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临床试验/NCT03079609
NCT03079609Unknown不适用

The Search for Viral and Bacterial Etiology of Varicocele

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2016年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Level of presence od viral or bacterial infection, level of expression of SHH and VEGF in varicose vein wall. .

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

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

排除标准

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

研究组 & 干预措施

microsurgery urology

Experimental

20 patients with varicocele (grade II or III) undergoing subinguinal microsurgery varicocelectomy due to infertility and/or pain in the scrotum.

干预措施: subinguinal microscopic varicocelectomy (Procedure)

open general surgery

Active Comparator

20 patients (without varicocele) undergoing open hernia repair.

干预措施: open hernia repair (Procedure)

结局指标

主要结局

Level of presence od viral or bacterial infection, level of expression of SHH and VEGF in varicose vein wall. .

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (1)

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