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）是女性不孕症的常见原因，在许多情况下与胰岛素抵抗有关。它通常通过体外受精（IVF）治疗，但在体外受精时，由于高胰岛素血症对卵母细胞质量和成功着床的影响，这些患者往往成功率不高。如果是这样，二甲双胍用于多囊卵巢综合征患者的体外受精将改善结果，降低多胎妊娠的风险，也将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现场应用的一部分，该概念方案假设PCOS患者在体外受精过程中添加二甲双胍可以提高卵母细胞成熟度、受精率、着床率和妊娠率，并且在确定妊娠后，继续使用二甲双胍可以降低胚胎损失率，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名受试者的多中心、三臂、随机、盲法临床试验，在试管婴儿周期前和周期中给予二甲双胍3个月，并评估卵母细胞和胚胎质量。此外，该建议在妊娠前12周继续使用二甲双胍或安慰剂，以评估减少胚胎丢失的潜在有益效果。如果这一假设被证明是正确的，那么二甲双胍在体外受精中的应用将代表一种新颖而廉价的方法，可以优化PCOS患者的体外受精周期，从而降低成本和胚胎移植数量，从而降低多胎妊娠率，同时提高这一过程的成功率。这一概念方案的优势，结合佛蒙特大学生殖医学努力的固有优势，在本应用中概述。说明该机构作为生殖医学网络临床站点的适宜性。

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.