Comparing a biosimilar follitropin alfa (Cinnal-fⓇ) with Gonal-fⓇ in women undergoing ovarian stimulation: An RCT.

Autor: Hossein Rashidi B; Vali-e-Asr Reproductive Health Research Centre, Tehran University of Medical Sciences, Tehran, Iran., Sayyari K; Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran., Heshmat R; Chronic Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran., Amanpour S; Vali-e-Asr Reproductive Health Research Centre, Tehran University of Medical Sciences, Tehran, Iran., Shahrokh Tehraninejad E; Vali-e-Asr Reproductive Health Research Centre, Tehran University of Medical Sciences, Tehran, Iran., Masoumi M; Vali-e-Asr Reproductive Health Research Centre, Tehran University of Medical Sciences, Tehran, Iran., Rezaei F; Medical Department, Orchid Pharmed Company, Tehran, Iran.
Jazyk: angličtina
Zdroj: International journal of reproductive biomedicine [Int J Reprod Biomed] 2021 Dec 13; Vol. 19 (11), pp. 1015-1024. Date of Electronic Publication: 2021 Dec 13 (Print Publication: 2021).
DOI: 10.18502/ijrm.v19i11.9917
Abstrakt: Background: Advances in recombinant DNA technology led to the development of recombinant follitropin alfa. Recombinant human follicle-stimulating hormone products are used to stimulate follicular maturation.
Objective: To compare the efficacy and safety of a biosimilar-candidate recombinant human follicle-stimulating hormone (Cinnal-fⓇ; CinnaGen, Iran) with the reference product (Gonal-fⓇ; Merck Serono, Germany) in women undergoing ovarian stimulation for intracytoplasmic sperm injection (ICSI).
Materials and Methods: In this randomized controlled trial, a total sample size of 200 women (age < 35 yr, candidate for ICSI) was calculated. Participants began a pituitary downregulation protocol with buserelin. They received 150 IU daily of either Cinnal-fⓇ or Gonal-fⓇ from the second day of their cycle. The primary outcome of the study was the percentage of metaphase II (MII) oocytes. The secondary outcomes included the number and quality of oocytes retrieved, duration of stimulation, fertilization rate, embryo quality, the number of clinical and ongoing pregnancies, and the incidence of ovarian hyperstimulation syndrome (as an important safety marker).
Results: A total of 208 women were enrolled, of whom, 200 completed the study period. Ovarian stimulation with Cinnal-fⓇ resulted in a comparable percentage of MII oocytes as with Gonal-fⓇ (78.64% vs 80.02%, respectively; p = 0.81). No statistically significant difference was seen in the secondary outcomes between the groups.
Conclusion: Cinnal-fⓇ proved non-inferior to Gonal-fⓇ, based on the percentage of MII oocytes in women aged < 35 yr undergoing ICSI. Our findings confirm that the efficacy and safety profiles of Cinnal-fⓇ and Gonal-fⓇ are similar.
Competing Interests: Farhang Rezaei is an employee of Orchid Pharmed, which is a CinnaGen partner in conducting clinical trials. This study was funded by CinnaGen Co., Iran. Batool Hossein Rashidi, Khashayar Sayyari, Ramin Heshmat, Saeid Amanpour, Ensieh Shahrokh Tehraninejad, and Masoumeh Masoumi declare that they have no conflict of interest.
(Copyright © 2021 Hossein Rashidi et al.)
Databáze: MEDLINE
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