Experience in using biosimilars in IVF programs with donor oocytes in protocols with micronized progesterone
DOI:
https://doi.org/10.37800/RM.1.2024.27-33Keywords:
progestin-primed ovarian stimulation, biosimilars, PPOS, micronized progesterone, IVF, ICSIAbstract
Relevance: Stimulation of oocyte donors' superovulation occupies a key place in the development of general assisted reproduction technology (ART). Oocyte donation programs involve young and healthy women undergoing severe ovarian stimulation protocols to obtain good-quality oocytes. Advances in recombinant DNA technology led to the development of recombinant follitropin alfa.
The study aimed to evaluate the effectiveness of the biosimilar folitropin alfa in the superovulation stimulation cycles of oocyte donors in comparison with the original medication in Progestin primed ovarian stimulation (PPOS) protocols.
Materials and Methods: A prospective cohort study included 25 oocyte donors who underwent superovulation induction. The first group consisted of 25 oocyte donors in whom superovulation was stimulated with a bio-analogue of follitropin alfa. The second group (control) included the same 25 oocyte donors stimulated with the original rFSH medication. The donors of the leading group were stimulated with biosimilar recombinant follicle-stimulating hormone and human menopausal gonadotropin. For the control group, a protocol was used using the original drug rFSH and CHMG in the same doses. The obtained donor oocytes were fertilized with ICSI or frozen. The program's result was determined by taking a blood test for b-hCG 14 days after embryo transfer.
Results: The number of mature oocytes in the study groups did not differ significantly, amounting to 20.6 ± 1.1 in group 1 and 21.2 ± 1.3 in group 2. The average number of fertilized oocytes in group 1 was 5.6 ± 0.8, and in group 2 – 6.1 ± 1.1; thus, the fertilization rate in the two groups did not differ (67,5% in group 1 vs 79,2% in group 2, р> 0,05). The blastulation rate (49.1% in group 1 and 52.2% in group 2) did not differ significantly in both the biosimilar group and the original medication. The Top Quality Blastocysts in Group 1 were 1.5 ± 0.7 (55%) vs 1.8 ± 0.5 (48%) in Group 2. At the same time, the level of NNB in both groups also had no statistically significant differences.
Conclusion: Sinnal-F was not inferior to the original medication in terms of the proportion of mature oocytes in oocyte donors. The study's results confirm that Synnal-f demonstrates favorable and comparable efficacy to the original medication in oocyte maturation in IVF/ICSI cycles.
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