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| ID | Type | Description | Link |
|---|---|---|---|
| 5U10HD055925 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
| Penn State University | OTHER |
| University of Colorado, Denver | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subject who accepted participation | 4.2 years |
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Inclusion Criteria:
Exclusion Criteria:
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Current patients of the ongoing and future RMN clinical protocols, who consents to participate in this repository.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama Birmingham | Birmingham | Alabama | 35249-7333 | United States | ||
| University of California, San Francisco |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| University of Michigan |
| OTHER |
| University of Pennsylvania | OTHER |
| University of Texas | OTHER |
| University of Vermont | OTHER |
| Wayne State University | OTHER |
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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.
| Heping Zhang, PhD | Yale University | Study Director |
| San Francisco |
| California |
| 94115 |
| United States |
| Stanford University Medical Center | Stanford | California | 94305-5317 | United States |
| University of Colorado | Aurora | Colorado | 80045 | United States |
| University of Connecticut | Storrs | Connecticut | 06269 | United States |
| University of Michigan | Ann Arbor | Michigan | 48108 | United States |
| Wayne State University | Detroit | Michigan | 48201 | United States |
| Hackensack University | Hackensack | New Jersey | 07601 | United States |
| Carolinas Medical Center | Charlotte | North Carolina | 28232-2861 | United States |
| University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | 73104 | United States |
| Pennsylvania State University College of Medicine | Hershey | Pennsylvania | 17033 | United States |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | 78207 | United States |
| University of Vermont | Burlington | Vermont | 05405 | United States |
| Virginia Commonwealth University, School of Medicine | Richmond | Virginia | 23235 | United States |