING REVIEW 3
FORM CREATED
07/24/2018
AMENDMENT 10 FORM
-.
V
V
APPROVED
07/24/2018
AMENDMENT 10 FORM
REVIEWER(S)
ASSIGNED
07/23/2018
AMENDMENT 10 FORM
Y
SUBMITTED
07123/2018
AMENDMENT 10 FORM
CREATED
05/01/2018
AMENDMENT 9 FORM
V
V
APPROVED
04/30/2018
AMENDMENT 9 FORM
REVIEWER(S)
ASSIGNED
04/23/2018
AMENDMENT 9 FORM
V
SUBMITTED
01/19/2018
AMENDMENT 9 FORM
CREATED
01/19/2018
CONTINUING REVIEW 2
V
V
FORM APPROVED
Page 40 of 44

e-pnoT000L
PROTOCOL
Protocol# 26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
01/18/2018
CONTINUING REVIEW 2
FORM REVIEWER(S)
ASSIGNED
01/16/2018
CONTINUING REVIEW 2
Y
FORM SUBMITTED
(CYCLE 1)
01/11/2018
CONTINUING REVIEW 2
FORM PANEL
MANAGER REVIEW
01/09/2018
CONTINUING REVIEW 2
Y
FORM SUBMITTED
1212212017
CONTINUING REVIEW 2
FORM CREATED
08/10/2017
REPORT 2 FORM
Y
Y
APPROVED
07/21/2017
REPORT 2 FORM
REVIEWER(S)
ASSIGNED
07/20/2017
REPORT 2 FORM
PANEL MANAGER
REVIEW
07/14/2017
REPORT 2 FORM
PANEL REASSIGNED
07/07/2017
REPORT 2 FORM
REVIEWER(S)
ASSIGNED
07/07/2017
REPORT 2 FORM
PANEL MANAGER
REVIEW
07/07/2017
REPORT 2 FORM
PANEL REASSIGNED
07/07/2017
REPORT 2 FORM
PANEL REASSIGNED
07/07/2017
REPORT 2 FORM
PANEL MANAGER
REVIEW
06/26/2017
REPORT 2 FORM
PANEL REASSIGNED
06/26/2017
REPORT 3 FORM
DELETED
06/26/2017
REPORT 3 FORM
RETURNED
06/23/2017
REPORT 3 FORM
Y
SUBMITTED
06/23/2017
REPORT 3 FORM
CREATED
06/22/2017
REPORT 2 FORM
Y
SUBMITTED
Page 41 of44

e-pRoT000L
PROTOCOL
Protocol #26221
Biomedical Research
Veung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evalualion and Surveillance of Treatment
for Infertility and Miscarriage
06/20/2017
REPORT 2 FORM
CREATED
06/1312017
AMENDMENT S FORM
V
Y
APPROVED
06112/2017
AMENDMENT 8 FORM
REVIEWER(S)
ASSIGNED
06/12/2017
AMENDMENTSFORM
Y
SUBMITTED (CYCLE 1)
06/08/2017
AMENDMENTS FORM
PANEL MANAGER
REVIEW
06/08/2017
AMENDMENTS FORM
V
SUBMITTED
06/06/2017
AMENDMENTS FORM
CREATED
05/30/2017
AMENDMENT 7 FORM
V
V
APPROVED
05/26/2017
AMENDMENT 7 FORM
REVIEWER(S)
ASSIGNED
05/23/2017
AMENDMENT 7 FORM
Y
SUBMITTED
05/19/2017
• AMENDMENT 7 FORM
CREATED
02/08/2017
AMENDMENT 6 FORM
V
V
APPROVED
02/07/2017
AMENDMENT 6 FORM
REVIEWER(S)
ASSIGNED
02/03/2017
AMENDMENT 6 FORM
Y
SUBMITTED
01/31/2017
AMENDMENT 6 FORM
CREATED
12/22/2016
CONTINUING REVIEW 1
Y
Y
FORM APPROVED
12/22/2016
CONTINUING REVIEW 1
FORM REVIEWER(S)
ASSIGNED
12/06/2016
CONTINUING REVIEW 1
V
FORM SUBMITTED
11/21/2016
CONTINUINGREVIEW1
FORM CREATED
09/23/2016
AMENDMENT 5 FORM
V
V
APPROVED
09/22/2016
AMENDMENT 5 FORM
REVIEWER(S)
ASSIGNED
Page 42 of 44

e-PRD-I-000L
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
09/20/2016
AMENDMENT 5 FORM
Y
SUBMITTED (CYCLE 1)
09/19)2016
AMENDMENT 5 FORM
PANEL MANAGER
REVIEW
09/16/2016
AMENDMENT 5 FORM
Y
SUBMITtED
09/13/2016
AMENDMENT 5 FORM
CREATED
09/12/2016
AMENDMENT 4 FORM
Y
Y
APPROVED
09/09/2016
AMENDMENT 4 FORM
REVIEWER(S)
ASSIGNED
09/06/2016
AMENDMENT 4 FORM
Y
SUBMITTED
09/06/2016
AMENDMENT 4 FORM
CREATED
05/27/2016
REPORT 1 FORM
Y
Y
APPROVED
05/20/2016
REPORT 1 FORM
REVIEWER(S)
ASSIGNED
05/19/2016
REPORT 1 FORM
V
SUBMITTED
05/19/2016
REPORT 1 FORM
CREATED
04/12/2016
AMENDMENT 3 FORM
V
V
APPROVED
04/1212016
AMENDMENTS FORM
REVIEWER(S)
ASSIGNED
04/07/2016
AMENDMENTS FORM
V
SUB METED
04/07/2016
AMENDMENTS FORM
CREATED
02/24/2016
AMENDMENT 2 FORM
DELETED
02/24/2016
AMENDMENT 2 FORM
CREATED
02/24/2016
AMENDMENT 1 FORM
V
V
APPROVED
02/23/2016
AMENDMENT I FORM
REVIEWER(S)
ASSIGNED
02/18/2016
AMENDMENT 1 FORM
V
SUBMITTED
Page 43 of44

e-ppcmDcaL
PROTOCOL
Protocol #26221
Biomedical Research
Yeung
Saint Louis University
Protocol Title:
Natural Procreative Technology Evaluation and Surveillance of Treatment
for Infertility and Miscarriage
02/17/2016
AMENDMENT 1 FORM
CREATED
02/17/2016
NEW FORM APPROVED
Y
Y
02/16/2016
NEW FORM
REVIEWER(S)
ASSIGNED
02/09/2016
NEW FORM
SUBMITTED (CYCLE 2)
01/27/2016
NEW FORM
Y
SUBMITTED (CYCLE 1)
01/11/2016
NEWFORM
REVIEWER(S)
ASSIGNED
01/04/2016
NEW FORM PANEL
ASSIGNED
12/31/2015
NEW FORM
Y
SUBMITTED
12/28/2015
NEW FORM
P REREVIEWED
12/17/2015
NEW FORM
P REAP P ROVAL
08/3112015
NEW FORM CREATED
Page 44 of 44