Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

Summary

The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/ICSI

Timeline

Start

2017-02-08

Primary completion

2018-08-17

Completion

2018-08-17

Publications

• Results M. Polzikov, Z. Barakhoeva, S. Yakovenko, M. Ovchinnikova, L.Vovk, Y. Fetisova. A multicenter, randomized study comparing the efficacy of follitropin alpha biosimilar and the original follitropin alpha. Abstracts of the 35th Annual Meeting of the ESHRE, Vienna, Austria 24 to 26 June 2019 (abstract P-649), Human Reproduction, 2019; Vol. 34, Suppl. 1, p. i439.
• Results Barakhoeva Z, Vovk L, Fetisova Y, Marilova N, Ovchinnikova M, Tischenko M, Scherbatyuk Y, Kolotovkina A, Miskun A, Kasyanova G, Teterina T, Zorina I, Belousova N, Morozova E, Yakovenko S, Apryshko V, Sichinava L, Shalinsmall a, Cyrillic R, Polzikov M. A multicenter, randomized, phase III study comparing the efficacy and safety of follitropin alpha biosimilar and the original follitropin alpha. Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:6-12. doi: 10.1016/j.ejogrb.2019.07.032. Epub 2019 Jul 26.
• Results 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®). Akusherstvo, ginekologiya i reprodukciya. 2018;12(3):5-16. (In Russ.) https://doi.org/10.17749/2313-7347.2018.12.3.005-016
• Polzikov M, Blinov D, Barakhoeva Z, Vovk L, Fetisova Y, Ovchinnikova M, Tischenko M, Zorina I, Yurasov V, Ushakova T, Sergeyev O. Association of the Serum Folate and Total Calcium and Magnesium Levels Before Ovarian Stimulation With Outcomes of Fresh In Vitro Fertilization Cycles in Normogonadotropic Women. Front Endocrinol (Lausanne). 2022 Feb 11;13:732731. doi: 10.3389/fendo.2022.732731. eCollection 2022.

Drugs

Indications