Reproductive Medicine Network Biologic Specimen Repository

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
Penn State University
University of Colorado, Denver
University of Michigan
University of Pennsylvania
University of Texas
University of Vermont
Wayne State University
Information provided by (Responsible Party):
Heping Zhang, Yale University
ClinicalTrials.gov Identifier:
NCT01180387
First received: August 5, 2010
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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.


Condition
Infertility

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Reproductive Medicine Network Biologic Specimen Repository

Resource links provided by NLM:


Further study details as provided by Yale University:

Biospecimen Retention:   Samples With DNA

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.


Estimated Enrollment: 3682
Study Start Date: September 2010
Estimated Study Completion Date: November 2013
Estimated Primary Completion Date: November 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01180387

Locations
United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 35249-7333
United States, California
University of California, San Francisco
San Francisco, California, United States, 94115
Stanford University Medical Center
Stanford, California, United States, 94305-5317
United States, Colorado
University of Colorado
Aurora, Colorado, United States, 80045
United States, Connecticut
University of Connecticut
Storrs, Connecticut, United States, 06269
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48108
Wayne State University
Detroit, Michigan, United States, 48201
United States, New Jersey
Hackensack University
Hackensack, New Jersey, United States, 07601
United States, North Carolina
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, Pennsylvania
Pennsylvania State University College of Medicine
Hershey, Pennsylvania, United States, 17033
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78207
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05405
United States, Virginia
Virginia Commonwealth University, School of Medicine
Richmond, Virginia, United States, 23235
Sponsors and Collaborators
Yale University
Penn State University
University of Colorado, Denver
University of Michigan
University of Pennsylvania
University of Texas
University of Vermont
Wayne State University
Investigators
Study Director: Esther Eisenberg, MD, MPH Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study Chair: Nanette Santoro, MD University of Colorado, Denver
Principal Investigator: Peter Casson, MD University of Vermont
Study Director: Michael Diamond, MD Wayne State University
Study Director: Richard Legro, MD Pennsylvania State University College of Medicine
Study Director: William Schlaff, MD University of Colorado Denver Health Science Center
Study Director: Gregory Christman, MD University of Michigan
Study Director: Christos Coutifaris, MD University of Pennsylvania
Study Director: Robert Brzyski, MD, PhD The University of Texas Health Science Center at San Antonio
Study Director: Heping Zhang, PhD Yale University
  More Information

Additional Information:
No publications provided

Responsible Party: Heping Zhang, Principal Investigator, Yale University
ClinicalTrials.gov Identifier: NCT01180387     History of Changes
Other Study ID Numbers: RMN-Repository, 5U10HD055925
Study First Received: August 5, 2010
Last Updated: October 23, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on July 28, 2014