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

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 co... Mehr ...

Verfasser: 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
Dokumenttyp: Artikel
Erscheinungsdatum: 2023
Reihe/Periodikum: Zaat , T , de Bruin , J P , Goddijn , M , van Baal , M , Benneheij , S , Brandes , M , Broekmans , F , Cantineau , A , Cohlen , B , van Disseldorp , J , Gielen , S , Groenewoud , E , van Heusden , A , Kaaijk , E , Koks , C , de Koning , C , Klijn , N , van der Linden , P , Manger , P , Moolenaar , L , van Oppenraaij , R , Pieterse , Q , Smeenk , J , Visser , J , van Wely , M & Mol , F 2023 , ' 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 , vol. 402 , no. 10410 , pp. 1347-1355 . https://doi.org/10.1016/S0140-6736(23)01312-0
Sprache: Englisch
Permalink: https://search.fid-benelux.de/Record/base-27601146
Datenquelle: BASE; Originalkatalog
Powered By: BASE
Link(s) : https://hdl.handle.net/11370/865cae4b-ebac-409b-92b8-864650efc718

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 ...