- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01732172
Chronic Inflammatory Condition of the Male Genital Tract (URIS)
Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.
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
Study Overview
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Paris, France, 75014
- Hospital Cochin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient Group
Patient with urethritis
|
Sperm sample
|
Other: Control group
Subjects with no urethritis and no history urogenital infection
|
Sperm sample
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
6 months after the end of treatment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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)
|
6 to 12 months after the end of treatment
|
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)
|
6 to 12 months after the end of treatment
|
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))
|
6 to 12 months after the end of treatment
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jean-Philippe WOLF, MD, PhD, Cochin Hospital
- Principal Investigator: Khaled POCATE, MD, Cochin Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P 111004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Urethritis
-
National Institute of Allergy and Infectious Diseases...CompletedUrethritisUnited States
-
Oslo University HospitalMøre og Romsdal Hospital TrustTerminatedChlamydia Trachomatis Infection | Chlamydial UrethritisNorway
-
Cairo UniversityRecruitingNon-Specific UrethritisEgypt
-
University of WashingtonNational Institute of Allergy and Infectious Diseases (NIAID)Completed
-
Centers for Disease Control and PreventionTulane UniversityCompletedUrethritis | Trichomonas VaginalisUnited States
-
Massachusetts General HospitalAmerican Sexually Transmitted Diseases AssociationRecruitingSexually Transmitted Infections | Cervicitis | UrethritisUnited States
-
University of Alabama at BirminghamTerminatedMycoplasma Genitalium InfectionUnited States
-
Ostergotland County Council, SwedenStatens Serum InstitutUnknownChlamydia Trachomatis | Cervicitis | Urethritis | Genital Mycoplasma InfectionSweden
Clinical Trials on Sperm sample
-
University Hospital, ToulouseInstitut National de la Santé Et de la Recherche Médicale, France; ANRS, Emerging...Completed
-
Assistance Publique - Hôpitaux de ParisCompleted
-
CREA Medicina de la Reproducción SLRecruitingIntracytoplasmic Sperm Injection | Sperm | MicrofluidicsSpain
-
Royan InstituteCompletedInfertilityIran, Islamic Republic of
-
Nadezhda Women's Health HospitalEnrolling by invitation
-
Sapientiae InstituteTerminated
-
Instituto Valenciano de Infertilidad, IVI AlicanteIgenomixCompleted
-
Centro de Infertilidad y Reproducción HumanaTerminated
-
FertilysInstitut national de la recherche scientifiqueTerminatedCovid19 | Infertility, MaleCanada
-
IVI AmericaRecruitingInfertilityUnited States