Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications

Infertility Clinical Trial

Official title:

Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00902382
• Other study ID #: RMN-PregReg
• Secondary ID: RMN Pregnancy Re
• Status: Completed
• Phase: N/A
• First received: May 13, 2009
• Last updated: February 6, 2018
• Start date: May 2009
• Est. completion date: June 27, 2014

Study information

• Verified date: February 2018
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 264
• Est. completion date: June 27, 2014
• Est. primary completion date: June 27, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	University of Vermont	Burlington	Vermont
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Wayne State University	Detroit	Michigan
United States	Hackensack University	Hackensack	New Jersey
United States	Pennsylvania State University College of Medicine	Hershey	Pennsylvania
United States	Yale University	New Haven	Connecticut
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	Stanford University Medical Center	Stanford	California

Sponsors (9)

Lead Sponsor	Collaborator
Yale University	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The relative risks of genetic abnormalities identified at birth and within the first 60 days of life		2009 - 2016
Primary	The relative risk of structural anomalies		2009 - 2016
Primary	The relative risk of cognitive differences		2009 - 2016
Primary	The relative risk of perceived differences of neuro-developmental milestones		2009 - 2016
Secondary	The rate of pregnancy complications, including pregnancy loss		2009 - 2016
Secondary	Rates of neonatal and infant medical disorders		2009 - 2016
Secondary	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