Reproductive Medicine Network Biologic Specimen Repository

Infertility Clinical Trial

Official title:

Reproductive Medicine Network Biologic Specimen Repository

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180387
• Other study ID #: RMN-Repository
• Secondary ID: 5U10HD055925
• Status: Completed
• Phase: N/A
• First received: August 5, 2010
• Last updated: March 2, 2015
• Start date: September 2010
• Est. completion date: January 2015

Study information

• Verified date: March 2015
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1640
• Est. completion date: January 2015
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Any subject of an RMN clinical trial and consents to participate in the repository is eligible for inclusion.

Exclusion Criteria:

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Infertility

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado	Aurora	Colorado
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	University of Vermont	Burlington	Vermont
United States	Carolinas Medical Center	Charlotte	North Carolina
United States	Wayne State University	Detroit	Michigan
United States	Hackensack University	Hackensack	New Jersey
United States	Pennsylvania State University College of Medicine	Hershey	Pennsylvania
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Virginia Commonwealth University, School of Medicine	Richmond	Virginia
United States	University of Texas Health Science Center at San Antonio	San Antonio	Texas
United States	University of California, San Francisco	San Francisco	California
United States	Stanford University Medical Center	Stanford	California
United States	University of Connecticut	Storrs	Connecticut

Sponsors (9)

Lead Sponsor	Collaborator
Yale University	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Penn State University, University of Colorado, Denver, University of Michigan, University of Pennsylvania, University of Texas, University of Vermont, Wayne State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subject who accepted participation		4.2 years	No