The Search for Viral and Bacterial Etiology of Varicocele

Not Applicable

• Conditions: VEGF Expression; Sonic Hedgehog Expression; Varicocele; Bacterial Infections; Viral Infection
• Interventions: Procedure: subinguinal microscopic varicocelectomy; Procedure: open hernia repair

• Registration Number: NCT03079609
• Lead Sponsor: Medical University of Warsaw

Brief Summary

This study is to answer the question is there any relationship between viral ( HSV 1 , HSV 2 , HPV 6/11, CMV, HHV 6 , HHV 8, BKV) or bacterial (Porphyromonas gingivalis, Treponema denticola, Tannerella forsythia, Fusobacterium nucleatum) infection and occurrence of varicocele in men.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07
• Study First Submitted: 2017-02-08
• Study First Submitted QC: 2017-03-07
• Study First Posted: 2017-03-14
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-05
• Last Update Posted: 2019-03-06
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 40

Inclusion Criteria

• in experimental arm - varicocele grade II or III and infertility and/or pain

Exclusion Criteria

• in control arm: presence of varicocele in ultrasound before surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
microsurgery urology	subinguinal microscopic varicocelectomy	20 patients with varicocele (grade II or III) undergoing subinguinal microsurgery varicocelectomy due to infertility and/or pain in the scrotum.
open general surgery	open hernia repair	20 patients (without varicocele) undergoing open hernia repair.

Primary Outcome Measures

Name	Time	Method
Level of presence od viral or bacterial infection, level of expression of SHH and VEGF in varicose vein wall. .	one year after finishing recruitment	Qualitative and quantitive analysis (presence and concentration - µl or U/µl in two different laboratory tests.) to detect genetic material (DNA, mRNA) of bacteria/viruses will be performed. The outcomes from both gropus will be compared.

Trial Locations

Locations (1)

Chair and Department of Urology Warsaw Medical University; 🇵🇱 Warsaw, Poland