Male Infertility Related With Post Infection Inflammatory Syndrome

NCT01407484 | Completed DMC

• 1 other identifier: P081215
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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 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

Keywords

Infertility; Assisted reproductive technology; Double blind therapeutical trial; Multicentric study; Prospective randomized study

Outcome Measures

Primary Outcomes (1)

• The number of live motile spermatozoa six month after the treatment

  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

  6 months

Secondary Outcomes (1)

• biological markers

  6 months

Study Arms (2)

Treatment

EXPERIMENTAL

Cortancyl (prednisone) 0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week

Drug: Prednisone

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Prednisone DRUG

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

Treatment

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Man over 18 years old
• Patient presenting a leukocytospermia ≥ 0,5\*106 /ml or an elastase ≥ 500ng/ml
• No infection
• Signed informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (1)

Cochin Hospital

Paris, 75014, France

Location

MeSH Terms

Conditions

Infertility, Male; Leukopenia; Infertility

Interventions

Prednisone

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Cytopenia; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukocyte Disorders

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Jean-Philippe Wolf, MD, Phd

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2011
• First Posted: August 2, 2011
• Study Start: March 2, 2011
• Primary Completion: May 14, 2015
• Study Completion: May 14, 2015
• Last Updated: November 20, 2025

Record last verified: 2025-10

Locations

FR (1)