Actively Recruiting
Led by UMC Utrecht · Updated on 2025-12-31
1008
Participants Needed
1
Research Sites
82 weeks
Total Duration
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 MOH/IUI 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 MOH/IUI 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.
CONDITIONS
Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 months
Participants receive mild ovarian hyperstimulation and intrauterine insemination (IUI). Those in the treatment group start luteal phase support with vaginal progesterone capsules on the day of IUI. Treatment continues until menstruation, a negative pregnancy test, miscarriage, or confirmed pregnancy at 7 weeks gestation.
1 visit per cycle for insemination and monitoring over 6 months
Duration - Up to 1 year
Participants are monitored for pregnancy outcomes, side effects, and compliance for up to one year after treatment initiation.
Periodic visits depending on pregnancy status and follow-up assessments
Total: 1 location
1
UMC Utrecht
Utrecht, Netherlands
Actively Recruiting
S
Simone Broer, Dr.
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Emma Preesman, Katja Drechsel, Heleen Crommelin...
https://pubmed.ncbi.nlm.nih.gov/41263858