UrethritisURISNCT01732172
Chronic Inflammatory Condition of the Male Genital Tract
A study testing Sperm sample in people with Urethritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urethritis
- What is being tested?
- Sperm sample
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteFrance
- Study dates
- 10 Dec 2012to 29 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects aged 18 and over
- Voluntary and signed informed consent
- 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;
- Patients with no urethritis or no history of urogenital infection
Who cannot join
- 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
- Patients with no signs of urethritis
- Subjects with signs of urethritis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Urethritis
- Being tested
- Sperm sample
- Keywords
- Urethritis, Prevalence of a chronic inflammatory male genital tract
- Medical subject headings
- Urethritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sperm sampleOther
Sperm sample
| Study group | Role | What they receive |
|---|---|---|
| Patient Group | Experimental | Patient with urethritis Receives: Other: Sperm sample |
| Control group | Other | Subjects with no urethritis and no history urogenital infection Receives: Other: Sperm sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seminal elastase value
The dosage of elastase will be do 6 months after the end of treatment.
Measured: 6 months after the end of treatment.
Secondary outcomes (4)
Seminal elastase value
The dosage of elastase will be do 12 months after the end of treatment.
Measured: 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)
Measured: 6 to 12 months after the end of treatment
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)
Measured: 6 to 12 months after the end of treatment
Signs reflecting the sperm function
Presence of signs reflecting the sperm function (vitality, mobility, analysis of motion parameters by Computer Assisted Semen Analyzer(CASA))
Measured: 6 to 12 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2012 (estimated)
- Study start10 Dec 2012
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrethritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe WOLF, MD, PhD, Principal investigator, Cochin HospitalKhaled POCATE, MD, Principal investigator, Cochin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01732172
- Sponsor's protocol ID
- P111004
- Acronym
- URIS
- Status last verified
- Feb 2026
- First submitted
- 19 Nov 2012
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.
- ClinicalTrials.gov ID
- NCT01732172
- Acronym / sponsor ID
- URIS / P111004
- Conditions
- Urethritis
- Keywords
- Urethritis, Prevalence of a chronic inflammatory male genital tract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- 10 Dec 2012 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 22 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Group | Experimental | Other: Sperm samplePatient with urethritis |
| Control group | Other | Other: Sperm sampleSubjects with no urethritis and no history urogenital infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Subjects aged 18 and over
- Voluntary and signed informed consent
- 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;
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sperm sampleSperm sample | Other | Control group, Patient Group |
Primary outcome
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.
4 secondary outcomes
Seminal elastase value
Time frame: 12 months after the end of treatment.
Presence of markers of oxidative stress
Time frame: 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
Signs reflecting the sperm function
Time frame: 6 to 12 months after the end of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
Related trials for Urethritis
Not yet recruitingPhase 2
Omadacycline for Treatment Refractory Mycoplasma Genitalium Urethritis
Mycoplasma Genitalium Infection, Urethritis
RecruitingPhase 2
"Sexual Health Assessment of TinidaZole Against M. Genitalium (SHAZAM)"
Mycoplasma Genitalium, Non-gonococcal Urethritis (NGU)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe WOLF, MD, PhD principal investigator
Cochin Hospital
Khaled POCATE, MD principal investigator
Cochin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sperm sample in people with Urethritis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seminal elastase value (time frame: 6 months after the end of treatment.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.