This trial is active, not recruiting.

Condition infertility
Sponsor Yale University
Collaborator Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Start date May 2009
End date December 2016
Trial size 1650 participants
Trial identifier NCT00902382, RMN Pregnancy Registry, RMN-PregReg


To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Infertile women who conceive spontaneously
Infertile women who conceive on various ovulation stimulation medications

Primary Outcomes

The relative risks of genetic abnormalities identified at birth and within the first 60 days of life
time frame: 2009 - 2016
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

Secondary Outcomes

The rate of pregnancy complications, including pregnancy loss
time frame: 2009 - 2016
Rates of neonatal and infant medical disorders
time frame: 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.
time frame: 2009 - 2016

Eligibility Criteria

Female participants from 18 years up to 40 years old.

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.

Additional Information

Official title Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
Principal investigator Esther Eisenberg, MD, MPH
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Yale University.