Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infertility
- Sponsor
- Yale University
- Enrollment
- 264
- Locations
- 13
- Primary Endpoint
- The relative risk of structural anomalies
- Status
- Completed
- Last Updated
- 8 years ago
Overview
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 include a patient completed log of prescribed and over the counter medications taken during a normal pregnancy, a review of their pregnancy, delivery, and neonatal records, an exam of the infant within 60 days of birth by a dysmorphologist, and yearly review of infant medical records, growth charts, and a yearly parent administered developmental questionnaire (Ages and Stages) for the first three years of the infant's life.
Investigators
Heping Zhang
Principal Investigator
Yale University
Eligibility Criteria
Inclusion Criteria
- •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 Criteria
- •Unable to comply with the demands of the trial.
Outcomes
Primary Outcomes
The relative risk of structural anomalies
Time Frame: 2009 - 2016
The relative risk of cognitive differences
Time Frame: 2009 - 2016
The relative risk of perceived differences of neuro-developmental milestones
Time Frame: 2009 - 2016
The relative risks of genetic abnormalities identified at birth and within the first 60 days of life
Time Frame: 2009 - 2016
Secondary Outcomes
- 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)
- The rate of pregnancy complications, including pregnancy loss(2009 - 2016)
- Rates of neonatal and infant medical disorders(2009 - 2016)