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

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

Detailed Description
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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.

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

Conditions
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Pregnancy Related, Fertility Issues, Luteal Phase Defect, Infertility Unexplained

Intervention / Treatment
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* Drug: Progesterone Vaginal Product
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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).
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MOH/IUI treatment with LPS<br>(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<br>* 3dd200mg<br>* Other names: Utrogestan;|
| Placebo Comparator: MOH/IUI treatment with placebo<br>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<br>* 3dd1 vaginal capsule<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Live Birth | Pregnancy leading to Live birth within six months. | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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progesterone, Cost-effective, Intrauterine insemination, live birth, luteal support, ongoing pregnancy, ovulation induction, unexplained infertility