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Efficacy Study of a Food Supplement With Myo-inositol, N-Acetyl-Cystein, Zinc and Vitamins on Sperm DNA Fragmentation

RecruitingNAAges 20 Years - 45 YearsMaleGYNOV
NCT04959864 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

In industrialised countries, it is estimated that about 15% of couples who wish to have a child are currently facing infertility problems, of which, in half of the cases, an anomaly in sperm quality or at least a factor of male origin is identified. The evaluation of sperm quality in males is based, for the most part, on the micro and macroscopic examination of various parameters (concentration, motility, physical abnormalities of the spermatozoa, etc.). Nevertheless, an increasing number of scientific studies have shown that the quality of sperm DNA, and in particular its fragmentation rate, is also associated with a lower fertilisation rate. The integrity of sperm DNA may be affected by an imbalance in the Red/Ox balance leading to uncompensated oxidative stress, and could be restored or improved by dietary hygiene measures and the consumption of specific dietary products. The ISITOL c

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📋 Eligibility rules (as published)
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
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What it tests

  • Isitol®
  • Placebo
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Where

1 site
Laboratoire Drouot
Paris, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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