Reproductive Medicine Network Biologic Specimen Repository
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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 |
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 |
Current patients of the ongoing and future RMN clinical protocols, who consents to participate in this repository.
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| 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 | |
| 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 | 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: | Yale University |
| ClinicalTrials.gov Identifier: | NCT01180387 History of Changes |
| Other Study ID Numbers: | RMN-Repository, 5U10HD055925 |
| Study First Received: | August 5, 2010 |
| Last Updated: | November 28, 2011 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Infertility Genital Diseases, Male Genital Diseases, Female |
ClinicalTrials.gov processed this record on May 16, 2013