Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment
NCT ID: NCT05080569
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1008 participants
INTERVENTIONAL
2023-03-01
2027-07-31
Brief Summary
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Detailed Description
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Eligibility criteria are: 1) couples starting IUI with Mild Ovarian HyperStimulation (MOH), with the intend to receive this treatment for at least six months. 2) Indication for MOH/IUI treatment is in accordance with current (dutch) NVOG guidelines; Diagnosis of unexplained (primary or secondary) infertility with Hunault \<30% (or \>30%, after an expectant management period of at least 6 additional months). Total mobile sperm count (VCM) \>10 million. 3) Females aged \>18 years with regular menstrual cycle.
(Mild) Ovarian stimulating treatment and insemination are according to regular treatment protocol. Females assigned to the treatment group start LPS, applying 3dd200mg Utrogestan in vaginal capsules, on the day of IUI. Treatment is continued until the onset of menstruation, a negative pregnancy test, miscarriage or confirmed vital intra-uterine pregnancy at 7 weeks gestation.
Main outcome is pregnancy within 6 months of treatment, leading to Live birth. Secondary outcomes are; Clinical pregnancy rate. Miscarriage rate. Multiple pregnancy rate. Pregnancy complications. Perinatal outcomes. Side effects and compliance to therapy. Added Medication Costs. Budget impact.
The analyses will include a cost-effectiveness analysis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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MOH/IUI treatment with LPS
(Mild) Ovarian stimulating treatment and insemination are according to regular treatment protocol. Females assigned to the treatment group start LPS, applying 3dd200mg Utrogestan in vaginal capsules, on the day of IUI. Treatment is continued until the onset of menstruation, a negative pregnancy test, miscarriage or confirmed vital intra-uterine pregnancy at 7 weeks gestation
Progesterone Vaginal Product
3dd200mg
MOH/IUI treatment with placebo
Females will receive regular MOH/IUI treatment. The female cycle is mildly stimulated and monitored until the desired amount of ripe follicles is achieved. In the absence of other reasons to cancel the treatment, ovulation is triggered and subsequently pre-washed semen is inseminated into the uterus.
Females assigned to the placebo group start placebo, applying 3dd1 vaginal capsules, on the day of IUI. Treatment is continued until the onset of menstruation, a negative pregnancy test, miscarriage or confirmed vital intra-uterine pregnancy at 7 weeks gestation
Placebo
3dd1 vaginal capsule
Interventions
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Progesterone Vaginal Product
3dd200mg
Placebo
3dd1 vaginal capsule
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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UMC Utrecht
OTHER
Responsible Party
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Frank JM Broekmans
Professor in Reproductive Endocrinology & Surgery
Principal Investigators
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Broekmans, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
Professor Reproductive Medicine
Locations
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UMC Utrecht
Utrecht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Simone Broer
Role: primary
Broer
Role: backup
References
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Preesman E, Drechsel K, Crommelin H, Broekmans F, Verpoest W, Broer S; LUMO Study Group. Does luteal phase support in MOH-IUI treatment improve cumulative live birth rates in couples with unexplained subfertility? Study protocol of the LUMO study: a centre, randomised, double-blind, controlled trial with cost-effectiveness analysis. BMJ Open. 2025 Nov 19;15(11):e111872. doi: 10.1136/bmjopen-2025-111872.
Other Identifiers
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2359660
Identifier Type: -
Identifier Source: org_study_id