Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
2 other identifiers
observational
264
1 country
13
Brief Summary
To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Longer than P75 for all trials
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 13, 2009
CompletedFirst Posted
Study publicly available on registry
May 15, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 27, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 27, 2014
CompletedFebruary 7, 2018
February 1, 2018
5.2 years
May 13, 2009
February 6, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
The relative risks of genetic abnormalities identified at birth and within the first 60 days of life
2009 - 2016
The relative risk of structural anomalies
2009 - 2016
The relative risk of cognitive differences
2009 - 2016
The relative risk of perceived differences of neuro-developmental milestones
2009 - 2016
Secondary Outcomes (3)
The rate of pregnancy complications, including pregnancy loss
2009 - 2016
Rates of neonatal and infant medical disorders
2009 - 2016
Rates of infant growth related to use of letrozole for stimulation of ovulation compared to other treatment modalities for ovulation stimulation, including compared to women who conceive spontaneously.
2009 - 2016
Study Arms (2)
1
Infertile women who conceive spontaneously
2
Infertile women who conceive on various ovulation stimulation medications
Eligibility Criteria
The population will include women with infertility who receive ovulation stimulation drugs within the context of a Reproductive Medicine Network sponsored trial as well as their infants.
You may qualify if:
- Positive serum hCG within the context of a RMN trial;
- History of infertility meeting female subject entry criteria for a RMN trial;
- Informed consent.
You may not qualify if:
- Unable to comply with the demands of the trial.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)collaborator
- Penn State Universitycollaborator
- University of Colorado, Denvercollaborator
- University of Michigancollaborator
- University of Pennsylvaniacollaborator
- University of Texascollaborator
- University of Vermontcollaborator
- Wayne State Universitycollaborator
Study Sites (13)
University of Alabama Birmingham
Birmingham, Alabama, 35249-7333, United States
Stanford University Medical Center
Stanford, California, 94305-5317, United States
University of Colorado
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06511, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
Hackensack University
Hackensack, New Jersey, 07601, United States
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207, United States
University of Vermont
Burlington, Vermont, 05405, United States
Biospecimen
Mothers of newborn infants will be asked to consent to the collection of buccal cells from their infants for DNA testing. Fathers will also be asked to provide buccal cells via buccal swab smears, if blood has not been obtained from them in the course of an RMN trial. The DNA specimens will be available for use in other vetted studies to enable study of independent genetic and environmental factors and gene-environment interactions for a broad range of birth defects and infertility.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Esther Eisenberg, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- STUDY CHAIR
Nanette Santoro, MD
Albert Einstein College of Medicine
- PRINCIPAL INVESTIGATOR
Richard Legro, MD
Pennsylvania State University College of Medicine
- STUDY DIRECTOR
Robert Brzyski, MD, PhD
The University of Texas Health Science Center at San Antonio
- STUDY DIRECTOR
Peter Casson, MD
University of Vermont
- PRINCIPAL INVESTIGATOR
Michael Diamond, MD
Wayne State University
- STUDY DIRECTOR
Heping Zhang, PhD
Yale University
- STUDY DIRECTOR
Gregory Christman, MD
University of Michigan
- STUDY DIRECTOR
Christos Coutifaris, MD
University of Pennsylvania
- STUDY DIRECTOR
William Schlaff, MD
University of Colorado Denver Health Science Center
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 13, 2009
First Posted
May 15, 2009
Study Start
May 1, 2009
Primary Completion
June 27, 2014
Study Completion
June 27, 2014
Last Updated
February 7, 2018
Record last verified: 2018-02