Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2025-12-31 @ 2:02 AM
Study NCT ID:
NCT07008495
Status:
RECRUITING
Last Update Posted:
2025-06-13
First Post:
2025-05-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Testicular Sperm Retrieval Rate After Varicocele Ligation in Men With Non Obstructive Azoospermia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2025-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-10', 'studyFirstSubmitDate': '2025-05-28', 'studyFirstSubmitQcDate': '2025-05-28', 'lastUpdatePostDateStruct': {'date': '2025-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sperm retrieval rate', 'timeFrame': 'Two Weeks', 'description': 'Evaluation of Sperm retrieval rate after varicocelectomy in men with non obstructive azoospermia'}], 'secondaryOutcomes': [{'measure': 'fertility rate', 'timeFrame': '3 months from the operation', 'description': 'Evaluation of fertility rate after varicocelectomy in men with non obstructive azoospermia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Non-obstructive Azoospermia']}, 'descriptionModule': {'briefSummary': 'A varicocele is an abnormal dilatation and tortuosity of the veins of the spermatic cord. Although varicoceles are common in the general population and are frequently found on routine physical examinations, they represent the most common correctable cause of male factor infertility.\n\nMale factor infertility affects up to half of all couples struggling to conceive, and 10-20% of men evaluated for infertility are found to be azoospermic.', 'detailedDescription': 'Generally, azoospermia is classified as obstructive azoospermia (OA) or non-obstructive azoospermia (NOA). While OA is obviously caused by obstruction, NOA has many possible causes and is more difficult to manage.\n\nNon-obstructive azoospermia (NOA) is most often a result of primary testicular dysfunction, Varicoceles are found in 20% of the general male population, in up to 40% of men with infertility, and specifically 4.3-13.3% of men with NOA.\n\nThe role of varicoceles in NOA has not been fully elucidated. The current best practice statement on the evaluation of azoospermic males from the AUA acknowledges that impaired spermatogenesis associated with varicoceles may be reversible but does not give a clear recommendation for management.\n\nThe primary advantage of varicocelectomy in cases of NOA is the possibility of getting motile sperms in the ejaculate. Other benefit of varicocele repairs in azoospermic men is that there are increased success rates of assisted reproductive techniques (ART) such as intracytoplasmic sperm injection (ICSI) or testicular sperm extraction (TESE).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men with non obstructive azoospermia.\n* Clinically palpable varicocele ( unilateral or bilateral ).\n\nExclusion Criteria:\n\n* Known cases of obstructive azoospermia.\n* Non palpable varicocele.\n* Uncorrectable female causes of infertility.\n* genetic abnormalities like klinefelter syndrome.'}, 'identificationModule': {'nctId': 'NCT07008495', 'briefTitle': 'Testicular Sperm Retrieval Rate After Varicocele Ligation in Men With Non Obstructive Azoospermia', 'organization': {'class': 'OTHER', 'fullName': 'South Valley University'}, 'officialTitle': 'Testicular Sperm Retrieval Rate After Varicocele Ligation in Men With Non Obstructive Azoospermia.', 'orgStudyIdInfo': {'id': 'Non-Obstructive Azoospermia'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group of varicocele ligation', 'description': 'About 25 male patients will undergo varicocele ligation then microTESE.', 'interventionNames': ['Procedure: varicocelectomy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group of TESE', 'description': 'About 25 male patients will undergo microTESE without varicocele ligation.', 'interventionNames': ['Procedure: varicocelectomy']}], 'interventions': [{'name': 'varicocelectomy', 'type': 'PROCEDURE', 'otherNames': ['TESE'], 'description': 'to detect testicular sperm retrieval rate after varicocelectomy in men with non obstructive azoospermia.', 'armGroupLabels': ['Group of TESE', 'Group of varicocele ligation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qina', 'state': 'South Valley', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mostafa AbdelRazek Ahmed, Assist.Prof', 'role': 'CONTACT', 'email': 'mostafa_uro@med.svu.edu.eg', 'phone': '+201004116386'}, {'name': 'Omar Mohamed El-Saghier, Assist.Prof', 'role': 'CONTACT', 'email': 'omarelsoqier1983@yahoo.com', 'phone': '+201095421734'}], 'facility': 'South Valley University Hospital', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}], 'centralContacts': [{'name': 'Yacoub Nagah Abdelwahab, Resident', 'role': 'CONTACT', 'email': 'dryacoubn99@gmail.com', 'phone': '+201092142396'}], 'overallOfficials': [{'name': 'Gamal A. Alsagheer, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Urology Department, Faculty of Medicine, South Valley University, Qena, Egypt'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'South Valley University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident at Urology Department, Faculty of Medicine', 'investigatorFullName': 'Yacoub Nagah Abdelwahab', 'investigatorAffiliation': 'South Valley University'}}}}