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This was a prospective, open-label, non-comparative, multicentric phase IV 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 (FSH).
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-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 as the next step in innovation in Serono capitalised on the fact that Serono recognised that follitropin alfa manufacturing was highly controlled and with a controlled specific activity that allowed to fill 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.
To evaluate the ease-of-use of Gonal-f (filled by mass in a prefilled pen) in subjects undergoing IVF/ICSI.
To evaluate the local tolerance, safety and effectiveness of Gonal-f prefilled pens.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Gonal-f (follitropin alfa)
EMBRYOGENESIS IVF Unit
49, Kifisias aV
Published on BioPortfolio: 2014-08-27T03:13:59-0400
The purpose of this study is to show equivalence with regard to the number of oocytes retrieved between follitropin alfa (pen-injectors) Primapur® and Gonal-f® in woman undergoing IVF/IC...
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 fo...
To evaluate oligoanovulatory infertile women's satisfaction with follitropin alfa injection applied by Pen device compared to their previous experience with injectable gonadotropins. To ev...
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Ther purpose of this study is to show equivalence with regard to the number of oocytes retrieved between AFOLIA and Gonal-f® in women for assisted reproductive treatment
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A recombinant alfa interferon consisting of 165 amino acids with arginine at positions 23 and 34. It is used extensively as an antiviral and antineoplastic agent.
A recombinant alfa interferon consisting of 165 amino acids with lysine at position 23 and histidine at position 34. It is used extensively as an antiviral and antineoplastic agent.
A recombinant alfa interferon consisting of 165 amino acid residues with arginine in position 23 and histidine in position 34. It is used extensively as an antiviral and antineoplastic agent.
Inability to reproduce after a specified period of unprotected intercourse. Reproductive sterility is permanent infertility.
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