A patient satisfaction evaluation study of Bemfola (recombinant FSH) administered with a 12mm needle or a 4mm needle in the treatment of subjects undergoing invitro fertilisation (IVF)

Bemfola is a recombinant follicle stimulating hormone used for ovarian stimulation during an Invitro Fertilization (IVF) cycle. It is approved by the TGA for use in IVF procedures. Bemfola is administered via daily injections using a 12mm needle. Treatment is tailored to the individual patient's response as assessed by measuring 1) follicle size by ultrasound and/or 2) oestrogen secretion. A commonly used regimen commences at 75 – 150 IU (5.5 to 11 microgram) Bemfola daily and is increased in increments of 37.5 IU (2.75 microgram) up to 75 IU (5.5 microgram) at 7 or 14 day intervals if necessary, to obtain an adequate response. The purpose of this study is to compare the current needle with a smaller 4mm needle. Patient satisfaction and safety will be assessed. Subjects will be randomised into 2 groups with 51 subjects per group. One group will use the 12mm needle and the other group will use the 4mm needle. Subjects will inject Bemfola daily until the appropriate level of follicle stimulation is achieved (approx 3 weeks). Subjects will complete a satisfaction questionnaire at each clinic visit as well as clinical assessments as per the clinics usual practice. Adherence will be monitored by clinic and nurse visits on 2-4 occasions during the treatment process.