At the present time, male infertility becomes a sensitive topic not only for personal life, but from social and economic points of view. Spermatogenesis is a very complex journey that goes through several stages, such as mitosis, meiosis, differentiation, and requires strong coordination of different links. This role is performed by endogenous regulatory bioactive peptides locally released as a result of proteolysis that create local regulatory pool to support the consecutive process of spermatogenesis. 
It was previously revealed in the mouse model of D-galactose induced male infertility related to aging processes, that Testiwell has multiple antioxidant and reparative mechanisms of action, protecting spermatozoa from damage. The study was continued to expand understanding of the drug's mechanisms of action. An immunohistochemical study was carried out to determine the intensity of expression of SOX9 (sex determining region Y-box 9), which is a marker of Sertoli cells and specifies their differentiation and functioning. Also, using RT-PCR, the intensity of mRNA expression of the Ube2n gene, which is responsible for DNA repair and, ultimately, is involved in the process of spermatogenesis, was assessed. Testiwell was found to increase the expression of nuclear transcription factor SOX9 in Sertoli cells and ubiquitin conjugating enzyme E2 N. Thus, using an in vivo model, it was proven that the drug Testiwell protects against DNA damage and stimulates the process of spermatogenesis.

An observational trial involving 50 patients with idiopathic male infertility is also currently underway, and preliminary data show very encouraging results. Testiwell demonstrates good safety profile and normalizes specific semen parameters that affect the success of assisted reproduction technologies.

After 1.5 months of therapy (i.e. after 5-6 injections), clinically significant decrease in sperm DNA fragmentation was recorded by 22% (p<0.01) compared with baseline data. 
After 1.5 months of therapy, there was also a significant reduction in the ratio of histones / protamines in the sperm nucleus to a normal level (by 28.6% compared to baseline data, p=0.002; the normal value for histone-positive spermatozoa according to AUA G1+G2 <30%).

Testiwell, a peptide complex based on the extract of bovine testicles, has demonstrated the clinical potential to improve spermatozoa motility and count.

Thus, the peptide complex based on the extract of bovine testicles causes a multimodal protective effect on spermatozoa and testis cells and shows high effectiveness in patients with male infertility.