Schering-Plough Announces Phase II and III Data for Corifollit...(day 5 was 4.6 (+/-4.3) and 2.6 (+/-3.3) ...)

About ENSURE

The ENSURE trial is a multinational (Europe/Asia), double-blind, randomized trial; 396 patients weighing 60 kg or less were randomized in a 2:1 ratio to treatment with either a single dose of 100 mcg corifollitropin alfa or daily 150 IU rFSH (follitropin beta) followed by daily follitropin beta (maximum 200 IU/day) from stimulation day eight onwards when required, to reach the criterion for human chorionic gonadotropin (hCG) administration (at least three follicles 17 mm or greater). Starting on stimulation day five all patients received 0.25 mg gonadotropin-releasing hormone (GnRH) antagonist until induction of final oocyte maturation by hCG. About 34-36 hours after induction of final oocyte maturation, oocyte pick up followed by IVF or ICSI was performed. At embryo transfer, three or five days after oocyte pick up, a maximum of two embryos were transferred. The primary endpoint of the ENSURE trial was the number of oocytes retrieved and the predefined equivalence margin was -3 and +5 oocytes for the 95 percent confidence interval (CI) of the difference. The incidence of moderate and severe OHSS was 3.4 percent in the corifollitropin alfa treatment arm versus 1.6 percent in the rFSH treatment group.(5)

Key Findings

• The mean (SD) number of oocytes retrieved per started cycle in the corifollitropin alfa group was 13.3 (+/-7.3) versus 10.6 (+/-5.9) in the reference group.(5)
• Following a single injection of corifollitropin alfa, patients required on average another two days of further stimulation with rFSH to reach the criterion to administer hCG. This was equal to the average duration of stimulation of nine days of the reference group treated with daily rFSH.(5)

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