To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen
Condition: Infertility; Ovulation Induction
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Follitropin alfa liquid formulation; Follitropin beta liquid formulation
Intervention type(s): Drug; Drug
Intervention description(s): Follitropin alfa (Gonal-f) liquid pen (300, 450 and 900 IU) was applied by subcutaneous (sc) administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center; Follitropin beta (Puregon) liquid cartridge (300 and 600 IU) used with the Pen was applied by sc administration. Regimen of recombinant FSH-stimulation followed the standard protocol of the IVF-center
Other intervention name(s): Gonal-f; Puregon
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Follitropin alfa; Follitropin beta; Fertilization, in vitro; Intracytoplasmic sperm injection; Assisted reproductive techniques; Polycystic ovary syndrome