IVFNCT04969822

eValuating iDA Selection Ability. The VISA Study.

A study testing iDAScore® in people with IVF and Infertility, run by Vitrolife at 14 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Any age
Conditions the study is for: IVF, Infertility
What is being tested?: iDAScore®
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,066 participants
Where: 14 sitesin 4 countries
Study dates: 20 Feb 2020to 1 Nov 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.
Age: Up to and including the 42nd completed birthday on the day of randomization.
Has at least two early blastocysts on day 5.

Who cannot join

Treatment involving donated eggs
Intention to perform any form of preimplantation genetic testing
The use of IMSI or polarized light in the ICSI process
The use of assisted hatching prior to randomization
Previous participation in this RCT
Where the cycle is carried out for fertility preservation
If a day 2-4 transfer is planned
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)

Trial locations and contacts

14 sites in 4 countries.

Country

City, postcode or hospital

14 sites in 4 countries

Australia5 sites

IVFAustralia Alexandria
Alexandria, New South Wales, 2015
Queensland Fertility Group (QFG)
Benowa, Queensland, 4217
Melbourne IVF
East Melbourne, Victoria, 3002
IVFAustralia Greenwich
Sydney, Greenwich, 2065
IVFAustralia, Westmead
Sydney, New South Wales, 2145

Other trials in Australia

United Kingdom4 sites

Thames Valley Fertility (TFP)
Maidenhead, SL6 4BY
Nurture Fertility (TFP)
Nottingham, NG10 5QG
Oxford Fertility (TFP)
Oxford, OX4 2HW
Wessex Fertility (TFP)
Southampton, SO15 5QS

Other trials in United Kingdom

Denmark3 sites

Universitetshospitalet
Aalborg, 9000
Aagaard Fertilitetsklinik
Aarhus, 8200
Regionshospitalet
Horsens, 8700

Other trials in Denmark

Sweden2 sites

Livio Gothenburg
Gothenburg, 412 55
Reproductive medicine, Sahlgrenska University Hospital
Gothenburg, 413 46

Other trials in Sweden

About this study

Official title: Will Embryo Selection Through Use of Artificial Intelligence (iDA) Perform Equally Compared to Day 5 Morphology?

Conditions: IVF, Infertility
Being tested: iDAScore®
Keywords: Embryo, Embryo scoring, Blastocyst selection, Pregnancy rate, Live birth rate
Medical subject headings: Infertility

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

iDAScore®Device
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.

Study groups in NCT04969822
Study group	Role	What they receive
Embryo selection by standard morphologic criteria	No intervention	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.
Embryo selection by iDA	Experimental	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. Receives: Device: iDAScore®

What is being measured

The primary outcome is the main question the study is designed to answer.

Clinical Pregnancy Rate
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
Measured: After 7-9 weeks of gestation

Secondary outcomes (4)

Live Birth Rate
Defined as the number of patients with at least one live birth after 22 completed weeks of gestation. If the exact gestational age is not known then a birth weight of ≥500gr can be used as a cut-off
Measured: 9 months
Positive hCG Rate Per Randomized Patient
Defined as the number of patients with a positive β-hCG, determined by a hCG measurement from a blood sample or using urinary sticks
Measured: Tested on day 9-13 following embryo transfer
Rate of Non-viable Pregnancies
Defined as the difference between number of clinical pregnancies (excluding ectopic pregnancies) and number of positive β-hCG pregnancies
Measured: After 7-9 weeks of gestation
Ongoing Pregnancy Rate
Defined as the number of patients with a viable pregnancy at ≥12 weeks of gestation
Measured: After 7-9 weeks of gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Feb 20201 Nov 2023

First posted21 Jul 2021
Study start20 Feb 2020
Primary completion24 Jan 2023
Study completion1 Nov 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for IVFStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,066 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04969822
Sponsor's protocol ID: 1571 - VISA
Status last verified: Nov 2024
First submitted: 30 Jun 2021
Last updated: 2 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Illingworth PJ, Venetis C, Gardner DK, Nelson SM, Berntsen J, Larman MG, Agresta F, Ahitan S, Ahlstrom A, Cattrall F, Cooke S, Demmers K, Gabrielsen A, Hindkjaer J, Kelley RL, Knight C, Lee L, Lahoud R, Mangat M, Park H, Price A, Trew G, Troest B, Vincent A, Wennerstrom S, Zujovic L, Hardarson T. Deep learning versus manual morphology-based embryo selection in IVF: a randomized, double-blind noninferiority trial. Nat Med. 2024 Nov;30(11):3114-3120. doi: 10.1038/s41591-024-03166-5. Epub 2024 Aug 9.
PubMed 39122964

