Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications
NCT ID: NCT00902382
Last Updated: 2018-02-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
264 participants
OBSERVATIONAL
2009-05-31
2014-06-27
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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1
Infertile women who conceive spontaneously
No interventions assigned to this group
2
Infertile women who conceive on various ovulation stimulation medications
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* History of infertility meeting female subject entry criteria for a RMN trial;
* Informed consent.
Exclusion Criteria
18 Years
40 Years
FEMALE
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Penn State University
OTHER
University of Colorado, Denver
OTHER
University of Michigan
OTHER
University of Pennsylvania
OTHER
University of Texas
OTHER
University of Vermont
OTHER
Wayne State University
OTHER
Yale University
OTHER
Responsible Party
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Heping Zhang
Principal Investigator
Principal Investigators
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Esther Eisenberg, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nanette Santoro, MD
Role: STUDY_CHAIR
Albert Einstein College of Medicine
Richard Legro, MD
Role: PRINCIPAL_INVESTIGATOR
Pennsylvania State University College of Medicine
Robert Brzyski, MD, PhD
Role: STUDY_DIRECTOR
The University of Texas Health Science Center at San Antonio
Peter Casson, MD
Role: STUDY_DIRECTOR
University of Vermont
Michael Diamond, MD
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Heping Zhang, PhD
Role: STUDY_DIRECTOR
Yale University
Gregory Christman, MD
Role: STUDY_DIRECTOR
University of Michigan
Christos Coutifaris, MD
Role: STUDY_DIRECTOR
University of Pennsylvania
William Schlaff, MD
Role: STUDY_DIRECTOR
University of Colorado Denver Health Science Center
Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
University of Michigan
Ann Arbor, Michigan, United States
Wayne State University
Detroit, Michigan, United States
Hackensack University
Hackensack, New Jersey, United States
Carolinas Medical Center
Charlotte, North Carolina, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States
University of Vermont
Burlington, Vermont, United States
Countries
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Other Identifiers
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RMN Pregnancy Registry
Identifier Type: -
Identifier Source: secondary_id
RMN-PregReg
Identifier Type: -
Identifier Source: org_study_id
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