Schering-Plough Announces Phase II and III Data for Corifollit...(ollitropin beta). A total of 1506 patie...)

Date:7/1/2009

ollitropin beta). A total of 1,506 patients (greater than 60 kg) at 34 IVF clinics in North America and Europe were randomized to receive either corifollitropin alfa 150 mcg or a daily dose of 200 IU rFSH, followed by rFSH (maximum 200 IU/day) from stimulation day eight onward, when required. Starting on stimulation day five, all patients received 0.25 mg gonadotropin-releasing hormone (GnRH) antagonist until triggering of final oocyte maturation by human chorionic gonadotropin (hCG). The primary endpoint was the ongoing pregnancy rate assessed at ten weeks or more after embryo transfer. The number of oocytes retrieved was the co-primary endpoint. The incidence of ovarian hyperstimulation syndrome (OHSS) was similar between both groups, 7.0 percent in the corifollitropin alfa group (1.9 percent severe) and 6.3 percent in the follitropin beta group (1.3 percent severe).(1)

Key Findings

• The ongoing pregnancy rate in the 150 mcg corifollitropin alfa treatment arm (38.9 percent per started cycle) was similar to that achieved in patients receiving daily 200 IU rFSH (follitropin beta) (38.1 percent per started cycle).(1)
• Corifollitropin alfa achieved similar efficacy regardless of fertilization procedure; number of embryos transferred; or day of embryo transfer;(1) as detailed in the table below:

                         Overall  IVF   ICSI   Single Double  Day 3  Day 5
                         N=1506  N=481  N=830  N=363  N=1013  N=850  N=506
    Corifollitropin alfa  38.9%  36.5%  39.7%  34.7%  46.9%   41.7%  47.1%
    rFSH                  38.1%  35.4%  40.3%  28.9%  44.9%   35.1%  50.6%

• The mean number of oocytes retrieved per attempt was 13.7 (+/-8.2) for the corifollitropin alfa group and 12.5 (+/-6.7) for the rFSH group.(2)
• The mean number of good quality embryos obtained at day 3 and
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