Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment

Phase 4

Not yet recruiting

• Conditions: Fertility Issues; Pregnancy Related; Luteal Phase Defect; Infertility Unexplained
• Interventions: Drug: Placebo; Drug: Progesterone Vaginal Product

• Registration Number: NCT05080569
• Lead Sponsor: UMC Utrecht

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 Timeline

• Study First Submitted: 2021-08-09
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-12
• Last Update Submitted: 2021-10-12
• Study First Posted: 2021-10-15
• Last Update Posted: 2021-10-15
• Study Start: 2022-12
• Primary Completion: 2025-07
• Study Completion: 2026-08

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 1008

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MOH/IUI treatment with placebo	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
MOH/IUI treatment with LPS	Progesterone Vaginal Product	(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

Primary Outcome Measures

Name	Time	Method
Live Birth	6 months	Pregnancy leading to Live birth within six months.

Secondary Outcome Measures

Name	Time	Method
Budget impact	1 year	Economic assessment that estimated financial consequences of adopting a new intervention
Clinical pregnancy rate	<6 months	Number and rate of patients that achieve a clinical pregnancy within six months
Miscarriage rate	<6 months	Number and rate of patients that experience miscarriage (gestation \<16weeks) within six months
Multiple pregnancy rate	<6 months	Number of pregnancies with 2 or more fetuses
Pregnancy complications	1 year	Pregnancies complicated by preterm labor (\<37 weeks), loss of pregnancy (\>16weeks), gestational diabetes, preeclampsia, HELLP syndrome or pregnancy induced hypertension.
Perinatal outcomes	<6 weeks	Stillbirth/Livebirth/Perinatal death, Gestational age at delivery, birthweight
Side effects	<1 year	Nausea, stomach ache, vaginal discharge, other (self reported) side effects
Compliance to therapy	6 months	Use of medication as prescribed
Added medication costs	1 year	Increae in total therapy costs due to the addition of Utrogestan (the treatment).