Synbiotic (FamiLact) administration in idiopathic male infertility enhances sperm quality, DNA integrity, and chromatin status: A triple-blinded randomized clinical trial

Background: Idiopathic male infertility is often treated empirically. A recent body of evidence has indicated the association between pro $\pm$ prebiotics administration and improvement in semen parameters.

Objective: To assess the effect of FamiLact (probiotic + prebiotic) administration on male subjects with idiopathic infertility.

Materials and methods: Fifty-six men with idiopathic male infertility were randomly/equally divided into two groups. Men in the case and control groups received 500 mg of FamiLact and an identical placebo for 80 days, respectively. A semen sample was obtained from each of the participants before initiation and after the termination of the treatment course. Samples underwent regular semen analysis and were further analyzed to assess the level of DNA damage (sperm chromatin structure assay), oxidative stress (BODIPY C11 staining), and protamine deficiency (chromomycin-A3 staining) in spermatozoa.

Results: No significant difference was observed between the baseline values of both groups. After intervention, mean sperm concentration, motility, and normal morphology were significantly higher in the FamiLact group compared to the placebo group (p $<$ 0.05). In the FamiLact receivers, we detected improvement regarding the following parameters: concentration, motility, abnormal morphology, sperm lipid peroxidation, and DNA fragmentation (p $\le$ 0.02). Likewise, in the placebo group, we noticed a decrease in the post-medication mean value of DNA fragmentation (p = 0.03) while observing no significant difference regarding other parameters.

Conclusion: FamiLact administration improves sperm concentration, motility, and abnormal morphology and decrease sperm DNA damage, possibly through alleviating oxidative stress in the seminal fluid.