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.
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.
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
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
Denmark3 sites
Universitetshospitalet
Aalborg, 9000
Aagaard Fertilitetsklinik
Aarhus, 8200
Regionshospitalet
Horsens, 8700
Sweden2 sites
Livio Gothenburg
Gothenburg, 412 55
Reproductive medicine, Sahlgrenska University Hospital
Gothenburg, 413 46
About this study
Official title: Will Embryo Selection Through Use of Artificial Intelligence (iDA) Perform Equally Compared to Day 5 Morphology?
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- Vitrolife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Illingworth, A/Prof, Principal investigator, Virtus Health, Sydney, Australia
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
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.
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.
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
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
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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.