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

Launched by GYNOV · Jul 12, 2021

Keywords

ClinConnect Summary

This clinical trial, called the ISITOL study, is investigating the effects of a dietary supplement on male infertility, particularly focusing on sperm DNA fragmentation. Sperm DNA fragmentation refers to damage to the genetic material in sperm, which can affect fertility. The study aims to see if a supplement containing Myo-inositol, N-Acetyl-Cystein, Zinc, and vitamins can improve the quality of sperm DNA and potentially help men facing infertility issues.

To participate in this study, men aged 20 to 45 who have a sperm DNA fragmentation rate of 30% or higher may be eligible. Participants will be randomly assigned to either receive the supplement or a placebo (a non-active treatment) and will be monitored throughout the trial. It's important to note that men with specific health conditions, such as infections or genetic disorders affecting fertility, or those who have recently taken dietary supplements, may not qualify. This study is taking place in Paris, France, and aims to provide valuable insights into how diet can impact male reproductive health.

Gender

MALE

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