Reproductive Medicine Network Biologic Specimen Repository

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.

Study Overview

• Status: Completed
• Conditions: Infertility

• Study Type: Observational
• Enrollment (Anticipated): 1640

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249-7333
      • University of Alabama Birmingham
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco
    • Stanford, California, United States, 94305-5317
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado
  • Connecticut
    • Storrs, Connecticut, United States, 06269
      • University of Connecticut
  • Michigan
    • Ann Arbor, Michigan, United States, 48108
      • University of Michigan
    • Detroit, Michigan, United States, 48201
      • Wayne State University
  • New Jersey
    • Hackensack, New Jersey, United States, 07601
      • Hackensack University
  • North Carolina
    • Charlotte, North Carolina, United States, 28232-2861
      • Carolinas Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • University of Oklahoma Health Sciences Center
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Pennsylvania State University College of Medicine
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • San Antonio, Texas, United States, 78207
      • University of Texas Health Science Center at San Antonio
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont
  • Virginia
    • Richmond, Virginia, United States, 23235
      • Virginia Commonwealth University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Current patients of the ongoing and future RMN clinical protocols, who consents to participate in this repository.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• N/A

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of subject who accepted participation	4.2 years

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: University of Colorado, Denver; Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); University of Pennsylvania; Wayne State University; University of Michigan; University of Vermont; Penn State University; University of Texas
• Investigators: Study Chair: Nanette Santoro, MD, University of Colorado, Denver; Study Director: Michael Diamond, MD, Wayne State University; Principal Investigator: Peter Casson, MD, University of Vermont

Study record dates

Study Major Dates

• Study Start: September 1, 2010
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): January 1, 2015

Study Registration Dates

• First Submitted: August 5, 2010
• First Submitted That Met QC Criteria: August 10, 2010
• First Posted (Estimate): August 12, 2010

Study Record Updates

• Last Update Posted (Estimate): March 4, 2015
• Last Update Submitted That Met QC Criteria: March 2, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: RMN-Repository; 5U10HD055925 (U.S. NIH Grant/Contract)