Chronic Inflammatory Condition of the Male Genital Tract
- Conditions
- Urethritis
- Interventions
- Other: Sperm sample
- Registration Number
- NCT01732172
- Lead Sponsor
- Assistance Publique - Hôpitaux de Paris
- Brief Summary
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
- Detailed Description
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
Progress of research. Time frame Search :
* Duration of inclusions: 12 months
* Duration of patient follow-up: 12 months for control group, 14 months at most for patients taking into account the duration of treatment for urethritis which is 4 to 6 weeks
* Total duration of the study: 26 months
Patients \& Methods: French monocentric, prospective trial. 300 subjects are planned to be included for 150 subjects in each group
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 113
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Patient Group Sperm sample Patient with urethritis Control group Sperm sample Subjects with no urethritis and no history urogenital infection
- Primary Outcome Measures
Name Time Method Seminal elastase value 6 months after the end of treatment. The dosage of elastase will be do 6 months after the end of treatment.
- Secondary Outcome Measures
Name Time Method Seminal elastase value 12 months after the end of treatment. The dosage of elastase will be do 12 months after the end of treatment.
Presence of markers of oxidative stress 6 to 12 months after the end of treatment Presence of markers objectifying the existence of oxidative stress resulting in cellular alterations: Determination of 8-hydroxydeoxyguanosine (8-OHdG) and AOPP (Advanced Oxidation Protein Products)
Functional impairment of the glands of the reproductive tract 6 to 12 months after the end of treatment Presence of biochemical evidence indicating a functional impairment of the glands of the reproductive tract (markers of prostate, seminal vesicles, and epididymis to the seminal biochemistry)
Signs reflecting the sperm function 6 to 12 months after the end of treatment Presence of signs reflecting the sperm function (vitality, mobility, analysis of motion parameters by Computer Assisted Semen Analyzer(CASA))
Trial Locations
- Locations (1)
Hospital Cochin
🇫🇷Paris, France