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.
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.
Platteau
Peter
P
Centre for Reproductive Medicine, University Hospital and Medical school, Dutch-speaking Brussels Free University, Laarbeeklaan 101, Belgium. peter.platteau@az.vub.ac.be
Laurent
Els
E
Albano
Carola
C
Osmanagaoglu
Kaan
K
Vernaeve
Valérie
V
Tournaye
Herman
H
Camus
Michel
M
Van Steirteghem
André
A
Devroey
Paul
P
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
D037201:Follicle Stimulating Hormone, beta Subunit; D015292:Glycoprotein Hormones, alpha Subunit; D011994:Recombinant Proteins