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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

Tracking Information
First Submitted Date  ICMJE November 19, 2012
First Posted Date  ICMJE November 22, 2012
Last Update Posted Date March 19, 2018
Actual Study Start Date  ICMJE December 10, 2012
Actual Primary Completion Date February 29, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 19, 2012)
  • 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.
  • 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)
  • 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)
  • 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))
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Chronic Inflammatory Condition of the Male Genital Tract
Official Title  ICMJE Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.
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

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Urethritis
Intervention  ICMJE Other: Sperm sample
Sperm sample
Study Arms  ICMJE
  • Experimental: Patient Group
    Patient with urethritis
    Intervention: Other: Sperm sample
  • Control group
    Subjects with no urethritis and no history urogenital infection
    Intervention: Other: Sperm sample
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 20, 2015)
113
Original Estimated Enrollment  ICMJE
 (submitted: November 19, 2012)
300
Actual Study Completion Date  ICMJE February 29, 2016
Actual Primary Completion Date February 29, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01732172
Other Study ID Numbers  ICMJE P 111004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Assistance Publique - Hôpitaux de Paris
Study Sponsor  ICMJE Assistance Publique - Hôpitaux de Paris
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jean-Philippe WOLF, MD, PhD Cochin Hospital
Principal Investigator: Khaled POCATE, MD Cochin Hospital
PRS Account Assistance Publique - Hôpitaux de Paris
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP