Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-25 @ 8:40 PM
Study NCT ID:
NCT05080569
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-10-15
First Post:
2021-08-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000624167', 'term': 'Utrogestan'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Double-blinded superiority design'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1008}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2026-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-10-12', 'studyFirstSubmitDate': '2021-08-09', 'studyFirstSubmitQcDate': '2021-10-12', 'lastUpdatePostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Live Birth', 'timeFrame': '6 months', 'description': 'Pregnancy leading to Live birth within six months.'}], 'secondaryOutcomes': [{'measure': 'Clinical pregnancy rate', 'timeFrame': '<6 months', 'description': 'Number and rate of patients that achieve a clinical pregnancy within six months'}, {'measure': 'Miscarriage rate', 'timeFrame': '<6 months', 'description': 'Number and rate of patients that experience miscarriage (gestation \\<16weeks) within six months'}, {'measure': 'Multiple pregnancy rate', 'timeFrame': '<6 months', 'description': 'Number of pregnancies with 2 or more fetuses'}, {'measure': 'Pregnancy complications', 'timeFrame': '1 year', 'description': 'Pregnancies complicated by preterm labor (\\<37 weeks), loss of pregnancy (\\>16weeks), gestational diabetes, preeclampsia, HELLP syndrome or pregnancy induced hypertension.'}, {'measure': 'Perinatal outcomes', 'timeFrame': '<6 weeks', 'description': 'Stillbirth/Livebirth/Perinatal death, Gestational age at delivery, birthweight'}, {'measure': 'Side effects', 'timeFrame': '<1 year', 'description': 'Nausea, stomach ache, vaginal discharge, other (self reported) side effects'}, {'measure': 'Compliance to therapy', 'timeFrame': '6 months', 'description': 'Use of medication as prescribed'}, {'measure': 'Added medication costs', 'timeFrame': '1 year', 'description': 'Increae in total therapy costs due to the addition of Utrogestan (the treatment).'}, {'measure': 'Budget impact', 'timeFrame': '1 year', 'description': 'Economic assessment that estimated financial consequences of adopting a new intervention'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['progesterone', 'Cost-effective', 'Intrauterine insemination', 'live birth', 'luteal support', 'ongoing pregnancy', 'ovulation induction', 'unexplained infertility'], 'conditions': ['Pregnancy Related', 'Fertility Issues', 'Luteal Phase Defect', 'Infertility Unexplained']}, 'referencesModule': {'references': [{'pmid': '41263858', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': 'The LUMO study is a multicenter, randomized controlled trial that evaluates the effectivity of luteal phase support in MOH/IUI treatment.', 'detailedDescription': '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).\n\nEligibility 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.\n\n(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.\n\nMain 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.\n\nThe analyses will include a cost-effectiveness analysis.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Couples starting IUI with Mild Ovarian HyperStimulation (MOH), with the intend to receive this treatment for at least six months.\n* Diagnosis of unexplained (primary or secondary) infertility\n* Hunault \\<30% (or \\>30%, after an expectant management period of at least 6 additional months).\n* Females aged \\>18 years with regular menstrual cycle.\n* Total mobile sperm count (VCM) \\>10 million.\n\nExclusion cirteria:\n\n* Cycle irregularities\n* Male factor infertility'}, 'identificationModule': {'nctId': 'NCT05080569', 'acronym': 'LUMO', 'briefTitle': 'Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH Treatment', 'organization': {'class': 'OTHER', 'fullName': 'UMC Utrecht'}, 'officialTitle': 'LUMO Study: Luteal Phase Support in IUI MOH Treatment Luteal Phase Support in IUI MOH', 'orgStudyIdInfo': {'id': '2359660'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MOH/IUI treatment with LPS', 'description': '(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', 'interventionNames': ['Drug: Progesterone Vaginal Product']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'MOH/IUI treatment with placebo', 'description': '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.\n\nFemales 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', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Progesterone Vaginal Product', 'type': 'DRUG', 'otherNames': ['Utrogestan'], 'description': '3dd200mg', 'armGroupLabels': ['MOH/IUI treatment with LPS']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '3dd1 vaginal capsule', 'armGroupLabels': ['MOH/IUI treatment with placebo']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Broekmans, Prof. Dr.', 'role': 'CONTACT', 'email': 'F.Broekmans@umcutrecht.nl', 'phone': '+31651050295'}], 'overallOfficials': [{'name': 'Broekmans, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor Reproductive Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UMC Utrecht', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in Reproductive Endocrinology & Surgery', 'investigatorFullName': 'Frank JM Broekmans', 'investigatorAffiliation': 'UMC Utrecht'}}}}