Male Infertility Related With Post Infection Inflammatory Syndrome (SIGMA)
BACKGROUND: One couple out of 6 consults for infertility during their sexual life. In 60% of cases a male factor is associated or is the main infertility factor. Inflammatory Syndrome (IS), characterized by the presence of a leukocytospermia is found in 12% of the cases. Leukocyte degranulation causes oxidative stress (OS) through the formation of free radicals attacking the sperm cell functions.
HYPOTHESIS: To establish the responsibility of the IS, and OS, in chronicle inflammatory male infertility, the investigators hypothesize that its treatment (as well as its possible cause) must restore or improve the fertilizing capacity of patients sperm.
METHODS: This prospective randomized study will test the response to the treatment. The investigators shall measure cellular degradation products due to the OS, thereby certifying that it does have a deleterious effect on sperm cell. Seminal biochemistry will also assess the impact of the syndrome on the genital tract glands and follow its evolution.
The patients will be included in the study as soon as the leukocytospermia will be > 0,5*106/ml or as soon as the elastase will be > 500 ng/mL.
The examinations will be performed using flow cytometry, CASA (Computer Assisted Semen Analysis). The analysis of sperm morphology will be centralized.
Primary endpoint will be a reduction in the percentage of 8OH-dG below 35 %. We anticipate that it should arrive to 20 % of the patients included in the arm treatment by corticosteroid therapy. All in all will thus be needed 50 patients in the group placebo and 50 in the group treated.
Secondary endpoint the improvement of the spermatic parameters and the reduction of the fragmentation of the DNA of sperm cells to the treated subjects.
All these biological markers will be evaluated 6 month after the treatment:
- Fragmentation of the spermatic DNA below 37 % during the follow-up in 6 months
- Leukocytospermia and elastase
- Seminal biochemistry
- Other markers of the inflammatory syndrome and oxidative stress (protein carbonyl, 8OHd-Guanosine)
- Possibly the radiological examinations (Ultrasound and MRI of the genital tract)
In addition it would allow us to propose a policy of prevention towards acquired post-infectious male infertility.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|Official Title:||Diagnosis and Treatment of Male Infertility Related to Inflammatory Syndrome: Therapeutic Trial|
- The number of live motile spermatozoa six month after the treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]Reduction of the percentage of the spermatic 8OH-dG under 35 % to 20 % of the patients between the visit of inclusion / randomization and the visit of follow-up in 6 months
- biological markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]Several biological markers will be evaluated 6 months after the treatment, as markers of inflammation and oxidative stress (sperm DNA fragmentation, protein carbonyl, 8OHdGuanosine, leukocytospermia and elastase, seminal biochemistry,ultrasound, and MRI of the genital tract
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||November 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
Cortancyl (prednisone) 0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week
0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week.
Placebo Comparator: Placebo
Placebo 0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01407484
|Paris, France, 75014|
|Principal Investigator:||Jean-Philippe Wolf, MD, Phd||Assistance Publique - Hôpitaux de Paris|