IVFNCT04956848
Comparing KIDScore™ D5 and iDAScore®. The KiDA Study
A study testing iDAScore® in people with IVF and Infertility, run by Vitrolife at 2 sites in Sweden.
Trial summary
A pilot study to gather information on clinical pregnancy rates for preparation of the planning of a larger randomized controlled trial comparing two decision support tools: the deep learning tool iDAScore® and the current annotation model, KIDScore™ D5. 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
- 165 participants
- Where
- 2 sitesSweden
- Study dates
- 6 Oct 2021to 14 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patients undergoing IVF/ICSI-treatment with controlled ovarian stimulation with gonadotrophins and the intention to treat by transfer of a single day 5 fresh blastocyst on day 5.
- At least two good quality blastocysts (GQB) on day 5 (3BB or better on the Gardner scale), originating from normally fertilized oocytes (2PN).
Who cannot join
- Previous participation in this RCT
- Concurrent participation in another investigation
- Intention to perform any form of preimplantation genetic testing
- Fertility preservation
- Planned transfer on day 2-4
- Female age >42 years
- A reduced likelihood of obtaining two good quality blastocysts on day 5 as evidenced by an AFC <5 (if available, AFC=antral follicle count)
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Göteborgs IVF klinik
Gothenburg, 412 50
Fertilitetsenheten, Universitetssjukhuset Örebro
Örebro, 703 62
About this study
Official title: A Comparison of Two Models Used for Identifying Embryos With the Best Chance of Inducing Pregnancy: A Pilot Study
A pilot study to gather information on clinical pregnancy rates for preparation of the planning of a larger randomized controlled trial comparing two decision support tools: the deep learning tool iDAScore® and the current annotation model, KIDScore™ D5.
- Conditions
- IVF, Infertility
- Being tested
- iDAScore®
- Keywords
- Embryos, 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
Images of all the embryos reaching at least developmental stage of 3BB will be analyzed by iDAScore®. The embryo with the highest iDAScore® will be proposed for transfer.
| Study group | Role | What they receive |
|---|---|---|
| Embryo selection supported by KIDScore™ D5 | No intervention | Each embryo reaching at least developmental stage of 3BB will annotated by an embryologist using the parameters required by the KIDScore™ D5. The embryo with the highest KIDScore™ will be selected proposed for transfer. |
| Embryo selection supported by iDAScore® | Experimental | Images of all the embryos reaching at least developmental stage of 3BB will be analyzed by iDAScore®. The embryo with the highest iDAScore® will be proposed selected for transfer. 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 6 weeks of gestation
Secondary outcomes (3)
Positive hCG rate per randomized patient
An hCG measurement using urinary sticks with a sensitivity of 25 IU/L
Measured: From day 13 following embryo transfer
Rate of non-viable intrauterine pregnancies per randomized patient
Ultrasound evidence of an intrauterine pregnancy but with no fetal heart observed
Measured: After 6 weeks of gestation
Clinical pregnancy rate in patients with maternal age above 35
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
Measured: After 6 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 posted9 Jul 2021
- Study start6 Oct 2021
- Primary completion14 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- A pilot study randomizing embryos into two study groups comparing two decision support tools in the ranking of embryos for transfer.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vitrolife
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johanna Schmidt, MD, Principal investigator, Göteborgs IVF klinik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04956848
- Sponsor's protocol ID
- 1571 - KiDA
- Status last verified
- Mar 2024
- First submitted
- 30 Jun 2021
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Models Used for Identifying Embryos With the Best Chance of Inducing Pregnancy: A Pilot Study
- ClinicalTrials.gov ID
- NCT04956848
- Acronym / sponsor ID
- 1571 - KiDA
- Conditions
- IVF, Infertility
- Keywords
- Embryos, Embryo scoring, Blastocyst selection, Pregnancy rate, Live birth rate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- VitrolifeIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2021 (actual)
- Primary completion
- 14 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 9 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A pilot study to gather information on clinical pregnancy rates for preparation of the planning of a larger randomized controlled trial comparing two decision support tools: the deep learning tool iDAScore® and the current annotation model, KIDScore™ D5.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A pilot study randomizing embryos into two study groups comparing two decision support tools in the ranking of embryos for transfer.
| Arm | Type | Receives |
|---|---|---|
| Embryo selection supported by KIDScore™ D5 | No intervention | –Each embryo reaching at least developmental stage of 3BB will annotated by an embryologist using the parameters required by the KIDScore™ D5. The embryo with the highest KIDScore™ will be selected proposed for transfer. |
| Embryo selection supported by iDAScore® | Experimental | Device: iDAScore®Images of all the embryos reaching at least developmental stage of 3BB will be analyzed by iDAScore®. The embryo with the highest iDAScore® will be proposed selected for transfer. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing IVF/ICSI-treatment with controlled ovarian stimulation with gonadotrophins and the intention to treat by transfer of a single day 5 fresh blastocyst on day 5.
- At least two good quality blastocysts (GQB) on day 5 (3BB or better on the Gardner scale), originating from normally fertilized oocytes (2PN).
Key exclusion criteria (7 listed)
- Previous participation in this RCT
- Concurrent participation in another investigation
- Intention to perform any form of preimplantation genetic testing
- Fertility preservation
- Planned transfer on day 2-4
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®Images of all the embryos reaching at least developmental stage of 3BB will be analyzed by iDAScore®. The embryo with the highest iDAScore® will be proposed for transfer. | Device | Embryo selection supported by iDAScore® |
Primary outcome
Clinical pregnancy rate
Time frame: After 6 weeks of gestation
Ultrasound evidence of an intrauterine pregnancy with a fetal heart observed
3 secondary outcomes
Positive hCG rate per randomized patient
Time frame: From day 13 following embryo transfer
Rate of non-viable intrauterine pregnancies per randomized patient
Time frame: After 6 weeks of gestation
Clinical pregnancy rate in patients with maternal age above 35
Time frame: After 6 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for IVF
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
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
Infertility (IVF Patients), Infertility Assisted Reproductive Technology
Active, not recruitingPhase 4
GnRH for Luteal Support in IVF/ICSI/FET Cycles
Infertility
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.
Johanna Schmidt, MD principal investigator
Göteborgs IVF klinik
2 sites in 1 country: 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 2 sites in Sweden.
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 2 inclusion and 7 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 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 6 weeks of gestation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Mar 2024.