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Clinical Trial
. 2009 Dec;24(12):3063-72.
doi: 10.1093/humrep/dep291. Epub 2009 Aug 14.

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 Devroey  1 , R Boostanfar, N P Koper, B M J L Mannaerts, P C Ijzerman-Boon, B C J M Fauser; ENGAGE Investigators
Collaborators, Affiliations
Clinical Trial

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 Devroey et al. Hum Reprod. 2009 Dec.

Erratum in

  • Hum Reprod. 2014 May;29(5):1116-20

Abstract

Background: Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation.

Methods: In this large, double-blind, randomized, non-inferiority trial the ongoing pregnancy rates were assessed after one injection of 150 microg corifollitropin alfa during the first week of stimulation and compared with daily injections of 200 IU rFSH using a standard GnRH antagonist protocol.

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 cumulus-oocyte-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).

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.

Trial registration: ClinicalTrials.gov NCT00696800.

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Figures

Figure 1
Figure 1
Graphical illustration of the treatment regimens applied in this trial. Upper panel depicts investigational group (corifollitropin alfa), lower panel depicts reference group (rFSH). rFSH: recombinant FSH, P: progesterone.
Figure 2
Figure 2
Flow chart showing the number of participants at each stage of the clinical trial.
Figure 3
Figure 3
Ongoing pregnancy rates stratified for fertilization procedure, number of embryos transferred and day of transfer. Subset with double embryo transfer includes three patients with three embryos transferred.
See this image and copyright information in PMC

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