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Trial registered on ANZCTR


Registration number
ACTRN12618000728235
Ethics application status
Approved
Date submitted
24/04/2018
Date registered
2/05/2018
Date last updated
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
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)
Scientific title
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)
Secondary ID [1] 294712 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Reproductive Health and Childbirth 307580 0
Invitro Fertilization 307581 0
Infertility 307584 0
Condition category
Condition code
Reproductive Health and Childbirth 306649 306649 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 301004 0
Treatment: Devices
Comparator / control treatment
Subjects using the 12mm needle will be the control group
Control group
Active

Outcomes
Primary outcome [1] 305648 0
Difference in subject satisfaction between the two needle sizes (the two study groups)
This outcome will be assess using the study questionnaires which are based on the validated Self-Injection Assessment Questionnaire and the Health and Quality Life Outcomes Questionnaire. These two questionnaires have been combined to create one study questionnaire which will be used to assess the primary outcome.
Timepoint [1] 305648 0
End of IVF cycle. The length of an IVF cycle is 24-35 days with an average duration of 26 days.
Secondary outcome [1] 346034 0
Difference in number of complications between the two study groups. Complications include
- Ovarian Hyper Stimulation Syndrome (OHSS)
- Bleeding
- Infection
- Ovarian absess
These outcomes will be monitored using the clinics usual procedures which include ultrasound, blood tests and regular doctor/nurse assessments
Timepoint [1] 346034 0
End of IVF cycle. The length of an IVF cycle is 24-35 days with an average duration of 26 days.
Secondary outcome [2] 346125 0
Difference in drug administration errors between the two study groups which will be monitored during the regular clinic/ nurse visits (2-4 per cycle) and entered into the CRF
Timepoint [2] 346125 0
End of IVF cycle. The length of an IVF cycle is 24-35 days with an average duration of 26 days.
Secondary outcome [3] 346126 0
Difference in number of oocytes harvested between the two study groups. Number of oocytes will be counted using the clinics usual practice.
Timepoint [3] 346126 0
End of IVF cycle. The length of an IVF cycle is 24-35 days with an average duration of 26 days.
Secondary outcome [4] 346129 0
Incidence of adverse events/Serious adverse events between the two study groups. These will be monitored and documented using the clinics usual procedures which include ultrasound, blood tests and regular doctor/nurse assessments
Timepoint [4] 346129 0
End of IVF cycle. The length of an IVF cycle is 24-35 days with an average duration of 26 days.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
38 Years
Gender
Females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by phone/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The null hypothesis (Ho) of primary interest is that there is no difference in the mean patient satisfaction scores, measured on the Visual Analogue Scale (VAS) between two study groups which administer Bemfola using 12 mm and 4mm needles. The alternative hypothesis (H1) is that the mean patient satisfaction score is lower in experimental group which used 4 mm needles compared to the reference group which used 12 mm needles. In mathematical terms, these hypotheses translate as Ho: ¯x4mm is equal to ¯x12mm and H1: ¯x4mm is less than ¯x12mm where ¯x12mm is the mean VAS score in the 12mm needle group, and ¯x4mm is the mean VAS score in the 4mm needle group. The hypotheses will be evaluated using a one-sided t-test of means.
Bemfola Patient satisfaction scores will be measured on Visual Analogue Scale (VAS) and recorded as a continuous response variable. Previously, Imthurn [Imthurn B, et al. Evaluation of the use and handling of three different pen systems considered for in vitro fertilization treatment. Expert Opin Drug Deliv. 2014 Dec;11(12):1859-641] evaluated the use of Bemfola pen and found the mean VAS score was normally distributed with mean 77.9 and standard deviation 14.0. Assuming the same satisfaction levels as in Imthurn B et al, a 10% true difference in the experimental and control means, and a significance level of 0.05 for one-sided two-sample t- test of means, a sample size of 102 subjects will provide 80% power to show the assumed difference in means. Approximately 112 subjects will be randomised in order to ensure availability of data from at least 102 evaluable subjects.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 299317 0
Commercial sector/Industry
Name [1] 299317 0
Gedeon Richter Australia Pty Ltd
Address [1] 299317 0
Unit 33-34
23 Narabang Way
Belrose NSW 2085
Country [1] 299317 0
Australia
Primary sponsor type
Individual
Name
Dr Rachael Knight
Address
Melbourne IVF
380 Victoria Parade
East Melbourne Vic 3002
Country
Australia
Secondary sponsor category [1] 298583 0
None
Name [1] 298583 0
Address [1] 298583 0
Country [1] 298583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300225 0
Melbourne IVF HREC
Ethics committee address [1] 300225 0
Melbourne IVF
380 Victoria Parade
East Melbourne Vic 3003
Ethics committee country [1] 300225 0
Australia
Date submitted for ethics approval [1] 300225 0
11/12/2017
Approval date [1] 300225 0
20/09/2018
Ethics approval number [1] 300225 0
57/17- MIVF

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 82974 0
Dr Rachael Knight
Address 82974 0
Melbourne IVF
380 Victoria Parade
East Melbourne Vic 3002
Country 82974 0
Australia
Phone 82974 0
+61 419367255
Fax 82974 0
Email 82974 0
rachael.knight@mivf.com.au
Contact person for public queries
Name 82975 0
Dr Rachael Knight
Address 82975 0
Melbourne IVF
380 Victoria Parade
East Melbourne Vic 3002
Country 82975 0
Australia
Phone 82975 0
+61 419367255
Fax 82975 0
Email 82975 0
rachael.knight@mivf.com.au
Contact person for scientific queries
Name 82976 0
Dr Rachael Knight
Address 82976 0
Melbourne IVF
380 Victoria Parade
East Melbourne Vic 3002
Country 82976 0
Australia
Phone 82976 0
+61 419367255
Fax 82976 0
Email 82976 0
rachael.knight@mivf.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual data will not be provided. Pooled data results will be shared
What supporting documents are/will be available?
No other documents available
Summary results
No Results