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Completed

NCT Number: NCT01732172

Chronic Inflammatory Condition of the Male Genital Tract

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

Completed

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Key information

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Cochin

Paris, 75014, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sperm sample

Other

Sperm sample

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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)

  4. 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))

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study title

Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.

Acronym: URIS

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Nov 22, 2012
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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