Study of Luteal Phase Support Using Progesterone Vaginal Capsules in Mild Ovarian Hyperstimulation with IUI for Unexplained Infertility

What this Trial Is About

The LUMO study is a randomized controlled trial conducted at multiple centers including academic and non-academic hospitals and fertility clinics in The Netherlands. It evaluates the effect of luteal phase support LPS in couples undergoing intrauterine insemination IUI with mild ovarian hyperstimulation MOH for unexplained infertility. The purpose is to assess whether LPS improves pregnancy outcomes, including live birth rates, compared to placebo over a six-month treatment period. Participants are randomly assigned to one of two groups one receives MOHIUI treatment with luteal phase support using vaginal progesterone capsules 3 times daily, 200 mg each, starting on the day of IUI and continuing until menstruation, negative pregnancy test, miscarriage, or confirmation of a viable pregnancy at 7 weeks. The other group receives MOHIUI treatment with a placebo vaginal capsule on the same schedule. The ovarian stimulation and insemination follow standard protocols, with monitoring for follicle development and ovulation triggering. During the study, participants will be monitored for pregnancy within six months, with the main outcome being live birth. Secondary outcomes include clinical pregnancy rate, miscarriage rate, multiple pregnancy rate, pregnancy complications, perinatal outcomes, side effects, therapy compliance, medication costs, and budget impact. Evaluations will include regular pregnancy testing and follow-up until pregnancy status is confirmed or menstruation occurs. The total study duration for each participant is six months of treatment with follow-up on pregnancy outcomes.

Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment