Ignite Creation Date:
2025-12-24 @ 11:30 PM
Ignite Modification Date:
2026-01-02 @ 4:39 PM
Study NCT ID:
NCT05846256
Status:
UNKNOWN
Last Update Posted:
2023-05-06
First Post:
2023-04-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007248', 'term': 'Infertility, Male'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 125}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-26', 'studyFirstSubmitDate': '2023-04-26', 'studyFirstSubmitQcDate': '2023-04-26', 'lastUpdatePostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The proportion of double-stranded DNA damage in sperm of men with unexplained infertility.', 'timeFrame': '30-60 minutes', 'description': 'Sperm DNA Fragmentation done with a Comet Assay analysis'}], 'secondaryOutcomes': [{'measure': 'The proportion of single-stranded DNA damage in sperm of men with unexplained infertility', 'timeFrame': '30-60 minutes', 'description': 'Sperm DNA Fragmentation done with a Comet Assay analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Sperm DNA Fragmentation', 'Lifestyle', 'Doublestrand DNA Fragmentatio'], 'conditions': ['Infertility, Male']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the extent of double-stranded DNA damage in sperm in men with unexplained infertility.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Men with unexplanied infertility undergoing fertility treatment', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Unexplained infertile men who will undergo 1st or 2nd IVF treatment\n* Age over 18 years\n* Normal sperm parameters according to WHO criteria\n* IVF treatment\n\nExclusion Criteria:\n\n\\- ICSI'}, 'identificationModule': {'nctId': 'NCT05846256', 'briefTitle': 'Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Regionshospitalet Viborg, Skive'}, 'officialTitle': 'Evaluation of Single and Double DNA Strand Breaks in Males With Unexplained Infertility Attending Fertility Treatment', 'orgStudyIdInfo': {'id': 'Doublestrand DNA Fragmentation'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Infertile male', 'description': 'Men with unexplained infertility', 'interventionNames': ['Other: Sperm DNA Fragmentation']}, {'label': 'Donors (control)', 'description': 'Fertile sperm donors', 'interventionNames': ['Other: Sperm DNA Fragmentation']}], 'interventions': [{'name': 'Sperm DNA Fragmentation', 'type': 'OTHER', 'description': 'Sperm DNA Fragmentation analysis.', 'armGroupLabels': ['Donors (control)', 'Infertile male']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7800', 'city': 'Skive', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Birgit Alsbjerg, M.D.', 'role': 'CONTACT', 'email': 'birgit.alsbjerg@midt.rm.dk', 'phone': '+45 78 44 57 60'}, {'name': 'Alice Mikkelsen', 'role': 'CONTACT', 'email': 'Alice.Toft.Mikkelsen@midt.rm.dk'}, {'name': 'Birgit Alsbjerg, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fertility Clinic Regional Hospital Skive', 'geoPoint': {'lat': 56.56699, 'lon': 9.02707}}], 'centralContacts': [{'name': 'Peter Humaidan, Professor', 'role': 'CONTACT', 'email': 'peter.humaidan@midt.rm.dk', 'phone': '78445760'}, {'name': 'Mette Jensen, Research assistant', 'role': 'CONTACT', 'email': 'mejen8@rm.dk', 'phone': '78445718'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Humaidan', 'class': 'OTHER'}, 'collaborators': [{'name': 'ExamenLab Ltd', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Consultant', 'investigatorFullName': 'Peter Humaidan', 'investigatorAffiliation': 'Regionshospitalet Viborg, Skive'}}}}