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Schering-Plough Announces Phase II and III Data for Corifollitropin Alfa
Date:7/1/2009

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About REALIZE

In this single-center, open-label, uncontrolled, pilot study, 50 women undergoing ovarian stimulation prior to IVF or ICSI were down-regulated with daily injections of 0.1 mg of GnRH agonist (starting on cycle day 21). Ovarian stimulation was started with a single dose of corifollitropin alfa (100 mcg or 150 mcg) followed by daily rFSH (follitropin beta) from stimulation day eight until the day of triggering oocyte maturation. Final oocyte maturation was induced by administration of hCG as soon as three follicles 17 mm or greater were present. Vaginal progesterone was administered for luteal phase support. Patients with proven poor response were excluded from participation. The main endpoint of this trial was ovarian response. The observed number of follicles, serum estradiol levels and number of oocytes indicated a relatively high ovarian response. Corifollitropin alfa was well tolerated and there were no serious adverse events or cases of OHSS.(6)

Key Findings

  • Both the 100 mcg and 150 mcg dose groups recruited a large number of follicles 11 mm or greater with mean (SD) values of 17.5 (+/-5.5) and 18.3 (+/-6.4), respectively on the day of hCG and median serum estradiol levels of 10,019 and 10,221 pmol/L, respectively.(6)
  • The mean (SD) number of oocytes retrieved per started cycle was 15.4 (+/-6.7) in the 100 mcg dose group and 17.8 (+/-5.1) in the 150 mcg dose group.(6)

About corifollitropin alfa

Corifollitropin alfa is an investigational product being developed as a potential treatment in Controlled Ovarian Stimulation (COS) for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. Corifollitropin alfa is designed as a sustained follicle stimulant (SFS) with the same pharmacodynamic profile as rFSH, but with a markedly prolonged duration
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