Infertility Clinical Trial
Official title:
Phase IV Study to Evaluate the Ease of Use, Local Tolerance Safety and Effectiveness of Gonal-f® (Filled-by-Mass in a Prefilled Pen)
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'.
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.
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