RecruitingACTRN12618000728235

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)


Sponsor

Dr Rachael Knight

Enrollment

112 participants

Start Date

Nov 26, 2018

Study Type

Interventional

Conditions

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.


Eligibility

Sex: FemalesMin Age: 18 YearssMax Age: 38 Yearss

Plain Language Summary

Simplified for easier understanding

IVF (in vitro fertilisation) involves daily hormone injections to stimulate egg production. One medication commonly used is Bemfola, a form of FSH (follicle-stimulating hormone) that is currently given using a 12mm needle. In other areas of medicine — like insulin for diabetes — a move to shorter 4mm needles has been shown to be just as effective while being more comfortable for patients. This study is investigating whether the same switch could benefit women undergoing IVF. Participants will be randomly assigned to use either the standard 12mm needle or a shorter 4mm needle throughout one IVF treatment cycle (approximately 28 days). At each clinic visit, they'll complete a short satisfaction questionnaire, and safety will be closely monitored. The goal is to see if the smaller needle is equally safe and potentially more comfortable. You may be eligible if you are a female aged 18 to 38 with a diagnosis of infertility and are about to begin an IVF cycle using Bemfola. Women with tumours of the pituitary gland, unexplained ovarian cysts, unexplained vaginal bleeding, ovarian or uterine cancer, or failed ovaries are not eligible. If you're starting IVF and interested in contributing to research that could make injections more comfortable for future patients, ask your fertility clinic about this study.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 administ

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.


Locations(1)

VIC, Australia

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