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评价 GnRH 拮抗剂预处理在正常排卵 IVF/ICSI 妇女 GnRH 拮抗剂方案卵巢刺激中的作用:一项随机对照试验。

Evaluation of GnRH antagonist pretreatment before ovarian stimulation in a GnRH antagonist protocol in normal ovulatory women undergoing IVF/ICSI: a randomized controlled trial.

机构信息

Department of Reproductive Medicine and Genetics Center, The People's Hospital of Guangxi Zhuang Autonomous Region, 6 Taoyuan Road, Nanning, 530021, Guangxi, China.

出版信息

Reprod Biol Endocrinol. 2021 Oct 12;19(1):158. doi: 10.1186/s12958-021-00836-8.

Abstract

BACKGROUND

Synchronization of follicles is key to improving ovulation stimulation with the gonadotropin-releasing hormone (GnRH) antagonist protocol. GnRH antagonist administration in the early follicular phase can quickly decrease gonadotrophin (Gn) levels and achieve downregulation before stimulation, which may improves synchronization. A previous small randomized controlled study (RCT) showed that pretreatment with a GnRH antagonist for 3 days before stimulation may increase oocyte retrieval but cannot increase the pregnancy rate. This study investigated whether the GnRH antagonist pretreatment protocol in ovulatory women can increase the synchronization of follicles and pregnancy outcomes compared with the conventional GnRH antagonist protocol.

METHODS

This RCT included 136 normal ovulatory women undergoing in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI). Both groups were treated with recombinant follicle-stimulating hormone (r-FSH) and a flexible GnRH antagonist protocol. The women were randomized into two equal groups with or without GnRH antagonist administration from day 2 of the menstrual cycle for 3 days before stimulation. Our primary outcome was the number of retrieved oocytes. Secondary outcomes included the pregnancy rate and live birth rate.

RESULTS

Both groups had similar baseline characteristics. The number of retrieved oocytes in the study group was comparable to that in the control group (9.5 [8.0-13.0] vs. 11.0 [7.0-14.8], P = 0.469). There was no significant difference in the follicle size. The fertilization rate, number of good-quality embryos, implantation rate, pregnancy rate, ongoing pregnancy rate, live birth rate per embryonic transfer cycle, and miscarriage rate were similar between the two groups.

CONCLUSION

This large RCT analysed GnRH antagonist pretreatment with the GnRH antagonist protocol applied to normal ovulatory women undergoing IVF/ICSI. The number of retrieved oocytes and pregnancy outcomes did not significantly vary.

TRIAL REGISTRATION

Chinese Clinical Trial Registry, ChiCTR1800019730 . Registered 26 November 2018.

摘要

背景

通过促性腺激素释放激素(GnRH)拮抗剂方案同步卵泡是提高排卵刺激的关键。在卵泡早期给予 GnRH 拮抗剂可以迅速降低促性腺激素(Gn)水平,并在刺激前实现下调,这可能会改善同步性。先前的一项小型随机对照研究(RCT)表明,在刺激前预处理 GnRH 拮抗剂 3 天可能会增加卵母细胞的采集量,但不能提高妊娠率。本研究旨在探讨与常规 GnRH 拮抗剂方案相比,在排卵正常的妇女中使用 GnRH 拮抗剂预处理方案是否可以增加卵泡的同步性和妊娠结局。

方法

这项 RCT 纳入了 136 名接受体外受精(IVF)/胞浆内单精子注射(ICSI)的正常排卵妇女。两组均接受重组促卵泡激素(r-FSH)和灵活的 GnRH 拮抗剂方案治疗。这些妇女被随机分为两组,在刺激前的月经周期第 2 天开始连续 3 天给予或不给予 GnRH 拮抗剂。我们的主要结局是采集的卵母细胞数量。次要结局包括妊娠率和活产率。

结果

两组的基线特征相似。研究组的采集卵母细胞数量与对照组相似(9.5[8.0-13.0]vs.11.0[7.0-14.8],P=0.469)。卵泡大小无显著差异。受精率、优质胚胎数、着床率、妊娠率、持续妊娠率、每胚胎转移周期的活产率和流产率在两组间相似。

结论

这项大型 RCT 分析了 GnRH 拮抗剂预处理与 GnRH 拮抗剂方案在接受 IVF/ICSI 的正常排卵妇女中的应用。采集的卵母细胞数量和妊娠结局没有显著差异。

试验注册

中国临床试验注册中心,ChiCTR1800019730。注册于 2018 年 11 月 26 日。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/42f2/8507211/f20dea5c7eef/12958_2021_836_Fig1_HTML.jpg

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