Study of Isitol4 Supplement Effects on Improving Sperm DNA Quality in Men with Male Infertility Aged 20 to 45

What this Trial Is About

Male infertility affects about 15% of couples in industrialized countries, with male factors like sperm quality issues contributing to half of these cases. Researchers are studying the dietary supplement Isitol4 made by GYNOV SAS to see if it can improve sperm DNA fragmentation, a key factor linked to fertility. This interventional, double-blind, randomized clinical trial compares Isitol4 to a placebo in men aged 20 to 45 with high sperm DNA fragmentation rates. Participants are randomly assigned to one of two groups one group takes a daily sachet of Isitol4 containing myo-inositol, N-acetyl-cysteine, zinc, and vitamins for 16 weeks, while the other group receives a placebo sachet with similar appearance and taste. The study aims to measure changes in sperm DNA fragmentation and secondary sperm quality parameters after the treatment period. During the study, sperm DNA fragmentation and other sperm characteristics are measured at the start and after about 16 weeks of treatment. Researchers also assess sperm chromatin decondensation, semen volume, pH, liquefaction time, sperm counts, morphology, redox potential, and gene expression related to sperm production. The study includes safety monitoring and aims to provide detailed information about the supplements impact on male fertility over the treatment duration.

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