Infertility Clinical Trial
Official title:
Phase III Study on the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Formulation Applied by a Pen Versus Follitropin Beta Liquid Formulation Applied by Pen
This was a prospective, randomised, open comparative monocentric phase IIIb study to evaluate the convenience, safety and efficacy of follitropin alfa (Gonal-f) liquid pen compared with follitropin beta (Puregon) liquid pen.
Treatment of subfertility and infertility by assisted reproduction technologies (ART) such
as in-vitro fertilisation (IVF) and embryo transfer (ET) requires multiple follicular
development to increase the number of female gametes, and the chances of a successful
treatment outcome. Ovarian stimulation in IVF/intracytoplasmic sperm injection (ICSI)
currently includes suppression of endogenous luteinizing hormone (LH) secretion by
administration of a gonadotrophin releasing hormone (GnRH) agonist, followed by stimulation
of multiple follicular development by exogenous FSH administration. When adequate follicular
development is achieved, a single dose of u-hCG (urinary-hCG) is administered to mimic the
endogenous LH surge and induce final oocyte maturation. Recombinant-human FSH (r-hFSH) has
been shown to be superior to u-hFSH in terms of requiring fewer ampules and more efficacious
in terms of number of oocytes recovered and in terms of pregnancy rates.
Recently, a new formulation of follitropin alfa has been developed due to a general trend in
the field of therapeutic recombinant proteins to move from presentations based on biological
activity to presentations based on physico-chemical characteristics. Until now follitropin
alfa has been produced as a powder for injection (either as monodose or multidose
preparations) in glass ampoules or in glass vials and administered using plastic or glass
syringe. Serono developed a multidose solution for injection in a prefilled disposable
injection pen. This study involved comparing the administration of follitropin alfa liquid
formulation applied by pen with that of follitropin beta liquid formulation also applied by
pen.
OBJECTIVES The objectives of this study were to evaluate the convenience, safety and
efficacy of Follitropin alfa (Gonal-f) liquid pen compared with Follitropin beta (Puregon)
liquid pen.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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