Background: This user experience study evaluated the suitability of single-use versus multi-dose follitropin alfa pen injectors for self-administration by women undergoing fertility treatment.Methods: Twenty-four fertility patients and 19 specialist nurses were recruited in four European countries to assess their use of Bemfola (a single-use pen), Gonal-f®, and Ovaleap® (multi-use pens). Participants completed usability tests in which their performance in assembling and administering doses of each pen was assessed against defined critical steps for ensuring safe and correct administration.Results: Critical error rates among nurses were 4%, 40%, and 49% for Bemfola®, Ovaleap®, and Gonal-f®, respectively; and among patients were 7%, 16%, and 38%. The most frequently reported critical errors occurred with the multi-use pens and were incorrect/lack of priming and failure to check the dose window prior to setting a new dose. The need to 'top up' doses from a new pen or cartridge when a pen contained insufficient dose also caused errors. The single-use pens did not cause these errors. Overall, 63% of nurses and 67% of patients had most confidence in Bemfola® for correct dosing and self-administration.Conclusions: Single-use pens require fewer preparation and administration steps than multi-use pens and are associated with fewer critical handling errors.
Keywords: Follitropin α; human factors; in vitro fertilization; infertility; pen injector; recombinant human follicle-stimulating hormone; self-administration; user experience.