Male Infertility Related With Post Infection Inflammatory Syndrome (SIGMA)
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Purpose
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 | Intervention |
|---|---|
|
Male Infertility Leukopenia Postinfection Inflammation Oxidative Stress |
Drug: Prednisone Drug: Placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Diagnosis and Treatment of Male Infertility Related to Inflammatory Syndrome: Therapeutic Trial |
- The number of live motile spermatozoa six month after the treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
- biological markers [ Time Frame: 6 months ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 600 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | April 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
Other Name: Prednisone
|
|
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo 0,2 mg/kg/day for 3 weeks and 0,1mg/kg/day for 1 week
Other Name: Placebo
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders 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%.
Contacts and Locations| Contact: Jean-Philippe WOLF, MD, PhD | 0033158411171 | jean-philippe.wolf@cch.aphp.fr |
| Contact: Laurence Lecomte, PhD | +331 58 41 35 45 | laurence.lecomte@cch.aphp.fr |
| France | |
| Cochin Hospital | Recruiting |
| Paris, France, 75014 | |
| Principal Investigator: Jean-Philippe Wolf, MD, PhD | |
| Principal Investigator: | Jean-Philippe Wolf, MD, Phd | AP-HP |
More Information
No publications provided
| Responsible Party: | Assistance Publique - Hôpitaux de Paris |
| ClinicalTrials.gov Identifier: | NCT01407484 History of Changes |
| Other Study ID Numbers: | P081215 |
| Study First Received: | June 30, 2011 |
| Last Updated: | February 19, 2013 |
| Health Authority: | France: Ministry of Health |
Keywords provided by Assistance Publique - Hôpitaux de Paris:
|
Infertility Assisted reproductive technology Double blind therapeutical trial Multicentric study Prospective randomized study |
Additional relevant MeSH terms:
|
Infertility Infertility, Male Inflammation Leukopenia Genital Diseases, Male Genital Diseases, Female Pathologic Processes Leukocyte Disorders Hematologic Diseases Prednisone |
Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Pharmacologic Actions Antineoplastic Agents, Hormonal Antineoplastic Agents Therapeutic Uses Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 19, 2013