Clinical trial NCT01732172: Chronic Inflammatory Condition of the Male Genital Tract
Official title: Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urethritis
Keywords: Urethritis
Prevalence of a chronic inflammatory male genital tract
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2012-11-22
Enrollment: 113
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Seminal elastase value
timeFrame: 6 months after the end of treatment.
Secondary outcomes:
measure: Seminal elastase value
timeFrame: 12 months after the end of treatment.
measure: Presence of markers of oxidative stress
timeFrame: 6 to 12 months after the end of treatment
measure: Functional impairment of the glands of the reproductive tract
timeFrame: 6 to 12 months after the end of treatment
measure: Signs reflecting the sperm function
timeFrame: 6 to 12 months after the end of treatment
Other outcomes:
Locations:
city: Paris
country: France
facility: Hospital Cochin
Study officials:
affiliation: Cochin Hospital
name: Jean-Philippe WOLF, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cochin Hospital
name: Khaled POCATE, MD
role: PRINCIPAL_INVESTIGATOR
References: