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Assessment of corifollitropin alfa for assisted reproduction: a review study

Introduction:
Corifollitropin alfa, a fusion product of recombinant human follicle-stimulating hormone (rFSH) with a hybrid beta subunit C-terminal peptide of human chorionic gonadotropin, plays a similar pharmacologic role as traditional rFSH, but with a longer half life. Clinical applications of corifollitropin alfa in assisted reproductive realm have reported that it stimulates multifollicular growth for 7 days with the same safety and ovarian response as rFSH administration. In 2003, the first report of live birth using corifollitropin alfa stimulation was released in Netherland. In 2010, European union approved corifollitropin alfa in its market, and then Taiwan approved the release of corifollitropin alfa in 2013. To assess the outcomes of corifollitropin alfa in following embryo development of IVF program, including fertilization, good embryo formation (culture to the day 3), and blastocyst formation (culture to the day 5), we analyzed the results generated from the cases stimulating by long-acting rFSH (L-rFSH, corifollitropin alfa) and by traditional rFSH (T-rFSH) shots in this study.

Materials and Methods:
Study Cohort IGeneral patients


A total of 252 cycles were recruited since December, 2012 to September, 2013. There were 91 cycles (average age: 34.9 y/o, range from 28-42) using L-rFSH stimulation (14 cycles with single shots and 77 cycles with T-rFSH supplements), and 161 cycles (average age: 34.9 y/o, range from 23-40) using T-rFSH stimulation, which was set as the control cohort (Table 1). The patients with polycystic ovarian symptoms were excluded from the study cohort. Number of antral follicles, number of retrieval oocyte, hormone levels after stimulating, number of mature oocytes(MII) after retrieving and the fertilization rates were compared between the two groups. Then the good embryo rate (GER) of day3-culture and the good blastocyst rate (GBR) of day5-culture were determined from each group.



Table 1



Study Cohort IIOocyte Donor Cohort
A total of 89 oocyte donating cycles were recruited since December, 2012 to September, 2013. There were 64 cycles using L-rFSH stimulation, and 25 cycles using T-rFSH stimulation, which was set as the control cohort. The same parameters associated with embryo yield were also compared in these two groups.

Treatment Protocol Design
To assess the more friendly protocol to the IVF cases, we designed a protocol with fewer injections based on the traditional rFSH short protocol and the corifollitropin α in GnRH antagonist protocol. The modified protocols were displayed in Figure 1.


Figure 1

Statistics
Statistical evaluations were carried out using nonparametric Student’s t test with Welch’s corrections. The statistical software, prism (http://www.graphpad.com/scientific-software/prism, GraphPad) was administrated in the data processing.

Results
Although the number of antral follicles showed difference between L-rFSH recipients and T-rFSH recipients (10.16±0.44 vs. 8.39±0.31, p<0 .01="" font="" nbsp="">

After oocyte retrieving of L-rFSH recipients and T- rFSH recipients, number of MII oocytes (11.16±0.69 vs. 9.52±0.50, p=0.03), maturation rates (75.8% vs. 78.31%, p=0.16) and fertilization rates (78.72% vs. 77.12%, p=0.26) were no different. In following cultural results of embryos, GER of day3 (61.32% vs. 58.22%, p=0.24) and GBR of day5 (60.39% vs. 57.36%, p=0.21) also performed the similar outcomes from the two groups (Figure 2).


Table 2 General IVF case

After oocyte retrieving of L-rFSH recipients and T- rFSH recipients, number of MII oocytes (11.16±0.69 vs. 9.52±0.50, p=0.03), maturation rates (75.8% vs. 78.31%, p=0.16) and fertilization rates (78.72% vs. 77.12%, p=0.26) were no different. In following cultural results of embryos, GER of day3 (61.32% vs. 58.22%, p=0.24) and GBR of day5 (60.39% vs. 57.36%, p=0.21) also performed the similar outcomes from the two groups (Figure 2).



Figure 2

In the oocyte-donor cohort, the group stimulated by corifollitropin alfa also displayed similar ovarian responses and clinical outcomes in the following embryo culture (Table 3, Figure 3).


Table 3 Oocyte donating cycles


Figure 3

Discussion:
Based on the efficiencies of controlled ovarian stimulation and embryo culture, no significant differences were observed between the recipients of L-rFSH and of T-rFSH. Due to the long lasting effect of corifollitropin alfa, a more patient-friendly option with reduced injective frequencies could be applied to the overseas cases or cases afraid of injections (Table 4, Table 5).


Table 4 Frequency of Injection


Table 5 Cost List

(The study has been published in 2014 Annual Meeting of Taiwanese Obstetrics and Gynecology Society)

References:
1.    A comparison of long-acting FSH versus daily FSH did not show evidence of difference in effect on overall live birth rate or OHSS in 2335 IVF participants (Cochrane Database Syst. Review, 2013)
2.    Long-acting rFSH and short-acting rFSH treatment protocols provided equal success rates of live birth and cumulative pregnancy
(Boostanfar et al., Fertil Steril 2012)
3.    Treatment of poor ovarian responders with corifollitropin α  in a GnRH antagonist protocol results in low pregnancy rates, similarly to conventional stimulation with a short agonist protocol
4.    (Polyzos et al., Fertil Steril 2013)









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Stork Fertility Center送子鳥 Stork Fertility Center送子鳥 Author