In response to RFA-HD-14-018, we are re-competing for the Data Coordination Center (DCC) as a part of the Cooperative Multicenter Reproductive Medicine Network (RMN) and will be responsible for Study Design, Conduct, Analyses and Publications;Data Management;Site Monitoring;Regulatory Requirements;and Financial Administration as a continuation of our current work. We will participate in a highly cooperative manner and provide vital support to the Clinical Sites and the NICHD in all aspects of the RMN. For example, we will communicate regularly with and report in a timely manner to the NICHD Program Administrators, Steering Committee (SC), Data and Safety Monitoring Board (DSMB), Advisory Board (AB) and RMN investigators;actively participate in all aspects of protocol development;arrange logistics for RMN-related meetings and teleconferences;prepare and distribute meeting and teleconference agendas, minutes, and action items for the RMN committees and boards;conduct site monitoring visits;oversee biospecimen management;monitor adverse events;assist RMN with regulatory requirements;collaborate with study drug and biorepository representatives;provide or coordinate training for study personnel;facilitate data and resource sharing and retrieve the data generated from the RMN samples used by outside investigators;perform data quality control, analysis and reporting;manage the protocol-related costs;and most importantly, initiate and/or collaborate in scientific publications. The RMN has experienced unprecedented productivity, exceeding our goals in many areas. As a key contributor to this success, our DCC "stands tall with the best of the best." The RMN has greatly enjoyed and benefited from our presence and contribution, and vice versa. We have full support from our institution, including world renowned facilities and information technology. We are determined to advance the RMN and NICHD mission for improving infertility treatment, and more broadly, public health policy and practice.

Public Health Relevance

The RMN has an important mission to enhance conception, live birth, and the health of children born to women and men with impaired fertility, and more broadly, to improve public health policy and practice. We at the DCC serve many of the RMN central functions in order to achieve the RMN aims, and hence play a significant role in advancing reproductive sciences and improving the clinical practice for infertility treatment.

Agency
National Institute of Health (NIH)
Institute
Eunice Kennedy Shriver National Institute of Child Health & Human Development (NICHD)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10HD055925-06
Application #
8645852
Study Section
Special Emphasis Panel (ZHD1-DSR-L (50))
Program Officer
De Paolo, Louis V
Project Start
2007-08-24
Project End
2018-11-30
Budget Start
2014-01-15
Budget End
2014-11-30
Support Year
6
Fiscal Year
2014
Total Cost
$3,299,000
Indirect Cost
$399,000
Name
Yale University
Department
Public Health & Prev Medicine
Type
Schools of Medicine
DUNS #
043207562
City
New Haven
State
CT
Country
United States
Zip Code
06520
Brower, Meredith A; Jones, Michelle R; Rotter, Jerome I et al. (2015) Further investigation in europeans of susceptibility variants for polycystic ovary syndrome discovered in genome-wide association studies of Chinese individuals. J Clin Endocrinol Metab 100:E182-6
Legro, Richard S; Brzyski, Robert G; Diamond, Michael P et al. (2014) The Pregnancy in Polycystic Ovary Syndrome II study: baseline characteristics and effects of obesity from a multicenter randomized clinical trial. Fertil Steril 101:258-269.e8
Legro, Richard S; Brzyski, Robert G; Diamond, Michael P et al. (2014) Letrozole versus clomiphene for infertility in the polycystic ovary syndrome. N Engl J Med 371:119-29
Legro, Richard S; Chen, Gang; Kunselman, Allen R et al. (2014) Smoking in infertile women with polycystic ovary syndrome: baseline validation of self-report and effects on phenotype. Hum Reprod 29:2680-6
Huang, Hao; Hansen, Karl R; Factor-Litvak, Pamela et al. (2012) Predictors of pregnancy and live birth after insemination in couples with unexplained or male-factor infertility. Fertil Steril 97:959-67
Legro, Richard S; Kunselman, Allen R; Brzyski, Robert G et al. (2012) The Pregnancy in Polycystic Ovary Syndrome II (PPCOS II) trial: rationale and design of a double-blind randomized trial of clomiphene citrate and letrozole for the treatment of infertility in women with polycystic ovary syndrome. Contemp Clin Trials 33:470-81
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
Aubuchon, Mira; Kunselman, Allen R; Schlaff, William D et al. (2011) Metformin and/or clomiphene do not adversely affect liver or renal function in women with polycystic ovary syndrome. J Clin Endocrinol Metab 96:E1645-9
Krawetz, Stephen A; Casson, Peter R; Diamond, Michael P et al. (2011) Establishing a biologic specimens repository for reproductive clinical trials: technical aspects. Syst Biol Reprod Med 57:222-7

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