Infertility
Conditions
Keywords
Infertility, Ovulation stimulation, Pregnancy
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.
Interventions
None listed
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Penn State University
University of Colorado, Denver
University of Michigan
University of Pennsylvania
University of Texas
University of Vermont
Wayne State University
Yale University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
| The rate of pregnancy complications, including pregnancy loss | 2009 - 2016 |
Countries
United States
Outcome results
None listed