Clinical trial NCT01180387: Reproductive Medicine Network Biologic Specimen Repository
Official title: Reproductive Medicine Network Biologic Specimen Repository
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Penn State University
name: University of Colorado, Denver
name: University of Michigan
name: University of Pennsylvania
name: University of Texas
name: University of Vermont
name: Wayne State University
First posted: 2010-08-12
Enrollment: 1640
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Current patients of the ongoing and future RMN clinical protocols, who consents to participate in this repository.

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.


Eligibility 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

Primary outcomes:
measure: Proportion of subject who accepted participation
timeFrame: 4.2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Birmingham
state: Alabama
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
city: Hackensack
country: United States
facility: Hackensack University
state: New Jersey
city: Charlotte
country: United States
facility: Carolinas Medical Center
state: North Carolina
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
city: Hershey
country: United States
facility: Pennsylvania State University College of Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Richmond
country: United States
facility: Virginia Commonwealth University, School of Medicine
state: Virginia
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Esther Eisenberg, MD, MPH
role: STUDY_DIRECTOR
affiliation: University of Colorado, Denver
name: Nanette Santoro, MD
role: STUDY_CHAIR
affiliation: University of Vermont
name: Peter Casson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Michael Diamond, MD
role: STUDY_DIRECTOR
affiliation: Pennsylvania State University College of Medicine
name: Richard Legro, MD
role: STUDY_DIRECTOR
affiliation: University of Colorado Denver Health Science Center
name: William Schlaff, MD
role: STUDY_DIRECTOR
affiliation: University of Michigan
name: Gregory Christman, MD
role: STUDY_DIRECTOR
affiliation: University of Pennsylvania
name: Christos Coutifaris, MD
role: STUDY_DIRECTOR
affiliation: The University of Texas Health Science Center at San Antonio
name: Robert Brzyski, MD, PhD
role: STUDY_DIRECTOR
affiliation: Yale University
name: Heping Zhang, PhD
role: STUDY_DIRECTOR
References: