Chronic Inflammatory Condition of the Male Genital Tract

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01732172

Acronym

URIS

Enrollment

113

Registered

2012-11-22

Start date

2012-12-10

Completion date

2016-02-29

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urethritis

Keywords

Urethritis, Prevalence of a chronic inflammatory male genital tract

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

Interventions

OTHERSperm sample

Sperm sample

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

MALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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))

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean-Philippe WOLF, MD, PhD

Cochin Hospital

PRINCIPAL_INVESTIGATORKhaled POCATE, MD