Chronic Inflammatory Condition of the Male Genital Tract (URIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Assistance Publique - Hôpitaux de Paris
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT01732172
First received: November 19, 2012
Last updated: August 2, 2013
Last verified: July 2013
  Purpose

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


Condition Intervention
Urethritis
Other: Sperm sample

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Seminal elastase value [ Time Frame: 6 months after the end of treatment. ] [ Designated as safety issue: No ]
    The dosage of elastase will be do 6 months after the end of treatment.


Secondary Outcome Measures:
  • Seminal elastase value [ Time Frame: 12 months after the end of treatment. ] [ Designated as safety issue: No ]
    The dosage of elastase will be do 12 months after the end of treatment.

  • Presence of markers of oxidative stress [ Time Frame: 6 to 12 months after the end of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 to 12 months after the end of treatment ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 to 12 months after the end of treatment ] [ Designated as safety issue: No ]
    Presence of signs reflecting the sperm function (vitality, mobility, analysis of motion parameters by Computer Assisted Semen Analyzer(CASA))


Estimated Enrollment: 60
Study Start Date: June 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patient Group
Patient with urethritis
Other: Sperm sample
Sperm sample
Control group
Subjects with no urethritis and no history urogenital infection
Other: Sperm sample
Sperm sample

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01732172

Contacts
Contact: Jean-Philippe WOLF, MD, PhD ++33158413701 jean-philippe.wolf@cch.aphp.fr
Contact: Laurence Lecomte, PhD +33 1 71 19 64 94 laurence.lecomte@nck.aphp.fr

Locations
France
Hospital Cochin Recruiting
Paris, France, 75014
Contact: Jean-Philippe WOLF, MD, PhD    +33158413701    jean-philippe.wolf@cch.aphp.fr   
Sub-Investigator: Khaled POCATE, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Jean-Philippe WOLF, MD, PhD Cochin Hospital
Principal Investigator: Khaled POCATE, MD Cochin Hospital
  More Information

No publications provided

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01732172     History of Changes
Other Study ID Numbers: P 111004
Study First Received: November 19, 2012
Last Updated: August 2, 2013
Health Authority: France: Ministry of Health

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Urethritis
Prevalence of a chronic inflammatory male genital tract

Additional relevant MeSH terms:
Urethritis
Urethral Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on July 22, 2014