Reproductive Medicine Network Biologic Specimen Repository

NCT01180387 | Completed

• 2 other identifiers: RMN-Repository5U10HD055925
• Study Type: observational
• Target: 1,640
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Proportion of subject who accepted participation

  4.2 years

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Yale University: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• Penn State University: collaborator
• University of Colorado, Denver: collaborator
• University of Michigan: collaborator
• University of Pennsylvania: collaborator
• University of Texas: collaborator
• University of Vermont: collaborator
• Wayne State University: collaborator

Study Sites (15)

University of Alabama Birmingham

Birmingham, Alabama, 35249-7333, United States

Location

University of California, San Francisco

San Francisco, California, 94115, United States

Location

Stanford University Medical Center

Stanford, California, 94305-5317, United States

Location

University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Connecticut

Storrs, Connecticut, 06269, United States

Location

University of Michigan

Ann Arbor, Michigan, 48108, United States

Location

Wayne State University

Detroit, Michigan, 48201, United States

Location

Hackensack University

Hackensack, New Jersey, 07601, United States

Location

Carolinas Medical Center

Charlotte, North Carolina, 28232-2861, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Pennsylvania State University College of Medicine

Hershey, Pennsylvania, 17033, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

University of Texas Health Science Center at San Antonio

San Antonio, Texas, 78207, United States

Location

University of Vermont

Burlington, Vermont, 05405, United States

Location

Virginia Commonwealth University, School of Medicine

Richmond, Virginia, 23235, United States

Location

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.

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Esther Eisenberg, MD, MPH

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  STUDY DIRECTOR

• Nanette Santoro, MD

  University of Colorado, Denver

  STUDY CHAIR

• Peter Casson, MD

  University of Vermont

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Week
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 5, 2010
• First Posted: August 12, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2014
• Study Completion: January 1, 2015
• Last Updated: March 4, 2015

Record last verified: 2015-03

Locations

US (15)