Oxidative Stress Clinical Trial
— SIGMAOfficial title:
Diagnosis and Treatment of Male Infertility Related to Inflammatory Syndrome: Therapeutic Trial
Verified date | March 2018 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | May 14, 2015 |
Est. primary completion date | May 14, 2015 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
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%. |
Country | Name | City | State |
---|---|---|---|
France | Cochin Hospital | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | biological markers | 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 | 6 months |
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