Ignite Creation Date:
2025-12-24 @ 11:52 AM
Ignite Modification Date:
2026-02-06 @ 12:28 PM
Study NCT ID:
NCT03850561
Status:
COMPLETED
Last Update Posted:
2019-02-22
First Post:
2019-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Two Doses of Coenzyme Q10 on Seminal Fluid and Semen Antioxidant Status
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': 'NONE', 'maskingDescription': 'Open Label'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel Assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-20', 'studyFirstSubmitDate': '2019-02-20', 'studyFirstSubmitQcDate': '2019-02-20', 'lastUpdatePostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-11-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Semen volume (WHO 2010 guidelines)', 'timeFrame': '3 months', 'description': 'Semen volume in ml'}, {'measure': 'Sperm concentration in semen (WHO 2010 guidelines)', 'timeFrame': '3 months', 'description': 'Sperm concentration in million/ml'}, {'measure': 'Sperm motility in semen (WHO 2010 guidelines)', 'timeFrame': '3 months', 'description': 'Sperm motility (%)'}, {'measure': 'Sperm morphology in semen (WHO 2010 guidelines)', 'timeFrame': '3 months', 'description': 'Normal sperm morphology (%)'}, {'measure': 'Seminal plasma TAC', 'timeFrame': '3 months', 'description': 'Seminal plasma total antioxidant capacity in mmol/ml'}, {'measure': 'Seminal plasma CAT', 'timeFrame': '3 months', 'description': 'Seminal plasma catalase in U/ml'}, {'measure': 'Seminal plasma SOD', 'timeFrame': '3 months', 'description': 'Superoxide dismutase in U/ml'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Male infertility', 'Coenzyme Q10', 'Antioxidants'], 'conditions': ['Male Infertility']}, 'referencesModule': {'references': [{'pmid': '29984205', 'type': 'BACKGROUND', 'citation': 'Alahmar AT. The effects of oral antioxidants on the semen of men with idiopathic oligoasthenoteratozoospermia. Clin Exp Reprod Med. 2018 Jun;45(2):57-66. doi: 10.5653/cerm.2018.45.2.57. Epub 2018 Jun 29.'}, {'pmid': '28771785', 'type': 'BACKGROUND', 'citation': 'Alshahrani S, Aldossari K, Al-Zahrani J, Gabr AH, Henkel R, Ahmad G. Interpretation of semen analysis using WHO 1999 and WHO 2010 reference values: Abnormal becoming normal. Andrologia. 2018 Mar;50(2). doi: 10.1111/and.12838. Epub 2017 Aug 3.'}, {'pmid': '23289958', 'type': 'BACKGROUND', 'citation': 'Nadjarzadeh A, Shidfar F, Amirjannati N, Vafa MR, Motevalian SA, Gohari MR, Nazeri Kakhki SA, Akhondi MM, Sadeghi MR. Effect of Coenzyme Q10 supplementation on antioxidant enzymes activity and oxidative stress of seminal plasma: a double-blind randomised clinical trial. Andrologia. 2014 Mar;46(2):177-83. doi: 10.1111/and.12062. Epub 2013 Jan 7.'}]}, 'descriptionModule': {'briefSummary': 'The study was conducted to assess the impact of two doses of coenzyme Q10 on seminal fluid parameters and antioxidant status in infertile men.', 'detailedDescription': 'The aim of this study was to assess the impact of two doses of coenzyme Q10 on seminal fluid parameters and antioxidant status in infertile men with idiopathic oligoasthenoteratospermia.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Male Infertility', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of infertility of at least 12 months despite regular unprotected intercourse.\n\nOligoasthenoteratospermia was diagnosed by semen analysis showing abnormal sperm concentration (\\<15 million/ml), progressive motility (\\<32%), total motility (\\<40%) and morphology (\\<30% WHO criteria) as defined by WHO manual for semen analysis 2010\n\nExclusion Criteria:\n\n* Azoospermia,\n* Varicocele,\n* Genital tract infection,\n* Cryptorchidism,\n* Testicular trauma or scrotal surgery,\n* Endocrine disorder,\n* Systemic illness,\n* Smoking\n* The presence of female factor'}, 'identificationModule': {'nctId': 'NCT03850561', 'briefTitle': 'Effect of Two Doses of Coenzyme Q10 on Seminal Fluid and Semen Antioxidant Status', 'organization': {'class': 'OTHER', 'fullName': 'University of Sumer'}, 'officialTitle': 'The Effect of Two Doses of Coenzyme Q10 on Seminal Fluid Parameters and Antioxidant Status: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'EC/2018/8878'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Coenzyme Q10 200', 'description': 'Coenzyme Q10 200mg/day for 3 months', 'interventionNames': ['Dietary Supplement: Coenzyme Q10 200']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Coenzyme Q10 400', 'description': 'Coenzyme Q10 400mg/day for 3 months', 'interventionNames': ['Dietary Supplement: Coenzyme Q10 400']}], 'interventions': [{'name': 'Coenzyme Q10 200', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Coenzyme Q10 200 mg/day', 'armGroupLabels': ['Coenzyme Q10 200']}, {'name': 'Coenzyme Q10 400', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Coenzyme Q10 400 mg/day', 'armGroupLabels': ['Coenzyme Q10 400']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00964', 'city': 'Hillah', 'country': 'Iraq', 'facility': 'Fertility Unit, Babyl', 'geoPoint': {'lat': 32.46367, 'lon': 44.41963}}], 'overallOfficials': [{'name': 'Ahmed T Alahmar, MBChB, MSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sumer, Iraq'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Patients data are anonymous and in hold with the principal investigator'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sumer', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Ahmed T Alahmar', 'investigatorAffiliation': 'University of Sumer'}}}}