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- 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.
- Authors
Platteau, Peter; Laurent, Els; Albano, Carola; Osmanagaoglu, Kaan; Vernaeve, Valérie; Tournaye, Herman; Camus, Michel; Van Steirteghem, André; Devroey, Paul
- Abstract
<bold>Background: </bold>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.<bold>Methods: </bold>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.<bold>Results: </bold>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.<bold>Conclusions: </bold>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.
- Subjects
SUBCUTANEOUS injections; CHORIONIC gonadotropins; CLINICAL trials; COMPARATIVE studies; EMBRYO transfer; FERTILIZATION in vitro; FOLLICLE-stimulating hormone; RESEARCH methodology; EVALUATION of medical care; MEDICAL cooperation; INDUCED ovulation; PREGNANCY; RECOMBINANT proteins; RESEARCH; SELF medication; EVALUATION research; RANDOMIZED controlled trials
- Publication
Human Reproduction, 2003, Vol 18, Issue 6, p1200
- ISSN
0268-1161
- Publication type
journal article
- DOI
10.1093/humrep/deg234