Results of a multicentre observational program to study the efficacy and safety of multidose menotropin in patients with male infertility

Introduction. Currently, menotropins are widely used to treat male infertility, both to stimulate spermatogenesis and to compensate for hormonal imbalance. But the actual practice of using menotropins may differ from the recommendations given by the manufacturer. Therefore, observational programs are particularly important, which allow assessing the effectiveness of a drug in routine practice. Purpose. To establish prognostic criteria for response to short and stadard course of multidose menotropin therapy in men with pathospermia. Materials and methods. The study was designed as a multicentre, prospective, observational cohort study. The study included 1120 men with infertility enrolled between January 2020 and April 2021. The study included men with the absence of pregnancy during 12 months of regular unprotected sexual activity. The average duration of infertility was 20.6 months. As a treatment, men received multidose menotropin at a dosage of 75 IU, 112.5 IU or 150IU every other day with hCG 2000 IU 2-3 times a week. Sperm parameters and hormones (total testosterone, Sex hormone-binding globulin - SHBG, luteinizing hormone - LH, follicle stimulating 12 months - FSH, Inhibin B, estradiol) were evaluated before treatment and for 12 months. Results. When comparing the parameters of the spermogram, it was noted that without differentiation according to the prescribed dose, after 3 months of administration, the concentration of spermatozoa increased by 32.6%, the total number of spermatozoa in the ejaculate increased by 32.3%, progressive mobility increased by 20.7%, the proportion of morphologically normal forms increased increased by 34.8%. The level of total testosterone after 3 months of use of multidose menotropin increased by 33.6%. The levels of inhibin B and estradiol did not change significantly. When using multi-dose menotropin for 12 months, sperm concentration increased by 88.5%, the total number of spermatozoa in the ejaculate increased by 55.3%, progressive mobility increased by 42%, the proportion of morphologically normal forms increased by 64.3%. Conclusions. We found the increase of the effectiveness of menotropins with an increase in the duration of their use and an increase in dosage.