Center of Reproductive Medicine, Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, China.
Reproductive Medicine center, Jiangmen Central Hospital, Affiliated Hospital of Sun Yat-Sen University, Jiangmen, China.
Front Endocrinol (Lausanne). 2021 Oct 18;12:722253. doi: 10.3389/fendo.2021.722253. eCollection 2021.
This prospective randomized controlled trial compared the reproductive outcomes of frozen embryo transfer (FET) with hormone replacement treatment (HRT) with or without gonadotropin-releasing hormone agonist (GnRHa) pretreatment.
A total of 133 patients scheduled for HRT-FET mainly because of tubal and/or male factors who received two high-quality cleavage-stage embryos were enrolled at two participating centers. The GnRHa group ( = 65) received GnRHa pretreatment, while the control group ( = 68) did not. Analysis was based on the intention-to-treat (ITT) principle.
Among the 133 participants, 130 (97.7%) underwent embryo transfer and 127 (95.5%) completed the protocol. The clinical pregnancy rate according to ITT did not differ between the GnRHa and control groups [39/65 (60.0%) . 41/68 (60.3%), = 0.887]. The implantation rate (47.6% . 45.3%, = 0.713), early pregnancy loss rate (5.1% . 19.5%, = 0.09), and live birth rate (49.2% . 50.0%, = 0.920) were also comparable between groups.
Pretreatment with GnRHa does not improve the reproductive outcomes for women receiving HRT-FET.
The study was registered with the Chinese Clinical Trial Registry (ChiCTR-IOR-17014170; http://www.chictr.org.cn).
本前瞻性随机对照试验比较了激素替代治疗(HRT)联合或不联合促性腺激素释放激素激动剂(GnRHa)预处理的冻融胚胎移植(FET)的生殖结局。
本研究纳入了在两个参与中心就诊、因输卵管和/或男性因素拟行 HRT-FET 且接受了两枚高质量卵裂期胚胎的 133 名患者。GnRHa 组(n=65)接受了 GnRHa 预处理,而对照组(n=68)未接受。分析基于意向治疗(ITT)原则。
在 133 名参与者中,有 130 名(97.7%)进行了胚胎移植,127 名(95.5%)完成了方案。根据 ITT,GnRHa 组和对照组的临床妊娠率无差异[39/65(60.0%). 41/68(60.3%),=0.887]。两组的种植率(47.6%. 45.3%,=0.713)、早期妊娠丢失率(5.1%. 19.5%,=0.09)和活产率(49.2%. 50.0%,=0.920)也相似。
在接受 HRT-FET 的女性中,预处理加用 GnRHa 并不能改善其生殖结局。
本研究在中国临床试验注册中心注册(ChiCTR-IOR-17014170;http://www.chictr.org.cn)。