Overview

This trial is active, not recruiting.

Condition urethritis
Treatment sperm sample
Sponsor Assistance Publique - Hôpitaux de Paris
Start date June 2012
End date April 2016
Trial size 113 participants
Trial identifier NCT01732172, P 111004

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
Patient with urethritis
sperm sample
Sperm sample
(Other)
Subjects with no urethritis and no history urogenital infection
sperm sample
Sperm sample

Primary Outcomes

Measure
Seminal elastase value
time frame: 6 months after the end of treatment.

Secondary Outcomes

Measure
Seminal elastase value
time frame: 12 months after the end of treatment.
Presence of markers of oxidative stress
time frame: 6 to 12 months after the end of treatment
Functional impairment of the glands of the reproductive tract
time frame: 6 to 12 months after the end of treatment
Signs reflecting the sperm function
time frame: 6 to 12 months after the end of treatment

Eligibility Criteria

Male participants at least 18 years old.

Inclusion criteria 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 Exclusion criteria 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

Additional Information

Official title Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.
Principal investigator Jean-Philippe WOLF, MD, PhD
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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Assistance Publique - Hôpitaux de Paris.