Chronic Inflammatory Condition of the Male Genital Tract

NCT ID: NCT01732172

Last Updated: 2018-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 113 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-10
• Study Completion Date: 2016-02-29

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

Conditions

Urethritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Patient Group

Patient with urethritis

Group Type: EXPERIMENTAL

Sperm sample

Intervention Type: OTHER

Sperm sample

Control group

Subjects with no urethritis and no history urogenital infection

Group Type: OTHER

Sperm sample

Intervention Type: OTHER

Sperm sample

Interventions

Sperm sample

Sperm sample

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Subjects aged 18 and over
• Voluntary and signed informed consent

• 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;

• Patients with no urethritis or no history of urogenital infection

Exclusion Criteria

• 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

• Patients with no signs of urethritis

• Subjects with signs of urethritis

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Philippe WOLF, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Cochin Hospital

Khaled POCATE, MD

Role: PRINCIPAL_INVESTIGATOR

Cochin Hospital

Locations

Hospital Cochin

Paris, , France

Countries

France

Other Identifiers

P 111004

Identifier Type: -

Identifier Source: org_study_id