TY - JOUR
T1 - Home-based monitoring of ovulation to time frozen embryo transfers in the Netherlands (Antarctica-2)
T2 - an open-label, nationwide, randomised, non-inferiority trial
AU - Zaat, Tjitske
AU - de Bruin, Jan Peter
AU - Goddijn, Mariëtte
AU - van Baal, Marchien
AU - Benneheij, Sofie
AU - Brandes, Monique
AU - Broekmans, Frank
AU - Cantineau, Astrid
AU - Cohlen, Ben
AU - van Disseldorp, Jeroen
AU - Gielen, Susanne
AU - Groenewoud, Eva
AU - van Heusden, Arne
AU - Kaaijk, Eugenie
AU - Koks, Carolien
AU - de Koning, Corry
AU - Klijn, Nicole
AU - van der Linden, Paul
AU - Manger, Petra
AU - Moolenaar, Lobke
AU - van Oppenraaij, Robbert
AU - Pieterse, Quirine
AU - Smeenk, Jesper
AU - Visser, Jantien
AU - van Wely, Madelon
AU - Mol, Femke
N1 - Role of the funding source:
The funder of the study had no role in study design, data
collection, data analysis, data interpretation, or writing of
the report.
The Dutch Organisation for Health Research and Development.
Publisher Copyright:
© 2023 Elsevier Ltd
PY - 2023/10/14
Y1 - 2023/10/14
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85170407105&partnerID=8YFLogxK
U2 - 10.1016/S0140-6736(23)01312-0
DO - 10.1016/S0140-6736(23)01312-0
M3 - Article
C2 - 37678290
AN - SCOPUS:85170407105
SN - 0140-6736
VL - 402
SP - 1347
EP - 1355
JO - The Lancet
JF - The Lancet
IS - 10410
ER -