Evaluation of the efficacy of a short course of multidose menotropins in the treatment of male infertility in real clinical practice

Abstract Study question Is it possible to establish prognostic criteria for response to short course of multidose menotropin therapy in men with sperm pathology. Summary answer We found the increase of the effectiveness of menotropins with an increase in the duration of their use and an increase in dosage. What is known already 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. In real-world practice, hormonal treatment of the infertility is often carried out during the preparation of a couple for IVF and lasts no more than 4-6 weeks. At the same time, there is almost no scientific data in the literature of the effectiveness of such short treatment regimens. Study design, size, duration The study was designed as a multicentre, prospective, observational cohort study. The study included 1117 men with infertility enrolled between January 2020 and April 2021. Participants/materials, setting, methods 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 150 IU every other day with hCG 2000 IU 2-3 times a week. Sperm parameters and hormones (total testosterone, SHBG, LH, FSH, Inhibin B, estradiol) were evaluated before treatment and 4 weeks after. Main results and the role of chance The age of the patients was 18 to 65 years (33.6 ± 7.0 years). The sperm concentration after 1 month of treatment increased by 23.8% from 17.6±18.1 to 23.1 million/ml, the total sperm count increased by 32.1% from 40.2±41.7 to 53.1± 49.1 million, progressive motility increased on average from 26.5±16.2 to 32.0±16.5%, the proportion of morphologically normal spermatozoa increased from 2.3±2.5 to 3.0±2.7 %. The level of total testosterone increased by 33.3% from 11.1±4.6 to 14.8±6.3 nmol/l. The levels of Inhibin B and estradiol did not change significantly. In a comparative analysis of the effect of dosage on the parameters of the ejaculate, the dose of 112.5 IU showed the greatest effect. Limitations, reasons for caution The main limitation of this study is the large heterogeneity of enrolled patients. There will be a very large variability in the age of men, as well as the severity of deviations from the norm in the analysis of ejaculate. Wider implications of the findings Thus, multidose menotropin, already when used for 4 weeks, can significantly improve the quality of the ejaculate (concentration, total count, progressive motility, morphology). In case of insufficient effectiveness of a short course (1 month), it is advisable to continue treatment for at least 3 months or increase the dosage. Trial registration number not applicable