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Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®)

https://doi.org/10.17749/2313-7347.2018.12.3.005-016

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Abstract

A clinical study on the efficacy and safety of follitropin alfa has been conducted. The aim of the study was to confirm the therapeutic equivalence between the follitropin alfa biosimilar (Primapur®) and the reference medication (Gonal-f®) in controlled induction of superovulation within the assisted reproductive technologies (ART) programs. Materials and methods. This multicenter, randomized, blind at the embryological stage, in parallel groups, comparative study of phase III (RCT 754 from 26.10.16/NCT03088137) involved 110 women aged 20-35 years with established causes of infertility (tubal factor, male factor). The patients were randomized into 2 equal groups of 55 participants each. The primary end-point for assessing the therapeutic equivalence was the number of aspirated oocytes. The secondary end-points included the number of fertilized oocytes, the number of days of stimulation, the total dose of the injected drug, the occurrence rate of biochemical and clinical pregnancies. Results. In this study, the follitropin alfa biosimilar was shown to be equivalent to the original follitropin in terms of the number of aspirated oocytes. Also, no statistically significant differences were found in the number of mature and fertilized oocytes, the days of stimulation, the dose of the drug administered during the treatment, and the rate of the onset of biochemical or clinical pregnancy. Conclusion. The therapeutic equivalence between the follitropin alfa containing Primapur® and Gonal-f® has been demonstrated.

About the Authors

Z. B. Barakhoeva
«AltraVita» Human Reproduction Clinic
Russian Federation

Barakoeva Zarema Bekkhanovna – PhD, Reproductologist
4A, ul. Nagornaya, Moscow, 117186, Russia



L. A. Vovk
Perinatal Medical Center, GC «Mother and Child»
Russian Federation
Vovk Lyudmila Anatolyevna – Reproductologist
24, korp. 1, Sevastopolskiy prospekt, Moscow, 117209, Russia


I. V. Zorina
«AltraVita» Human Reproduction Clinic
Russian Federation
Zorina Irina Vadimovna – PhD, Reproductologist
4A, ul. Nagornaya, Moscow, 117186, Russia


N. Yu. Belousova
«AltraVita» Human Reproduction Clinic
Russian Federation
Belousova Nadezhda Yurievna – Reproductologist
4A, ul. Nagornaya, Moscow, 117186, Russia


T. A. Teterina
«AltraVita» Human Reproduction Clinic
Russian Federation
Teterina Tatyana Alexandrovna – PhD, Reproductologist
4A, ul. Nagornaya, Moscow, 117186, Russia


S. A. Yakovenko
«AltraVita» Human Reproduction Clinic; Lomonosov Moscow State University
Russian Federation
Yakovenko Sergey Aleksandrovich – PhD, General Director, «AltraVita» Clinic for Human Reproduction; Department of Biophysics, Faculty of Physics, Lomonosov MSU
4A, ul. Nagornaya, Moscow, 117186, Russia;
12, str. 1, Leninskie Gory, Moscow, 119234, Russia


V. P. Apryshko
«AltraVita» Human Reproduction Clinic
Russian Federation
Aprishko Valentina Petrovna – PhD, Head of Embryology Laboratory
4A, ul. Nagornaya, Moscow, 117186, Russia


Yu. A. Fetisova
Perinatal Medical Center, GC «Mother and Child»
Russian Federation
Fetisova Julia Andreevna – Reproductologist
24, korp. 1, Sevastopolskiy prospekt, Moscow, 117209, Russia


N. A. Marilova
Perinatal Medical Center, GC «Mother and Child»
Russian Federation
Marilova Nina Alexandrovna – PhD, Reproductologist
24, korp. 1, Sevastopolskiy prospekt, Moscow, 117209, Russia


E. G. Morozova
Perinatal Medical Center, GC «Mother and Child»
Russian Federation
Morozova Ekaterina Gennadievna – Reproductologist
24, korp. 1, Sevastopolskiy prospekt, Moscow, 117209, Russia


