Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-26 @ 1:24 AM
Study NCT ID:
NCT05330533
Status:
UNKNOWN
Last Update Posted:
2022-04-15
First Post:
2022-03-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Recent Ejaculation on Scrotal Duplex Parameters in Infertile Males With 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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2023-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-09', 'studyFirstSubmitDate': '2022-03-16', 'studyFirstSubmitQcDate': '2022-04-09', 'lastUpdatePostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of varicose vein diameter pre and post ejaculation.', 'timeFrame': 'within 30 minutes post ejaculation', 'description': 'Assessment of the change in varicose vein diameter by scrotal colour doppler ultrasonography pre ejaculation and within 30 minutes post ejaculation.'}], 'secondaryOutcomes': [{'measure': 'Assessment of varicose vein reflux time pre and post ejaculation.', 'timeFrame': 'Within 30 minutes post ejaculation', 'description': 'Assessment of varicose vein reflux time by scrotal duplex pre ejaculation and within 30 minutes post ejaculation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Varicocele']}, 'referencesModule': {'references': [{'pmid': '33913191', 'type': 'BACKGROUND', 'citation': 'Kizilkan Y, Duran MB, Senel S, Yikilmaz TN, Akbelen B, Toksoz S. The effect of ejaculation time on varicose vein diameter and reflux level. Andrologia. 2021 Aug;53(7):e14090. doi: 10.1111/and.14090. Epub 2021 Apr 28.'}, {'pmid': '34552777', 'type': 'BACKGROUND', 'citation': 'Bello JO, Bhatti KH, Gherabi N, Philipraj J, Narayan Y, Tsampoukas G, Shaikh N, Papatsoris A, Moussa M, Buchholz N. The usefulness of elastography in the evaluation and management of adult men with varicocele: A systematic review. Arab J Urol. 2021 Sep 16;19(3):255-263. doi: 10.1080/2090598X.2021.1964256. eCollection 2021.'}, {'pmid': '32271466', 'type': 'BACKGROUND', 'citation': 'Senturk AB, Cakiroglu B, Yaytokgil M, Aydin C, Sungur M, Akkoc A. Effect of venous reflux time on testosterone and semen parameters of infertile males after microscopic varicocelectomy. Andrologia. 2020 Jul;52(6):e13583. doi: 10.1111/and.13583. Epub 2020 Apr 9.'}, {'pmid': '29594932', 'type': 'BACKGROUND', 'citation': 'Sihag P, Tandon A, Pal R, Jain BK, Bhatt S, Kaur S, Sinha A. Sonography in male infertility: a look beyond the obvious. J Ultrasound. 2018 Sep;21(3):265-276. doi: 10.1007/s40477-018-0294-5. Epub 2018 Mar 28.'}, {'pmid': '33553999', 'type': 'BACKGROUND', 'citation': 'Raveendran AV, Agarwal A. Premature ejaculation - current concepts in the management: A narrative review. Int J Reprod Biomed. 2021 Jan 25;19(1):5-22. doi: 10.18502/ijrm.v19i1.8176. eCollection 2021 Jan.'}]}, 'descriptionModule': {'briefSummary': 'Evaluate the effect of recent ejaculation on scrotal duplex parameters in infertile males with varicocele', 'detailedDescription': 'Varicocele is abnormal dilatation of the pampiniform plexus veins draining the testicles.\n\nIt manifests as an abnormal retrograde flow in the internal spermatic venous system or dilation of venous branches in the external cremasteric system .\n\nIt affects approximately 15% in the general population, 35 - 40% in men with primary infertility and approximately 80% of men with secondary infertility. It could often concomitantly occur with infertility or chronic scrotal pain causing impaired spermatogenesis and is the most common correctable cause of male infertility. it may affects spermatogenesis via different mechanisms such as increased testicular heat, hormonal disorders and reflux of toxic metabolites.\n\nScrotal colour Doppler ultrasonography (USG) is a widely used method for evaluation of varicocele patients . It can be used along with physical examination in these patients through evaluation of vein reflux and diameter; in cases where palpation may be problematic. Furthermore, the degree of reflux and vein diameter can be used during the decision-making stage while treating varicocele .\n\nEjaculation is the process by which sperms move from epididymis via vas deferens to urethra and finally expelled out through the urethral meatus by the contraction of smooth muscles. A normal antegrade ejaculation consists of emission, expulsion (ejection), and orgasm .\n\nIn the evaluation of infertile patients, semen analysis is required for evaluation of number, motility and morphology of spermatozoa with scrotal colour Doppler USG. Ejaculation for the purpose of sperm analysis is known to significantly increase testicular blood supply .'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'genderBased': True, 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infertile male patients with scrotal varicocele aging over 18 years old.', 'genderDescription': 'Effect of Recent( Ejaculation) on Scrotal Duplex Parameters in Infertile( Males) With Varicocele', 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Infertile male patients.\n2. patients with scrotal varicocele.\n3. male patients aging over 18 years old.\n\nExclusion Criteria:\n\n1. Pyospermia.\n2. Epididymitis.\n3. Orchitis.\n4. Anejaculation.\n5. Recurrent varicocele.\n6. Patients who previously underwent scrotal or inguinal surgery.'}, 'identificationModule': {'nctId': 'NCT05330533', 'briefTitle': 'Effect of Recent Ejaculation on Scrotal Duplex Parameters in Infertile Males With Varicocele', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Effect of Recent Ejaculation on Scrotal Duplex Parameters in Infertile Males With Varicocele', 'orgStudyIdInfo': {'id': 'Ejaculation effect on Duplex'}}, 'armsInterventionsModule': {'interventions': [{'name': 'scrotal duplex', 'type': 'RADIATION', 'description': 'Scrotal colour doppler ultrasonography'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Mahmoud Elsebaity, Master', 'role': 'CONTACT', 'email': 'mahmoud.elsebaity88@gmail.com', 'phone': '+201065938686'}, {'name': 'Emad eldien Ali, professor', 'role': 'CONTACT', 'email': 'emad@infertility-eg.com', 'phone': '+201155680777'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator , resident doctor', 'investigatorFullName': 'Mahmoud Thabet Mohamed Ali Elsebaity', 'investigatorAffiliation': 'Assiut University'}}}}