Registry of Pregnancies Conceived Following Exposure to Ovulation Stimulation Medications

NCT ID: NCT00902382

Last Updated: 2018-02-07

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

264 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2014-06-27

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Penn State University

OTHER

Sponsor Role collaborator

University of Colorado, Denver

OTHER

Sponsor Role collaborator

University of Michigan

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role collaborator

University of Texas

OTHER

Sponsor Role collaborator

University of Vermont

OTHER

Sponsor Role collaborator

Wayne State University

OTHER

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Heping Zhang

Principal Investigator

Responsibility Role 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

Site Status

Stanford University Medical Center

Stanford, California, United States

Site Status

University of Colorado

Aurora, Colorado, United States

Site Status

Yale University

New Haven, Connecticut, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Wayne State University

Detroit, Michigan, United States

Site Status

Hackensack University

Hackensack, New Jersey, United States

Site Status

Carolinas Medical Center

Charlotte, North Carolina, United States

Site Status

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status

Pennsylvania State University College of Medicine

Hershey, Pennsylvania, United States

Site Status

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

University of Texas Health Science Center at San Antonio

San Antonio, Texas, United States

Site Status

University of Vermont

Burlington, Vermont, United States

Site Status

Countries

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United States

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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