M. M. Ovchinnikova
Lapino Clinical Hospital, GC «Mother and Child»
Russian Federation
Ovchinnikova Maria Mikhailovna – Reproductologist
111, Pervoe Uspenskoe shosse, Moscow region, 143081, Russia


M. A. Tishenko
Lapino Clinical Hospital, GC «Mother and Child»
Russian Federation
Tishchenko Marina Alexandrovna – Reproductologist
111, Pervoe Uspenskoe shosse, Moscow region, 143081, Russia


Yu. V. Sherbatyuk
Lapino Clinical Hospital, GC «Mother and Child»
Russian Federation
Sherbatyuk Yulia Vladimirovna – Reproductologist
111, Pervoe Uspenskoe shosse, Moscow region, 143081, Russia


A. V. Kolotovkina
Lapino Clinical Hospital, GC «Mother and Child»
Russian Federation
Kolotovkina Alexandra Vladimirovna – Reproductologist
111, Pervoe Uspenskoe shosse, Moscow region, 143081, Russia


A. A. Miskun
Lapino Clinical Hospital, GC «Mother and Child»
Russian Federation
Miskun Anna Anatolyevna – Reproductologist
111, Pervoe Uspenskoe shosse, Moscow region, 143081, Russia


G. V. Kasyanova
Lapino Clinical Hospital, GC «Mother and Child»
Russian Federation
Kasyanova Galina Viktorovna – Reproductologist
111, Pervoe Uspenskoe shosse, Moscow region, 143081, Russia


L. G. Sichinava
Perinatal Medical Center, GC «Mother and Child»; Russian National Research Medical University named after N.I. Pirogov, Health Ministry of Russian Federation; Moscow Center for Family Planning and Reproduction, Moscow Healthcare Department
Russian Federation

Sichinava Lali Grigoryevna – Obstetrician-gynecologist, Perinatal Medical Center, GC «Mother and Child»; MD, Professor, Department of Obstetrics and Gynecology, RNRMU n.a. N.I. Pirogov HM of RF; Moscow Center for Family Planning and Reproduction.

24, korp. 1, Sevastopolskiy prospekt, Moscow, 117209, Russia;
1, ul. Ostrovityanova, Moscow, 117997, Russia;
24А, Sevastopolskiy prospekt, Moscow, 117209, Russia



R. I. Shalinа
Lapino Clinical Hospital, GC «Mother and Child»; Russian National Research Medical University named after N.I. Pirogov, Health Ministry of Russian Federation; Moscow Center for Family Planning and Reproduction, Moscow Healthcare Department
Russian Federation
Shalina Raisa Ivanovna – Obstetrician-gynecologist, Lapino Clinical Hospital, GC «Mother and Child»; MD, Professor, Department of Obstetrics and Gynecology, RNRMU n.a. N.I. Pirogov HM of RF; Moscow Center for Family Planning and Reproduction.
111, Pervoe Uspenskoe shosse, Moscow region, 143081, Russia;
1, ul. Ostrovityanova, Moscow, 117997, Russia;
24А, Sevastopolskiy prospekt, Moscow, 117209, Russia


M. A. Polzikov
IVFarma LLC
Russian Federation
Polzikov Mikhail Aleksandrovich – PhD, General Director
20, str. 2, Nauchnyi proezd, Moscow, 117246, Russia


For citation:


Barakhoeva Z.B., Vovk L.A., Zorina I.V., Belousova N.Y., Teterina T.A., Yakovenko S.A., Apryshko V.P., Fetisova Y.A., Marilova N.A., Morozova E.G., Ovchinnikova M.M., Tishenko M.A., Sherbatyuk Y.V., Kolotovkina A.V., Miskun A.A., Kasyanova G.V., Sichinava L.G., Shalinа R.I., Polzikov M.A. Major results of a phase III comparative multicenter study on the follitropin alfa biosimilar (Primapur®) and the original follitropin alfa (Gonal-f®). Obstetrics, Gynecology and Reproduction. 2018;12(3):5-16. (In Russ.) https://doi.org/10.17749/2313-7347.2018.12.3.005-016

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ISSN 2313-7347 (Print)
ISSN 2500-3194 (Online)