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All IVF trials

Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Will Embryo Selection Through Use of Artificial Intelligence (iDA) Perform Equally Compared to Day 5 Morphology?
ClinicalTrials.gov ID: NCT04969822
Acronym / sponsor ID: 1571 - VISA
Conditions: IVF, Infertility
Keywords: Embryo, Embryo scoring, Blastocyst selection, Pregnancy rate, Live birth rate
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,066 participants (actual)
Lead sponsor: VitrolifeIndustry (pharma, biotech, devices)
Study start: 20 Feb 2020 (actual)
Primary completion: 24 Jan 2023 (actual)
Study completion: 1 Nov 2023 (actual)
First posted: 21 Jul 2021 (actual)
Results: Posted 2 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Embryo selection by standard morphologic criteria	No intervention	–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.
Embryo selection by iDA	Experimental	Device: iDAScore®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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

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.
Age: Up to and including the 42nd completed birthday on the day of randomization.
Has at least two early blastocysts on day 5.

Key exclusion criteria (8 listed)

Treatment involving donated eggs
Intention to perform any form of preimplantation genetic testing
The use of IMSI or polarized light in the ICSI process
The use of assisted hatching prior to randomization
Previous participation in this RCT

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Device	Embryo selection by iDA

Primary outcome

Clinical Pregnancy Rate
Time frame: After 7-9 weeks of gestation
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed

4 secondary outcomes

Live Birth Rate
Time frame: 9 months
Positive hCG Rate Per Randomized Patient
Time frame: Tested on day 9-13 following embryo transfer
Rate of Non-viable Pregnancies
Time frame: After 7-9 weeks of gestation
Ongoing Pregnancy Rate
Time frame: After 7-9 weeks of gestation

Results and safety

Results posted to the registry on 2 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Embryo Selection by Standard Morphologic Criteria	533	533
Embryo Selection by iDA	533	533

Primary outcome: Clinical Pregnancy Rate

Time frame: After 7-9 weeks of gestation. Count of participants. Unit: Participants

Measure	Embryo Selection by Standard Morphologic Criteria n = 533	Embryo Selection by iDA n = 533
Value	257	248

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were recorded up to the date of live birth, i.e. 9 months after embryo transfer.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Embryo Selection by Standard Morphologic Criteria	0 of 533 (0%)	0 of 533 (0%)	0 of 533
Embryo Selection by iDA	0 of 533 (0%)	0 of 533 (0%)	0 of 533

Limitations and caveats (from the sponsor): The time-to-pregnancy and cumulative live birth rates were not assessed, as only the first embryo was prioritized for transfer.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 39122964Illingworth PJ, Venetis C, Gardner DK, Nelson SM, Berntsen J, Larman MG, Agresta F, Ahitan S, Ahlstrom A, Cattrall F, Cooke S, Demmers K, Gabrielsen A, Hindkjaer J, Kelley RL, Knight C, Lee L, Lahoud R, Mangat M, Park H, Price A, Trew G, Troest B, Vincent A, Wennerstrom S, Zujovic L, Hardarson T. Deep learning versus manual morphology-based embryo selection in IVF: a randomized, double-blind noninferiority trial. Nat Med. 2024 Nov;30(11):3114-3120. doi: 10.1038/s41591-024-03166-5. Epub 2024 Aug 9.
Individual participant dataSharing planned: No

Related trials for IVF

Not yet recruitingObservational study
Music Therapy and Sedation for Pain and Anxiety During Oocyte Retrieval
ANXIETY
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Recruiting
225 IU Versus 300 IU Starting FSH Dose in PPOS for Good-Prognosis Women
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Active, not recruitingPhase 4
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Not yet recruitingObservational study
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Infertility, Female, Pregnancy Related

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Peter Illingworth, A/Prof principal investigator

Virtus Health, Sydney, Australia

14 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing iDAScore® in people with IVF and Infertility, run by Vitrolife at 14 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Australia, United Kingdom, Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Clinical Pregnancy Rate (time frame: After 7-9 weeks of gestation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04969822, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.