Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications

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

Study Overview

• Status: Completed
• Conditions: Infertility

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.

• Study Type: Observational
• Enrollment (Actual): 264

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249-7333
      • University of Alabama Birmingham
  • California
    • Stanford, California, United States, 94305-5317
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Connecticut
    • New Haven, Connecticut, United States, 06511
      • Yale University
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University
  • North Carolina
    • Charlotte, North Carolina, United States, 28232-2861
      • Carolinas Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Pennsylvania State University College of Medicine
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • San Antonio, Texas, United States, 78207
      • University of Texas Health Science Center at San Antonio
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

The population will include women with infertility who receive ovulation stimulation drugs within the context of a Reproductive Medicine Network sponsored trial as well as their infants.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
1; Infertile women who conceive spontaneously
2; Infertile women who conceive on various ovulation stimulation medications

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Time Frame
The rate of pregnancy complications, including pregnancy loss	2009 - 2016
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

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: University of Colorado, Denver; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Pennsylvania; Wayne State University; University of Michigan; University of Vermont; Penn State University; University of Texas
• Investigators: Principal Investigator: Esther Eisenberg, MD, MPH, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); Principal Investigator: Richard Legro, MD, Pennsylvania State University College of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2009
• Primary Completion (Actual): June 27, 2014
• Study Completion (Actual): June 27, 2014

Study Registration Dates

• First Submitted: May 13, 2009
• First Submitted That Met QC Criteria: May 14, 2009
• First Posted (Estimate): May 15, 2009

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 6, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Infertility; Pregnancy; Ovulation stimulation
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: RMN-PregReg; RMN Pregnancy Registry