S-P fertility treatment achieves equivalence

US drug major Schering-Plough says that the sustained follicle stimulant, corifollitropin alfa, has met its primary endpoints in the Phase III ENGAGE trial, according to data the firm presented at the European Society of Human Reproduction and Embryology in Barcelona, Spain.

Ongoing pregnancy rate, assessed at 10 weeks or more after embryo transfer, the primary endpoint of the non-inferiority trial, obtained in the 150mcg corifollitropin alfa treatment arm was similar to that achieved in patients receiving 200 IU recombinant follitropin beta. The number of oocytes retrieved was the co-primary endpoint and was within the limits of clinical equivalence, and the estimated difference of +1.2 was in favor of the Schering-Plough treatment arm. Occurences of the disease, ovarian hyperstimulation syndrome, was similar between both groups: 7% in the corifollitropin alfa cohort and 6.3% in the follitropin beta arm.