NCT00902382|CompletedDMC
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Sponsor study identifier
Secondary identifiers
observational
264
1 country
13
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 27, 2014
Actual (reported)Study Completion
June 27, 2014
Actual (reported)To identify adverse effects of ovulation drugs on pregnancy, including pregnancy loss, fetal teratology and dysmorphology, and infant development up to age 3.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 27, 2014
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
May 13, 2009
Actual (reported)May 15, 2009
Actual (reported)June 27, 2014
Actual (reported)June 27, 2014
Actual (reported)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
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
Infertile women who conceive spontaneously
Infertile women who conceive on various ovulation stimulation medications
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.
University of Alabama Birmingham
Birmingham, Alabama, 35249-7333, United States
Stanford University Medical Center
Stanford, California, 94305-5317, United States
University of Colorado
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06511, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Wayne State University
Detroit, Michigan, 48201, United States
Hackensack University
Hackensack, New Jersey, 07601, United States
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.
Esther Eisenberg, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nanette Santoro, MD
Albert Einstein College of Medicine
Richard Legro, MD
Pennsylvania State University College of Medicine
Robert Brzyski, MD, PhD
The University of Texas Health Science Center at San Antonio
264 participants (actual enrollment reported by the registry).
First Submitted
May 13, 2009
First Posted
May 15, 2009
Study Start
May 2009
Date type not reportedThis date has not been verified as actual or estimated.
Study to Assess the Efficacy and Safety of Three Dosage Strengths of Pulsatile GnRH Delivered From a Iontophoretic Patch Compared to Oral Treatment With Clomiphene or Placebo in Infertile Females
Contact the study team to confirm eligibility.
Carolinas Medical Center
Charlotte, North Carolina, 28232-2861, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, 17033, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78207, United States
University of Vermont
Burlington, Vermont, 05405, United States
Peter Casson, MD
University of Vermont
Michael Diamond, MD
Wayne State University
Heping Zhang, PhD
Yale University
Gregory Christman, MD
University of Michigan
Christos Coutifaris, MD
University of Pennsylvania
William Schlaff, MD
University of Colorado Denver Health Science Center
Primary Completion
June 27, 2014
Actual (reported)Study Completion
June 27, 2014
Actual (reported)Last Updated
February 7, 2018
Record last verified: 2018-02
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Source: ClinicalTrials.gov.
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