Efficacy and safety of the drug based on bovine testicular polypeptides in the treatment of male infertility: results of a multicenter observational study

Rogozin D.S., Prokopyev Ya.V., Moskvichev D.V., Faniev M.V., Khamalyan A.Z., Nikiforov D.Yu., Staroselskaya M.A., Lazarev I.Yu., Zel A.N., Koval N.A.

1) South Ural State Medical University, Chelyabinsk, Russia; 2) Kazan State Medical Academy – Вranch Campus of the FSBEIPE MOH, Kazan, Russia; 3) «Mother and Child» Group of Companies, Moscow, Russia; 4) Lapino Clinical Hospital, Moscow, Russia; 5) Peoples’ Friendship University of Russia, clinical base in Krasnodar (URO-PRO Clinic), Krasnodar, Russia; 6) Embryo Sochi IVF Medical Center, Sochi, Russia; 7) Tyumen State Medical University, Tyumen, Russia; 8) PeptidPro LLC, Moscow, Russia; 9) Clinical Hospital «Mother and Child» IDС, Samara, Russia; 10) Obstetrics and Gynecology Center No.1, Chelyabinsk, Russia; 11) «Healthy Child» Group of Companies, Voronezh, Russia

Objective: providing objective data on the short‑term and long‑term efficacy and safety of the drug based on bovine testicular polypeptides in real‑world clinical practice. Materials and methods: A prospective, multicenter, non‑interventional observational study enrolled 668 patients with impaired spermatogenesis (oligoasthenozoospermia) and diagnosed male infertility. The patients received Testivell 5 mg once a week for 10 weeks. During the subsequent three visits at 3‑month intervals and the follow-up period of up to 9 months, the parameters listed below were analyzed: semen analysis parameters, DNA fragmentation index, and clinical outcomes (pregnancy achievement and live birth). Results: Treatment with Testivell demonstrated improvements in semen parameters in all study populations and subpopulations: sperm concentration increased from 21 [7; 46] to 34 [12; 62] mln/mL (p<0,001); the number of progressively motile sperm cells rose from 12.6 [2.3; 41.3] to 31.2 [6.6; 74.7] mln (p<0,001); and the proportion of morphologically normal sperm increased from 2 [1; 3] to 3 [1; 4]% (p<0,001). In patients with initially elevated DNA fragmentation, the index decreased from 27 [21; 37] to 11 [2; 17.5]% (p<0,001). 184 participants who completed the therapy course underwent a full follow‑up cycle with monitoring of conceptions and births. A total of 85 pregnancies were recorded, corresponding to a clinical efficacy rate of 48,9% [37.7%; 52.4%]. Data on 70 pregnancy outcomes were collected, and in all cases, the pregnancies resulted in the birth of a healthy live infant. Testivell demonstrated good tolerability when used in combination with other drugs. No clinically significant adverse reactions were observed. Conclusion: Real-orld clinical practice has provided evidence of both short‑term efficacy (regarding basic ejaculate parameters and DNA fragmentation) and long‑term efficacy (as reflected by pregnancy and live birth rates in couples), along with the safety of a course of therapy using a testicular polypeptide‑based drug. Testivell is suitable for use in the management of idiopathic infertility, as an adjunctive therapy in cases with established causes of infertility, and as part of preparation for assisted reproductive technologies (ART) for couples when male infertility is associated with spermatogenesis disorders (oligoasthenozoospermia).

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About the Authors

Corresponding author: D.S. Rogozin – Ph.D., Associate Professor, Department of General and Pediatric Surgery, South Ural State Medical University; Chelyabinsk, Russia; e-mail: rogozin.dmi@gmail.com

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