Patient evaluation of the redesigned follitropin alfa pen injector

Abstract

This study demonstrated that both IVF/ART-experienced and -naïve women with infertility found the redesigned pen injector easy to learn to use and to use.

An evaluation of the use and handling errors of currently available recombinant human follicle-stimulating hormone pen injectors by women with infertility and fertility nurses

“…The findings reported in this study are consistent with previous studies regarding the evaluation of the GONAL-f pen injector by women with recent or current infertility requiring ART or IVF and fertility nurses [4,5,19]. In a previous study, IVF/ART-experienced andnaïve women with infertility found the redesigned pen injector 'easy to learn to use' and 'easy to use' [5]. Fertility nurses rated the redesigned pen injector as 'easy to learn and use' and 'easier to teach' than expected [4].…”

“…The first GONAL-f pen injector was approved in Europe in 2011 and since then it has been redesigned based on feedback from human factors engineering evaluations to improve robustness, handling, and readability [3]. The redesigned GONAL-f pen injector was evaluated by women with recent or current infertility requiring ART or in-vitro fertilization (IVF) and fertility nurses, and the device was considered easy to use [4,5,6]. Furthermore, an estimated 16,525,975 treatment cycles have been conducted since GONAL-f r-hFSH first gained marketing authorization for the stimulation of multifollicular development in patients undergoing medically assisted reproduction.…”

The Development of Gonadotropins for Clinical Use in the Treatment of Infertility

“…In addition, these products have greater stability and liquid formulations of recombinant products have been produced, removing the need for reconstitution before injection. This in turn has enabled the development of pen injection devices, which are designed to improve ease-of-use and patient convenience, including the ability to both select the starting dose with greater precision (in increments as low as 12.5 IU) and adapt the dose during treatment, based on treatment response in small increments (12.5 IU) (142–144).…”

Open-Label, Randomized, Two-Way, Crossover Study Assessing the Bioequivalence of the Liquid Formulation versus the Freeze-Dried Formulation of Recombinant Human FSH and Recombinant Human LH in a Fixed 2:1 Combination (Pergoveris®) in Pituitary-Suppressed Healthy Women

“…A novel liquid formulation of r-hFSH/r-hLH was developed that does not require reconstitution and can be delivered subcutaneously using a prefilled, multi-dose pen injector, similar to the one currently available for GONAL-f ® (follitropin alfa; Merck KGaA, Darmstadt, Germany) and Ovidrel ® (rhCG; Merck KGaA, Darmstadt, Germany). Studies of this pen injector have demonstrated that health-care professionals find the pen injector easy to teach to use and that both health-care professionals and patients find the pen injector easy to learn to use, and can use it safely and effectively ( 4 , 5 ). The pen injector provides reassurance that the correct dose has been administered, displaying feedback on the dose administered, and as there is no need for reconstitution, concern about correct preparation is reduced ( 4 , 6 ).…”

“…Studies of this pen injector have demonstrated that health-care professionals find the pen injector easy to teach to use and that both health-care professionals and patients find the pen injector easy to learn to use, and can use it safely and effectively ( 4 , 5 ). The pen injector provides reassurance that the correct dose has been administered, displaying feedback on the dose administered, and as there is no need for reconstitution, concern about correct preparation is reduced ( 4 , 6 ). Furthermore, the pen injector has been demonstrated to reliably dispense accurate doses under a range of conditions, including cold, standard and warm atmospheres, and subsequent to freefall, vibration, dry-heat, cold-storage, and shipping preconditioning ( 7 ).…”