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Home-based monitoring of ovulation to time frozen embryo transfers in the Netherlands (Antarctica-2): an open-label, nationwide, randomised, non-inferiority trial
The Lancet ( IF 168.9 ) Pub Date : 2023-09-04 , DOI: 10.1016/s0140-6736(23)01312-0
Tjitske Zaat 1 , Jan-Peter de Bruin 2 , Mariëtte Goddijn 1 , Marchien van Baal 3 , Sofie Benneheij 4 , Monique Brandes 5 , Frank Broekmans 6 , Astrid Cantineau 7 , Ben Cohlen 8 , Jeroen van Disseldorp 9 , Susanne Gielen 10 , Eva Groenewoud 11 , Arne van Heusden 12 , Eugenie Kaaijk 13 , Carolien Koks 14 , Corry de Koning 15 , Nicole Klijn 16 , Paul van der Linden 17 , Petra Manger 18 , Lobke Moolenaar 19 , Robbert van Oppenraaij 20 , Quirine Pieterse 21 , Jesper Smeenk 22 , Jantien Visser 23 , Madelon van Wely 1 , Femke Mol 1
Affiliation  

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. 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). 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 725 153 [21·0%] of 727; RR 1·00 (90% CI 0·81 to 1·23); RD –0·08 [90% CI –3·60 to 3·44]). Home-based monitoring of ovulation is non-inferior to hospital-controlled monitoring of ovulation to time FET. The Dutch Organisation for Health Research and Development.

中文翻译:

荷兰家庭排卵监测以安排冷冻胚胎移植时间(Antarctica-2):一项开放标签、全国性、随机、非劣效性试验

不断发展的辅助生殖技术领域,包括冻融胚胎移植(FET),应该在不影响怀孕机会的情况下,引领最佳可持续医疗保健的道路。正确的 FET 时间对于植入解冻胚胎至关重要。如今,由于假设生育前景良好,基于医院控制的女性自然周期排卵监测的计时是首选策略。然而,家庭监测是一种防止患者旅行和任何相关环境问题的简单方法。我们比较了家庭监测与触发排卵的医院控制监测后的持续妊娠率。这项开放标签、多中心、随机、非劣效性试验在荷兰 23 家医院和诊所进行。通过基于网络的随机化程序,将年龄在 18 岁至 44 岁之间、具有规律排卵月经周期的女性按照 1:1 的比例随机分配到家庭监测或医院控制监测。那些分析数据的人对各组来说是不可见的;那些收集数据的人则不然。所有终点均按意向治疗和方案进行分析。当 90% CI 的下限超过 –4% 时,确定非劣效性。本研究已在荷兰试验登记处注册(试验 NL6414)。2018年4月10日至2022年4月13日期间,1464名女性被随机分配,其中732名分配至家庭监测,732名分配至医院控制监测。家庭监测组中 732 人中有 152 人 (20·8%) 发生持续妊娠,医院控制监测组 732 人中有 153 人 (20·9%) 发生持续妊娠(风险比 [RR] 0·99 [90%) CI 0·81 至 1·22];风险差异 [RD] –0·14 [90% CI –3·63 至 3·36])。符合方案分析证实了非劣效性(725 153 例中的 152 [21·0%] [727 例中的 21·0%];RR 1·00(90% CI 0·81 至 1·23);RD –0· 08 [90% CI –3·60 至 3·44])。家庭排卵监测并不逊色于医院控制的排卵时间 FET 监测。荷兰卫生研究与发展组织。
更新日期:2023-09-04
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