Metformin Use During in Vitro Fertilization in Polycystic Ovary Syndrome

描述（由申请人提供）：多囊卵巢综合征（PCOS）是女性不孕的常见原因，在许多情况下与胰岛素抵抗有关。它通常通过体外受精（IVF）进行治疗，但在IVF中，这些患者通常成功率不高，因为高胰岛素血症对卵母细胞质量和成功植入的影响。如果是这样，在PCOS患者的IVF中使用二甲双胍将改善结局，降低多胎妊娠的风险，并降低与这种生殖技术相关的成本。作为佛蒙特大学生殖医学网络临床站点应用的一部分，该概念方案假设在PCOS患者中，在IVF过程中添加二甲双胍将改善卵母细胞成熟度，受精率，植入率和妊娠率，并且在妊娠建立后，继续使用二甲双胍将降低胚胎丢失率，以及妊娠后期的不良产科结局。为了解决这一问题，本申请提出了一项500例受试者的多中心、三组、随机、盲法临床试验，在IVF周期前和IVF周期期间给予二甲双胍3个月，并评估卵母细胞和胚胎质量。此外，该提案继续二甲双胍或安慰剂通过妊娠的前12周，以评估减少胚胎损失的潜在有益作用。如果这一假设被证明是正确的，在IVF时给予二甲双胍将代表一种优化PCOS患者IVF周期的新颖且廉价的方法，可以降低成本和移植胚胎的数量，从而降低多胎妊娠率，同时增加该程序的成功率。如本申请中所述，说明该机构作为生殖医学网络临床研究中心的适用性。

DESCRIPTION (provided by applicant): 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.