A Randomized, Multicentre, Open Label, Evaluator Blinded Study to Evaluate Safety and Efficacy of Folitime® of Gemabiotech S.A., Versus Gonal-f ® of Merck Serono, in Patients With Infertility Undergoing ART
Condition: Infertility
MeSH terms: Infertility
Study type: Interventional
Phase: Phase 3

Summary: 
      This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental
      study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the
      original one (Gonal-f ®).
    

Detailed description: 
      Follitropin alfa is a human follicle stimulating hormone (FSH) preparation of recombinant DNA
      origin, which consists of two non-covalently linked, nonidentical glycoproteins designated as
      the alfa- and beta-subunits. Similar to other glycoprotein hormones, FSH has a high degree of
      heterogeneity due to differences in the amount and/or composition of the carbohydrate
      residues, particularly sialic acid. FSH, the active component of r-hFSH is the most important
      hormone responsible for follicular recruitment and development. In order to obtain final
      maturation of the follicle and ovulation in the absence of an endogenous LH surge, human
      chorionic gonadotropin (hCG) must be given following the administration of r-hFSH when
      monitoring of the patient indicates that sufficient follicular development has occurred.

      Secondary endpoints to be measured by the study are

      Efficacy

        -  Total dose of r-hFSH required,

        -  Number of days of r-hFSH stimulation

        -  Percentage of patients with need to increase or lower the dose of r-hFSH,

        -  Number of treatment cycle cancellations and their reason

        -  Fertilization rate

        -  Number of fertilized oocytes

        -  Number of good quality embryos

        -  Number of embryos transferred

        -  Implantation Rate

        -  Biochemical pregnancy

        -  Clinical pregnancy 10 weeks post embryo transfer

        -  Pregnancy outcome

      Safety

      Incidence of

        -  OHSS (and its severity)

        -  Local reactions (pain, bruising, redness, itching, swelling)

        -  Systemic drug adverse events

      Tolerability

        -  Frequency of patients who withdraw the study drug due to lack of tolerance

        -  Frequency of patients who withdraw the study drug treatment due to any reason

        -  Patient Reported Pain: measured by a Patients Visual Analog Scale (VAS)

      Immunogenicity Measurement of possible antibodies against exogenous r-hFSH will be evaluated.
      Pharmacodynamics

        -  Number and size distribution of follicles during treatment

        -  Number and size distribution of follicles at the day of ovulation induction (uHCG)

        -  Number of follicles >14 mm on the day of hCG injection.

        -  Hormone parameters: serum levels of estradiol, luteinizing hormone and progesterone on
           the day of hCG injection

        -  Metaphase II oocytes;

        -  Number of good quality oocytes
    

Intervention name(s): FOLITIME®; Gonal-F®
Intervention type(s): Drug; Drug
Other intervention name(s): Follitropin alfa (r-hFSH); Follitropin alfa (r-hFSH)
Intervention MeSH terms: Follicle Stimulating Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Assisted reproduction technologies; Follicle stimulating hormone (FSH).