Ignite Creation Date:
2025-12-24 @ 11:02 PM
Ignite Modification Date:
2025-12-30 @ 7:53 AM
Study NCT ID:
NCT04509869
Status:
COMPLETED
Last Update Posted:
2020-08-14
First Post:
2020-08-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
"Outcome of Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014646', 'term': 'Varicocele'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D007246', 'term': 'Infertility'}], 'ancestors': [{'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-13', 'studyFirstSubmitDate': '2020-08-07', 'studyFirstSubmitQcDate': '2020-08-10', 'lastUpdatePostDateStruct': {'date': '2020-08-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-08-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'sperm motility', 'timeFrame': '3 months postoperative is our aim', 'description': 'semen analysis will be done preoperative and post-operative'}, {'measure': 'sperm morphology', 'timeFrame': '3 months postoperative is our aim', 'description': 'semen analysis will be done preoperative and postoperative'}, {'measure': 'sperm number', 'timeFrame': '3 months postoperative is our aim', 'description': 'semen analysis will be done preoperative and postoperative'}, {'measure': 'pain of scrotum', 'timeFrame': '3 months postoperative is our aim', 'description': 'subjective sensation measured by visual analogue score preoperative and postoperative'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Varicocele', 'Pain', 'Fertility Issues']}, 'referencesModule': {'references': [{'pmid': '22784493', 'type': 'BACKGROUND', 'citation': 'Chen SS. Factors predicting symptomatic relief by varicocelectomy in patients with normospermia and painful varicocele nonresponsive to conservative treatment. Urology. 2012 Sep;80(3):585-9. doi: 10.1016/j.urology.2012.05.014. Epub 2012 Jul 10.'}, {'pmid': '24917707', 'type': 'BACKGROUND', 'citation': 'Abd Ellatif ME, Asker W, Abbas A, Negm A, Al-Katary M, El-Kaffas H, Moatamed A. Varicocelectomy to treat pain, and predictors of success: a prospective study. Curr Urol. 2012 May;6(1):33-6. doi: 10.1159/000338867. Epub 2012 Mar 18.'}, {'pmid': '30990285', 'type': 'BACKGROUND', 'citation': 'Cho CL, Esteves SC, Agarwal A. Indications and outcomes of varicocele repair. Panminerva Med. 2019 Jun;61(2):152-163. doi: 10.23736/S0031-0808.18.03528-0.'}, {'pmid': '11962551', 'type': 'BACKGROUND', 'citation': 'Maghraby HA. Laparoscopic varicocelectomy for painful varicoceles: merits and outcomes. J Endourol. 2002 Mar;16(2):107-10. doi: 10.1089/089277902753619627.'}, {'pmid': '9554356', 'type': 'BACKGROUND', 'citation': 'Peterson AC, Lance RS, Ruiz HE. Outcomes of varicocele ligation done for pain. J Urol. 1998 May;159(5):1565-7. doi: 10.1097/00005392-199805000-00043.'}, {'pmid': '10654904', 'type': 'BACKGROUND', 'citation': 'Yaman O, Ozdiler E, Anafarta K, Gogus O. Effect of microsurgical subinguinal varicocele ligation to treat pain. Urology. 2000 Jan;55(1):107-8. doi: 10.1016/s0090-4295(99)00374-x.'}]}, 'descriptionModule': {'briefSummary': "varicoclelectomy is done for subfertiltiy and varicocele induced orchialgia. The effect of varicocelectomy on semen analysis is controversial. Many articles report favorable outcomes and others do not.\n\nMost study don't focus on varicocelectomy done for varicocele induced orchialgia,and those studies dont report on postoperative semen.\n\nThis study will focus on the effect of operation on the semen postoperatively ."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '19 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Primary varicocele\n2. Patient's age more than 19 years\n3. Normal semen analysis (according to the WHO 5th guide to semen parameters where sperm concentration equal 15 million per ml , total sperm number 40 million per ejaculate ,normal morphology 4 % and motility A =25% or a+b = 32% is considered normal.\n4. Scrotal pain after exclusion of other causes.\n\nExclusion Criteria:\n\n* 1- Recurrent varicocele"}, 'identificationModule': {'nctId': 'NCT04509869', 'briefTitle': '"Outcome of Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Outcome of Subinguinal Varicocelectomy on Normal Semen in Patients Complaining of Orchialgia', 'orgStudyIdInfo': {'id': 'orchialgia treatment'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'pre-operative and postoperative', 'description': 'the patients who will undergo the operation to treat the pain', 'interventionNames': ['Procedure: varicocelectomy']}], 'interventions': [{'name': 'varicocelectomy', 'type': 'PROCEDURE', 'description': 'operation for varix ligation', 'armGroupLabels': ['pre-operative and postoperative']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71621', 'city': 'Asyut', 'state': 'Assuit', 'country': 'Egypt', 'facility': 'Assuit Medical School', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'chief resident of urology', 'investigatorFullName': 'Abdelrahman Mohamed Abdelkader', 'investigatorAffiliation': 'Assiut University'}}}}