title: Single-arm, observational study of the ease of use of a redesigned pen device to deliver recombinant human follicle-stimulating hormone (follitropin alfa) for assisted reproductive technology treatment.
abstract: OBJECTIVE
  Evaluation of patients' ease of use of the redesigned, disposable, ready-to-use follitropin alfa pen during controlled ovarian stimulation for assisted reproductive technology.
  
  
  METHODS
  This single-center, observational, open-label, single-arm study recruited infertile normo-ovulatory women (aged 18-45 years). Nurses trained patients to self-administer recombinant human follicle-stimulating hormone daily using the follitropin alfa pen (300 IU, 450 IU, and 900 IU). Before treatment, patients completed Questionnaire A. Following self-administered treatment, on stimulation days 5-6 and 7-8 (within a day of receiving recombinant human chorionic gonadotropin), patients completed Questionnaire B. Nurses completed an ease-of-learning/teaching questionnaire. The primary endpoint was proportion of patients rating the pen as "easy/very easy" to use (Questionnaire B) on the final visit before recombinant human chorionic gonadotropin. Secondary endpoints included: proportion of patients rating the follitropin alfa pen as easy to learn, use, prepare, deliver, and dispose of (Questionnaires A and B). Proportions (95% confidence intervals [CIs]) were provided for primary and secondary endpoints. Adverse events were reported descriptively.
  
  
  RESULTS
  Eighty-six patients received recombinant human follicle-stimulating hormone. Of the 72 patients who had completed the overall assessment questions, 66 (91.7%; 95% CI =82.7%-96.9%) found the pen "easy" to use. Also, 70/86 (81.4%) patients "strongly agreed/agreed" that, overall, it was easy to learn how to use the pen; 72/86 (83.7%) "strongly agreed/agreed" that easily understandable, verbal information was provided; and 70/86 (81.4%) were confident about using the pen correctly. In total, 24/26 nurses (92.3%; 95% CI =74.9%-99.1%) rated the pen as easy to use. Clinical pregnancy rate/patient/cycle/embryo transfer was 37%. Twenty-six ovarian hyperstimulation syndrome events were reported (none severe; 16 patients [19%]); of these, 13 occurred at embryo transfer.
  
  
  CONCLUSIONS
  In this observational study, patients had a high acceptance of the redesigned follitropin alfa pen, with most finding it very easy/easy to use. Assisted reproductive technology nurses found the pen very easy/easy to teach.
authors.affiliation: IVFAustralia, Greenwich, Sydney, NSW, Australia.
authors.forename: Peter J
authors.initials: PJ
authors.lastname: Illingworth
authors.affiliation: IVFAustralia, Greenwich, Sydney, NSW, Australia.
authors.forename: Robert
authors.initials: R
authors.lastname: Lahoud
authors.affiliation: IVFAustralia, Greenwich, Sydney, NSW, Australia.
authors.forename: Frank
authors.initials: F
authors.lastname: Quinn
authors.affiliation: Scientific Affairs, Merck Serono Australia Pty Ltd, Frenchs Forest, Sydney, NSW, Australia.
authors.forename: Kendal
authors.initials: K
authors.lastname: Chidwick
authors.affiliation: Scientific Affairs, Merck Serono Australia Pty Ltd, Frenchs Forest, Sydney, NSW, Australia.
authors.forename: Claire
authors.initials: C
authors.lastname: Wilkinson
authors.affiliation: IVFAustralia, Greenwich, Sydney, NSW, Australia.
authors.forename: Gavin
authors.initials: G
authors.lastname: Sacks
keywords: controlled ovarian stimulation; ease of learning; ease of teaching; prefilled pen; questionnaire; self-injection