Evaluation of long-term results of using the drug Fertiwell: impact on the likelihood of conception and pregnancy outcome

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Abstract

Introduction. 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.

Aim. 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.

Materials and 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).

Conclusion. 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.

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About the authors

L. G. Spivak

I.M. Sechenov First Moscow State Medical University

Author for correspondence.
Email: leonid.spivak@gmail.com

Ph.D., MD, professor, urologist, Institute for Urology and Reproductive Health

Russian Federation, Moscow

S. I. Gamidov

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

Email: leonid.spivak@gmail.com

Ph.D., MD, professor, urologist, andrologist, ultrasound diagnostic doctor, Head of the Department of Andrology and Urology

Russian Federation, Moscow

S. H. Al-Shukri

Pavlov First Saint Petersburg State Medical University of the Ministry of Health of Russia

Email: al-shukri@spbmedu.ru

Ph.D., MD, professor, Chief Urologist of the Northwestern Federal District, Honored Physician of the Russian Federation, Board Member of the Russian Society of Urologists (RSU), Head of the Department of Urology with clinic and postgraduate education

Russian Federation, Saint Petersburg

A. O. Morozov

Sechenov First Moscow State Medical University

Email: andrei.o.morozov@gmail.com

Ph.D., senior researcher, urologist, Institute for Urology and Reproductive Health

Russian Federation, Moscow

А. А. Androsov

Sechenov First Moscow State Medical University

Email: aleksandrr_androsov@mail.ru

resident, Department of the Pediatric surgery, urology and andrology named after professor L.P. Alexandrov

Russian Federation, Moscow

А. Yu. Popova

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

Email: secretariat@oparina4.ru

Ph.D., associate professor, senior researcher, urologist at the Department of Andrology and Urology

Russian Federation, Moscow

Yu. A. Kupriyanov

Russian University of Medicine

Email: urodepatment@mail.ru

Ph.D., urologist of the Highest Qualifying Category, Deputy Chief Urologist of Moscow Health Department, Deputy Chairman of the expert group for certification of urologists of the Moscow Healthcare Department

Russian Federation, Moscow

D. Yu. Pushkar

Russian University of Medicine

Email: urodepatment@mail.ru

Ph.D., MD, Professor, Academician of RAS, Honored Physician of the Russian Federation, Honored Scientist of the Russian Federation, Chief urologist of the Ministry of Health of Russia, Head of the Department of Urology

Russian Federation, Moscow

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