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Chronic Inflammatory Condition of the Male Genital Tract (URIS)

Primary Purpose

Urethritis

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Sperm sample
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urethritis focused on measuring Urethritis, Prevalence of a chronic inflammatory male genital tract

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Cochin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Patient Group

Control group

Arm Description

Patient with urethritis

Subjects with no urethritis and no history urogenital infection

Outcomes

Primary Outcome Measures

Seminal elastase value
The dosage of elastase will be do 6 months after the end of treatment.

Secondary Outcome Measures

Seminal elastase value
The dosage of elastase will be do 12 months after the end of treatment.
Presence of markers of oxidative stress
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
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
Presence of signs reflecting the sperm function (vitality, mobility, analysis of motion parameters by Computer Assisted Semen Analyzer(CASA))

Full Information

First Posted
November 19, 2012
Last Updated
March 16, 2018
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT01732172
Brief Title
Chronic Inflammatory Condition of the Male Genital Tract
Acronym
URIS
Official Title
Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
December 10, 2012 (Actual)
Primary Completion Date
February 29, 2016 (Actual)
Study Completion Date
February 29, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urethritis
Keywords
Urethritis, Prevalence of a chronic inflammatory male genital tract

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patient Group
Arm Type
Experimental
Arm Description
Patient with urethritis
Arm Title
Control group
Arm Type
Other
Arm Description
Subjects with no urethritis and no history urogenital infection
Intervention Type
Other
Intervention Name(s)
Sperm sample
Intervention Description
Sperm sample
Primary Outcome Measure Information:
Title
Seminal elastase value
Description
The dosage of elastase will be do 6 months after the end of treatment.
Time Frame
6 months after the end of treatment.
Secondary Outcome Measure Information:
Title
Seminal elastase value
Description
The dosage of elastase will be do 12 months after the end of treatment.
Time Frame
12 months after the end of treatment.
Title
Presence of markers of oxidative stress
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)
Time Frame
6 to 12 months after the end of treatment
Title
Functional impairment of the glands of the reproductive tract
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)
Time Frame
6 to 12 months after the end of treatment
Title
Signs reflecting the sperm function
Description
Presence of signs reflecting the sperm function (vitality, mobility, analysis of motion parameters by Computer Assisted Semen Analyzer(CASA))
Time Frame
6 to 12 months after the end of treatment

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Philippe WOLF, MD, PhD
Organizational Affiliation
Cochin Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Khaled POCATE, MD
Organizational Affiliation
Cochin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Cochin
City
Paris
ZIP/Postal Code
75014
Country
France

12. IPD Sharing Statement

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Chronic Inflammatory Condition of the Male Genital Tract

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