The Search for Viral and Bacterial Etiology of Varicocele

Bacterial Infections Clinical Trial

— ViBaVa  

Official title:

The Search for Viral and Bacterial Etiology of Varicocele

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03079609
• Other study ID #: ViBaVa
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 2016
• Est. completion date: December 2019

Study information

• Verified date: March 2019
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection
• Sonic Hedgehog Expression
• Varicocele
• VEGF Expression
• Viral Infection
• Virus Diseases

Intervention

Procedure:
• subinguinal microscopic varicocelectomy
During the procedure approximately 1cm long fragment of varicose vein will be taken for further investigation.
• open hernia repair
During the procedure approximately 1cm long fragment of spermatic cord vein will be taken for further investigation.

Locations

Country	Name	City	State
Poland	Chair and Department of Urology Warsaw Medical University	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (9)

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. — View 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. — View 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. — View Citation

Kilinç 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. — View 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. — View Citation

Paulis L, Fauconnier J, Cazorla O, Thireau J, Soleti R, Vidal B, Ouillé A, Bartholome M, Bideaux P, Roubille F, Le Guennec JY, Andriantsitohaina R, Martínez 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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