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NCT Number: NCT05080569

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

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

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Key information

Conditions

Pregnancy Related Fertility Issues Genital Diseases Infertility Infertility Unexplained Luteal Phase Defect Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progesterone Vaginal Product

Drug

3dd200mg

Other names: Utrogestan

Placebo

Drug

3dd1 vaginal capsule

Primary outcomes

  1. Live Birth

    Time frame: 6 months

    Pregnancy leading to Live birth within six months.

Secondary outcomes

  1. Clinical pregnancy rate

    Time frame: <6 months

    Number and rate of patients that achieve a clinical pregnancy within six months

  2. Miscarriage rate

    Time frame: <6 months

    Number and rate of patients that experience miscarriage (gestation <16weeks) within six months

  3. Multiple pregnancy rate

    Time frame: <6 months

    Number of pregnancies with 2 or more fetuses

  4. Pregnancy complications

    Time frame: 1 year

    Pregnancies complicated by preterm labor (<37 weeks), loss of pregnancy (>16weeks), gestational diabetes, preeclampsia, HELLP syndrome or pregnancy induced hypertension.

  5. Perinatal outcomes

    Time frame: <6 weeks

    Stillbirth/Livebirth/Perinatal death, Gestational age at delivery, birthweight

  6. Side effects

    Time frame: <1 year

    Nausea, stomach ache, vaginal discharge, other (self reported) side effects

  7. Compliance to therapy

    Time frame: 6 months

    Use of medication as prescribed

  8. Added medication costs

    Time frame: 1 year

    Increae in total therapy costs due to the addition of Utrogestan (the treatment).

  9. Budget impact

    Time frame: 1 year

    Economic assessment that estimated financial consequences of adopting a new intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Simone Broer, Dr.

CONTACT

[email protected]

088 755 75 25

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Registry information

Official study title

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

Acronym: LUMO

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Oct 15, 2021
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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