This study is a follow-up study of the M-ovin trial, a two-by-two factorial RCT in 48 Dutch hospitals that compared live birth rates after ovulation induction with gonadotrophins or CC, with or without IUI, in normogonadotropic anovulatory women with CC failure. Between December 2009 and December 2015, a total of 666 women were included. Subfertile women of at least 18 years of age with normogonadotropic anovulation who had been ovulatory for six cycles on CC, but who had not conceived, were eligible for the trial. Couples with severe male subfertility or double-sided tubal pathology were not eligible.
After written informed consent, women were randomly allocated to six cycles of gonadotrophins plus IUI, six cycles of gonadotrophins plus intercourse, six cycles of CC plus IUI or six cycles of CC plus intercourse on a 1:1:1:1 basis. We used a two-by-two factorial design to compare two pairs of interventions: a switch to ovulation induction with gonadotrophins versus continuing CC, and IUI versus intercourse. The primary outcome measure was conception leading to live birth within 8 months after randomization. A live birth was defined as any baby born alive after a gestational age beyond 24 weeks. During the study, the data were collected by research nurses and after the last live birth, we closed the database. We performed a cost-effectiveness analysis alongside the study. Further details about the study design, sample size calculation, study procedures and outcomes have been described previously (Nahuis et al., 2013 (link); Weiss et al., 2018 (link)).
All previously included women, for whom we had contact details, were asked by e-mail to participate in this follow-up study. They were all asked for informed consent and they received a digital questionnaire. The first contact was made by the principal investigators or representatives of the centres where the women were included. Women who did not respond were sent a second e-mail, followed by telephone contact. Collection of the follow-up data occurred between 02 December 2020 and 18 March 2022.
After written informed consent, women were randomly allocated to six cycles of gonadotrophins plus IUI, six cycles of gonadotrophins plus intercourse, six cycles of CC plus IUI or six cycles of CC plus intercourse on a 1:1:1:1 basis. We used a two-by-two factorial design to compare two pairs of interventions: a switch to ovulation induction with gonadotrophins versus continuing CC, and IUI versus intercourse. The primary outcome measure was conception leading to live birth within 8 months after randomization. A live birth was defined as any baby born alive after a gestational age beyond 24 weeks. During the study, the data were collected by research nurses and after the last live birth, we closed the database. We performed a cost-effectiveness analysis alongside the study. Further details about the study design, sample size calculation, study procedures and outcomes have been described previously (Nahuis et al., 2013 (link); Weiss et al., 2018 (link)).
All previously included women, for whom we had contact details, were asked by e-mail to participate in this follow-up study. They were all asked for informed consent and they received a digital questionnaire. The first contact was made by the principal investigators or representatives of the centres where the women were included. Women who did not respond were sent a second e-mail, followed by telephone contact. Collection of the follow-up data occurred between 02 December 2020 and 18 March 2022.
