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Reproductive Biomedicine
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Volume 19, Issue 11 (November 2021)
IJRM 2021, 19(11): 1015-1024 |
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Hossein Rashidi B, Sayyari K, Heshmat R, Amanpour S, Shahrokh Tehraninejad E, Masoumi M et al . Comparing a biosimilar follitropin alfa (Cinnal-f®) with Gonal-f® in women undergoing ovarian stimulation: An RCT. IJRM 2021; 19 (11) :1015-1024
URL: http://ijrm.ir/article-1-1594-en.html
URL: http://ijrm.ir/article-1-1594-en.html
Batool Hossein Rashidi * 
1, Khashayar Sayyari2 , Ramin Heshmat3 , Saeid Amanpour4 , Ensieh Shahrokh Tehraninejad4 , Masoumeh Masoumi4 , Farhang Rezaei5
1, Khashayar Sayyari2 , Ramin Heshmat3 , Saeid Amanpour4 , Ensieh Shahrokh Tehraninejad4 , Masoumeh Masoumi4 , Farhang Rezaei5
1- Vali-e-Asr Reproductive Health Research Centre, Tehran University of Medical Sciences, Tehran, Iran. , bhrashidi@tums.ac.ir
2- Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
3- Chronic Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
4- Vali-e-Asr Reproductive Health Research Centre, Tehran University of Medical Sciences, Tehran, Iran.
5- Medical Department, Orchid Pharmed Company, Tehran, Iran.
2- Faculty of Pharmacy, Tehran University of Medical Sciences, Tehran, Iran.
3- Chronic Diseases Research Center, Endocrinology and Metabolism Population Sciences Institute, Tehran University of Medical Sciences, Tehran, Iran.
4- Vali-e-Asr Reproductive Health Research Centre, Tehran University of Medical Sciences, Tehran, Iran.
5- Medical Department, Orchid Pharmed Company, Tehran, Iran.
Abstract: (1682 Views)
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.
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.
Type of Study: Original Article |
Subject:
Assisted Reproductive Technologies
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