P-748: Post marketing surveillance analysis of the routine use of of follitropin alfa in a prefilled ready to use injection pen in ART

Abstract

This report presents data from an observational study conducted in Germany on the use of the Gonal-f®1 (follitropin alfa) pre-filled pen in routine ART procedures. It focuses on the patient’s evaluation of the pen ease-of-use and acceptability. Observational study, patient questionnaire. Between April 2004 and December 2005, 40 German IVF centers participated in the study. Routine data for stimulated IVF and ICSI cycles were prospectively entered into an electronic database, and patients completed a questionnaire regarding: (1) the ease of use of the pen, and (2) the patients′ preference for the Gonal-f® pre-filled pen versus their prior experience with ampoules or vials, which have to be reconstituted, or a reusable pen with loadable cartridges. 3,522 of 35,724 prospective ART-cycles in Germany (IVF-register report 2004), one cycle per patient, were documented. Mean days of stimulation was 10.8+/-2.6 days, at a mean dose of 2,138+/-983 IU r-hFSH per patient. 2052 patients with previous gonadotropin treatment experience rated that the prefilled pen needed less training for 63.5% (n=1303), equal for 29.3% (n=602) and more for 7.2% (n=147) patients compared to the monodose or multidose vials with follitropin alfa (reconstitution required). 383 patients with prior experience using both pens judged that compared to the follitropin beta reusable pen with cartridges, the follitropin alfa ready-to-use solution in a prefilled pen device was easier to use for 59.8% (n=229), equal for 32.4% (n=124) and less easy for 7.8% (n=30) patients. From 2686 patients, 83.2% (n=2234) said they would prefer the GONAL-f® prefilled pen versus 8.9% (n=238) for the follitropin beta pen, 7.2% (n=194) for the multidose vials and 0.7% (n=20) for ampoules respectively, if future treatment was required. The routine use of follitropin alfa as a ready-to-use solution in a prefilled injection pen in ART was well accepted by patients. Patients′required less training compared to vials or ampoules and preferred the prefilled pen compared to the loadable device.