RCT研究:GnRH-a联合激素替代方案不改善PCOS患者冻融胚胎移植的临床结局

GnRH agonist combined with hormone replacement therapy does not improve the clinical outcomes of frozen-thawed embryo transfer in PCOS patients:a randomized controlled trial

目的初步探讨长效促性腺激素释放激素激动剂(GnRH-a)降调节后激素替代方案是否能够改善多囊卵巢综合征(PCOS)患者冻融胚胎移植(FET)的临床结局。方法采用前瞻性随机对照试验,选择2018年3~8月于我院生殖医学中心行首次或第2次FET的32例PCOS患者为研究对象,共32个周期。采用计算机生成随机数字法将纳入研究对象分为两组,采用不同的内膜准备方案:对照组(14个周期),采用单纯激素替代方案准备内膜;观察组(18个周期),采用长效GnRH-a降调后激素替代方案准备内膜。比较两组患者的一般资料、促排卵实验室指标及临床妊娠结局。结果两组患者的一般资料比较均无显著性差异(P>0.05);促排卵Gn用量、Gn天数、HCG日E 2水平、获卵数、正常受精数(2PN数)及可用胚胎数比较亦无显著性差异(P>0.05)。观察组和对照组的临床妊娠率(55.56%vs.71.43%)、胚胎种植率(46.88%vs.68.00%)、活产率(50.00%vs.71.43%)及流产率(10.00%vs.0.00%)比较均无显著性差异(P>0.05)。结论长效GnRH-a降调节后激素替代方案并不改善PCOS患者FET周期的临床结局。相比较而言,PCOS患者FET周期中应用单纯激素替代方案准备内膜可能更经济便捷。

Objective:To investigate whether GnRH agonist(GnRH-a)down-regulation combined with hormone replacement therapy(HRT)can improve the clinical outcomes of frozen-thawed embryo transfer(FET)in PCOS patients.Methods:A prospective randomized controlled trial was conducted in 32 patients with PCOS(32 cycles)who underwent the first or second FET cycle in our hospital from March to August 2018.The computer-generated random number method was used to divide the 32 patients into two groups to use different endometrial preparation protocols:the control group(n=14,the patients were treated with HRT only for preparing endometrium),and the observation group(n=18,the patients were treated with a long-acting GnRH-a down-regulation&HRT to prepare endometrium).The general data,ovulation induction laboratory indicators,and clinical pregnancy outcomes were compared between the two groups.Results:There was no significant difference in general data,Gn dosage and days for ovulation induction,E 2 level on HCG days,number of oocytes retrieved,number of normal fertilization(2PN)and number of embryos available between the two groups(P>0.05).Clinical pregnancy rate(55.56%vs.71.43%),embryo implantation rate(46.88%vs.68.00%),live birth rate(50.00%vs.71.43%)and abortion rate(10.00%vs.0.00%)were no significant different between the observation group and the control group(P>0.05).Conclusions:Long-acting GnRH-a down-regulation&HRT does not improve the clinical outcomes of FET cycles in PCOS patients.Simple HRT may be more economical and convenient in FET cycles for PCOS patients.