The Search for Viral and Bacterial Etiology of Varicocele (ViBaVa)
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|ClinicalTrials.gov Identifier: NCT03079609|
Recruitment Status : Active, not recruiting
First Posted : March 14, 2017
Last Update Posted : March 6, 2019
|Condition or disease||Intervention/treatment||Phase|
|Varicocele Viral Infection Bacterial Infections Sonic Hedgehog Expression VEGF Expression||Procedure: subinguinal microscopic varicocelectomy Procedure: open hernia repair||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Search for Viral and Bacterial Etiology of Varicocele|
|Actual Study Start Date :||July 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
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
During the procedure approximately 1cm long fragment of varicose vein will be taken for further investigation.
Active Comparator: open general surgery
20 patients (without varicocele) undergoing open hernia repair.
Procedure: open hernia repair
During the procedure approximately 1cm long fragment of spermatic cord vein will be taken for further investigation.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03079609
|Chair and Department of Urology Warsaw Medical University|
|Warsaw, Poland, 02-005|
|Study Chair:||Piotr Dobroński, MD PhD||Chair and Department of Urology Warsaw Medical University|