Hospital Cochin
Paris, 75014, France
NCT Number: NCT01732172
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
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Notify Me18 year and older
Male
Interventional
Not applicable
Paris, 75014, France
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:
Progress of research. Time frame Search :
Patients & Methods: French monocentric, prospective trial. 300 subjects are planned to be included for 150 subjects in each group
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
common to both groups:
Inclusion criteria
specific to the group "patient":
Inclusion criteria
specific to the group "control":
Exclusion criteria
common to both groups:
Exclusion criteria
specific to the group "patient":
Exclusion criteria
specific to the group "control":
Sperm sample
Time frame: 6 months after the end of treatment.
The dosage of elastase will be do 6 months after the end of treatment.
Time frame: 12 months after the end of treatment.
The dosage of elastase will be do 12 months after the end of treatment.
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)
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)
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))
Assistance Publique - Hôpitaux de Paris
Other
Study of the Prevalence of a Chronic Inflammatory Condition of the Male Genital Tract at a Distance and Urethritis Following.
Acronym: URIS
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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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