A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol

Efficacy and safety of late-start Corifollitropin-alfa administration for controlled ovarian hyperstimulation in IVF: a cohort, case–control study

“…Compared to the "classical" COS regimens, they show a lower follicular recruitment, and were repeatedly shown to lead to a lower oocyte yield (23)(24)(25). Indeed the mean number of retrieved MII oocytes in the present series was lower than reported in Engage (12) and Ensure (13) trials (7.5 vs. 13.8 and 12.7, respectively), but it was significantly higher than the one obtained in the control group (5.9), composed of patients who received daily rFSH from day 4. Anyway, the number of MII oocytes in CF-alfa group was sufficient to get an ongoing pregnancy rate/ET (36.…”

“…Herein we also show that the late administration of CFα allows to add GnRH-antagonist from day 8 of the cycle instead than from day 5, as suggested when CFα is given on day 2 to expected normal responders (12,13); this is another issue that further lowers the number of injections. In the present study, the late-start CFα protocol enabled us to complete COS with an average total number of injections of 7.8±3.8 (range [4][5][6][7][8][9][10][11], which is definitely low in comparison with a standard COS, lower than observed after day 2 CFα administration (12,13), and significantly lower than observed in case of daily rFSH administration from day 4 of the cycle. This could possibly increase the patients' satisfaction and compliance to treatment and, on the other side, decrease the economical costs of IVF for medications.…”

“…The long-acting rFSH molecule CFα was made available for clinical use a few years ago and was proven effective in inducing multiple follicular development in IVF patients with Serum E2 on day 8 (pg/ml) 744±317 492±305 <0.05 Serum peak E2 (pg/ml) 1431±471 1547±667 ns Follicles >11 mm diameter on hCG day 13.9±5.6 11.7±7.4 ns a the injection of hCG to trigger ovulation was not counted clinical characteristics of expected normal (12,13) or poor (19,20) responders, in association with GnRH-antagonists and either rFSH (12,13,19) or hMG (20). CFα has the ideal kinetic to be applied in late-start protocols, when exogenous gonadotropin administration is started on day 4 of the menstrual cycle.…”

“…As far as safety is concerned, the pooled analysis of three large clinical trials (12,13,28) showed that the incidence of severe OHSS was consistent with that expected in the relatively young patient population and was similar for patients receiving CFα (1.8 %) or daily rFSH (1.3 %) (26). In a recent pilot study comparing CFα given on day 2 vs. day 4 in young expected normal responders, the proportion of patients with more than 20 follicles >11 mm diameter the day of ovulation trigger was found to be higher in the day 4 group, raising the suspect that day 4 administration could be associated with a higher risk of OHSS (4).…”

“…A single subcutaneous injection of CFα on day 2 of the menstrual cycle was tested in two large, randomized, doubleblind, phase III trials that demonstrated that CFα is as effective as seven daily injections of rFSH when used in a COS protocol with GnRH-antagonist (12,13). Based on the results of the phase II dose-finding study, in view of the inverse relationship between exposure and body weight, the recommended dose of CFα was established at 100 μg for subjects with body weight below 60 kg and 150 μg for subjects above 60 kg.…”