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Status unknownNCT03079609ViBaVaUpdated Mar 6, 2019

The Search for Viral and Bacterial Etiology of Varicocele

An interventional study of subinguinal microscopic varicocelectomy and open hernia repair in Varicocele, Viral Infection and Bacterial Infections, sponsored by Medical University of Warsaw. Status unknown at 1 site in Poland. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-06.

Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Basic science

The sponsor has not verified this record recently (last verified Mar 2019), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Non-randomized
Ages
18 Years and older
Sex
Male
01

Study 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.

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Conditions studied

  • Varicocele
  • Viral Infection
  • Bacterial Infections
  • Sonic Hedgehog Expression
  • VEGF Expression
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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • Active comparator
    open general surgery

    20 patients (without varicocele) undergoing open hernia repair.

    Procedure: open hernia repair

Interventions

  • Proceduresubinguinal microscopic varicocelectomy

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

  • Procedureopen hernia repair

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

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What researchers measure

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.

    Time frame: one year after finishing recruitment

06

Study locations

1 site
  • Chair and Department of Urology Warsaw Medical University
    Warsaw, 02-005, Poland
07

References and documents

Publications

  • 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. PubMed 19030866 ↗
  • 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. PubMed 17475608 ↗
  • 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. PubMed 26867642 ↗
  • 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. PubMed 26588701 ↗
  • 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. PubMed 25141859 ↗
  • 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. PubMed 25613906 ↗
  • 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. PubMed 19593986 ↗
  • 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. PubMed 18701100 ↗
  • 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. PubMed 15311067 ↗

Individual participant data

Plan to share: Undecided

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Registry details

Key details

Study ID
NCT03079609
Lead sponsor
Medical University of Warsaw
Responsible party
Sponsor
First posted
Mar 14, 2017
Start date
Jul 2016
Primary completion
Dec 2019 (estimated)
Completion
Dec 2019 (estimated)
Last update
Mar 6, 2019

Study contacts

Piotr Dobroński, MD PhD
study chair · Chair and Department of Urology Warsaw Medical University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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