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

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

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

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

Tjitske Zaat
, Jan Peter de Bruin
, Mariëtte Goddijn
, Marchien van Baal
, Sofie Benneheij
, Monique Brandes
, Frank Broekmans
, Astrid Cantineau
, Ben Cohlen
, Jeroen van Disseldorp
, Susanne Gielen
, Eva Groenewoud
, Arne van Heusden
, Eugenie Kaaijk
, Carolien Koks
, Corry de Koning
, Nicole Klijn
, Paul van der Linden
, Petra Manger
, Lobke Moolenaar

Robbert van Oppenraaij, Quirine Pieterse, Jesper Smeenk, Jantien Visser, Madelon van Wely, Femke Mol^*

^*Corresponding author for this work

Obstetrics & Gynecology

University of Amsterdam
Amsterdam UMC
Jeroen Bosch Ziekenhuis
Flevo Hospital
Centre for Reproductive Medicine Nij Geertgen
Utrecht University
University Medical Centre Groningen
Isala Clinics
St. Antonius Ziekenhuis
Noordwest Ziekenhuisgroep
TFP Medisch Centrum Kinderwens
Onze Lieve Vrouwe Gasthuis
Maxima Medical Centre
Tergooi Medisch Centrum
Leiden University Medical Centre
Deventer Ziekenhuis
Diakonessenhuis Utrecht
Haga Ziekenhuis
ETZ Elisabeth
Amphia Hospital
Franciscus Gasthuis & Vlietland
Vrije Universiteit Amsterdam
Maasstad Hospital

Research output: Contribution to journal › Article › Academic › peer-review

15 Citations (Scopus)

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.

Original language	English
Pages (from-to)	1347-1355
Number of pages	9
Journal	The Lancet
Volume	402
Issue number	10410
DOIs	https://doi.org/10.1016/S0140-6736(23)01312-0
Publication status	Published - 14 Oct 2023

Bibliographical note

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

Access to Document

10.1016/S0140-6736(23)01312-0

https://research.rug.nl/en/publications/home-based-monitoring-of-ovulation-to-time-frozen-embryo-transferLicence: Article 25fa Dutch Copyright Act

Cite this

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., ... 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, 402(10410), 1347-1355. https://doi.org/10.1016/S0140-6736(23)01312-0

@article{25012c28ab3740cf932d9bd86a62a153,

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

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. ",

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

note = "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: {\textcopyright} 2023 Elsevier Ltd",

year = "2023",

month = oct,

day = "14",

doi = "10.1016/S0140-6736(23)01312-0",

language = "English",

volume = "402",

pages = "1347--1355",

journal = "The Lancet",

issn = "0140-6736",

publisher = "Elsevier",

number = "10410",

}

Zaat, T, de Bruin, JP, 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

Home-based monitoring of ovulation to time frozen embryo transfers in the Netherlands (Antarctica-2): an open-label, nationwide, randomised, non-inferiority trial. / Zaat, Tjitske; de Bruin, Jan Peter; Goddijn, Mariëtte et al.
In: The Lancet, Vol. 402, No. 10410, 14.10.2023, p. 1347-1355.

Research output: Contribution to journal › Article › Academic › peer-review

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 - https://www.scopus.com/pages/publications/85170407105

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 -

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

Abstract

Bibliographical note

Access to Document

Other files and links

Fingerprint

Cite this