Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Penn State University
University of Colorado, Denver
University of Michigan
University of Pennsylvania
University of Texas
University of Vermont
Wayne State University
Information provided by (Responsible Party):
Heping Zhang, Yale University
ClinicalTrials.gov Identifier:
NCT00902382
First received: May 13, 2009
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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


Condition
Infertility

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications

Resource links provided by NLM:


Further study details as provided by Yale University:

Primary Outcome Measures:
  • The relative risks of genetic abnormalities identified at birth and within the first 60 days of life [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
  • The relative risk of structural anomalies [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
  • The relative risk of cognitive differences [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
  • The relative risk of perceived differences of neuro-developmental milestones [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The rate of pregnancy complications, including pregnancy loss [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
  • Rates of neonatal and infant medical disorders [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]
  • 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. [ Time Frame: 2009 - 2016 ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Mothers of newborn infants will be asked to consent to the collection of buccal cells from their infants for DNA testing. Fathers will also be asked to provide buccal cells via buccal swab smears, if blood has not been obtained from them in the course of an RMN trial. The DNA specimens will be available for use in other vetted studies to enable study of independent genetic and environmental factors and gene-environment interactions for a broad range of birth defects and infertility.


Estimated Enrollment: 1650
Study Start Date: May 2009
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Infertile women who conceive spontaneously
2
Infertile women who conceive on various ovulation stimulation medications

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00902382

Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35249-7333
United States, California
Stanford University Medical Center
Stanford, California, United States, 94305-5317
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Wayne State University
Detroit, Michigan, United States, 48201
United States, New Jersey
Hackensack University
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
United States, Virginia
Virginia Commonwealth University, School of Medicine
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
Yale University
Penn State University
University of Colorado, Denver
University of Michigan
University of Pennsylvania
University of Texas
University of Vermont
Wayne State University
Investigators
Principal Investigator: Esther Eisenberg, MD, MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Nanette Santoro, MD Albert Einstein College of Medicine of Yeshiva University
Principal Investigator: Richard Legro, MD Pennsylvania State University College of Medicine
Study Director: Robert Brzyski, MD, PhD University of Texas Health Science Center at San Antonio
Study Director: Peter Casson, MD University of Vermont
Principal Investigator: Michael Diamond, MD Wayne State University
Study Director: Heping Zhang, PhD Yale University
Study Director: Gregory Christman, MD University of Michigan
Study Director: Christos Coutifaris, MD University of Pennsylvania
Study Director: William Schlaff, MD University of Colorado Denver Health Science Center
  More Information

Additional Information:
No publications provided

Responsible Party: Heping Zhang, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT00902382     History of Changes
Other Study ID Numbers: RMN-PregReg, RMN Pregnancy Registry
Study First Received: May 13, 2009
Last Updated: July 16, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
Infertility
Ovulation stimulation
Pregnancy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on April 17, 2014