荷兰基于家庭的排卵监测以确定冷冻胚胎移植时间（南极洲-2）：一项开放标签、全国性、随机、非劣效性试验。

Home-based monitoring of ovulation to time frozen embryo transfers in the Netherlands (Antarctica-2): an open-label, nationwide, randomised, non-inferiority trial.

作者信息

Zaat Tjitske, de Bruin Jan-Peter, Goddijn Mariëtte, van Baal Marchien, Benneheij Sofie, Brandes Monique, Broekmans Frank, Cantineau Astrid, Cohlen Ben, van Disseldorp Jeroen, Gielen Susanne, Groenewoud Eva, van Heusden Arne, Kaaijk Eugenie, Koks Carolien, de Koning Corry, Klijn Nicole, van der Linden Paul, Manger Petra, Moolenaar Lobke, van Oppenraaij Robbert, Pieterse Quirine, Smeenk Jesper, Visser Jantien, van Wely Madelon, Mol Femke

机构信息

Department of Obstetrics and Gynaecology, Centre for Reproductive Medicine, Amsterdam UMC, University of Amsterdam, Amsterdam, Netherlands; Amsterdam Reproduction and Development Research Institute, Amsterdam, Netherlands.

Department of Obstetrics and Gynaecology, Jeroen Bosch Ziekenhuis, 's-Hertogenbosch, Netherlands.

出版信息

Lancet. 2023 Oct 14;402(10410):1347-1355. doi: 10.1016/S0140-6736(23)01312-0. Epub 2023 Sep 4.

DOI:10.1016/S0140-6736(23)01312-0

PMID:37678290

Abstract

BACKGROUND

The growing field of assisted reproductive techniques, including frozen-thawed embryo transfer (FET), should lead the way to the best sustainable health care without compromising pregnancy chances. Correct timing of FET is crucial to allow implantation of the thawed embryo. Nowadays, timing based on hospital-controlled monitoring of ovulation in the natural cycle of a woman is the preferred strategy because of the assumption of favourable fertility prospects. However, home-based monitoring is a simple method to prevent patient travel and any associated environmental concerns. We compared ongoing pregnancy rates after home-based monitoring versus hospital-controlled monitoring with ovulation triggering.

METHODS

This open-label, multicentre, randomised, non-inferiority trial was undertaken in 23 hospitals and clinics in the Netherlands. Women aged between 18 and 44 years with a regular ovulatory menstrual cycle were randomly assigned in a 1:1 ratio via a web-based randomisation program to home-based monitoring or hospital-controlled monitoring. Those who analysed the data were masked to the groups; those collecting the data were not. All endpoints were analysed by intention to treat and per protocol. Non-inferiority was established when the lower limit of the 90% CI exceeded -4%. This study was registered at the Dutch Trial Register (Trial NL6414).

FINDINGS

1464 women were randomly assigned between April 10, 2018, and April 13, 2022, with 732 allocated to home-based monitoring and 732 to hospital-controlled monitoring. Ongoing pregnancy occurred in 152 (20·8%) of 732 in the home-based monitoring group and in 153 (20·9%) of 732 in the hospital-controlled monitoring group (risk ratio [RR] 0·99 [90% CI 0·81 to 1·22]; risk difference [RD] -0·14 [90% CI -3·63 to 3·36]). The per-protocol analysis confirmed non-inferiority (152 [21·0%] of 725 vs 153 [21·0%] of 727; RR 1·00 (90% CI 0·81 to 1·23); RD -0·08 [90% CI -3·60 to 3·44]).

INTERPRETATION

Home-based monitoring of ovulation is non-inferior to hospital-controlled monitoring of ovulation to time FET.

FUNDING

The Dutch Organisation for Health Research and Development.

摘要

背景

包括冻融胚胎移植（FET）在内的辅助生殖技术领域不断发展，应引领实现最佳可持续医疗保健，同时不影响怀孕几率。FET的正确时机对于解冻胚胎的着床至关重要。如今，基于医院对女性自然周期排卵进行监测的时机选择是首选策略，因为人们认为这样有良好的生育前景。然而，居家监测是一种简单的方法，可以避免患者往返医院以及减少相关的环境问题。我们比较了居家监测与医院控制监测并触发排卵后的持续妊娠率。

方法

这项开放标签、多中心、随机、非劣效性试验在荷兰的23家医院和诊所进行。年龄在18至44岁之间、月经周期规律且排卵正常的女性，通过基于网络的随机程序以1:1的比例随机分配至居家监测组或医院控制监测组。数据分析人员对分组情况不知情；数据收集人员知情。所有终点均按意向性分析和符合方案分析。当90%置信区间的下限超过-4%时，确定非劣效性。本研究已在荷兰试验注册库注册（试验编号NL6414）。

结果

2018年4月10日至2022年4月13日期间，1464名女性被随机分组，732名被分配至居家监测组，732名被分配至医院控制监测组。居家监测组732名中有152名（20.8%）发生持续妊娠，医院控制监测组732名中有153名（20.9%）发生持续妊娠（风险比[RR]0.99[90%置信区间0.81至1.22]；风险差值[RD]-0.14[90%置信区间-3.63至3.36]）。符合方案分析证实了非劣效性（725名中的152名[21.0%]对比727名中的153名[21.0%]；RR 1.00[90%置信区间0.81至1.23]；RD -0.08[90%置信区间-3.60至3.44]）。