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A Study to Evaluate the Ease of Use, Local Tolerance, Safety and Effectiveness of Gonal-f® (Filled-by-mass in a Prefilled Pen)

2014-08-27 03:13:59 | BioPortfolio

Summary

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).

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-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.

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Infertility

Intervention

Gonal-f (follitropin alfa)

Location

EMBRYOGENESIS IVF Unit
Athens
49, Kifisias aV
Greece
151 25

Status

Completed

Source

Merck KGaA

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:13:59-0400

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