title: An open, randomized single-centre study to compare the efficacy and convenience of follitropin beta administered by a pen device with follitropin alpha administered by a conventional syringe in women undergoing ovarian stimulation for IVF/ICSI.
abstract: BACKGROUND
  A pen device, similar to an insulin pen, has been recently marketed for the administration of follitropin beta in cartridges. A randomized controlled trial was performed to compare the efficacy and convenience of this pen device delivering follitropin beta with a conventional syringe delivering follitropin alpha.
  
  
  METHODS
  A total of 200 patients needing IVF/ICSI treatment and willing to self-inject were enrolled in the study. All subjects had ovarian stimulation according to a long protocol and were randomized to the pen or the conventional syringe group during down-regulation by means of a computer-generated randomization list using random numbers. Patients were asked to fill in a daily local tolerance book after each injection. On the day of hCG the patients scored a Visual Analogue Scale (VAS) for pain and convenience.
  
  
  RESULTS
  The average duration, total dose of recombinant FSH and number of cumulus oocyte complexes retrieved were 10.8/12.0 days (P = 0.001), 1880/2226 IU (P < 0.001) and 15.2/13.1 respectively in the pen device and conventional syringe groups; the presence of pain after the daily injection was significantly higher in the conventional syringe group (P = 0.027); the visual analogue scale score was similar for pain but significantly more convenient for the pen device (P < 0.001). The live birth rate per embryo transfer was 32.9 and 34.4% respectively in the pen device and conventional syringe groups.
  
  
  CONCLUSIONS
  Self-injection with the pen device is safe and easy, more convenient and less painful for the patient, requires less FSH and shortens the treatment duration.
authors.affiliation: Centre for Reproductive Medicine, University Hospital and Medical school, Dutch-speaking Brussels Free University, Laarbeeklaan 101, Belgium. peter.platteau@az.vub.ac.be
authors.forename: Peter
authors.initials: P
authors.lastname: Platteau
authors.forename: Els
authors.initials: E
authors.lastname: Laurent
authors.forename: Carola
authors.initials: C
authors.lastname: Albano
authors.forename: Kaan
authors.initials: K
authors.lastname: Osmanagaoglu
authors.forename: Valérie
authors.initials: V
authors.lastname: Vernaeve
authors.forename: Herman
authors.initials: H
authors.lastname: Tournaye
authors.forename: Michel
authors.initials: M
authors.lastname: Camus
authors.forename: André
authors.initials: A
authors.lastname: Van Steirteghem
authors.forename: Paul
authors.initials: P
authors.lastname: Devroey
mesh_terms: D000293:Adolescent; D000328:Adult; D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro; D037201:Follicle Stimulating Hormone, beta Subunit / Q000008:administration & dosage*; D015292:Glycoprotein Hormones, alpha Subunit / Q000008:administration & dosage*; D006801:Humans; D007279:Injections, Subcutaneous / Q000295:instrumentation; D010062:Ovulation Induction / Q000379:methods*; D011247:Pregnancy; D011256:Pregnancy Outcome; D011994:Recombinant Proteins / Q000008:administration & dosage; D012646:Self Administration; D020554:Sperm Injections, Intracytoplasmic
chemical_list: D037201:Follicle Stimulating Hormone, beta Subunit; D015292:Glycoprotein Hormones, alpha Subunit; D011994:Recombinant Proteins