Ignite Creation Date:
2025-12-24 @ 11:35 PM
Ignite Modification Date:
2026-02-20 @ 8:08 PM
Study NCT ID:
NCT06342856
Status:
UNKNOWN
Last Update Posted:
2024-04-02
First Post:
2024-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009845', 'term': 'Oligospermia'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014451', 'term': 'Ubiquinone'}, {'id': 'D002331', 'term': 'Carnitine'}], 'ancestors': [{'id': 'D016227', 'term': 'Benzoquinones'}, {'id': 'D011809', 'term': 'Quinones'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D003067', 'term': 'Coenzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-07-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-29', 'studyFirstSubmitDate': '2024-03-08', 'studyFirstSubmitQcDate': '2024-03-29', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Semen analysis parameters compared to baseline', 'timeFrame': '6 months', 'description': 'Changes in Semen analysis parameters compared to baseline'}], 'secondaryOutcomes': [{'measure': 'Serum hormone levels ([FSH], [LH], testosterone, and prolactin) levels compared to baseline and Cost analysis', 'timeFrame': '6 moths', 'description': 'Serum hormone levels (\\[FSH\\], \\[LH\\], testosterone, and prolactin) levels compared to baseline and Cost analysis'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['infertility', 'oligospermia', 'coenzyme Q1o'], 'conditions': ['Infertility Unexplained', 'Oligospermia']}, 'referencesModule': {'references': [{'pmid': '34070761', 'type': 'RESULT', 'citation': 'Salvio G, Cutini M, Ciarloni A, Giovannini L, Perrone M, Balercia G. Coenzyme Q10 and Male Infertility: A Systematic Review. Antioxidants (Basel). 2021 May 30;10(6):874. doi: 10.3390/antiox10060874.'}]}, 'descriptionModule': {'briefSummary': 'Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia', 'detailedDescription': 'Evaluation of treatment with Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile men with Idiopathic Oligoasthenoteratospermia a placebo controlled clinical trial'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'semen analysis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* of in¬fertility of 1 year or more without the use of contraception\n\nExclusion Criteria:\n\n* o Active genital infections.\n\n * Patients with ejaculatory dysfunction\n * Azoospermia'}, 'identificationModule': {'nctId': 'NCT06342856', 'acronym': 'infertility', 'briefTitle': 'Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Evaluation of Treatment With Coenzyme Q10 and L-Carnitine on Semen Parameters in Infertile Men With Idiopathic Oligoasthenoteratospermia a Placebo Controlled Clinical Trial', 'orgStudyIdInfo': {'id': 'idiopathic infertility'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1', 'description': 'will receive a daily dose of 200 mg of CoQ10 for 3 months', 'interventionNames': ['Drug: co enzyme Q10 , L- Carnitine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'will receive L-carnitine 1 tablet per day orally for 3 months', 'interventionNames': ['Drug: co enzyme Q10 , L- Carnitine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 3', 'description': 'will receive combination of a daily dose of 200 mg of CoQ10 and 1 tablet of L-carnitine for 3 months', 'interventionNames': ['Drug: co enzyme Q10 , L- Carnitine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group 4', 'description': 'will receive a placebo for 3 months', 'interventionNames': ['Drug: co enzyme Q10 , L- Carnitine']}], 'interventions': [{'name': 'co enzyme Q10 , L- Carnitine', 'type': 'DRUG', 'description': 'Patient fulfilling inclusion criteria after obtaining consent will be randomized into four equal groups randomization will be computer based', 'armGroupLabels': ['Group 1', 'Group 2', 'Group 3', 'Group 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '002', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ahmed ma maher, lecturer', 'role': 'CONTACT', 'email': 'drwaleedabdelhamid@gmail.com', 'phone': '01013340534'}], 'facility': 'Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'waleed,mo abdelhamid, ass lecturer', 'role': 'CONTACT', 'email': 'drwaleedabdelhamid@gmail.com', 'phone': '01013340534', 'phoneExt': 'wa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}