Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-31 @ 5:03 AM
Study NCT ID:
NCT04761250
Status:
COMPLETED
Last Update Posted:
2022-09-27
First Post:
2021-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a Multimodal Lifestyle Program on Male Fertility
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-09-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-26', 'studyFirstSubmitDate': '2021-02-12', 'studyFirstSubmitQcDate': '2021-02-17', 'lastUpdatePostDateStruct': {'date': '2022-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in the total amount of motil sperm in male patients undergoing fertility treatment', 'timeFrame': '90 days', 'description': 'Change in classical sperm parameters'}], 'secondaryOutcomes': [{'measure': 'Change in DNA fragmentation index (DFI)', 'timeFrame': '90 days', 'description': 'DFI is measured by Comet Assay'}, {'measure': 'Changes in parameters for metabolic syndrome', 'timeFrame': '90 days', 'description': 'Weight in kilograms'}, {'measure': 'Changes in parameters for metabolic syndrome', 'timeFrame': '90 days', 'description': 'BMI (Body Mass Index). Weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Changes in parameters for metabolic syndrome', 'timeFrame': '90 days', 'description': 'Blood pressure in millimeters of mercury'}, {'measure': 'Change in plasma lipids', 'timeFrame': '90 days', 'description': 'Plasma lipids i.e. Total cholesterol, high density lipoprotein, low density lipoprotein and triglycerides'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Male infertility', 'Semen quality', 'Lifestyle intervention'], 'conditions': ['Infertility, Male']}, 'descriptionModule': {'briefSummary': 'A non-pharmacological study, which examines the effect of lifestyle intervention on sperm quality among men in fertility treatment.\n\nThe primary endpoint is to increase the total amount of motile sperm in male patients undergoing fertility treatment'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men of couples who are about to start 2nd or 3rd fertility treatment\n* \\> 18 years old\n* Sperm concentration between 2-40 mill./ml\n\nExclusion Criteria:\n\n* Use of testicular sperm'}, 'identificationModule': {'nctId': 'NCT04761250', 'briefTitle': 'The Effect of a Multimodal Lifestyle Program on Male Fertility', 'organization': {'class': 'OTHER', 'fullName': 'Regionshospitalet Viborg, Skive'}, 'officialTitle': 'Evaluation of the Effect of a Multimodal Lifestyle Program on Semen Quality and DNA Fragmentation in Male Patients Attending Fertility Treatment', 'orgStudyIdInfo': {'id': '1-10-72-109-20'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation', 'interventionNames': ['Dietary Supplement: Lifestyle']}], 'interventions': [{'name': 'Lifestyle', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Lifestyle intervention i.e. diet, exercise, smoking cessation, alcohol limitations, dietary supplementation', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7800', 'city': 'Skive', 'country': 'Denmark', 'facility': 'Fertility Clinic Skive, Skive Regional Hospital', 'geoPoint': {'lat': 56.56699, 'lon': 9.02707}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter Humaidan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Consultant', 'investigatorFullName': 'Peter Humaidan', 'investigatorAffiliation': 'Regionshospitalet Viborg, Skive'}}}}