Human Reproduction, Vol. 18, No. 6, 1200-1204,
June 2003
© 2003 European Society of Human Reproduction and Embryology
An open, randomized single-centre study to compare the efficacy and convenience of follitropin 
administered by a pen device with follitropin 
administered by a conventional syringe in women undergoing ovarian stimulation for IVF/ICSI
Centre for Reproductive Medicine, University Hospital and Medical school, Dutch-speaking Brussels Free University, Laarbeeklaan 101, 1090 Brussels, Belgium
1 To whom correspondence should be addressed. e-mail: peter.platteau{at}az.vub.ac.be
BACKGROUND: A pen device, similar to an insulin pen, has been recently marketed for the administration of follitropin 
in cartridges. A randomized controlled trial was performed to compare the efficacy and convenience of this pen device delivering follitropin with a conventional syringe delivering follitropin 
. 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.
Key words: controlled ovarian stimulation/IVF/local tolerance/pen device/recombinant FSH
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