Male Infertility Related With Post Infection Inflammatory Syndrome

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 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.

Conditions

• Male Infertility
• Leukopenia
• Postinfection Inflammation
• Oxidative Stress

Interventions

DRUG

Prednisone

0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week.

DRUG

Placebo

Placebo 0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week

Sponsors & Collaborators

• URC-CIC Paris Descartes Necker Cochin

  collaborator OTHER

• Assistance Publique - Hôpitaux de Paris

  lead OTHER

Principal Investigators

• Jean-Philippe Wolf, MD, Phd · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-02

Primary Completion

2015-05-14

Completion

2015-05-14

Countries

• France

Study Locations