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

NCT05080569 | Recruiting Phase 4 DMC

• 1 other identifier: 2359660
• Study Type: interventional
• Target: 1,008
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

progesterone; Cost-effective; Intrauterine insemination; live birth; luteal support; ongoing pregnancy; ovulation induction; unexplained infertility

Outcome Measures

Primary Outcomes (1)

• Live Birth

  Pregnancy leading to Live birth within six months.

  6 months

Secondary Outcomes (9)

• Clinical pregnancy rate

  <6 months

• Miscarriage rate

  <6 months

• Multiple pregnancy rate

  <6 months

• Pregnancy complications

  1 year

• Perinatal outcomes

  <6 weeks

Study Arms (2)

MOH/IUI treatment with LPS

EXPERIMENTAL

(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

MOH/IUI treatment with placebo

PLACEBO COMPARATOR

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

Interventions

Placebo DRUG

3dd1 vaginal capsule

MOH/IUI treatment with placebo

Progesterone Vaginal Product DRUG

3dd200mg

Also known as: Utrogestan

MOH/IUI treatment with LPS

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Cycle irregularities
• Male factor infertility

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

UMC Utrecht

Utrecht, Netherlands

RECRUITING

Related Publications (1)

• Preesman E, Drechsel K, Crommelin H, Broekmans F, Verpoest W, Broer S; LUMO Study Group. Does luteal phase support in MOH-IUI treatment improve cumulative live birth rates in couples with unexplained subfertility? Study protocol of the LUMO study: a centre, randomised, double-blind, controlled trial with cost-effectiveness analysis. BMJ Open. 2025 Nov 19;15(11):e111872. doi: 10.1136/bmjopen-2025-111872.

  PMID: 41263858 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Utrogestan

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Broekmans, Prof. Dr.

  Professor Reproductive Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone Broer, Dr.

CONTACT

088 755 75 25; s.l.broer-2@umcutrecht.nl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blinded superiority design
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Reproductive Endocrinology & Surgery

Model Details: 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).

Study Record Dates

• First Submitted: August 9, 2021
• First Posted: October 15, 2021
• Study Start: March 1, 2023
• Primary Completion: December 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: December 31, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

NL (1)