Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-25 @ 9:25 PM
Study NCT ID:
NCT03540056
Status:
UNKNOWN
Last Update Posted:
2019-10-15
First Post:
2018-05-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Testicular Growth During Puberty in Boys With and Without a Left-sided Varicocele
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014646', 'term': 'Varicocele'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'targetDuration': '7 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-10-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-10-13', 'studyFirstSubmitDate': '2018-05-03', 'studyFirstSubmitQcDate': '2018-05-25', 'lastUpdatePostDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in testicular volumes in adolescents boys', 'timeFrame': '3 years', 'description': 'Scrotal ultrasound is performed to assess testicular dimensions after which testicular volume is calculated. Multiple measurements are performed over a time period of 3 years.'}, {'measure': 'Chang in haemodynamic parameters in adolescent boys with a varicocele', 'timeFrame': '3 years', 'description': 'Scrotal doppler ultrasound is performed and the peak retrograde flow is determined. Multiple measurements are performed over a time period of 3 years.'}], 'secondaryOutcomes': [{'measure': 'Semen analysis in varicoele patients', 'timeFrame': 'After liquefaction (30-35 minutes after ejaculation)', 'description': 'Routine standard semen analysis as well as DNA fragmentation testing.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['varicocele', 'testicular growth'], 'conditions': ['Varicocele', 'Scrotal Disorder']}, 'descriptionModule': {'briefSummary': "Prospective observational study.\n\nA varicocele is defined as a dilatation of the veins in the plexus pampiniformis in the testicles. Varicoceles are a diagnostic dilemma and a therapeutic challenge. Most of the boys with a varicocele don't show any symptoms, but approximately 15-20% experience some sort of infertility later during their life. There still isn't any consensus on when treating the patient is the right choice. Reliable scientific research about parameters able to predict the later stages of the boy with a varicocele is therefore needed. The purpose of this study is to how testicular growth could predict the outcome of boys with a varicocele.\n\nDuring this study, testicular growth in boys with and without a left-sided varicocele will be examined in different schools using ultrasound to measure the testicular volumes, the PRF and the TAI to be able to collect sufficient data with the purpose to be able to predict whether testicular growth is a significant predictor on the progression of a varicocele."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '20 Years', 'minimumAge': '11 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consists of adolescent boys with or without a varicocele being between the age 11 and 16 years old when enlisting in the study. Recruitment took place at the Antwerp University Hospital and through medical checkups in secondary schools in Antwerp and West-Flanders.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1\\. Boys aged 11-16 years without any evidence of a current or past pathology influencing testicular growth\n\nExclusion Criteria:\n\n1. Boys with a current or past inguinoscrotal pathology (varicocele, testicular microlithiasis, cryptorchidism, retractile testis, orchidectomy, testicular torsion, orchitis or epididymitis, hypospadias, inguinal hernia, oeprated varicocele, hydrocele and epididymal cysts)\n2. Boys with evidence of disorders influencing testicular growth (e.g. growth disorders)\n3. Boys with missing or incomplete data on Tanner stages for genital development\n4. Boys with a psychiatric disorder'}, 'identificationModule': {'nctId': 'NCT03540056', 'briefTitle': 'Testicular Growth During Puberty in Boys With and Without a Left-sided Varicocele', 'organization': {'class': 'OTHER', 'fullName': 'Universiteit Antwerpen'}, 'officialTitle': 'Testicular Growth During Puberty in Boys With and Without a Left-sided Varicocele', 'orgStudyIdInfo': {'id': 'B300201730926'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Boys without varicocele', 'description': 'Boys thoroughly examined but without diagnose of varicocele', 'interventionNames': ['Diagnostic Test: Ultrasound']}, {'label': 'Boys with a varicocoele', 'description': 'Boys with a diagnosed varicocele of any stage possible.', 'interventionNames': ['Diagnostic Test: Ultrasound']}], 'interventions': [{'name': 'Ultrasound', 'type': 'DIAGNOSTIC_TEST', 'description': 'We use ultrasound to measure the PRF and the testicular volumes.', 'armGroupLabels': ['Boys with a varicocoele', 'Boys without varicocele']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2650', 'city': 'Edegem', 'state': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Stefan De Wachter, MD PhD FEABU', 'role': 'CONTACT', 'email': 'stefan.dewachter@uantwerpen.be', 'phone': '38215934', 'phoneExt': '+32'}, {'name': 'Thierry Vanderheyde', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Valérie van Dam', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cynthia Leysen', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ward Bauwens', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Antwerp University Hospital', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}], 'centralContacts': [{'name': 'Gunter De Win, MD PhD FEABU', 'role': 'CONTACT', 'email': 'gunter.dewin@uza.be', 'phone': '3 821 55 86', 'phoneExt': '+32'}, {'name': 'Donald Vaganée, Dr.', 'role': 'CONTACT', 'email': 'donald.vaganee@gmail.com', 'phone': '3 821 30 47', 'phoneExt': '+32'}], 'overallOfficials': [{'name': 'Gunter De Win, MD PhD FEABU', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Antwerp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universiteit Antwerpen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Donald Vaganée', 'investigatorAffiliation': 'Universiteit Antwerpen'}}}}