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

Primary Purpose

Varicocele, Viral Infection, Bacterial Infections

Status
Unknown status
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
subinguinal microscopic varicocelectomy
open hernia repair
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Varicocele

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Chair and Department of Urology Warsaw Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

microsurgery urology

open general surgery

Arm Description

20 patients with varicocele (grade II or III) undergoing subinguinal microsurgery varicocelectomy due to infertility and/or pain in the scrotum.

20 patients (without varicocele) undergoing open hernia repair.

Outcomes

Primary Outcome Measures

Level of presence od viral or bacterial infection, level of expression of SHH and VEGF in varicose vein wall. .
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.

Secondary Outcome Measures

Full Information

First Posted
February 8, 2017
Last Updated
March 5, 2019
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT03079609
Brief Title
The Search for Viral and Bacterial Etiology of Varicocele
Acronym
ViBaVa
Official Title
The Search for Viral and Bacterial Etiology of Varicocele
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicocele, Viral Infection, Bacterial Infections, Sonic Hedgehog Expression, VEGF Expression

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
microsurgery urology
Arm Type
Experimental
Arm Description
20 patients with varicocele (grade II or III) undergoing subinguinal microsurgery varicocelectomy due to infertility and/or pain in the scrotum.
Arm Title
open general surgery
Arm Type
Active Comparator
Arm Description
20 patients (without varicocele) undergoing open hernia repair.
Intervention Type
Procedure
Intervention Name(s)
subinguinal microscopic varicocelectomy
Intervention Description
During the procedure approximately 1cm long fragment of varicose vein will be taken for further investigation.
Intervention Type
Procedure
Intervention Name(s)
open hernia repair
Intervention Description
During the procedure approximately 1cm long fragment of spermatic cord vein will be taken for further investigation.
Primary Outcome Measure Information:
Title
Level of presence od viral or bacterial infection, level of expression of SHH and VEGF in varicose vein wall. .
Description
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.
Time Frame
one year after finishing recruitment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Piotr Dobroński, MD PhD
Organizational Affiliation
Chair and Department of Urology Warsaw Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Chair and Department of Urology Warsaw Medical University
City
Warsaw
ZIP/Postal Code
02-005
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
19030866
Citation
Iafrate M, Galfano A, Macchi V, Ejituru E, Sarasin G, Porzionato A, Novara G, De Caro R, Artibani W, Ficarra V. Varicocele is associated with an increase of connective tissue of the pampiniform plexus vein wall. World J Urol. 2009 Jun;27(3):363-9. doi: 10.1007/s00345-008-0352-2. Epub 2008 Nov 22.
Results Reference
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PubMed Identifier
17475608
Citation
Lee JD, Jeng SY, Lee TH. Bcl-2 overexpression in the internal spermatic vein of patients with varicocele. J Formos Med Assoc. 2007 Apr;106(4):308-12. doi: 10.1016/S0929-6646(09)60257-6.
Results Reference
background
PubMed Identifier
26867642
Citation
Wang SH, Yang WK, Lee JD. Increased expression of the sonic hedgehog and vascular endothelial growth factor with co-localization in varicocele veins. Phlebology. 2017 Mar;32(2):115-119. doi: 10.1177/0268355515627717. Epub 2016 Jul 9.
Results Reference
background
PubMed Identifier
26588701
Citation
Petrovic I, Milivojevic M, Popovic J, Schwirtlich M, Rankovic B, Stevanovic M. SOX18 Is a Novel Target Gene of Hedgehog Signaling in Cervical Carcinoma Cell Lines. PLoS One. 2015 Nov 20;10(11):e0143591. doi: 10.1371/journal.pone.0143591. eCollection 2015.
Results Reference
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PubMed Identifier
25141859
Citation
Hwang J, Kang MH, Yoo YA, Quan YH, Kim HK, Oh SC, Choi YH. The effects of sonic hedgehog signaling pathway components on non-small-cell lung cancer progression and clinical outcome. World J Surg Oncol. 2014 Aug 21;12:268. doi: 10.1186/1477-7819-12-268.
Results Reference
background
PubMed Identifier
25613906
Citation
Paulis L, Fauconnier J, Cazorla O, Thireau J, Soleti R, Vidal B, Ouille A, Bartholome M, Bideaux P, Roubille F, Le Guennec JY, Andriantsitohaina R, Martinez MC, Lacampagne A. Activation of Sonic hedgehog signaling in ventricular cardiomyocytes exerts cardioprotection against ischemia reperfusion injuries. Sci Rep. 2015 Jan 23;5:7983. doi: 10.1038/srep07983.
Results Reference
background
PubMed Identifier
19593986
Citation
Ai QY, Tian H, Ma L, Miao NZ, Huo YW, Wang HX, Wang LR, Qiu SD, Zhang QY. [Experimental varicocele affects VEGF and Flt-1 protein expressions in the testis and epididymis of adolescent rats]. Zhonghua Nan Ke Xue. 2009 Jun;15(6):488-92. Chinese.
Results Reference
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PubMed Identifier
18701100
Citation
Tek M, Cayan S, Yilmaz N, Oguz I, Erdem E, Akbay E. The effect of vascular endothelial growth factor on spermatogenesis and apoptosis in experimentally varicocele-induced adolescent rats. Fertil Steril. 2009 May;91(5 Suppl):2247-52. doi: 10.1016/j.fertnstert.2008.06.008. Epub 2008 Aug 12.
Results Reference
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PubMed Identifier
15311067
Citation
Kilinc F, Kayaselcuk F, Aygun C, Guvel S, Egilmez T, Ozkardes H. Experimental varicocele induces hypoxia inducible factor-1alpha, vascular endothelial growth factor expression and angiogenesis in the rat testis. J Urol. 2004 Sep;172(3):1188-91. doi: 10.1097/01.ju.0000135455.97627.15.
Results Reference
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The Search for Viral and Bacterial Etiology of Varicocele

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