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Male Infertility Related With Post Infection Inflammatory Syndrome (SIGMA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01407484
Recruitment Status : Completed
First Posted : August 2, 2011
Last Update Posted : March 19, 2018
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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.

Condition or disease Intervention/treatment Phase
Male Infertility Leukopenia Postinfection Inflammation Oxidative Stress Drug: Prednisone Drug: Placebo Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Diagnosis and Treatment of Male Infertility Related to Inflammatory Syndrome: Therapeutic Trial
Actual Study Start Date : March 2, 2011
Actual Primary Completion Date : May 14, 2015
Actual Study Completion Date : May 14, 2015

Arm Intervention/treatment
Experimental: Treatment
Cortancyl (prednisone) 0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week
Drug: Prednisone
0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week.

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

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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%.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01407484

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Cochin Hospital
Paris, France, 75014
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
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Principal Investigator: Jean-Philippe Wolf, MD, Phd Assistance Publique - Hôpitaux de Paris

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Responsible Party: Assistance Publique - Hôpitaux de Paris Identifier: NCT01407484     History of Changes
Other Study ID Numbers: P081215
First Posted: August 2, 2011    Key Record Dates
Last Update Posted: March 19, 2018
Last Verified: March 2018
Keywords provided by Assistance Publique - Hôpitaux de Paris:
Assisted reproductive technology
Double blind therapeutical trial
Multicentric study
Prospective randomized study
Additional relevant MeSH terms:
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Infertility, Male
Pathologic Processes
Genital Diseases, Male
Genital Diseases, Female
Leukocyte Disorders
Hematologic Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents