Modified Ovulation Induction.
Treatment alternatives for subfertile women with class II anovulation not conceiving after six ovulatory cycles with clomiphene citrate: A randomized controlled trial.
Go to the M-ovin' website.
Ovulation induction with Clomiphene citrate (CC) is the first line of treatment in women with WHO class II anovulation. Whereas almost 80% of these patients ovulate after CC, only 40 to 50% conceive. When unsuccessful in conception, treatment can be proceeded with gonadotropins. CC treatment is associated with a 8% risk of multiple gestation, whereas treatment with gonadotropins is associated with a risk of 30-40 %. At present, it is unclear for how many cycles ovulation induction with CC should be repeated, and when to switch to ovulation induction with gonadotropins and/or add of intra-uterine insemination.
The purpose of this study is to assess the effectiveness of extended treatment with CC compared to treatment with gonadotropins and/or the use of intra-uterine insemination (IUI), in patients who had six ovulatory cycles after CC, but did not conceive.
A multicenter randomised controlled trial in The Netherlands.
Subfertile women with WHO class II anovulation who are ovulatory on CC, but have not conceived in 6 ovulatory cycles.
Patients will be randomly allocated to four treatment arms: extended CC treatment for 6 months, ovulation induction with gonadotropins for 6 months, extended CC treatment with IUI for 6 months and ovulation induction with gonadotropins with IUI for 6 months
Main outcome measures
Pregnancy leading to live birth.
The analysis will be by intention to treat. Two comparisons will be made, one in which CC is compared to gonadotropins and one in which the addition of IUI is compared to ovulation induction only. Assuming a live birth rate of 40% after CC, 55% after addition of IUI and 55% after ovulation induction with gonadotrophins, with an alpha of 5% and a power of 80%, we need to recruit 200 women per arm (800 women in total).
An independant Data and Safety Monitoring Committee has critized the data of the first 150 women and concluded that a sample size re-estimation should be performed after including 320 patients (i.e. 80 per arm).
Nature and extent of the burden and risks associated with participation, benefit and group relatedness
As we compare strategies that are already applied in current practice, no additional risks or burdens are expected from the study.