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Comparing a biosimilar follitropin alfa (Cinnal-f®) with Gonal-f® in women undergoing ovarian stimulation: An RCT
Rashidi, Batool Hossein; Sayyari, Khashayar; Heshmat, Ramin; Amanpour, Saeid; Tehraninejad, Ensieh Shahrokh; Masoumi, Masoumeh & Rezaei, Farhang
Abstract
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.
Keywords
Follitropin alfa; Biosimilar; Efficacy; Safety; Intracytoplasmic sperm injection.
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