Luteal phase support during IUI with mild ovarian stimulation
Official title: LUMO Study: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH
Run by UMC Utrecht · NCT05080569 · Data updated 2026-11-12
This trial tests whether taking vaginal progesterone after intrauterine insemination with mild ovarian stimulation increases pregnancy and live birth rates for people with unexplained infertility over six months.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 1008 (estimated) |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Status | Recruiting |
| Started | March 1, 2023 |
| Main results expected | December 2025 |
| Study ends | July 2027 |
| Registry record updated | December 31, 2025 |
| Trial ID | NCT05080569 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are couples starting IUI with mild ovarian hyperstimulation for unexplained infertility, where the female is over 18 with regular cycles and the total motile sperm count exceeds 10 million, intending to continue treatment for at least six months.
✕Probably not a fit
Patients with male factor infertility, irregular cycles, or those who do not meet the Hunault/VCM criteria are unlikely to benefit from this specific intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
LUMO is a multicenter, randomized controlled trial in the Netherlands comparing luteal phase support with vaginal progesterone versus placebo in couples undergoing IUI with mild ovarian hyperstimulation. Participants are randomized into two arms and treated for up to six months with progesterone started on the day of insemination and continued until menstruation, a negative test, miscarriage, or confirmed viable pregnancy. The primary outcome is pregnancy within six months leading to live birth, with secondary outcomes including clinical pregnancy rate, miscarriage, multiple pregnancies, pregnancy complications, perinatal outcomes, side effects, and compliance. Sites include academic and non-academic hospitals and fertility clinics, and the trial uses a non-blinded superiority design.
Why it matters
Potential benefit: If successful, adding vaginal progesterone could increase the chance of pregnancy and live birth after IUI and offer a simple, low-cost way to improve outcomes.
How similar studies have gone: Some smaller trials and meta-analyses have suggested luteal phase progesterone can improve pregnancy rates after stimulated IUI, but results are mixed and definitive, large-scale evidence is still limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Couples starting IUI with Mild Ovarian HyperStimulation (MOH), with the intend to receive this treatment for at least six months. * Diagnosis of unexplained (primary or secondary) infertility * Hunault \<30% (or \>30%, after an expectant management period of at least 6 additional months). * Females aged \>18 years with regular menstrual cycle. * Total mobile sperm count (VCM) \>10 million. Exclusion cirteria: * Cycle irregularities * Male factor infertility
Where it's running
-
UMC Utrecht
Utrecht, Netherlands Recruiting
Study contacts
- Principal investigator: Broekmans, Prof. Dr. — Professor Reproductive Medicine
- Study coordinator: Simone Broer, Dr.
- Email: s.l.broer-2@umcutrecht.nl
- Phone: 088 755 75 25
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.