[Effects of testis polypeptides on sperm parameters and sperm DNA fragmentation index in patients with male...

To evaluate the effect of a drug based on bovine testicular polypeptides (Testiwell) on sperm parameters and sperm DNA fragmentation index in patients with idiopathic male infertility.

A total of 100 men with a diagnosis of infertility were included in the study. They received Testiwell intramuscularly once a week for 10 weeks. Before and after treatment, basic sperm parameters according to WHO criteria and sperm DNA fragmentation index using the TUNEL method were assessed. Statistical analysis included Shapiro-Wilk, Wilcoxon, paired Student's t-test, and McNemar's test.

The median age of patients was 32 years. Significant improvement was noted in the proportion of morphologically normal sperm (p<0.001), concentration of morphologically normal sperm (from 1.16 to 1.55 million/ml, p=0.048). A decrease in sperm DNA fragmentation index was observed (from 20.8% to 17.8%, p<0.001), a reduction in the frequency of oligozoospermia from 34% to 22% (p=0.0047), and a decrease in the proportion of patients with increased DNA fragmentation index from 79% to 67% (p=0.0013). In patients with oligozoospermia at baseline, the median increase in concentration was 142%, while in those with asthenozoospermia an increase in motility by 77% was seen, and in men with high levels of DNA fragmentation, a decrease in DNA fragmentation index by 15.5% was found.

Testiwell demonstrated the ability to positively influence not only quantitative but also qualitative sperm parameters, including morphology and sperm DNA fragmentation. Proposed mechanisms of action include regulation of protamination, reduction of apoptosis, and immunologically mediated effects on sperm maturation. The obtained data are consistent with previously described effects of polypeptide drugs in preclinical models and expand the possibilities of using the Testiwell for various forms of male infertility, including assisted reproduction techniques failures.

Testiwell significantly improves morphological and molecular parameters of spermatogenesis in patients with male infertility. It can be used both in the basic therapy of idiopathic infertility and, possibly, in cases of miscarriage and inefficiency of assisted reproduction techniques.