NCT01180387|Completed
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Sponsor study identifier
Secondary identifiers
NIH
observational
1,640
1 country
15
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
Actual (reported)Study Completion
January 2015
Actual (reported)The Reproductive Medicine Network (RMN) is a nationwide cooperative network of 7 clinical sites and a data coordination center, and is sponsored in 5 year increments by The Eunice Kennedy Shriver National Institute for Child Health and Human Development (NICHD). The RMN is charged with designing, implementing and publishing high quality clinical research in reproductive medicine. It has been in existence for over 15 years and has performed several seminal clinical trials that have fundamentally changed clinical practice in this field. In addition, many worthy ancillary protocols have been generated and published. It is this latter fact, as well as the continued interest by investigators both inside and outside the RMN for access to DNA or serum samples from the previously performed trials, that has motivated the present investigators to proactively begin a biologic samples repository from the ongoing and pending RMN clinical trials. Ideally, this repository would allow investigators to seamlessly access trial samples for many years into the future, and thus greatly amplify the use of resources and the impact of the RMN.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
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.
August 5, 2010
Actual (reported)August 12, 2010
Actual (reported)September 2010
Date type not reportedThis date has not been verified as actual or estimated.
November 2014
Actual (reported)January 2015
Actual (reported)Proportion of subject who accepted participation
4.2 years
Current patients of the ongoing and future RMN clinical protocols, who consents to participate in this repository.
Contact the study team to confirm eligibility.
University of Alabama Birmingham
Birmingham, Alabama, 35249-7333, United States
University of California, San Francisco
San Francisco, California, 94115, United States
Stanford University Medical Center
Stanford, California, 94305-5317, United States
University of Colorado
Aurora, Colorado, 80045, United States
University of Connecticut
Storrs, Connecticut, 06269, United States
University of Michigan
Ann Arbor, Michigan, 48108, United States
Wayne State University
Detroit, Michigan, 48201, United States
The RMN plans to collect baseline serum samples (5 cc) and DNA for storage and eventual DNA extraction. The whole blood will also be collected by the clinical sites. As part of the RMN effort, pregnancies conceived as part of the study protocols are entered into a pregnancy registry if the subjects consent to be part of the registry. Saliva samples from the child conceived as part of the protocols, as well as the parent from whom the DNA was not collected as part of the original protocols will be collected at that time. The newborn's saliva will be collected with up to 5 saliva sponges, the tips of which are cut off and stored using an Oragene® kit. The adults will be asked to provide 2 cc of saliva, which will be stored with the same kits. These saliva samples will be stored at -20°C. Two of the RMN studies involve assessing semen parameters. As part of this protocol, we anticipate collecting semen samples from male subjects.
Esther Eisenberg, MD, MPH
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Nanette Santoro, MD
University of Colorado, Denver
Peter Casson, MD
University of Vermont
Michael Diamond, MD
Wayne State University
First Submitted
August 5, 2010
First Posted
August 12, 2010
Study Start
September 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2014
The Impact of an Online Stress Management Program on In Vitro Fertilization (IVF) Outcome
Hackensack University
Hackensack, New Jersey, 07601, United States
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
Virginia Commonwealth University, School of Medicine
Richmond, Virginia, 23235, United States
Richard Legro, MD
Pennsylvania State University College of Medicine
William Schlaff, MD
University of Colorado Denver Health Science Center
Gregory Christman, MD
University of Michigan
Christos Coutifaris, MD
University of Pennsylvania
Robert Brzyski, MD, PhD
The University of Texas Health Science Center at San Antonio
Heping Zhang, PhD
Yale University
Study Completion
January 2015
Actual (reported)Last Updated
March 4, 2015
Record last verified: 2015-03
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