Luteal phase support during IUI with mild ovarian stimulation
LUMO Study: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH
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 |
| Enrollment | 1008 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UMC Utrecht Academic / other |
| Locations | 1 site (Utrecht) |
| Trial ID | NCT05080569 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Utrecht
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.