<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01732172</url>
  </required_header>
  <id_info>
    <org_study_id>P 111004</org_study_id>
    <nct_id>NCT01732172</nct_id>
  </id_info>
  <brief_title>Chronic Inflammatory Condition of the Male Genital Tract</brief_title>
  <acronym>URIS</acronym>
  <official_title>Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Men following after proven and treated urethritis, looking for signs of chronic genital&#xD;
      inflammatory syndrome with oxidative stress.&#xD;
&#xD;
      This group of patients will be compared to a control group with no urethritis and no history&#xD;
      of urogenital infection. Monocentric, prospective trial.&#xD;
&#xD;
      Duration of study : one year&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The presence of leucospermia in an chronic inflammatory genital tract syndrome leads to an&#xD;
      oxidative stress and alterations in sperm parameters. Inflammation also affect the glands of&#xD;
      the genital tract. This can eventually leads to male infertility, long after the initial&#xD;
      infection. But 10% of men who seek treatment for infertility have such a leucospermia, while&#xD;
      it is a potentially treatable cause.&#xD;
&#xD;
      Main aim of this study: Search of development of an inflammatory genital tract syndrome in&#xD;
      patients with urethritis proven and treated at 6 months after the end of treatment.This group&#xD;
      of patients will be compared to a control group with no urethritis and no history of&#xD;
      urogenital infection. Monocentric, prospective trial.&#xD;
&#xD;
      Primary endpoint: Seminal elastase value to 6 months after the end of treatment. (500ng/ml or&#xD;
      greater)&#xD;
&#xD;
      Secondary objective:&#xD;
&#xD;
        -  Search for a genital inflammation in patients with urethritis proven and treated at 12&#xD;
           months after the end of treatment&#xD;
&#xD;
        -  Search for oxidative stress in patients with urethritis proven and treated at 6 and 12&#xD;
           months after the end of treatment&#xD;
&#xD;
        -  Study of the frequency of relapses infectious and / or passages at the stage of chronic&#xD;
           infection after acute urethritis&#xD;
&#xD;
        -  Assessment of the parallel evolution of the quality of sperm in the two groups&#xD;
&#xD;
      Progress of research. Time frame Search :&#xD;
&#xD;
        -  Duration of inclusions: 12 months&#xD;
&#xD;
        -  Duration of patient follow-up: 12 months for control group, 14 months at most for&#xD;
           patients taking into account the duration of treatment for urethritis which is 4 to 6&#xD;
           weeks&#xD;
&#xD;
        -  Total duration of the study: 26 months&#xD;
&#xD;
      Patients &amp; Methods: French monocentric, prospective trial. 300 subjects are planned to be&#xD;
      included for 150 subjects in each group&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 10, 2012</start_date>
  <completion_date type="Actual">February 29, 2016</completion_date>
  <primary_completion_date type="Actual">February 29, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Seminal elastase value</measure>
    <time_frame>6 months after the end of treatment.</time_frame>
    <description>The dosage of elastase will be do 6 months after the end of treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Seminal elastase value</measure>
    <time_frame>12 months after the end of treatment.</time_frame>
    <description>The dosage of elastase will be do 12 months after the end of treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence of markers of oxidative stress</measure>
    <time_frame>6 to 12 months after the end of treatment</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional impairment of the glands of the reproductive tract</measure>
    <time_frame>6 to 12 months after the end of treatment</time_frame>
    <description>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)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Signs reflecting the sperm function</measure>
    <time_frame>6 to 12 months after the end of treatment</time_frame>
    <description>Presence of signs reflecting the sperm function (vitality, mobility, analysis of motion parameters by Computer Assisted Semen Analyzer(CASA))</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">113</enrollment>
  <condition>Urethritis</condition>
  <arm_group>
    <arm_group_label>Patient Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient with urethritis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects with no urethritis and no history urogenital infection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sperm sample</intervention_name>
    <description>Sperm sample</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Patient Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria common to both groups:&#xD;
&#xD;
          -  Subjects aged 18 and over&#xD;
&#xD;
          -  Voluntary and signed informed consent&#xD;
&#xD;
        Inclusion criteria specific to the group &quot;patient&quot;:&#xD;
&#xD;
          -  Patients with clinical signs of urethritis / or&#xD;
&#xD;
          -  Patients treated for urethritis following the usual protocols in the month before&#xD;
             inclusionand / or&#xD;
&#xD;
          -  Patients with positive chlamydial research, or Mycoplasma genitallium or Garderella&#xD;
             vaginalis or gonorrhea in the sperm or first urinary stream;&#xD;
&#xD;
        Inclusion criteria specific to the group &quot;control&quot;:&#xD;
&#xD;
        - Patients with no urethritis or no history of urogenital infection&#xD;
&#xD;
        Exclusion criteria common to both groups:&#xD;
&#xD;
          -  Subjects not wishing to participate in the study&#xD;
&#xD;
          -  Subjects that have not signed the informed consent&#xD;
&#xD;
          -  Those not affiliated to the social security system (or entitled beneficiary)&#xD;
&#xD;
          -  Immunodepressed or have an infection associated with HIV, HBV or HCV&#xD;
&#xD;
          -  Chronic systemic disease&#xD;
&#xD;
        Exclusion criteria specific to the group &quot;patient&quot;:&#xD;
&#xD;
        - Patients with no signs of urethritis&#xD;
&#xD;
        Exclusion criteria specific to the group &quot;control&quot;:&#xD;
&#xD;
        - Subjects with signs of urethritis&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jean-Philippe WOLF, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cochin Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Khaled POCATE, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cochin Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>November 19, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 22, 2012</study_first_posted>
  <last_update_submitted>March 16, 2018</last_update_submitted>
  <last_update_submitted_qc>March 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Urethritis</keyword>
  <keyword>Prevalence of a chronic inflammatory male genital tract</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urethritis</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01732172
org study id: P 111004
nct id: NCT01732172
lead sponsor: 
has dmc: No
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
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
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Seminal elastase value
time frame: 6 months after the end of treatment.
description: The dosage of elastase will be do 6 months after the end of treatment.
measure: Seminal elastase value
time frame: 12 months after the end of treatment.
description: The dosage of elastase will be do 12 months after the end of treatment.
measure: Presence of markers of oxidative stress
time frame: 6 to 12 months after the end of treatment
description: 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)
measure: Functional impairment of the glands of the reproductive tract
time frame: 6 to 12 months after the end of treatment
description: 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)
measure: Signs reflecting the sperm function
time frame: 6 to 12 months after the end of treatment
description: Presence of signs reflecting the sperm function (vitality, mobility, analysis of motion parameters by Computer Assisted Semen Analyzer(CASA))
arm group label: Patient Group
arm group type: Experimental
description: Patient with urethritis
arm group label: Control group
arm group type: Other
description: Subjects with no urethritis and no history urogenital infection
intervention type: Other
intervention name: Sperm sample
description: Sperm sample
arm group label: Control group
arm group label: Patient Group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Philippe WOLF, MD, PhD
role: Principal Investigator
affiliation: Cochin Hospital
last name: Khaled POCATE, MD
role: Principal Investigator
affiliation: Cochin Hospital
facility: 
country: France
responsible party type: Sponsor
mesh term: Urethritis