Chronic Inflammatory Condition of the Male Genital Tract — URIS  

Urethritis Clinical Trial

Official title: Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.

Status Completed

Clinical Trial 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

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Urethritis

• NCT number: NCT01732172
• Study type: Interventional
• Source: Assistance Publique - Hôpitaux de Paris
• Status: Completed
• Phase: N/A
• Start date: December 10, 2012
• Completion date: February 29, 2016