Aim: To evaluate the clinical efficacy of biosimilar (Ovaleap) compared with the referenced follitropin alfa (Gonal-f), within the context of antagonistic multiple doses protocol of controlled ovarian hyperstimulation (COH) for in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) techniques.
Methods: A retrospective, monocentric study included 229 infertile women aged 22 to 43 years who underwent their first cycle of COH for the purpose of the IVF or ICSI during the period of 2017. Eligible patients underwent ovarian stimulation with either Ovaleap (n = 152) or Gonal-f (n = 77) starting at Cycle Day 2 and were receiving gonadotropin-releasing hormone (GnRH) antagonist in either fixed or flexible antagonist protocol manner.
Results: Ovaleap-treatment resulted in fewer number of oocytes retrieved in regard to Gonal-f-treatment, with the median of seven oocytes retrieved in the Ovaleap group versus nine in the Gonal-f group (U = 5369.5, P = 0.3079). Clinical pregnancy rate was 24.3% in the overall study sample and 31.9% in women with embryo transfer, in the Ovaleap group. Similarly, in the Gonal-f group these rates were 25.0% and 34.5%, respectively. Only four patients experienced ovarian hyperstimulation syndrome, with one case in Ovaleap-treatment group and three cases in Gonal-f-treatment group.
Conclusion: While the clinical efficacy profile favored using Gonal-f formulation of follitropin alfa, this analysis showed that there is no significant difference in the number of oocytes retrieved between Ovaleap and Gonal-f follitropin alfa formulations, used within GnRH antagonist protocols of COH.
Keywords: GnRH antagonist; assisted reproductive technology; follitropin alfa; infertility; oocytes retrieved.
© 2020 Japan Society of Obstetrics and Gynecology.