美国马里兰州Shady Grove生育中心 Kate Devine团队近期取得重要工作进展，他们研究比较了体外受精患者子宫内膜容受性测试指导时间与冷冻胚胎移植标准时间对婴儿出生率的影响，这是一项随机临床试验。相关研究论文2022年12月6日在线发表于《美国医学会杂志》上。

据介绍，子宫内膜容受性测试可以通过确定个体患者的最佳胚胎移植时间来改善冷冻胚胎移植后的存货情况，然而，目前的临床数据是相互矛盾的。

研究人员比较了两种时间条件下（根据子宫内膜容受性测试得出的最佳移植时间与标准移植时间），单倍体冷冻胚胎移植的婴儿出生情况。

在美国东部的一个多中心私人生育实践中，在30个地点进行了双盲随机临床试验。时间期限为2018年5月至2020年9月，后续追踪调查工作于2021年8月结束。参与者接受了体外受精、植入前非整倍体基因检测、子宫内膜容受性检测和冷冻胚胎移植。那些具有整倍体囊胚和信息接受性结果的人被随机分组。排除标准包括复发性妊娠丢失、复发性植入失败、手术抽吸精子、供卵和未缓解的解剖性子宫腔缺陷。

干预组(n = 381)进行容受性定时冷冻胚胎移植，在移植前调整黄体酮暴露的持续时间。对照组（n=386）按标准时间进行移植，无论容受性测试结果如何。

主要结局是婴儿顺利出生。有3个次要结局，包括生化妊娠和临床妊娠。

767名随机（平均年龄35岁）参与者中，755人（98%）完成了试验。研究人员对所有随机参与者进行数据分析。在预设的主要结局中，干预组58.5%的移植（381例中的223例）与对照组61.9%的移植（386例中的239例）顺利生出婴儿（差异，-3.4%[95%CI，-10.3%至3.5%]；比率[RR]，0.95[95%可信区间，0.79至1.13]；P=.38）。在预设的次要结局中，干预组与对照组没有显著差异，包括生化妊娠率（分别为77.2%与79.5%；差异，-2.3% [95% 可信区间, -8.2% to 3.5%]; RR, 0.97[95%可信区间, 0.83 to 1.14]; P=.48）和临床妊娠率（分别为68.8% 和72.8%; 差异，-4.0%[95%CI, -10.4% to 2.4%]; RR, 0.94 [95%可信区间, 0.80 to 1.12] ; P=.25）。没有不良事件的报告。

研究结果表明，在体外受精产生整倍体囊胚的患者中，与标准移植时间相比，容受性测试指导冷冻胚胎移植的时间并没有显著提高婴儿出生率。这些发现不支持常规使用容受性测试来指导体外受精过程中胚胎移植的最佳时间选择。

附：英文原文

Title: Effect of Timing by Endometrial Receptivity Testing vs Standard Timing of Frozen Embryo Transfer on Live Birth in Patients Undergoing In Vitro Fertilization: A Randomized Clinical Trial

Author: Nicole Doyle, Samad Jahandideh, Micah J. Hill, Eric A. Widra, Michael Levy, Kate Devine

Issue&Volume: 2022/12/06

Abstract: Importance  Endometrial receptivity testing is purported to improve live birth following frozen embryo transfer by identifying the optimal embryo transfer time for an individual patient; however, data are conflicting.

Objective  To compare live birth from single euploid frozen embryo transfer according to endometrial receptivity testing vs standardized timing.

Design, Setting, and Participants  Double-blind, randomized clinical trial at 30 sites within a multicenter private fertility practice in the Eastern US. Enrollment was from May 2018 to September 2020; follow-up concluded in August 2021. Participants underwent in vitro fertilization, preimplantation genetic testing for aneuploidy, endometrial receptivity testing, and frozen embryo transfer. Those with euploid blastocyst(s) and an informative receptivity result were randomized. Exclusion criteria included recurrent pregnancy loss, recurrent implantation failure, surgically aspirated sperm, donor egg(s), and unmitigated anatomic uterine cavity defects.

Interventions  The intervention group (n=381) underwent receptivity-timed frozen embryo transfer, with adjusted duration of progesterone exposure prior to transfer, if indicated by receptivity testing. The control group (n=386) underwent transfer at standard timing, regardless of receptivity test results.

Main Outcomes and Measures  The primary outcome was live birth. There were 3 secondary outcomes, including biochemical pregnancy and clinical pregnancy.

Results  Among 767 participants who were randomized (mean age, 35 years), 755 (98%) completed the trial. All randomized participants were analyzed. The primary outcome of live birth occurred in 58.5% of transfers (223 of 381) in the intervention group vs 61.9% of transfers (239 of 386) in the control group (difference, 3.4% [95% CI, 10.3% to 3.5%]; rate ratio [RR], 0.95 [95% CI, 0.79 to 1.13]; P=.38). There were no significant differences in the intervention vs the control group for the prespecified secondary outcomes, including biochemical pregnancy rate (77.2% vs 79.5%, respectively; difference, 2.3% [95% CI, 8.2% to 3.5%]; RR, 0.97 [95% CI, 0.83 to 1.14]; P=.48) and clinical pregnancy rate (68.8% vs 72.8%, respectively; difference, 4.0% [95% CI, 10.4% to 2.4%]; RR, 0.94 [95% CI, 0.80 to 1.12]; P=.25). There were no reported adverse events.

Conclusions and Relevance  Among patients for whom in vitro fertilization yielded a euploid blastocyst, the use of receptivity testing to guide the timing of frozen embryo transfer, compared with standard timing for transfer, did not significantly improve the rate of live birth. The findings do not support routine use of receptivity testing to guide the timing of embryo transfer during in vitro fertilization.

DOI: 10.1001/jama.2022.20438

Source: https://jamanetwork.com/journals/jama/article-abstract/2799154