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Chronic Inflammatory Condition of the Male Genital Tract (URIS)

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ClinicalTrials.gov Identifier: NCT01732172
Recruitment Status : Completed
First Posted : November 22, 2012
Last Update Posted : March 19, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Study Description
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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


Condition or disease Intervention/treatment Phase
Urethritis Other: Sperm sample Not Applicable

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Actual Study Start Date : December 10, 2012
Actual Primary Completion Date : February 29, 2016
Actual Study Completion Date : February 29, 2016
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Seminal elastase value [ Time Frame: 6 months after the end of treatment. ]
    The dosage of elastase will be do 6 months after the end of treatment.


Secondary Outcome Measures :
  1. Seminal elastase value [ Time Frame: 12 months after the end of treatment. ]
    The dosage of elastase will be do 12 months after the end of treatment.

  2. Presence of markers of oxidative stress [ Time Frame: 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)

  3. Functional impairment of the glands of the reproductive tract [ Time Frame: 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)

  4. Signs reflecting the sperm function [ Time Frame: 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))


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01732172


Locations
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France
Hospital Cochin
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Jean-Philippe WOLF, MD, PhD Cochin Hospital
Principal Investigator: Khaled POCATE, MD Cochin Hospital
More Information
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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01732172    
Other Study ID Numbers: P 111004
First Posted: November 22, 2012    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Urethritis
Prevalence of a chronic inflammatory male genital tract
Additional relevant MeSH terms:
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Urethritis
Urethral Diseases
Urologic Diseases