Pre-IVF treatment with a GnRH antagonist in women with endometriosis - A prospective double blind placebo controlled trial (Pregnant)

子宫内膜异位症女性体外受精前使用 GnRH 拮抗剂治疗——一项前瞻性双盲安慰剂对照试验（孕妇）

• 批准号: 10834508
• 负责人: STEVEN L YOUNG
• 金额: $ 17.39万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-09-26 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10834508
• 关键词: Pre; IVF; treatment; GnRH; antagonist

Abstract Infertility is a common complication of endometriosis; while IVF successfully treats endometriosis- associated infertility, pregnancy rates are diminished compared to other etiologies of infertility. Our long- term objectives are to better identify and treat endometriosis related infertility. Our central hypothesis is that in infertile woman with endometriosis undergoing in vitro fertilization- embryo transfer (IVF-ET), live birth rates will improve in those pretreated with GnRH antagonist compared to placebo. The use of gonadotropin releasing hormone (GnRH) agonist prior to IVF has been suggested to improve success, however studies have been small and rarely reported live birth rates. Further, use of this approach is limited by the long treatment time required. Recent approval of an oral GnRH antagonist for endometriosis provides a novel option for women with endometriosis who are undergoing IVF. This agent avoids parenteral administration and the prolonged delay in initiation of action as was seen with GnRH agonists. There have been no studies on the efficacy of GnRH antagonists for the treatment of endometriosis-related infertility. We propose a randomized clinical trial of oral GnRH antagonist pre-treatment for women with endometriosis who are undergoing IVF, with a primary outcome of live birth rate. We have also recently demonstrated aberrant microRNAs in the circulation of women with endometriosis, a panel of which we have subsequently validated as a biomarker with high sensitivity and specificity for the detection of active disease. We secondarily propose that disease biomarkers will identify women who will benefit from GnRH antagonist pre-treatment, allowing a precision medicine approach to endometriosis-related infertility. The proposed study is significant due to the common occurrence of both infertility and endometriosis as well as the lack of precision in both diagnosis and therapy. We use an innovative approach to identify endometriosis as well as a novel intervention designed to improve the prognosis of women with endometriosis undergoing IVF.

抽象的 不孕是子宫内膜异位症的常见并发症；而IVF成功治疗子宫内膜异位症- 与其他不孕病因相比，妊娠率降低。 我们的长期目标是更好地识别和治疗子宫内膜异位症相关的不孕症。我们的 中心假设是，患有子宫内膜异位症的不孕妇女接受体外受精- 胚胎移植 (IVF-ET)，接受 GnRH 拮抗剂预处理的患者的活产率将会提高 与安慰剂相比。 IVF 前使用促性腺激素释放激素 (GnRH) 激动剂 有人建议提高成功率，但研究规模较小且很少报道 活产率。此外，该方法的使用受到所需长治疗时间的限制。最近的 口服 GnRH 拮抗剂治疗子宫内膜异位症的批准为患有子宫内膜异位症的女性提供了一种新的选择 正在接受 IVF 的子宫内膜异位症患者。该药物避免了肠胃外给药，并且 与 GnRH 激动剂一样，作用开始延迟较长。没有出现过 GnRH拮抗剂治疗子宫内膜异位症相关不孕症的疗效研究。 我们提出一项针对女性口服 GnRH 拮抗剂预处理的随机临床试验 患有子宫内膜异位症并正在接受 IVF 的患者，主要结局是活产率。我们 最近还证明患有以下疾病的女性循环中存在异常的 microRNA 子宫内膜异位症，我们随后将其验证为高生物标志物 检测活动性疾病的敏感性和特异性。我们其次提出疾病 生物标志物将识别哪些女性将从 GnRH 拮抗剂预处理中受益，从而允许 子宫内膜异位症相关不孕症的精准医学方法。拟议的研究意义重大 由于不孕症和子宫内膜异位症的普遍发生以及缺乏精准性 在诊断和治疗方面。我们还使用创新方法来识别子宫内膜异位症 作为一种旨在改善子宫内膜异位症女性预后的新型干预措施 正在进行试管受精。