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Patient and nurse evaluation of recombinant human follicle-stimulating hormone administration methods: comparison of two follitropin injection pens.

Author(s): Porter R, Kissel C, Saunders H, Keck C

Affiliation(s): IVF Australia, Sydney, New South Wales, Australia.

Publication date & source: 2008-03, Curr Med Res Opin., 24(3):727-35. Epub 2008 Jan 28.

Publication type: Clinical Trial; Comparative Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't

OBJECTIVE: Ovarian stimulation by injection of gonadotrophins is an essential part of assisted reproductive technology (ART) protocols. Two studies (a German pilot study and an Australian study) aimed to assess and compare the ease-of-use, safety and efficacy of two follitropin injection pens. METHODS: Patient satisfaction (questionnaire) and safety were assessed in patients undergoing ART at a German centre for in vitro fertilisation (IVF), randomised either to the follitropin alfa pen or to the follitropin beta pen. Patient satisfaction (questionnaire) was assessed in patients undergoing ART at an Australian IVF centre, using the follitropin alfa pen, and previous experience with the follitropin beta pen was compared. The experience of IVF nurses with both pens was assessed using a similar questionnaire. Statistical significance was not determined in either study. RESULTS: In the German study (n = 31), patients favored the follitropin alfa pen over the follitropin beta pen because they found preparation faster, were more confident of accurate dosing and had to make fewer dose adjustments. Treatments delivered by both pens were well tolerated; eight adverse events (AEs) occurred, two AEs (including one case of ovarian hyperstimulation syndrome, OHSS) in two patients using the follitropin alfa pen and six AEs (including three cases of OHSS, one of which was serious) in six patients using the follitropin beta pen. Patients (n = 140) and nurses (n = 11) in the Australian study scored the follitropin alfa pen highly and patients favored it over the follitropin beta pen; the risk of OHSS was also considered greater in the follitropin beta pen group, with nearly a twofold higher rate of cycle cancellation due to OHSS risk compared with the follitropin alfa pen group. CONCLUSIONS: Taken together, results from these two small studies suggest that the follitropin alfa pen was effective, well tolerated, and patient and nurse acceptance appeared to be higher for the follitropin alfa pen versus the follitropin beta pen, which may benefit compliance, leading to improved outcomes.

Page last updated: 2008-06-22

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