Polycystic Ovarian Syndrome (PCOS), a common cause of female infertility, is in many cases associated with insulin resistance. It is often treated by In Vitro Fertilization (IVF), but at IVF, these patients frequently have poor success, because of the effects of hyperinsulinemia on oocyte quality and successful implantation. If so, metformin use at IVF in PCOS patients will improve outcome, with a reduced risk of multiple pregnancy, and will also decrease the costs associated with this reproductive technology. As part of the University of Vermont Reproductive Medicine Network clinical site application, this concept protocol hypothesizes that in PCOS patients, the addition of metformin to the process of IVF will improve oocyte maturity, fertilization rates, implantation and pregnancy rates, and after pregnancy is established, continued metformin use will reduce the rate of embryonic loss, as well as adverse obstetric outcomes later in gestation. To address this issue, this application proposes a 500 subject multicenter, three arm, and randomized, blinded clinical trial, giving metformin both for 3 months prior and during the IVF cycle, and assessing oocyte and embryo quality. Further, the proposal continues the metformin or placebo through the first 12 weeks of gestation to assess the potential beneficial effect reducing embryonic loss. If this hypothesis is proven true, metformin administration at IVF would represent a novel and inexpensive way of optimizing IVF cycles in PCOS patients, allowing for a reduction in costs and number of embryos transferred, thus decreasing multiple pregnancy rates, while increasing the success of this procedure The strength of this concept protocol, combined with the inherent strengths of the reproductive medicine endeavor at the University of Vermont, as outlined in this application, illustrate the suitability of this institution as a clinical site for the Reproductive Medicine Network.

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 #
5U10HD055944-05
Application #
8130789
Study Section
Special Emphasis Panel (ZHD1-DSR-A (08))
Program Officer
De Paolo, Louis V
Project Start
2007-08-24
Project End
2013-07-31
Budget Start
2011-08-01
Budget End
2013-07-31
Support Year
5
Fiscal Year
2011
Total Cost
$319,065
Indirect Cost
Name
University of Vermont & St Agric College
Department
Obstetrics & Gynecology
Type
Schools of Medicine
DUNS #
066811191
City
Burlington
State
VT
Country
United States
Zip Code
05405
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
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
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
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
Hayes, M Geoffrey; Urbanek, Margrit; Ehrmann, David A et al. (2015) Genome-wide association of polycystic ovary syndrome implicates alterations in gonadotropin secretion in European ancestry populations. Nat Commun 6:7502
Diamond, Michael P; Legro, Richard S; Coutifaris, Christos et al. (2015) Letrozole, Gonadotropin, or Clomiphene for Unexplained Infertility. N Engl J Med 373:1230-40
Usadi, Rebecca S; Diamond, Michael P; Legro, Richard S et al. (2015) Recruitment strategies in two reproductive medicine network infertility trials. Contemp Clin Trials 45:196-200

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