Corifol·litropina alfa (Elonva®) per a l’estimulació ovàrica controlada en tècniques de reproducció humana assistida
Background: Corifollitropin alfa received marketing authorisation from the European Medicines Agency in January 2010 and it is indicated for controlled ovarian stimulation, together with a gonadotrophin-releasing hormone (GnRH) antagonist for the development of multiple follicles in women who participate in assisted human reproductive technique programmes. One of the potential advantages of this new medication is the reduced complexity and duration of the treatment as seven injections of the follicle stimulating hormone (FSHr) are replaced with just one single injection. This makes it easier for patients to adhere to the treatment, reducing the anxiety that the daily treatment pattern (injections) may represent. Objectives:To analyse the available scientific evidence on the efficacy, safety and efficiency of corifollitropin alfa for controlled ovarian stimulation, used together with GnRH antagonists for the development of multiple follicles in women who participate in assisted human reproduction technique programmes. Methodology: Systematic review of the available scientific evidence until May 2011. The internal validity and degree of recommendation of the studies included have been appraised by a review, using the criteria of the Scottish Intercollegiate Guidelines Network (SIGN). A qualitative synthesis has been carried out of the scientific evidence. Result: The main data on efficacy come from two phase III multicentre, randomised, double blind controlled clinical trials (ENGAGE and ENSURE studies). The ENGAGE study showed the non-inferiority of corifollitropin alfa with respect to the FSHr, regarding ongoing pregnancy percentage and the equivalence regarding the number of oocytes recovered in women >60 kg and ≤ 90 kg in weight (corifollitropin alfa dose of 150 µg). On the other hand, the ENSURE study, performed on women < 60 kg in weight, showed the equivalence of corifollitropin alfa with FSHr regarding the number of recovered oocytes, but not in connection with the ongoing pregnancy percentage (corifollitropin alfa dose of 100 µg). The corifollitropin alfa presented an acceptable safety profile. The incidence of adverse effects was comparable in both treatments. However, it has not been excluded that corifollitropin alfa is related to a higher risk of suffering from ovarian hyperstimulation syndrome. There are no cost-effectiveness data about the administration of corifollitropin alfa. Conclusions: The results of the clinical trials do not show substantial advantages of corifollitropin alfa with respect to the treatment of reference. Despite the convenience and adherence to the treatment represented by the use of corifollitropin alfa, from the viewpoint of the public sector portfolio, the uncertainty regarding safety as well as the higher cost limit the potential advantages posed by its use as a substitute for FSHr during the first seven days of controlled ovarian hyperstimulation.
Controlled ovarian stimulation; Pharmacotherapy; Assisted human reproduction techniques
Sunyer B, Almazán C, Paladio N. Corifol·litropina alfa (Elonva®) per a l’estimulació ovàrica controlada en tècniques de reproducció humana assistida. Barcelona:Agència d’Informació, Avaluació i Qualitat en Salut; 2011.
Use this identifier for quote and/or link this documenthttp://hdl.handle.net/11351/3041
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