Infertility Clinical Trial
Official title:
Corifollitropin Alfa (Elonva) Versus Follitropin Beta in High Responders: A Randomized Controlled Trial
The purpose of this randomized controlled trial (RCT) is to compare a single injection of corifollitropin-alfa versus daily injections of follitropin beta regarding the number of oocytes retrieved, hormonal profile and follicle development in patients with high response undergoing ovarian stimulation for in vitro fertilization treatment using a gonadotropin-releasing hormone (GnRH) antagonist protocol combined with GnRH agonist trigger and cryopreservation of all embryos.
Corifollitropin alfa, a novel fusion protein lacking luteinizing hormone (LH) activity, has
a longer elimination half-life and extended time to peak levels than recombinant follicle
stimulating hormone (rFSH). A single injection of corifollitropin alfa may replace seven
daily injections follitropin beta during the first week of ovarian stimulation, reducing
patient discomfort.
The purpose of this RCT is to compare a single injection of corifollitropin-alfa versus
daily injections of follitropin beta regarding the number of oocytes retrieved, as well as
hormonal profile and follicle development in patients with high response undergoing ovarian
stimulation for IVF using a GnRH antagonist protocol. In addition, incidence of unexpected
ovarian hyperstimulation syndrome (OHSS) will be evaluated, although it is anticipated that
GnRH agonist triggering will eliminate occurrence of the syndrome.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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