Disorders of the reproductive system, such as male and female infertility, leiomyomata, endometriosis, polycystic ovarian syndrome, and sexual dysfunction, have a major public health and economic impact. For some conditions, such as infertility, many patients are responsible for all costs associated with therapy, and unintended consequences, such as multiple gestations, are relatively common. For other conditions, such as endometriosis or leiomyomata, definitive therapy may result in the loss of childbearing potential, and long-term evidence about alternatives is scant. Relatively few interventions for these disorders have subjected to rigorous scientific evaluation. The long-term objective of this project is to improve the care of men and women with disorders affecting the reproductive system by conducting controlled trials of selected diagnostic and therapeutic interventions.
The specific aims of the Data Coordinating Center (DCC) for the Cooperative Reproductive Medicine Network are (A) to develop trial protocols that address important clinical problems using scientifically valid, clinically feasible, and economically reasonable approaches through collaboration with participating Reproductive Medicine Units (RMUs) and NICHD staff, (B) to provide leadership in defining and measuring a range of important outcomes, including physiological measurements, clinical outcomes, and economic and quality of life measures, (C) to coordinate and/or provide all services necessary for conducting trials, including recruiting services, and quality control, and (D) to coordinate the analysis, reporting, and dissemination of trial results to the Data Safety and Monitoring Committee, the RMUs, NICHD, peer-reviewed journals, and the public.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Research Project--Cooperative Agreements (U01)
Project #
1U01HD038997-01
Application #
6132646
Study Section
Special Emphasis Panel (ZHD1-DRG-D (05))
Program Officer
Parrott, Estella C
Project Start
2000-03-10
Project End
2005-02-28
Budget Start
2000-03-10
Budget End
2001-02-28
Support Year
1
Fiscal Year
2000
Total Cost
$348,982
Indirect Cost
Name
Duke University
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
071723621
City
Durham
State
NC
Country
United States
Zip Code
27705
Leach, Richard E; Jessmon, Philip; Coutifaris, Christos et al. (2012) High throughput, cell type-specific analysis of key proteins in human endometrial biopsies of women from fertile and infertile couples. Hum Reprod 27:814-28
Diamond, Michael P; Kruger, Michael; Santoro, Nanette et al. (2012) Endometrial shedding effect on conception and live birth in women with polycystic ovary syndrome. Obstet Gynecol 119:902-8
Jones, Michelle R; Chua, Angela K; Mengesha, Emebet A et al. (2012) Metabolic and cardiovascular genes in polycystic ovary syndrome: a candidate-wide association study (CWAS). Steroids 77:317-22
Pagidas, Kelly; Carson, Sandra A; McGovern, Peter G et al. (2010) Intercourse compliance, ovulation, and treatment success in the National Institute of Child Health and Human Development-Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome (PPCOS) Trial. Fertil Steril 94:1444-6
Legro, Richard S; Schlaff, William D; Diamond, Michael P et al. (2010) Total testosterone assays in women with polycystic ovary syndrome: precision and correlation with hirsutism. J Clin Endocrinol Metab 95:5305-13
Pagidas, Kelly; Carson, Sandra A; McGovern, Peter G et al. (2010) Body mass index and intercourse compliance. Fertil Steril 94:1447-50
Rausch, Mary E; Legro, Richard S; Barnhart, Huiman X et al. (2009) Predictors of pregnancy in women with polycystic ovary syndrome. J Clin Endocrinol Metab 94:3458-66
Legro, Richard S; Barnhart, Huiman X; Schlaff, William D et al. (2008) Ovulatory response to treatment of polycystic ovary syndrome is associated with a polymorphism in the STK11 gene. J Clin Endocrinol Metab 93:792-800
Cataldo, Nicholas A; Barnhart, Huiman X; Legro, Richard S et al. (2008) Extended-release metformin does not reduce the clomiphene citrate dose required to induce ovulation in polycystic ovary syndrome. J Clin Endocrinol Metab 93:3124-7
McGovern, Peter G; Carson, Sandra A; Barnhart, Huiman X et al. (2008) Medication adherence and treatment success in the National Institute of Child Health and Human Development-Reproductive Medicine Network's Pregnancy in Polycystic Ovary Syndrome Trial. Fertil Steril 90:1283-6

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