BACKGROUND: Current methods of treating male infertility have limited efficiency, since they are aimed to individual stages of the pathogenesis. Preparations based on testicular regulatory polypeptides are the most physiological and universal, owing to a complex effect on the self-regulation of testicular tissue.
OBJECTIVE: To study the delayed efficiency and safety of therapy with Fertiwell in patients with pathospermia and to assess the frequency of conception and pregnancy outcome in their partners based on the collection, analysis and interpretation of medical data.
METHODS: A telephone survey of patients participating in the phase III clinical trial was carried out. The fact of conception in a couple was assessed over a period of 1 to 9 months after completion of therapy, as well as time from completion of the course to conception, pregnancy outcomes, newborn health outcomes.
RESULTS: In the period from 1 to 9 months after completion of therapy, pregnancy occurred in 17 out of 34 couples (50%) in the Fertiwell group and in 13 out of 42 couples (30.95%) in the placebo group. This difference was statistically and clinically significant (p<0.05). All pregnancies resulted in a live birth. The median time from completion of the course to conception was 4 months in Fertiwell group and 6 months in the placebo group. There were no significant differences in anthropometric parameters of newborns between the two groups (p>0.05).
CONCLUSIONS: When using the drug Fertiwell, pregnancy and live birth rate was significantly higher (2.23 times) compared to the control group. There was a trend toward earlier pregnancies in partners of men receiving Fertiwell. Thus, this drug can be recommended for the treatment of men with idiopathic infertility as monotherapy, as well as in combination with assisted reproductive technologies.

OBJECTIVE: To investigate the specific mechanisms of action of Fertiwell in a mouse model of D-galactose-induced aging of the reproductive system.
METHODS: C57BL/6J mice were randomized into four groups: intact mice (control group), a group of mice with artificial accelerated aging treated with D-galactose alone (Gal), D-galactose followed by Fertiwell (PP), and D-galactose followed by a combination of L-carnitine and acetyl-L-carnitine (LC). The artificial accelerated aging of reproductive system was induced by daily intraperitoneal administration of D-galactose at a dose of 100 mg/kg for 8 weeks. After the end of therapy in all groups, the characteristics of sperm, the level of serum testosterone, immunohistochemical parameters, and the expression of specific proteins were evaluated.
RESULTS: Fertiwell had a pronounced therapeutic effect on testicular tissues and spermatozoa, restored testosterone levels to normal values, and, in addition, was more effective protector against oxidative stress in the reproductive system compared to L-carnitine and acetyl-L-carnitine, which are widely used in male infertility. Fertiwell at a dose of 1 mg/kg allowed to significantly increase the number of motile spermatozoa to 67.4+/-3.1%, which was comparable to indicators in the intact group. The introduction of the Fertiwell positively affected the activity of mitochondria, which was also expressed in an increase in sperm motility. In addition, Fertiwell restored the intracellular level of ROS to the values of the control group and reduced the number of TUNEL+ cells (with fragmented DNA) to the level of intact control. Thus, Fertiwell, containing testis polypeptides, has a complex effect on reproductive function, leading to a change in gene expression, an increase in protein synthesis, the prevention of DNA damage in the testicular tissue, and an increase in mitochondrial activity in testicular tissue and spermatozoa of the vas deferens, which leads to the subsequent improvement of testicular function.