Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT07016867
Status:
RECRUITING
Last Update Posted:
2025-06-12
First Post:
2025-05-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072660', 'term': 'Teratozoospermia'}], 'ancestors': [{'id': 'D007248', 'term': 'Infertility, Male'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002331', 'term': 'Carnitine'}, {'id': 'D000975', 'term': 'Antioxidants'}], 'ancestors': [{'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020011', 'term': 'Protective Agents'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 126}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-11', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-06-11', 'lastUpdatePostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with Treatment of Teratozoospermia', 'timeFrame': '3 months', 'description': 'Treatment of the male patients that suffering from abnormally shaped sperms (Teratozoospermia) by medical treatment and or subinguinal varicocelcetomy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Teratozoospermia']}, 'descriptionModule': {'briefSummary': 'A varicocele is defined as an abnormal venous dilatation and/or tortuosity of the pampiniform plexus in the scrotum. Although varicoceles are almost always and more common on the left side, up to 50% of the men with varicocele, have bilateral varicoceles.\n\nVaricocele has a negative impact on spermatogenesis, testicular volume, Standard semen parameters, and fertilization, implantation, and embryo outcomes.', 'detailedDescription': "Varicocelectomy remains the first-line treatment option in infertile men with palpable varicocele and abnormal semen parameters, with the microsurgical subinguinal approach conveying the greatest success rate and fewest complications. The empirical use of antioxidant supplement may confer some benefits in men to reduce oxidative damage.\n\nMedical management, including antioxidants, could offer a potential solution with lower risks given the increasing evidence suggesting the role of oxidative stress in varicocele-induced infertility.\n\nPhysical examination of the scrotum remains the most commonly used technique to diagnose varicoceles. Palpation of the scrotum is best performed in a relaxed patient in standing position, in a warm room and carried out by a well-trained physician.\n\nSurgical treatment of varicocele has a significant effect on semen parameters, so it is considered the 'gold standard' treatment for subfertile males with palpable varicoceles associated with abnormal semen analysis."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sub-fertile men with clinically palpable varicoceles ( unilateral or bilateral ).\n* Men with teratozoospermia.\n\nExclusion Criteria:\n\n* Recurrent varicoceles.\n* Significant medical diseases as: Hepatic insufficiency.\n* Hypersensitivity to the drugs.\n* Female factor of infertility.'}, 'identificationModule': {'nctId': 'NCT07016867', 'briefTitle': 'Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Medical Treatment Alone Versus Varicocelectomy Versus Varicocelectomy and Medical Treatment in Management of Male Subfertility With Isolated Teratozoospermia: A Prospective Randomized Study', 'orgStudyIdInfo': {'id': 'Isolated Teratozoospermia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group of l-carnitine and antioxidant', 'description': 'About 42 male patients suffering from teratozoospermia will take medical treatment (l-carnitine and antioxidant) once daily for 3 months', 'interventionNames': ['Drug: l-carnitine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group of varicocelectomy', 'description': 'About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy.', 'interventionNames': ['Drug: l-carnitine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group of Mixed Treatment(varicocelectomy then l-carnitine and antioxidant)', 'description': 'About 42 male patients suffering from teratozoospermia will undergo subinguinal varicocelectomy then adjuvant treatment (l-carnitine and antioxidant) for 3 months.', 'interventionNames': ['Drug: l-carnitine']}], 'interventions': [{'name': 'l-carnitine', 'type': 'DRUG', 'otherNames': ['Antioxidants', 'varicocelectomy'], 'description': 'to compare the efficacy of medical treatment (l-carnitine and antioxidants) versus surgical treatment (varicocelectomy) versus surgical treatment and medical treatment (varicocelectomy with adjuvant medications) on pregnancy rate on varicocele related subfertility patients with isolated teratozoospermia.', 'armGroupLabels': ['Group of Mixed Treatment(varicocelectomy then l-carnitine and antioxidant)', 'Group of l-carnitine and antioxidant', 'Group of varicocelectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qina', 'state': 'South Valley', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Omar Mohamed El-Saghier, Assist.Prof', 'role': 'CONTACT', 'email': 'Omarelsoqier1983@yahoo.com', 'phone': '+201095421734'}, {'name': 'Atef Fathi Ali, Assist.Prof', 'role': 'CONTACT', 'email': 'ateffathi2010@yahoo.com', 'phone': '+201111380109'}], 'facility': 'South Valley University Hospital', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'centralContacts': [{'name': 'Marwan Mohamed Ali Bastawy, Resident', 'role': 'CONTACT', 'email': 'marwan13156@gmail.com', 'phone': '+201066067330'}], 'overallOfficials': [{'name': 'Mohammad Sayed Abdel-Kader, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of Urology, Faculty of Medicine', 'investigatorFullName': 'Marwan Mohamed Ali', 'investigatorAffiliation': 'South Valley University'}}}}