Status:

COMPLETED

Male Infertility Related With Post Infection Inflammatory Syndrome

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Collaborating Sponsors:

URC-CIC Paris Descartes Necker Cochin

Conditions:

Male Infertility

Leukopenia

Eligibility:

MALE

18+ years

Phase:

NA

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), characteri...

Detailed Description

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...

Eligibility Criteria

Inclusion

  • Inclusion criteria :
  • Man over 18 years old
  • Patient presenting a leukocytospermia ≥ 0,5\*106 /ml or an elastase ≥ 500ng/ml
  • No infection
  • Signed informed consent
  • Exclusion criteria :
  • Patient having less of 106 /ml of sperm cells in the ejaculate
  • Patients with diabetes or receiving treatment for diabetes
  • Patients already taking anti-inflammatory drugs
  • Patients with ongoing anticoagulant therapy
  • Patients with history of allergy to anti-inflammatory drug
  • Patients with a history of peptic ulcers
  • Patient with history of cardiovascular disease (hypertension, cardiac arrhythmia, ...)
  • Patients with psychological disorders
  • Patient with an infectious condition except for specified indications of Prednisone
  • Patients with some evolutional viruses(including hepatitis, herpes, chickenpox, shingles)
  • Patient is in a psychotic state still not controlled by treatment
  • Patient receiving a live vaccine
  • Patients with hypersensitivity to any component of Prednisone
  • Patient not affiliated with a social security system
  • Criteria for randomization
  • \- Patient meeting all inclusion criteria and none of exclusion, and having a 8OH desoxy Guanosine increased ≥ 35%.

Exclusion

    Key Trial Info

    Start Date :

    March 2 2011

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    May 14 2015

    Estimated Enrollment :

    200 Patients enrolled

    Trial Details

    Trial ID

    NCT01407484

    Start Date

    March 2 2011

    End Date

    May 14 2015

    Last Update

    November 20 2025

    Active Locations (1)

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    Page 1 of 1 (1 locations)

    1

    Cochin Hospital

    Paris, France, 75014