Efficacy Study of a Food Supplement With Myo-inositol, N-Acetyl-Cystein, Zinc and Vitamins on Sperm DNA Fragmentation
Male Infertility
About this trial
This is an interventional treatment trial for Male Infertility focused on measuring Spermatozoa, DNA Fragmentation, Chromatin Condensation, Food supplement, TUNEL
Eligibility Criteria
Selection Criteria:
- Male patient volunteers aged 20 to 45 years (limits included);
- Socially insured patient receiving benefits from the French Social Security's health branch
Non-Selection Criteria:
- Patients suffering from infertility of infectious or genetic origin, or from a pathology requiring concomitant medical treatment;
- Consumption of dietary supplements during the previous 3 months and during the course of the study;
- Smoking ≥ 5 cigarettes/day;
- Alcoholism ≥ 10 drinks (alcohol standard)/week ;
- Body Mass Index (BMI) not between [19 and 29] (inclusive).
- Occupation at risk of exposure to carcinogenic, mutagenic and toxic agents for reproduction defined according to articles R.4412-2 2°, R.4412-3 and R.4412-60 of the French Labour Code;
- Patient unable to give consent;
- Minors and protected adults, vulnerable persons;
- Patient participating in another clinical research study
Inclusion Criteria:
- Sperm DNA fragmentation rate ≥ 30 %
Exclusion Criteria:
- Positive semen culture
Sites / Locations
- Laboratoire DrouotRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Isitol® (Food supplement treated group)
Placebo treated group
36 eligible males between 20 and 45 yo. (included limits) will take 1 sachet of Isitol® per day during 16 (± 2) weeks. The sachet of powder is to dissolve in a glass of water or directly in mouth. 1 sachet of Isitol® (2,1g) contains 1000 mg of myo-inositol, 300 mg of N-acetyl-cysteine, 150 % of the Nutritional Reference Values (NRV) in zinc and 100 % of the NRV: in vitamins B2, B3, B6, B9 and E.
36 eligible males between 20 and 45 yo. (included limits) will take 1 sachet of placebo per day during 16 (± 2) weeks. The sachet of powder is to dissolve in a glass of water or directly in mouth. 1 sachet of placebo (2,1g) contains only excipients used in Isitol® and excipients to get similar organoleptic aspect (maltodextrin, sucralose, silicon dioxide, magnesium carbonate, citric acid and beta-carotene).