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Trial record 90 of 126 for:    HSV-2

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

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ClinicalTrials.gov Identifier: NCT03079609
Recruitment Status : Active, not recruiting
First Posted : March 14, 2017
Last Update Posted : March 6, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Varicocele Viral Infection Bacterial Infections Sonic Hedgehog Expression VEGF Expression Procedure: subinguinal microscopic varicocelectomy Procedure: open hernia repair Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: The Search for Viral and Bacterial Etiology of Varicocele
Actual Study Start Date : July 2016
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

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.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079609


Locations
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Poland
Chair and Department of Urology Warsaw Medical University
Warsaw, Poland, 02-005
Sponsors and Collaborators
Medical University of Warsaw
Investigators
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Study Chair: Piotr Dobroński, MD PhD Chair and Department of Urology Warsaw Medical University

Publications:

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Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT03079609     History of Changes
Other Study ID Numbers: ViBaVa
First Posted: March 14, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Bacterial Infections
Varicocele
Virus Diseases
Genital Diseases, Male
Vascular Diseases
Cardiovascular Diseases