Clinical Trial: Male Infertility Related With Post Infection Inflammatory Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Diagnosis and Treatment of Male Infertility Related to Inflammatory Syndrome: Therapeutic Trial

Brief Summary:

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 para

Detailed Summary:

Progress of research. Timeframe Search

  • Duration of inclusions: 30 months
  • Duration of patient follow-up: 7 months
  • Total duration of the study: 37 months Within the framework of their coverage in AMP, the barren couples have a consultation with the doctors of the reproduction and one with the biologists. Between these two visits, a spermatic balance assessment (EXAMINATION N°0) is made including a semen culture, a spermogram or a test of migration survival (TMS) and an elastase.

On the occasion of this examination, aliquots for the measure of 8OH-dG, fragmentation of the spermatic DNA and seminal biochemistry will systematically be taken.

Within the framework of this standard balance assessment of infertility, it is possible that an echography and a MRI of the genital ways are prescribed; if it is the case, the data of these examinations will be collected in the case report form. But these examinations will not be specifically asked for the search.

If a leukocytospermia ≥ 0,5*106/ml is discovered or an increase of the elastase ≥ 500 ng / ml, the dosages of 8OH-dG, the fragmentation and the seminal biochemistry will be made.

The patients will then be seen in consultation of biology (CONSULTATION OF BIOLOGY N°0 = visit of inclusion and randomization).

  • If the patients present 8OH-dG > 35 %, and that their semen culture is negative, it will be suggested to them being included in the protocol and the randomization will be made that very day; the patients will receive or
    Sponsor: Assistance Publique - Hôpitaux de Paris

    Current Primary Outcome: The number of live motile spermatozoa six month after the treatment [ Time Frame: 6 months ]

    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


    Original Primary Outcome: The number of live motile spermatozoa six month after the treatment [ Time Frame: 6 months ]

    The number of live motile spermatozoa 24 h after a migration test through a Percoll gradient, six month after the treatment. It is expected to be increased of 20%


    Current Secondary Outcome: biological markers [ Time Frame: 6 months ]

    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


    Original Secondary Outcome: biological markers [ Time Frame: 6 months ]

    All these biological markers will be evaluated 6 month after the treatment

    • Markers of inflammation and oxidative stress (sperm DNA fragmentation, protein carbonyl, 8OHdGuanosine)
    • Leukocytospermia and elastase
    • Seminal biochemistry
    • Ultrasound and MRI of the genital tract


    Information By: Assistance Publique - Hôpitaux de Paris

    Dates:
    Date Received: June 30, 2011
    Date Started: March 2011
    Date Completion:
    Last Updated: July 5, 2016
    Last Verified: July 2016