None listed
Conditions
Brief summary
Bemfola is a recombinant follicle stimulating hormone used for ovarian stimulation during an IVF cycle. It is approved by the TGA for use in IVF procedures. Bemfola is administered via daily injections using a 12mm needle. Other medications, such as insulin, which are administered using a similar device are moving to a 4mm needle for patient comfort with no adverse effects on delivery of the drug.or complications. 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 complete a satisfaction questionnaire at each clinic visit as well as clinical assessments as per the clinics usual practice. Study duration will be one IVF treatment cycle which is approximately 28 days.
Interventions
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 in
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.
Sponsors
Dr Rachael Knight
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 38 Years
Healthy volunteers
No
Inclusion criteria
1. Female subjects aged 18-38 years 2. Written informed consent prior to any of the study procedures including discontinuation of prohibited medications 3. A diagnosis of infertility
Exclusion criteria
1. Tumours of the hypothalamus or pituitary gland 2. Enlarged ovaries 3. Unexplained ovarian cyst 4. Unexplained vaginal or uterine bleeding 5. Cancer of the ovaries, uterus or breasts 6. Failed ovaries 7. Fibroids in uterus that would make pregnancy impossible 8. Use of any investigational product within 30 days prior to screening
Outcome results
None listed