The Search for Viral and Bacterial Etiology of Varicocele (ViBaVa)

March 5, 2019 updated by: Medical University of Warsaw
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 02-005
        • Chair and Department of Urology Warsaw Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: microsurgery urology
20 patients with varicocele (grade II or III) undergoing subinguinal microsurgery varicocelectomy due to infertility and/or pain in the scrotum.
Procedure: subinguinal microscopic varicocelectomy
During the procedure approximately 1cm long fragment of varicose vein will be taken for further investigation.
Active Comparator: open general surgery
20 patients (without varicocele) undergoing open hernia repair.
Procedure: open hernia repair
During the procedure approximately 1cm long fragment of spermatic cord vein will be taken for further investigation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of presence od viral or bacterial infection, level of expression of SHH and VEGF in varicose vein wall. .
Time Frame: 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.
one year after finishing recruitment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Study Chair: Piotr Dobroński, MD PhD, Chair and Department of Urology Warsaw Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2016

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

February 8, 2017

First Submitted That Met QC Criteria

March 7, 2017

First Posted (Actual)

March 14, 2017

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 5, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ViBaVa

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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