ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12620000197932

Ethics application status

Approved

Date submitted

30/01/2020

Date registered

20/02/2020

Date last updated

29/09/2024

Date data sharing statement initially provided

20/02/2020

Date results provided

29/09/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Evaluation of the role of an artificial intelligence system (iDA) in embryo selection.

Scientific title

A randomised controlled trial comparing the clinical pregnancy per embryo transfer between an embryo that is selected by an artificial intellligence system (iDA) and and an embryo that is selected by an embryologist.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1247-4885

Trial acronym

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

Selection of an embryo for transfer by artificial intelligence.
a) The intervention will involve use of a deep learning system, iDA, to review time lapse images (every 10 minutes for five days) taken of embryos growing in an incubator. The deep learning system will analyse these images and use a published validated process to identify which embryo has the highest likelihood of successful implantation.
b) The participants will be treated by their doctor as per normal. The embryos will be cultured as per normal. The only change for the participants will be which embryo is selected FIRST for transfer.
c) The intervention will be implemented by the embryologist following randomisation.
d) The artificial intelligence system is built into the incubators
e) The intervention will be delivered once on Day 5 of embryo culture and will direct which embryo is transferred that morning.
f) The software will be locked to ensure that the embryologist will not be able to implement the deep learning system unless the participant is randomised to use of iDA for embryo selection. All randomisation will be done through an electronic CRF which will monitor and record all randomisations.

Intervention code [1]

Treatment: Devices

Comparator / control treatment

Selection of an embryo for transfer by an embryologist using his/her professional skills

Control group

Active

Outcomes

Primary outcome [1]

Fetal heart rate pregnancy from the first embryo transfer.
All participants will undergo a serum assay of hCG at 10-13 days after the embryo transfer. Where the hCG level demonstrates a pregnancy, an ultrasound scan will be performed by the managing doctor at 42-46 days gestation. Both the hCG level and the ultrasound scan findngs will be recorded in the patient's own electronic medical record. The study nurse will use this data source to enter the outcome data into the electronic CRF

Timepoint [1]

8 weeks gestation.

Secondary outcome [1]

Live birth rate from the first embryo transfer.
This outcome will be assessed by telephone follow up of participants. In all cycles of fertility treatment, the patient is followed by by telephone and full details of the birth outcome are required to be collected and recorded in the patient's EMR.
The research team will access this record to obtain the data for entry into the study eCRF.

Timepoint [1]

Expected date of delivery as calculated from the date of the embryo transfer

Secondary outcome [2]

Positive hCG rate per randomized patient.
Pregnancy will be tested either through a serum hCG measurement carried out from Day 9-13 following embryo transfer or through the use of urinary sticks (25 IU/L) on day 13.

Timepoint [2]

Day 13 following embryo transfer

Secondary outcome [3]

Rate of non-viable intrauterine pregnancies.
The rate of non-viable intrauterine pregnancies will derived by calculating the proportion of the total number of positive hCG pregnancies (by serum testing) which do NOT result in a fetal heart pregnancy by 8 weeks gestation.

Timepoint [3]

8 weeks gestation.

Secondary outcome [4]

Ongoing pregnancy rate in patients with maternal age above 35
All participants will undergo a serum assay of hCG at 10-13 days after the embryo transfer. Where the hCG level demonstrates a pregnancy, an ultrasound scan will be performed by the managing doctor at 42-46 days gestation. Both the hCG level and the ultrasound scan findngs will be recorded in the patient's own electronic medical record. The study nurse will use this data source to enter the outcome data into the electronic CRF
For this endpoint, this figure will be calculated specifically for women with maternal age above 35

Timepoint [4]

8 weeks gestation.

Eligibility

Key inclusion criteria

Inclusion Criteria
1) Women undergoing IVF or ICSI with controlled ovarian stimulation with gonadotrophins and the intention to treat by either transfer of a single fresh embryo on Day 5 or in case of a freeze all cycle, the first rewarmed embryo.
2) Age: Up to and including the 42nd completed birthday on the day of randomization.
3) Has at least two early blastocysts on Day 5

Minimum age

21 Years

Maximum age

41 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

Exclusion Criteria
1) Treatment involving donated eggs
2) Intention to perform any form of preimplantation genetic testing
3) IMSI patients
4) Previous participation in this RCT
5) Where the cycle is carried out for fertility preservation.
6) If a Day 2-4 transfer is planned
7) Has a reduced likelihood of obtaining two early blastocysts on day 5 as evidenced by either:
• An AMH level of <3pmol/L or AFC <5 (if available)

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

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

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Populations

The Intention-to-Treat (ITT) population will consist of all randomized women.
Per protocol (PP) population will consist of all randomized women without significant protocol violations. The ITT population and the PP population will be defined at the clean-file-meeting before the database lock.

