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 #
5U10HD055925-10
Application #
9392567
Study Section
Special Emphasis Panel (ZHD1)
Program Officer
De Paolo, Louis V
Project Start
2007-08-24
Project End
2018-11-30
Budget Start
2017-12-01
Budget End
2018-11-30
Support Year
10
Fiscal Year
2018
Total Cost
Indirect Cost
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
Diamond, Michael P; Legro, Richard S; Coutifaris, Christos et al. (2017) Sexual function in infertile women with polycystic ovary syndrome and unexplained infertility. Am J Obstet Gynecol 217:191.e1-191.e19
Styer, Aaron K; Jin, Susan; Liu, Dan et al. (2017) Association of uterine fibroids and pregnancy outcomes after ovarian stimulation-intrauterine insemination for unexplained infertility. Fertil Steril 107:756-762.e3
Engmann, Lawrence; Jin, Susan; Sun, Fangbai et al. (2017) Racial and ethnic differences in the polycystic ovary syndrome metabolic phenotype. Am J Obstet Gynecol 216:493.e1-493.e13
Mumford, Sunni L; Legro, Richard S; Diamond, Michael P et al. (2016) Baseline AMH Level Associated With Ovulation Following Ovulation Induction in Women With Polycystic Ovary Syndrome. J Clin Endocrinol Metab 101:3288-96
Pal, Lubna; Zhang, Heping; Williams, Joanne et al. (2016) Vitamin D Status Relates to Reproductive Outcome in Women With Polycystic Ovary Syndrome: Secondary Analysis of a Multicenter Randomized Controlled Trial. J Clin Endocrinol Metab 101:3027-35
Hansen, Karl R; He, Amy Linnea W; Styer, Aaron K et al. (2016) Predictors of pregnancy and live-birth in couples with unexplained infertility after ovarian stimulation-intrauterine insemination. Fertil Steril 105:1575-1583.e2
Hayes, M Geoffrey; Urbanek, Margrit; Ehrmann, David A et al. (2016) Corrigendum: Genome-wide association of polycystic ovary syndrome implicates alterations in gonadotropin secretion in European ancestry populations. Nat Commun 7:10762
Legro, Richard S; Dodson, William C; Kunselman, Allen R et al. (2016) Benefit of Delayed Fertility Therapy With Preconception Weight Loss Over Immediate Therapy in Obese Women With PCOS. J Clin Endocrinol Metab 101:2658-66
Santoro, Nanette; Eisenberg, Esther; Trussell, J C et al. (2016) Fertility-related quality of life from two RCT cohorts with infertility: unexplained infertility and polycystic ovary syndrome. Hum Reprod 31:2268-79
Kuang, Hongying; Jin, Susan; Hansen, Karl R et al. (2015) Identification and replication of prediction models for ovulation, pregnancy and live birth in infertile women with polycystic ovary syndrome. Hum Reprod 30:2222-33

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