DOUBLE-BLIND, RANDOMIZED PLACEBO-CONTROLLED STUDY OF EFFICIENCY AND SAFETY OF COMPLEX ACETYL-L-CARNITINE, L-CARNITINE FUMARATE AND ALPHA-LIPOIC ACID (SPERMACTIN® FORTE) FOR TREATMENT OF MALE INFERTILITY


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Abstract

Introduction. Oxidative stress of sperm is a common pathologic condition, which can be detected in 30-80% infertile men. It is established that dietary consumption of antioxidants and microelements contributes to an increase of conception probability in subfertile couples, and also reduces the risk of reproductive losses. Drug complexes influencing various factors of spermatogenesis disturbance (oligo-, astheno-, teratozoospermia), oxidative stress and the level of sperm DNA fragmentation are of greatest and reasonable interest. Aim. To study the effects of complex acetyl-l-carnitine, l-carnitine fumarate and alpha-lipoic acid (SpermActin® Forte) on oxidative stress, ejaculate quality and sperm DNA fragmentation in men with infertility. Materials and methods. A total of 80 infertile men aged 25-40 years with increased level of sperm DNA fragmentation and oxidative stress were included in open-label, prospective, randomized study. In Group A (n=20) patients received a placebo for 180 days, and in Group B patients were prescribed to SpermActin® Forte, 1 sachet of 10 g once a day. The criteria for the efficiency of therapy included sperm analysis, the level of sperm DNA fragmentation, the level of sperm oxidative stress, as well as information about achievement of pregnancy, obtained by interviewing all participants. Results: In patients taking antioxidant complex SpermActin® Forte there were significant positive changes in the main parameters of sperm analysis, including sperm mobility and morphology starting from the third month of therapy. The level of free oxygen radicals (as indicator of oxidative stress) in Group B also significantly decreased (by 86%). A more profound decrease in DNA fragmentation was seen in Group B compared to Group A (21.5% vs. 3.6%). Pregnancy was achieved in 1 and 13 cases in Group A and B, respectively. Conclusion. The use of the SpermActin® Forte antioxidant complex allowed to improve sperm analysis in most patients, and these changes were significant starting from the third month of therapy. Stimulation of spermatogenesis using the antioxidant complex SpermActin® Forte is an effective and safe method of treating male infertility.

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About the authors

S. I Gamidov

National Medical Research Center of Obstetrics, Gynecology and Perinatology named after V.I. Kulakov of the Ministry of Health of Russia; GBOU VPO I.M. Sechenov First Moscow State Medical University of Minzdrav of Russia

Email: safargamidov@yandex.ru
MD, professor at the Department of Andrology and Urology of National Medical Research Center of Obstetrics, Gynecology and Perinatology named after V.I. Kulakov of the Ministry of Health of Russia, Head of the Department of Andrology and Urology of National Medical Research Center of Obstetrics, Gynecology and Perinatology named after V.I. Kulakov of the Ministry of Health of Russia Moscow, Russia

R. I Ovchinnikov

National Medical Research Center of Obstetrics, Gynecology and Perinatology named after V.I. Kulakov of the Ministry of Health of Russia

Email: r_ovchinnikov@oparina4.ru
Ph.D., Head of the Department of Andrology and Urology Moscow, Russia

A. Yu Popova

IPO GBOU VPO I.M. Sechenov First Moscow State Medical University of Minzdrav of Russia

Email: a_popova@oparina4.ru
Ph.D., senior researcher at the Department of Andrology and Urology of National Medical Research Center of Obstetrics, Gynecology and Perinatology named after V.I. Kulakov of the Ministry of Health of Russia, associate professor at the Department of Obstetrics, Gynecology, Perinatology and Reproductology of IPO GBOU VPO I.M. Sechenov First Moscow State Medical University of Minzdrav of Russia Moscow, Russia

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