Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- Seminal elastase value
研究概览
简要总结
Men following after proven and treated urethritis, looking for signs of chronic genital inflammatory syndrome with oxidative stress.
This group of patients will be compared to a control group with no urethritis and no history of urogenital infection. Monocentric, prospective trial.
Duration of study : one year
详细描述
The presence of leucospermia in an chronic inflammatory genital tract syndrome leads to an oxidative stress and alterations in sperm parameters. Inflammation also affect the glands of the genital tract. This can eventually leads to male infertility, long after the initial infection. But 10% of men who seek treatment for infertility have such a leucospermia, while it is a potentially treatable cause.
Main aim of this study: Search of development of an inflammatory genital tract syndrome in patients with urethritis proven and treated at 6 months after the end of treatment.This group of patients will be compared to a control group with no urethritis and no history of urogenital infection. Monocentric, prospective trial.
Primary endpoint: Seminal elastase value to 6 months after the end of treatment. (500ng/ml or greater)
Secondary objective:
- Search for a genital inflammation in patients with urethritis proven and treated at 12 months after the end of treatment
- Search for oxidative stress in patients with urethritis proven and treated at 6 and 12 months after the end of treatment
- Study of the frequency of relapses infectious and / or passages at the stage of chronic infection after acute urethritis
- Assessment of the parallel evolution of the quality of sperm in the two groups
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •common to both groups:
- •Subjects aged 18 and over
- •Voluntary and signed informed consent
- •Inclusion criteria specific to the group "patient":
- •Patients with clinical signs of urethritis / or
- •Patients treated for urethritis following the usual protocols in the month before inclusionand / or
- •Patients with positive chlamydial research, or Mycoplasma genitallium or Garderella vaginalis or gonorrhea in the sperm or first urinary stream;
- •Inclusion criteria specific to the group "control":
- •- Patients with no urethritis or no history of urogenital infection
排除标准
- •common to both groups:
- •Subjects not wishing to participate in the study
- •Subjects that have not signed the informed consent
- •Those not affiliated to the social security system (or entitled beneficiary)
- •Immunodepressed or have an infection associated with HIV, HBV or HCV
- •Chronic systemic disease
- •Exclusion criteria specific to the group "patient":
- •- Patients with no signs of urethritis
- •Exclusion criteria specific to the group "control":
- •- Subjects with signs of urethritis
研究组 & 干预措施
Patient Group
Patient with urethritis
干预措施: Sperm sample (Other)
Control group
Subjects with no urethritis and no history urogenital infection
干预措施: Sperm sample (Other)
结局指标
主要结局
Seminal elastase value
时间窗: 6 months after the end of treatment.
The dosage of elastase will be do 6 months after the end of treatment.
次要结局
- Seminal elastase value(12 months after the end of treatment.)
- Presence of markers of oxidative stress(6 to 12 months after the end of treatment)
- Functional impairment of the glands of the reproductive tract(6 to 12 months after the end of treatment)
- Signs reflecting the sperm function(6 to 12 months after the end of treatment)