Status:
COMPLETED
Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
Lead Sponsor:
Yale University
Collaborating Sponsors:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Penn State University
Conditions:
Infertility
Eligibility:
FEMALE
18-40 years
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.
Detailed Description
This will be an observational cohort trial of the pregnancy of women who conceive in RMN trials, and of their resulting infants through the first 3 years of life. Study specific procedures will inclu...
Eligibility Criteria
Inclusion
- Positive serum hCG within the context of a RMN trial;
- History of infertility meeting female subject entry criteria for a RMN trial;
- Informed consent.
Exclusion
- Unable to comply with the demands of the trial.
Key Trial Info
Start Date :
May 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 27 2014
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT00902382
Start Date
May 1 2009
End Date
June 27 2014
Last Update
February 7 2018
Active Locations (13)
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1
University of Alabama Birmingham
Birmingham, Alabama, United States, 35249-7333
2
Stanford University Medical Center
Stanford, California, United States, 94305-5317
3
University of Colorado
Aurora, Colorado, United States, 80045
4
Yale University
New Haven, Connecticut, United States, 06511