title: Comfort, ease of use and practicality of the pen injector for follitropin α for assisted reproduction: an observational post-marketing study in Egypt.
abstract: OBJECTIVE
  We evaluated the ease of use of a pen injector for follitropin α (recombinant human follicle-stimulating hormone [r-hFSH]) during assisted reproduction technologies (ARTs) in Egypt.
  
  
  METHODS
  One hundred women undergoing ART completed a questionnaire in a non-interventional, observational study. The primary endpoint was patients' rating of the comfort associated with the injector. The main limitations of the study were the design and lack of knowledge regarding any impact of failure of ART on perceptions of treatment for a minority of patients.
  
  
  RESULTS
  Patients rated the follitropin α pen injector as 'very comfortable' (61%), 'comfortable' (29%), or 'somewhat comfortable' (10%). Understanding instructions and using it were 'very easy' or 'easy' for 97-99%; 94% reported 'no' or 'minimal' difficulty with injections, 83% were 'very confident' about altering doses, 77% reported no interference with normal daily activities and 94% reported 'no' or 'minimal' stress using the device. Women with previous experience of ART rated the device as more practical than their previous injection system. Overall, 96% were 'very satisfied' or 'satisfied' with the device and 99% would recommend its use to others. Pregnancy rates were consistent with previous clinical experience. Injection site reactions occurred in 10% (all of mild severity except one moderate event).
  
  
  CONCLUSIONS
  Positive perceptions of the follitropin α pen injector identify this device as suitable for use for Middle Eastern women undergoing ART.
authors.affiliation: Assisted Reproduction Unit - Department of Obstetrics & Gynecology, Ain Shams University , Cairo , Egypt.
authors.forename: Mohamed
authors.initials: M
authors.lastname: Yehia
authors.forename: Waleed
authors.initials: W
authors.lastname: El-Khayat
authors.forename: Ashraf
authors.initials: A
authors.lastname: Kortam
authors.forename: Aly Hossam
authors.initials: AH
authors.lastname: Mowafy
authors.forename: Amr A
authors.initials: AA
authors.lastname: Aziz Khalifa
authors.forename: Azza
authors.initials: A
authors.lastname: Awad
authors.forename: Sherif
authors.initials: S
authors.lastname: Khattab
mesh_terms: D000293:Adolescent; D000328:Adult; D004534:Egypt; D005260:Female; D043373:Follicle Stimulating Hormone, Human / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007267:Injections / Q000295:instrumentation; D016471:Ovarian Hyperstimulation Syndrome; D010062:Ovulation Induction / Q000379:methods*; D017060:Patient Satisfaction; D011247:Pregnancy; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D027724:Reproductive Techniques, Assisted / Q000295:instrumentation*; D012646:Self Administration / Q000295:instrumentation; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D043373:Follicle Stimulating Hormone, Human; D011994:Recombinant Proteins; C571801:follitropin alfa