LUMO: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment

Sponsor

UMC Utrecht (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05080569

Collaborator

(none)

1,008

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

The LUMO study is a multicenter, randomized controlled trial that evaluates the effectivity of luteal phase support in MOH/IUI treatment.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Related Fertility Issues Luteal Phase Defect Infertility Unexplained	Drug: Progesterone Vaginal Product Drug: Placebo	Phase 4

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

Anticipated Enrollment :

1008 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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).

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

Double-blinded superiority design

Primary Purpose:

Treatment

Official Title:

LUMO Study: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH

Anticipated Study Start Date :

Dec 1, 2022

Anticipated Primary Completion Date :

Jul 1, 2025

Anticipated Study Completion Date :

Aug 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	Drug: Progesterone Vaginal Product 3dd200mg Other Names: Utrogestan
Placebo Comparator: 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	Drug: Placebo 3dd1 vaginal capsule

Arm

Intervention/Treatment

Experimental: MOH/IUI treatment with LPS

Drug: Progesterone Vaginal Product

3dd200mg

Other Names:

Utrogestan

Placebo Comparator: 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

Drug: Placebo

3dd1 vaginal capsule

Outcome Measures

Primary Outcome Measures

Live Birth [6 months]
Pregnancy leading to Live birth within six months.

Secondary Outcome Measures

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).
Budget impact [1 year]
Economic assessment that estimated financial consequences of adopting a new intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.