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

Pregnancy Related Clinical Trial

— LUMO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05080569
• Other study ID #: 2359660
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: December 2022
• Est. completion date: August 2026

Study information

• Verified date: October 2021
• Source: UMC Utrecht
• Contact: Broekmans, Prof. Dr.
• Phone: +31651050295
• Email: F.Broekmans[@]umcutrecht.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1008
• Est. completion date: August 2026
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fertility Issues
• Infertility
• Infertility Unexplained
• Luteal Phase Defect
• Pregnancy Related

Intervention

Drug:
• Progesterone Vaginal Product
3dd200mg
• Placebo
3dd1 vaginal capsule

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
UMC Utrecht

Outcome

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