Sample Size calculation
It is estimated from the results in clinics that clinical pregnancy is estimated to
be 35.4% for trained embryologists. If non-inferiority margin is defined as - 5%,
the lower limit of the two-sided 95% confidence interval (CI) for the difference
between iDAScore group and Trained embryologist group shall not be less than
-5% with a probability of 90% (ß=10%), with an estimation of 5% or more clinical
pregnancies in iDAScore group, 494 women per randomization group is needed
to show non- inferiority with two-sided Farrington-Manning test. For protection
against a 5% loss to follow-up, 1040 patients in total, 520 per group, are needed
for recruitment

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

3/03/2020

Actual

1/08/2020

Date of last participant enrolment

Anticipated

1/03/2021

Actual

30/09/2022

Date of last data collection

Anticipated

3/05/2021

Actual

30/09/2022

Sample size

Target

1080

Accrual to date

Final

1066

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Recruitment postcode(s) [1]

2145 - Westmead

Recruitment postcode(s) [2]

2065 - Greenwich

Recruitment postcode(s) [3]

2015 - Alexandria

Recruitment postcode(s) [4]

3002 - East Melbourne

Recruitment postcode(s) [5]

4000 - Brisbane

Recruitment outside Australia

Country [1]

Denmark

State/province [1]

Aarhus and Aalborg

Country [2]

Sweden

State/province [2]

Goteborg

Country [3]

United Kingdom

State/province [3]

Nottingham, Oxford, Maidenhead, Southampton

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Vitrolife

Address [1]

Gustaf Werners gata 2, 421 32 Västra Frölunda, Sweden

Country [1]

Sweden

Primary sponsor type

Commercial sector/Industry

Name

Vitrolife

Address

Gustaf Werners gata 2, 421 32 Västra Frölunda, Sweden

Country

Sweden

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

IVFAustralia HREC

Ethics committee address [1]

176 Pacific Highway, Greenwich 2065, NSW

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

30/05/2019

Approval date [1]

21/06/2019

Ethics approval number [1]

Project No. 155

Summary

Brief summary

The project is a randomised controlled trial to evaluate the clinical effects of a deep learning system, (IVY). IVY studies the images of each embryo during culture. Previous work shows that it is a good predictor of which embryo has highest chance of implanting. This project aims to investigate what effects, if any, this has on the success rate from IVF.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Peter Illingworth

Address

IVFAustralia,
176 Pacific Highway,
Greenwich
NSW 2065

Country

Australia

Phone

+61 294251700

Fax

+61288441580

peter.illingworth@ivf.com.au

Contact person for public queries

Name

Peter Illingworth

Address

IVFAustralia
176 Pacific Highway,
Greenwich
NSW 2065

Country

Australia

Phone

+61 294251700

Fax

+61288441580

peter.illingworth@ivf.com.au

Contact person for scientific queries

Name

Peter Illingworth

Address

IVFAustralia
176 Pacific Highway,
Greenwich
NSW 2065

Country

Australia

Phone

+61 294251700

Fax

+61288441580

peter.illingworth@ivf.com.au

Data sharing statement

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

Yes

What data in particular will be shared?

Individual participant data after deidentification

When will data be available (start and end dates)?

Immediately following publication. No end date

Available to whom?

Case by case at the discretion of the sponsor

Available for what types of analyses?

Any purpose

How or where can data be obtained?

Access by contacting principal investigator by email peter.illingworth@ivf.com.au

What supporting documents are/will be available?

Doc. No.	Type	Email	Attachment
6678	Study protocol	peter.illingworth@ivf.com.au	379161-(Uploaded-13-02-2020-10-21-47)-Study-related document.docx
6679	Informed consent form	peter.illingworth@ivf.com.au	379161-(Uploaded-19-02-2020-23-03-43)-Study-related document.docx
6682	Ethical approval	peter.illingworth@ivf.com.au	379161-(Uploaded-13-02-2020-10-31-36)-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.

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