Ignite Creation Date:
2025-12-24 @ 7:18 PM
Ignite Modification Date:
2026-01-01 @ 12:20 PM
Study NCT ID:
NCT06950203
Status:
RECRUITING
Last Update Posted:
2025-05-01
First Post:
2025-04-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality
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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-29', 'studyFirstSubmitDate': '2025-04-22', 'studyFirstSubmitQcDate': '2025-04-22', 'lastUpdatePostDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total Progressive Motile count will be measured pre- and post-intervention and compared to the comparator arm.', 'timeFrame': 'From baseline to end of intervention at 3 months', 'description': 'The motile count will be performed by competent operators at each clinical site.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['VLCFA', 'VLC-PUFA', 'Very long chain polyunsaturated fatty acids', 'fertility', 'supplement'], 'conditions': ['Infertility, Male']}, 'descriptionModule': {'briefSummary': 'The study will enrol men that have a poor sperm quality. They will take either a placebo or fish oil capsule (2 per day) for 3 months. At the beginning and end of the study the participant will be asked for a sperm sample for measuring quality parameters.', 'detailedDescription': 'The study is a 2-armed, comparator controlled, double-blinded study. Subjects, study staff, sperm quality assessor and statistician will be blinded to the nutritional intervention.\n\nThe study Sponsor will be unblinded for purposes of packaging and supply of nutritional products.\n\nScreening (Visit 0). Subjects will be asked to join the study based on an analysis documenting poor semen quality. Subjects will be informed about the result of the semen analysis and informed that the clinic is participating in a study about sperm quality. Subjects that show interest to participate will be verbally and in writing given further information about the study and the study procedures by dedicated study personnel. Patients willing to sign the consent will have the possibility to ask further questions. The clinic will provide a screening log with restricted access, containing screening number and subject identification.\n\nEnrolment (Visit 1). For eligible subjects, the study coordinator will take the consent on behalf of the clinic.\n\nSubjects who satisfy all inclusion criteria and no exclusion criteria will be randomised to investigational product or comparator and given a randomisation number and will receive enough capsules for 12 weeks. The clinic will provide a randomization log with non-identifiable information.\n\nTelephone follow-up (Visit 2). After 6 weeks (± 1 week), a dedicated study nurse will contact the subject by phone. During the call, subjects will be asked about their well-being, whether they have been consistently taking their capsules, and if they are experiencing any issues that may be related to the study product.\n\nFinal Visit (Visit 3). 12 weeks (± 1 week) after the study commencement, the subject will attend a follow-up physical visit and return any remaining capsules.\n\nSubjects will be examined for vital signs, physical examination, relevant medical history, current medications, smoking and alcohol habits and a food frequency questionnaire. A period of abstinence (2 days) will be requested prior to study specific sperm samples.\n\nEach subject will take 2 x 1.0g capsules of EVOLVE 05 daily for 3 months or 2 x 1.0g comparator capsules.\n\nSperm samples for quality measurements will be taken at visit 1 and visit 3. The remaining sample will be frozen and maintained for analysis of VLCFA content.\n\nDietary intake will be recorded to control for marine specific dietary variables: Assessment at visit 1 and visit 3 using a brief questionnaire.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Males', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Men aged 18-55\n2. Referred for or claiming a semen analysis.\n3. Willing to have at least 2 days abstinence of sexual activity prior to a sperm sample being taken.\n4. Reduced semen quality defined as:\n\n • Progressive motility: \\<30%\n5. Willing to refrain from omega-3/cod liver oil supplementation during the study. Use of other supplements is allowed.\n\n \\-\n\nExclusion Criteria:\n\n1. Known allergy to fish products\n2. Historically, known, or suspected bacterial infection in reproductive organs\n3. Varicocele suspected from physical examination\n4. Azoospermia\n5. Diagnosis of diabetes (type 2)\n6. Diagnosis of Crohn´s Disease\n7. Inferior semen quality due to medical reasons, such as cryptorchidism (via questionnaire/medical records) -'}, 'identificationModule': {'nctId': 'NCT06950203', 'briefTitle': 'The Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality', 'organization': {'class': 'INDUSTRY', 'fullName': 'Epax Norway AS'}, 'officialTitle': 'A Randomised, Double Blinded Study to Determine the Effect of Supplementation With Fish Oil (EPAX EVOLVE 05) on Sperm Quality in Healthy Men.', 'orgStudyIdInfo': {'id': 'VLC 2024 01 Fertility'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': 'DHA fish oil to match DHA content in active arm', 'interventionNames': ['Dietary Supplement: Comparator arm (DHA)']}, {'type': 'EXPERIMENTAL', 'label': 'VLC-PUFA', 'description': 'EPAX EVOLVE 05 containing Very Long Chain Polyunsaturated Fatty Acids', 'interventionNames': ['Dietary Supplement: Very Long Chain Polyunsaturated Fatty Acids']}], 'interventions': [{'name': 'Very Long Chain Polyunsaturated Fatty Acids', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Fish oil with DHA and VLCPUFA', 'armGroupLabels': ['VLC-PUFA']}, {'name': 'Comparator arm (DHA)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oil containing equal DHA content to active arm', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0161', 'city': 'Oslo', 'status': 'RECRUITING', 'country': 'Norway', 'contacts': [{'name': 'Steven Mansell', 'role': 'CONTACT', 'email': 'information@medicus.com', 'phone': '+47 12345678', 'phoneExt': '+47 12345678'}], 'facility': 'Medicus Group AS', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Anonymised data may be shared on request from relevant academics.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Epax Norway AS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}