Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment (LUMO)

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

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

Study Overview

• Status: Recruiting
• Conditions: Pregnancy Related; Fertility Issues; Luteal Phase Defect; Infertility Unexplained
• Intervention / Treatment: Drug: Progesterone Vaginal Product; Drug: Placebo

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 Type: Interventional
• Enrollment (Estimated): 1008
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Simone Broer, Dr.; Phone Number: 088 755 75 25; Email: s.l.broer-2@umcutrecht.nl

Study Locations

• Netherlands
  • Utrecht, Netherlands
    • Recruiting
    • UMC Utrecht
    • Contact: Simone Broer; Phone Number: 088 755 75 25; Email: s.l.broer-2@umcutrecht.nl
    • Contact: Broer

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: UMC Utrecht
• Investigators: Principal Investigator: Broekmans, Prof. Dr., Professor Reproductive Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2023
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: August 9, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 23, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: progesterone; ovulation induction; live birth; Intrauterine insemination; luteal support; unexplained infertility; ongoing pregnancy; Cost-effective
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility; Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progestins; Utrogestan
• Other Study ID Numbers: 2359660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After finishing the project, data will not be shared publicly, but under restricted access, as the data is privacy sensitive. We publish the descriptive metadata in the data repository with a description of how a data request can be made (by sending an email to the corresponding author). If other researchers like to reuse our data, this can only be granted if the research question is in line with the original informed consent signed by the study participants. Every application therefore will be screened upon this requirement. If granted, a data usage and transfer agreement is signed by the receiving party. The specific data that will be shared with third parties after approval of the Principal Investigator, will be determined on a case-by case basis. Based on the specific research question, all raw data including the codebook and scripts of analysis in SPSS/R may be shared if considered of added value and with mutual trust and agreement in a Data usage agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No