Uploaded by 7260678 on Nov 20, 2009
一針抵七針? 6.7.9.10
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
P. Devroey1, R. Boostanfar2, N.P. Koper3, B.M.J.L. Mannaerts3,6, P.C. IJzerman-Boon4, B.C.J.M. Fauser5, on behalf of the ENGAGE Investigators
1 Center for Reproductive Medicine, UZ Brussel, Brussels, Belgium 2 Huntington Reproductive Center, Westlake Village, CA, USA 3 Global Clinical Research, Schering-Plough Research Institute, Molenstraat 110, PO Box 20, Oss, The Netherlands 4 Research Data and Quantitative Sciences, Schering-Plough Research Institute, Oss, The Netherlands 5 Department of Reproductive Medicine and Gynecology, University Medical Center, Utrecht, The Netherlands
CONCLUSION: Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800.
Key words: corifollitropin alfa/sustained follicle stimulant/FSH/ovarian stimulation/IVF
RESULTS: The study population comprised 1506 treated patients with mean age of 31.5 years and body weight of 68.6 kg. Ongoing pregnancy rates of 38.9% for the corifollitropin alfa group and 38.1%for rFSH were achieved, with an estimated non-significant difference of 0.9% [95% confidence interval (CI): 3.9; 5.7] in favor of corifollitropin alfa. Stratified analyses of pregnancy rates confirmed robustness of this primary outcome by showing similar results regardless of IVF or ICSI, or number of embryos transferred. A slightly higher follicular response with corifollitropin alfa resulted in a higher number of cumulusoocyte-complexes compared with rFSH [estimated difference 1.2 (95% CI: 0.5; 1.9)], whereas median duration of stimulation was equal (9 days) and incidence of (moderate/severe) ovarian hyperstimulation syndrome was the same (4.1 and 2.7%, respectively P = 0.15).
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