Technologic advancements allowing the early, nonsurgical diagnosis of ectopic pregnancy prompted the initiation of medical therapy for ectopic pregnancy. The medical regimens became popularized without efficacy assessment or rigid criteria for the limitations of usage. In May, 1999 the Reproductive Medicine Network initiated a pilot protocol to 1) compare the efficacy of single dose methotrexate and multiple dose methotrexate in the treatment of ectopic pregnancy and 2) determine the limitations of usage for each protocol. The Principal Investigator of this application is the principal author of the prospective randomized trial for this project, a project well suited for the multicenter network because of its importance to public health and its need for a large number of subjects due to the expected small differences in efficacy. As a Reproductive Medicine Network member for 10 years, the Principal Investigator and Co-Investigator have had a major role in the two completed network studies. We contributed 225 subjects or 24 percent of the total, to the project, """"""""Randomized Treatment of Unexplained Infertility"""""""", with 32 percent of the resultant pregnancies.' A comparable number were recruited for the """"""""Evaluation of Semen Parameters in Fertile Males"""""""". Our institution is especially well positioned to contribute to the newest initiated network-wide study, """"""""The Evaluation of the Luteal Phase in Fertile and Infertile Women"""""""" because the faculty at Baylor is responsible for 3 hospitals (1 public; 2 private) in the nation's largest concentration of health care facilities-the Texas Medical Center. In part, for this reason, the ectopic pilot study initiated only 6 weeks ago, is already 40 percent completed and ahead of the recruitment schedule. In addition, one of the largest male reproductive units (Dr. Larry Lipshultz) complements our 3 Reproductive Endocrinologists, 2 Reproductive Geneticists, and 4 Gynecologists. Our experience in the Reproductive Medical Network has enabled us to collaborate with the other clinical centers and data collection center in designing prospective clinical trials to test hypothesis relevant to clinical medicine. We acknowledge and accept first hand the loss of autonomy necessary to represent the collective wisdom of the several institutions participating in a multicenter effort. However, the gains are substantial to the scientific community -and long awaited in our field in particular.

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 #
5U10HD027011-16
Application #
6747952
Study Section
Special Emphasis Panel (ZHD1-DRG-D (05))
Program Officer
Parrott, Estella C
Project Start
2000-04-01
Project End
2007-03-31
Budget Start
2004-04-01
Budget End
2007-03-31
Support Year
16
Fiscal Year
2004
Total Cost
$503,447
Indirect Cost
Name
Baylor College of Medicine
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
051113330
City
Houston
State
TX
Country
United States
Zip Code
77030
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
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
Roth, Lauren W; Huang, Hao; Legro, Richard S et al. (2012) Altering hirsutism through ovulation induction in women with polycystic ovary syndrome. Obstet Gynecol 119:1151-6
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
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

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