Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications

Completed

• Conditions: Infertility

• Registration Number: NCT00902382
• Lead Sponsor: Yale University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-05-13
• Study First Submitted QC: 2009-05-14
• Study First Posted: 2009-05-15
• Primary Completion: 2014-06-27
• Study Completion: 2014-06-27
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-06
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 264

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.

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Exclusion Criteria

• Unable to comply with the demands of the trial.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (13)

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Pennsylvania State University College of Medicine; 🇺🇸 Hershey, Pennsylvania, United States

University of Texas Health Science Center at San Antonio; 🇺🇸 San Antonio, Texas, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

University of Alabama Birmingham; 🇺🇸 Birmingham, Alabama, United States

Hackensack University; 🇺🇸 Hackensack, New Jersey, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Carolinas Medical Center; 🇺🇸 Charlotte, North Carolina, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States

University of Oklahoma Health Sciences Center; 🇺🇸 Oklahoma City, Oklahoma, United States