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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04969822




Registration number
NCT04969822
Ethics application status
Date submitted
30/06/2021
Date registered
21/07/2021
Date last updated
12/06/2023

Titles & IDs
Public title
eValuating iDA Selection Ability. The VISA Study.
Scientific title
Will Embryo Selection Through Use of Artificial Intelligence (iDA) Perform Equally Compared to Day 5 Morphology?
Secondary ID [1] 0 0
1571 - VISA
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
IVF 0 0
Infertility 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - iDAScore®

No Intervention: Embryo selection by standard morphologic criteria - The embryo for transfer will be selected by the embryologist on the basis of the morphologic appearances on day 5, according to the Gardner criteria using the ranking guideline.

Experimental: Embryo selection by iDA - Time-lapse videos will be analyzed by iDA and the embryo for fresh transfer on day 5 will be prioritized on the strict basis of the embryo with the highest iDA score. For a frozen cycle; the first embryo to be warmed will be the one with the highest iDA score.


Treatment: Devices: iDAScore®
A system that studies time lapse images obtained from the embryo culture system, Embryoscope, throughout the development to blastocyst. The system uses data acquired from a sequence of embryo images and has taught itself to identify the embryos with the highest likelihood of implanting and leading to fetal heart-beat detection.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Clinical pregnancy rate
Timepoint [1] 0 0
After 7-9 weeks of gestation
Secondary outcome [1] 0 0
Live birth rate
Timepoint [1] 0 0
9 months
Secondary outcome [2] 0 0
Positive hCG rate per randomized patient
Timepoint [2] 0 0
Tested on day 9-13 following embryo transfer
Secondary outcome [3] 0 0
Rate of non-viable pregnancies
Timepoint [3] 0 0
After 7-9 weeks of gestation
Secondary outcome [4] 0 0
Ongoing pregnancy rate
Timepoint [4] 0 0
After 7-9 weeks of gestation

Eligibility
Key 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
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Treatment involving donated eggs

2. Intention to perform any form of preimplantation genetic testing

3. The use of IMSI or polarized light in the ICSI process

4. The use of assisted hatching prior to randomization

5. Previous participation in this RCT

6. Where the cycle is carried out for fertility preservation

7. If a day 2-4 transfer is planned

8. 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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
20/02/2020
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2023
Actual
Sample size
Target
1040
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
GreenwichNSW,QLD,VIC
Recruitment hospital [1] 0 0
IVFAustralia Greenwich - Sydney
Recruitment hospital [2] 0 0
IVFAustralia Alexandria - Alexandria
Recruitment hospital [3] 0 0
IVFAustralia, Westmead - Sydney
Recruitment hospital [4] 0 0
Queensland Fertility Group (QFG) - Benowa
Recruitment hospital [5] 0 0
Melbourne IVF - East Melbourne
Recruitment postcode(s) [1] 0 0
2065 - Sydney
Recruitment postcode(s) [2] 0 0
2015 - Alexandria
Recruitment postcode(s) [3] 0 0
2145 - Sydney
Recruitment postcode(s) [4] 0 0
4217 - Benowa
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
Denmark
State/province [1] 0 0
Aalborg
Country [2] 0 0
Denmark
State/province [2] 0 0
Aarhus
Country [3] 0 0
Denmark
State/province [3] 0 0
Horsens
Country [4] 0 0
Sweden
State/province [4] 0 0
Gothenburg
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Maidenhead
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Nottingham
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Oxford
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Vitrolife
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
A non-inferiority, prospective parallel group, multi-center, randomized controlled trial to
investigate whether selection of a single blastocyst for transfer using the deep learning
tool, iDA, results in non-inferior clinical pregnancy rate compared to trained embryologists
using standard morphology criteria.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04969822
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Peter Illingworth, A/Prof
Address 0 0
Virtus Health, Sydney, Australia
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04969822