VaricoceleViBaVaNCT03079609
The Search for Viral and Bacterial Etiology of Varicocele
A study testing subinguinal microscopic varicocelectomy and open hernia repair in people with Varicocele and Viral Infection, run by Medical University of Warsaw at 1 site in Poland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Varicocele, Viral Infection, Bacterial Infections
- What is being tested?
- subinguinal microscopic varicocelectomy and open hernia repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- Jul 2016to Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- in experimental arm - varicocele grade II or III and infertility and/or pain
Who cannot join
- in control arm: presence of varicocele in ultrasound before surgery
Trial locations and contacts
1 site in 1 country.
Poland1 site
Chair and Department of Urology Warsaw Medical University
Warsaw, 02-005
About this study
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
- Being tested
- subinguinal microscopic varicocelectomy, open hernia repair
- Medical subject headings
- Varicocele, Virus Diseases, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subinguinal microscopic varicocelectomyProcedure or surgery
During the procedure approximately 1cm long fragment of varicose vein will be taken for further investigation.
open hernia repairProcedure or surgery
During the procedure approximately 1cm long fragment of spermatic cord vein will be taken for further investigation.
| Study group | Role | What they receive |
|---|---|---|
| microsurgery urology | Experimental | 20 patients with varicocele (grade II or III) undergoing subinguinal microsurgery varicocelectomy due to infertility and/or pain in the scrotum. Receives: Procedure: subinguinal microscopic varicocelectomy |
| open general surgery | Active comparator | 20 patients (without varicocele) undergoing open hernia repair. Receives: Procedure: open hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year after finishing recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2017
- Study startJul 2016
- Primary completionDec 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for VaricoceleStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Piotr Dobroński, MD PhD, Study chair, Chair and Department of Urology Warsaw Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03079609
- Sponsor's protocol ID
- ViBaVa
- Acronym
- ViBaVa
- Status last verified
- Mar 2019
- First submitted
- 8 Feb 2017
- Last updated
- 6 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 19030866Lee 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 17475608Wang 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 26867642Petrovic 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 26588701Hwang 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 25141859Paulis 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 25613906Ai 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 19593986Tek 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 18701100Kilinc 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Search for Viral and Bacterial Etiology of Varicocele
- ClinicalTrials.gov ID
- NCT03079609
- Acronym / sponsor ID
- ViBaVa / ViBaVa
- Conditions
- Varicocele, Viral Infection, Bacterial Infections, Sonic Hedgehog Expression, VEGF Expression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 14 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| microsurgery urology | Experimental | Procedure: subinguinal microscopic varicocelectomy20 patients with varicocele (grade II or III) undergoing subinguinal microsurgery varicocelectomy due to infertility and/or pain in the scrotum. |
| open general surgery | Active comparator | Procedure: open hernia repair20 patients (without varicocele) undergoing open hernia repair. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- in experimental arm - varicocele grade II or III and infertility and/or pain
Key exclusion criteria (1 listed)
- in control arm: presence of varicocele in ultrasound before surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| subinguinal microscopic varicocelectomyDuring the procedure approximately 1cm long fragment of varicose vein will be taken for further investigation. | Procedure or surgery | microsurgery urology |
| open hernia repairDuring the procedure approximately 1cm long fragment of spermatic cord vein will be taken for further investigation. | Procedure or surgery | open general surgery |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
- Background: PubMed 19030866Iafrate 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.
- Background: PubMed 17475608Lee 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.
- Background: PubMed 26867642Wang 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.
- Background: PubMed 26588701Petrovic 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.
- Background: PubMed 25141859Hwang 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.
- Background: PubMed 25613906Paulis 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.
- Background: PubMed 19593986Ai 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.
- Background: PubMed 18701100Tek 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.
- Background: PubMed 15311067Kilinc 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piotr Dobroński, MD PhD study chair
Chair and Department of Urology Warsaw Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subinguinal microscopic varicocelectomy and open hernia repair in people with Varicocele and Viral Infection, run by Medical University of Warsaw at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03079609, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.