Clinical trial NCT05080569: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment
Official title: LUMO Study: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE4
Conditions: Pregnancy Related
Fertility Issues
Luteal Phase Defect
Infertility Unexplained
Keywords: progesterone
Cost-effective
Intrauterine insemination
live birth
luteal support
ongoing pregnancy
ovulation induction
unexplained infertility
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
First posted: 2021-10-15
Enrollment: 1008
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The LUMO study is a multicenter, randomized, placebo-controlled trial with cost-effectiveness analysis. Participating sites consist of academic and non-academic hospitals and fertility clinics. 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).
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Live Birth
timeFrame: 6 months
Secondary outcomes:
measure: Clinical pregnancy rate
timeFrame: <6 months
measure: Miscarriage rate
timeFrame: <6 months
measure: Multiple pregnancy rate
timeFrame: <6 months
measure: Pregnancy complications
timeFrame: 1 year
measure: Perinatal outcomes
timeFrame: <6 weeks
measure: Side effects
timeFrame: <1 year
measure: Compliance to therapy
timeFrame: 6 months
measure: Added medication costs
timeFrame: 1 year
measure: Budget impact
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Professor Reproductive Medicine
name: Broekmans, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: