LUMO Study: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH
Trial Snapshot
- Phase
- Phase 4
- Status
- Recruiting
- Sponsor
- UMC Utrecht
- Enrollment
- 1,008
- Locations
- 1
- Primary Endpoint
- Live Birth
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Double-blinded superiority design
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Exclusion Criteria
- Not provided
Arms & Interventions
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
Intervention: Progesterone Vaginal Product (Drug)
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
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Live Birth
Time Frame: 6 months
Pregnancy leading to Live birth within six months.
Secondary Outcomes
- Budget impact(1 year)
- Clinical pregnancy rate(<6 months)
- Miscarriage rate(<6 months)
- Multiple pregnancy rate(<6 months)
- Pregnancy complications(1 year)
- Perinatal outcomes(<6 weeks)
- Side effects(<1 year)
- Compliance to therapy(6 months)
- Added medication costs(1 year)
Investigators
Frank JM Broekmans
Professor in Reproductive Endocrinology & Surgery
UMC Utrecht