Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications

Yale University

Status: Completed

Conditions: Infertility

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00902382

RMN Pregnancy Registry

RMN-PregReg

Details and patient eligibility

About

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

Full 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.

Enrollment: 264 patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

264 participants in 2 patient groups

1

Description:

Infertile women who conceive spontaneously

2

Description:

Infertile women who conceive on various ovulation stimulation medications