A Study to Evaluate the Ease of Use, Local Tolerance, Safety and Effectiveness of Gonal-f® (Filled-by-mass in a Prefilled Pen)
Condition: Infertility
MeSH terms: Infertility
Study type: Observational

Summary: 
      This is a prospective, open-label, non-comparative, multicentric Phase 4 study to evaluate
      the ease of use, local tolerance, safety and effectiveness of Gonal-f® (filled-by-mass in a
      prefilled pen) in subjects undergoing ovarian hyperstimulation for in vitro fertilization
      (IVF) or intracytoplasmic sperm injection (ICSI) with recombinant follicle stimulating
      hormone (r-FSH).

      Clarification for change of study type:

      The study was erroneously registered as an interventional trial on ClinicalTrials.gov between
      2010 and 2012. It was shown recently that the study protocol and conduct of the study did not
      include any clinical interventions beyond those which are Standard Clinical Practice and the
      approved label for Gonal-f®. Furthermore, all other relevant study essential documentations
      (e.g. Informed Consent, CRF, etc.) are in line with an observational study design. As per EU
      regulations (Article 2(c) of Directive 2001/20/EC), this study is a 'non-interventional
      trial'.
    

Detailed description: 
      Treatment of subfertility and infertility by assisted reproduction technologies (ART) such as
      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 or ICSI currently includes suppression of endogenous luteinizing hormone (LH) secretion
      by administration of a gonadotropin 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-human chorionic gonadotropin) 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 (urinary-derived FSH)
      in terms of requiring fewer ampoules 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 as the next step in
      innovation in Serono capitalized on the fact that Serono recognized that follitropin alfa
      manufacturing was highly controlled and with a controlled specific activity that allowed
      filling the product by mass guaranteeing the dose being delivered. Until now follitropin alfa
      has been produced as a lyophilisate for injection (either as single dose or multidose
      applications) in glass ampoules or in glass vials and administered using syringes. Today,
      Gonal-f® fill-by-mass is available as a new liquid formulation that can be administered with
      the pen device which is prefilled and hence the subject does not have to assemble the device
      making it simpler to use.

      OBJECTIVES

      Primary objective:

      To evaluate the ease-of-use of Gonal-f® (filled by mass in a prefilled pen) in subjects
      undergoing IVF/ICSI.

      Secondary objectives:

      To evaluate the local tolerance, safety and effectiveness of Gonal-f® prefilled pens.
    

Intervention name(s): Gonal-f® (follitropin alfa)
Intervention type(s): Drug
Intervention description(s): Gonal-f® (follitropin alfa) will be given once daily subcutaneously at a starting dose of 150-375 international unit per day (IU/day) by self-administered injection via a pen device for first 5 days. After Day 5, Gonal-f® dose will be adjusted according to the investigator's discretion until ovarian response observed.
Other intervention name(s): Recombinant human follicle stimulating hormone (r-hFSH)
Intervention MeSH terms: Follicle Stimulating Hormone
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care clinic
      
Keywords: Follitropin alfa; Fertilization in vitro; Intracytoplasmic sperm injection; Reproductive techniques, assisted