Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000091909
Ethics application status
Approved
Date submitted
11/12/2019
Date registered
3/02/2020
Date last updated
3/02/2020
Date data sharing statement initially provided
3/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Ultrasound guided embryo transfer for women undergoing In Vitro Fertilisation (IVF) for infertility - is it helpful for the procedure to be guided by a trained ultrasonographer and does this lead to the embryo being correctly placed more often?
Scientific title
Effect of sonographer guided embryo transfer versus ultrasound assisted transfer for visualisation of the bubble during embryo transfer.
Secondary ID [1] 300062 0
Nil known
Universal Trial Number (UTN)
U1111-1245-2343
Trial acronym
The GET study (Guided Embryo Transfer)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility 315582 0
Condition category
Condition code
Reproductive Health and Childbirth 313868 313868 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sonographer guided embryo transfer - the sonographer holds the abdominal ultrasound probe and guides the doctor to correctly position the embryo transfer catheter. Following embryo transfer the sonographer measures the distance of the bubble(fluid with embryo in it) from the fundal endometrium. This will potentially add on 1-2 minutes to the procedure which takes approximately 5 minutes. A picture with the bubble and measurement will be printed and the data will be entered by an independent research nurse.
Intervention code [1] 316329 0
Treatment: Other
Comparator / control treatment
Ultrasound assisted embryo transfer ( the patient holds the abdominal ultrasound probe during embryo transfer) Following embryo transfer the doctor measures the position of the bubble from the fundal endometrium and a photo is printed. This may add 1-2 minutes to the procedure. The data will be entered by an independent research nurse.
Control group
Active

Outcomes
Primary outcome [1] 322424 0
Visualisation of the bubble via transabdominal ultrasound
Timepoint [1] 322424 0
Immediately following embryo transfer
Secondary outcome [1] 378449 0
Position of the bubble from the fundal endometrium - measured in mm via ultrasound and photo printed
Timepoint [1] 378449 0
Immediately following embryo transfer
Secondary outcome [2] 378450 0
Difficulty of embryo transfer - this is determined by use of extra instruments such as an obturator, tenaculum and is recorded in the embryology notes every time a doctor performs an embryo transfer
Timepoint [2] 378450 0
Immediately following embryo transfer

Eligibility
Key inclusion criteria
All women undergoing frozen embryo transfer
Minimum age
18 Years
Maximum age
38 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Donor egg or donor embryo

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)
Sealed envelope
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation - computer generated
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Intention to treat analysis with percentages and odds ratios

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
28/02/2020
Actual
Date of last participant enrolment
Anticipated
28/06/2020
Actual
Date of last data collection
Anticipated
28/07/2020
Actual
Sample size
Target
116
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 15457 0
Repromed Day Surgery - Dulwich
Recruitment postcode(s) [1] 28810 0
5065 - Dulwich

Funding & Sponsors
Funding source category [1] 304514 0
Commercial sector/Industry
Name [1] 304514 0
Repromed
Country [1] 304514 0
Australia
Primary sponsor type
Individual
Name
Dr Juliette Koch
Address
Repromed
180 Fullarton Rd
Dulwich SA 5065
Country
Australia
Secondary sponsor category [1] 304787 0
None
Name [1] 304787 0
Address [1] 304787 0
Country [1] 304787 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304945 0
Womens and Childrens Health Network HREC
Ethics committee address [1] 304945 0
Level 1 Samuel Way Building
72 King William Rd
North Adelaide SA 5006
Ethics committee country [1] 304945 0
Australia
Date submitted for ethics approval [1] 304945 0
23/09/2019
Approval date [1] 304945 0
28/10/2019
Ethics approval number [1] 304945 0

Summary
Brief summary
Embryo transfer is the final process in the highly technical treatment of IVF. It is performed via the cervix and the embryo is placed into the uterine cavity via a fine catheter. Studies demonstrate that pregnancy rates are better when embryo transfer is performed under ultrasound guidance. Studies have also looked at the position of the bubble(fluid containing the embryo) on ultrasound following embryo transfer, with a sweet spot at 15mm from the fundal endometrium.
Currently in most clinics ultrasound guidance is not performed by a person formally trained in pelvic ultrasound. The ultrasound probe is often positioned by the doctor and held by the patient whilst the doctor performs the transfer. The researchers hypothesize that performing the transfer with a trained sonographer will lead to a higher number of embryos being in the best position in the uterine cavity. We hypothesize that as compared to a patient holding the ultrasound probe, the sonographer is skilled at locating the endometrium, dynamically adjusting the probe and guiding the doctor to place the embryo in the ideal position.
This study will assess the distance of the bubble from the fundal endometrium immediately following embryo transfer.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 98722 0
Dr Juliette Koch
Address 98722 0
Repromed
180 Fullarton Rd
Dulwich SA 5063
Country 98722 0
Australia
Phone 98722 0
+61411608331
Fax 98722 0
Email 98722 0
[email protected]
Contact person for public queries
Name 98723 0
Dr Juliette Koch
Address 98723 0
Repromed
180 Fullarton Rd
Dulwich SA 5063
Country 98723 0
Australia
Phone 98723 0
+61411608331
Fax 98723 0
Email 98723 0
[email protected]
Contact person for scientific queries
Name 98724 0
Dr Juliette Koch
Address 98724 0
Repromed
180 Fullarton Rd
Dulwich SA 5063
Country 98724 0
Australia
Phone 98724 0
+61411608331
Fax 98724 0
Email 98724 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Burden and cost of sharing
Potential difficulty with maintaining privacy


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6149Study protocol    378916-(Uploaded-11-12-2019-18-54-28)-Study-related document.docx
6150Informed consent form    378916-(Uploaded-11-12-2019-18-55-09)-Study-related document.docx
6151Ethical approval    378916-(Uploaded-11-12-2019-18-55-26)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.