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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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Study to Compare Efficacy and Safety of Primapur and Gonal-f in Women for Assisted Reproductive Treatment

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To Evaluate the Convenience, Safety and Efficacy of Follitropin Alfa Liquid Pen Compared With Follitropin Beta Liquid Pen

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A Study to Evaluate Patient Preference for the Gonal-f Pen Versus Gonadotropins Administered by the Vial and Syringe Method

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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

PubMed Articles [355 Associated PubMed Articles listed on BioPortfolio]

In-vivo biological activity and glycosylation analysis of a biosimilar recombinant human follicle-stimulating hormone product (Bemfola) compared with its reference medicinal product (GONAL-f).

Recombinant human follicle-stimulating hormone (r-hFSH) is widely used in fertility treatment. Although biosimilar versions of r-hFSH (follitropin alfa) are currently on the market, given their struct...

A strategy to reduce inflammation and anemia treatment's related costs in dialysis patients.

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Changes in in vivo confocal microscopic findings of ocular surface squamous neoplasia during treatment with topical interferon alfa-2b.

To evaluate in vivo confocal microscopy (IVCM) findings of ocular surface squamous neoplasia (OSSN) during treatment with topical interferon alfa-2b (IFN alfa-2b).

Immune tolerance induction rescue with turoctocog-alfa in a poor risk haemophilia A inhibitor young child: the history of a success.

: The development of alloantibodies against the replacement of Factor VIII (FVIII) is the major complication in haemophilia A treatment. The gold standard to eradicate inhibitors is the immune toleran...

Infertility and self-rated health among Malawian women.

Infertility is prevalent and stigmatized in sub-Saharan Africa. Self-rated health, a subjective indicator that has been consistently related to objectively measured health, may be useful in evaluating...

Medical and Biotech [MESH] Definitions

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.

This recombinant erythropoietin, a 165-amino acid glycoprotein (about 62% protein and 38% carbohydrate), regulates red blood cell production. Epoetin alfa is produced by Chinese hamster ovary cells into which the human erythropoietin gene has been inserted. (USP Dictionary of USAN and International Drug Names, 1996).

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