Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Progesterone Vaginal Product, Placebo.
- Who it may be relevant to
- Registry conditions: Pregnancy Related, Fertility Issues, Luteal Phase Defect, Infertility Unexplained. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Netherlands
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
LUMO Study: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH
Overview
The LUMO study is a multicenter, randomized controlled trial that evaluates the effectivity of luteal phase support in MOH/IUI treatment.
Detailed description
Participating sites consist of academic and non-academic hospitals and fertility clinics in The Netherlands. There are two treatment arms (MOH/IUI treatment with LPS vs MOH/IUI treatment with placebo) with a non-blinded superiority design. Participants are randomly distributed across both treatment arms for the entire study-period (six months, non-crossover).
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.
Interventions
- Drug Progesterone Vaginal Product
3dd200mg - Drug Placebo
3dd1 vaginal capsule
Primary outcome measures
- Live Birth [Time frame: 6 months]
Secondary outcome measures (9)
- Clinical pregnancy rate [Time frame: <6 months]
- Miscarriage rate [Time frame: <6 months]
- Multiple pregnancy rate [Time frame: <6 months]
- Pregnancy complications [Time frame: 1 year]
- Perinatal outcomes [Time frame: <6 weeks]
- Side effects [Time frame: <1 year]
- Compliance to therapy [Time frame: 6 months]
- Added medication costs [Time frame: 1 year]
- Budget impact [Time frame: 1 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Netherlands · 1 center
- UMC Utrecht — Utrecht
Publications
- 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-2025-1 PMID 41263858
Identifiers
NCT: NCT05080569 · 2359660