The Search for Viral and Bacterial Etiology of Varicocele

NCT03079609 | Unknown

• 1 other identifier: ViBaVa
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Varicocele; Viral Infection; Bacterial Infections; Sonic Hedgehog Expression; VEGF Expression

Outcome Measures

Primary Outcomes (1)

• 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.

  one year after finishing recruitment

Study Arms (2)

microsurgery urology

EXPERIMENTAL

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

open general surgery

ACTIVE COMPARATOR

20 patients (without varicocele) undergoing open hernia repair.

Procedure: open hernia repair

Interventions

subinguinal microscopic varicocelectomy PROCEDURE

During the procedure approximately 1cm long fragment of varicose vein will be taken for further investigation.

microsurgery urology

open hernia repair PROCEDURE

During the procedure approximately 1cm long fragment of spermatic cord vein will be taken for further investigation.

open general surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (1)

Chair and Department of Urology Warsaw Medical University

Warsaw, 02-005, Poland

Location

Related Publications (9)

• 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.

  PMID: 19030866 BACKGROUND

• 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.

  PMID: 17475608 BACKGROUND

• 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.

  PMID: 26867642 BACKGROUND

• 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.

  PMID: 26588701 BACKGROUND

• 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.

  PMID: 25141859 BACKGROUND

• 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.

  PMID: 25613906 BACKGROUND

• 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.

  PMID: 19593986 BACKGROUND

• 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.

  PMID: 18701100 BACKGROUND

• 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.

  PMID: 15311067 BACKGROUND

MeSH Terms

Conditions

Varicocele; Virus Diseases; Bacterial Infections

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases; Infections; Bacterial Infections and Mycoses

Study Officials

• Piotr Dobroński, MD PhD

  Chair and Department of Urology Warsaw Medical University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: March 14, 2017
• Study Start: July 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 6, 2019

Record last verified: 2019-03

Locations

PL (1)