ANZCTR - Registration

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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

21/07/2024

Date data sharing statement initially provided

3/02/2020

Date results provided

21/07/2024

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]

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

Condition category

Condition code

Reproductive Health and Childbirth

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]

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]

Visualisation of the bubble via transabdominal ultrasound

Timepoint [1]

Immediately following embryo transfer

Secondary outcome [1]

Position of the bubble from the fundal endometrium - measured in mm via ultrasound and photo printed

Timepoint [1]

Immediately following embryo transfer

Secondary outcome [2]

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]

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?

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

Completed

Date of first participant enrolment

Anticipated

28/02/2020

Actual

1/08/2020

Date of last participant enrolment

Anticipated

28/06/2020

Actual

1/03/2021

Date of last data collection

Anticipated

28/07/2020

Actual

1/02/2022

Sample size

Target

116

Accrual to date

Final

118

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Repromed Day Surgery - Dulwich

Recruitment postcode(s) [1]

5065 - Dulwich

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Repromed

Address [1]

180 Fullarton Rd
Dulwich SA 5065

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Juliette Koch

Address

Repromed
180 Fullarton Rd
Dulwich SA 5065

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Womens and Childrens Health Network HREC

Ethics committee address [1]

Level 1 Samuel Way Building
72 King William Rd
North Adelaide SA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

23/09/2019

Approval date [1]

28/10/2019

Ethics approval number [1]

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

Dr Juliette Koch

Address

Repromed
180 Fullarton Rd
Dulwich SA 5063

Country

Australia

Phone

+61411608331

Fax

[email protected]

Contact person for public queries

Name

Juliette Koch

Address

Repromed
180 Fullarton Rd
Dulwich SA 5063

Country

Australia

Phone

+61411608331

Fax

[email protected]

Contact person for scientific queries

Name

Juliette Koch

Address

Repromed
180 Fullarton Rd
Dulwich SA 5063

Country

Australia

Phone

+61411608331

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Attachment
6149	Study protocol	378916-(Uploaded-11-12-2019-18-54-28)-Study-related document.docx
6150	Informed consent form	378916-(Uploaded-11-12-2019-18-55-09)-Study-related document.docx
6151	Ethical 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.

Trial Review

Documents added manually

Documents added automatically