冻融整倍体囊胚移植的子宫内膜准备：一项前瞻性随机试验，比较自然改良周期和使用GnRH激动剂进行外源性激素刺激的临床结果。
The endometrial preparation for frozen-thawed euploid blastocyst transfer: a prospective randomized trial comparing clinical results from natural modified cycle and exogenous hormone stimulation with GnRH agonist.
作者信息
Greco Ermanno, Litwicka Katarzyna, Arrivi Cristiana, Varricchio Maria Teresa, Caragia Alina, Greco Alessia, Minasi Maria Giulia, Fiorentino Francesco
机构信息
Centre for Reproductive Medicine, European Hospital, Via Portuense 700, 00149, Rome, Italy.
GENOMA-Molecular Genetics Laboratory, Via Castel Giubileo, 11, 00138, Rome, Italy.
出版信息
J Assist Reprod Genet. 2016 Jul;33(7):873-84. doi: 10.1007/s10815-016-0736-y. Epub 2016 May 24.
PURPOSE
The aim of the study was to evaluate two methods of endometrial preparation for frozen-thawed single euploid blastocyst transfer: modified natural and artificial cycle with GnRH-agonist pituitary suppression.
METHODS
In this prospective, controlled randomized trial, a total of 236 patients undergoing infertility treatment were randomized in 1:1 ratio; 118 received a frozen-thawed single euploid blastocyst transfer in a modified natural cycle and 118 in an artificial cycle with GnRH-agonist pituitary suppression. In the artificial protocol, GnRH-agonist combined with estradiol valerate was administered. In the natural protocol, only final oocyte maturation was induced using human chorionic gonadotropin administration. The primary end-points were the clinical pregnancy and implantation rates; the secondary end-points were the cost-benefit in terms of drug cost and the number of visits and the woman psychological distress caused by the treatment.
RESULTS
No significant differences were found in clinical pregnancy, implantation, and miscarriage rates between protocols. The number of clinical and ultrasound controls and the number of laboratory dosages and venous samplings were similar in both study groups. No significant differences were found between the groups in the anxiety and depression values before the start of treatment, on the days of progesterone administration, the blastocyst transfer, and pregnancy test.
CONCLUSIONS
The findings of this study evidence that in case of frozen-thawed single euploid blastocyst transfer, both protocols are equally effective in terms of clinical outcomes, cost-benefit, and patient compliance. The choice of endometrial preparation protocol should be based on women menstrual and ovulatory characteristics or otherwise on patient need for cycle planning.
TRIAL REGISTRATION
www.clinicaltrials.gov with number NCT02378584.
目的
本研究旨在评估两种用于冻融单倍体整倍体囊胚移植的子宫内膜准备方法：改良自然周期法和使用促性腺激素释放激素激动剂抑制垂体的人工周期法。
方法
在这项前瞻性、对照随机试验中，共有236名接受不孕症治疗的患者按1:1比例随机分组；118名患者在改良自然周期中接受冻融单倍体整倍体囊胚移植，118名患者在使用促性腺激素释放激素激动剂抑制垂体的人工周期中接受移植。在人工方案中，给予促性腺激素释放激素激动剂联合戊酸雌二醇。在自然方案中，仅使用人绒毛膜促性腺激素诱导最终卵母细胞成熟。主要终点是临床妊娠率和着床率；次要终点是药物成本、就诊次数方面的成本效益以及治疗引起的女性心理困扰。
结果
两种方案在临床妊娠率、着床率和流产率方面均未发现显著差异。两个研究组的临床和超声检查次数以及实验室检测和静脉采样次数相似。在治疗开始前、给予黄体酮的日子、囊胚移植日和妊娠测试日，两组之间的焦虑和抑郁值均未发现显著差异。
结论
本研究结果表明，在冻融单倍体整倍体囊胚移植的情况下，两种方案在临床结局、成本效益和患者依从性方面同样有效。子宫内膜准备方案的选择应基于女性的月经和排卵特征，或者基于患者对周期规划的需求。
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