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| Name | Class |
|---|---|
| URC-CIC Paris Descartes Necker Cochin | OTHER |
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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Group | Experimental | Patient with urethritis |
|
| Control group | Other | Subjects with no urethritis and no history urogenital infection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sperm sample | Other | Sperm sample |
|
| Measure | Description | Time Frame |
|---|---|---|
| Seminal elastase value | The dosage of elastase will be do 6 months after the end of treatment. | 6 months after the end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Seminal elastase value | 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 | 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) |
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Inclusion criteria common to both groups:
Inclusion criteria specific to the group "patient":
Inclusion criteria specific to the group "control":
- Patients with no urethritis or no history of urogenital infection
Exclusion criteria common to both groups:
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
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Philippe WOLF, MD, PhD | Cochin Hospital | Principal Investigator |
| Khaled POCATE, MD | Cochin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Cochin | Paris | 75014 | France |
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| ID | Term |
|---|---|
| D014526 | Urethritis |
| ID | Term |
|---|---|
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| 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) | 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)) | 6 to 12 months after the end of treatment |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |