PregnancyPRIDENCT07187934
EVALUATION OF A FULLY AUTOMATED AI TOOL FOR EMBRYO RANKING
A study testing AI algorithm in people with Pregnancy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
This study aims to investigate whether embryo ranking by a fully automated AI tool (iDAScore) results in a similar transfer-to-pregnancy compared to manual embryo ranking by an embryologist. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy
- What is being tested?
- AI algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,325 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Dec 2025to 1 Oct 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients undergoing an ICSI/IVF treatment (with donor or own oocytes) that are planned for a 'freeze-all' strategy on day 5
- all types of sperm samples (ejaculated or testicular, fresh or frozen, partner or donor origin)
- Minimum 8 follicles (≥ 12 mm) on last follicular measurement before oocyte retrieval
- 18 ≤ Age ≤ 42 years
- 18 ≤ BMI ≤ 35 kg/m²
- Maximum third IVF/ICSI cycle
- Participants can be included only once in the trial
Who cannot join
- Embassy patients
- Use of frozen oocytes
- In vitro maturation (IVM) cycles
- Pre-implantation genetic Testing (PGT) cycles
- Proven untreated intra-uterine pathologies (e.g. Asherman syndrome, adenomysosis)
- Endometriosis stage 3/4
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Brussels IVF, UZ Brussel
Brussels, Brussels Capital, 1090
Elsie Nulens, MSc, +32 2 477 66 48, Elsie.Nulens@uzbrussel.be
Tine Bosman, MSc, +32 2 477 40 49, tine.bosman@uzbrussel.be
About this study
Official title: PROSPECTIVE EVALUATION OF THE IDASCORE ALGORITHM FOR EMBRYO RANKING
This study aims to investigate whether embryo ranking by a fully automated AI tool (iDAScore) results in a similar transfer-to-pregnancy compared to manual embryo ranking by an embryologist. IVF patients who are planned for a freeze-all approach (where all usable embryos are frozen and transferred in later transfer cycles) will be allocated to either the control (ranking by embryologist) or intervention arm (ranking by iDAScore). The frozen embryos will be warmed and transferred one by one, according to their assigned rank. We want to see if the average number of embryo transfers that is needed to achieve a clinical pregnancy (transfer-to-pregnancy) is similar in both groups.
Read the detailed description
The study population consists of IVF/ICSI patients scheduled for a freeze-all policy on day 5. Inclusion takes place on the day prior to oocyte retrieval, based on predefined inclusion criteria. Embryo culture is performed in an EmbryoScope+ time-lapse incubator. On day 5 of embryo development, the embryologist evaluates the embryos using the Gardner criteria, assessing expansion stage, inner cell mass (ICM), and trophectoderm (TE). All embryos meeting our in-house cryopreservation criteria are vitrified. Embryos not yet meeting the criteria remain in culture and are re-evaluated on day 6. Once at least two blastocysts meet the cryopreservation criteria on day 5 and/or day 6, the patient is randomized in the control or study arm.
In the control group, the embryologist manually ranks all freezable embryos according to the assigned Gardner scores, applying a standard prioritization scheme: day of cryopreservation > expansion stage > TE score > ICM score.
If multiple embryos share the same Gardner score, the embryologist looks at the full morphokinetics to establish a final ranking. The order of warming for subsequent frozen embryo transfer (FET) cycles follows this ranking: the embryo ranked 1 is transferred first. If no clinical pregnancy results, the embryo ranked 2 is transferred in the next FET cycle, and so on.
In the study group, the iDA score is retrieved for each freezable embryo. Embryos are ranked solely based on their iDA score, with the highest score assigned rank 1, and so on. The order of warming for subsequent FET cycles is determined exclusively by this ranking. As in the embryologist group, the embryo ranked 1 is transferred first, followed by rank 2 in case of no clinical pregnancy, and so on.
+/- 10 days after embryo transfer, an hCG blood test is performed. In case of a positive result, the pregnancy is monitored until the 7-week ultrasound, at which the presence of fetal heartbeat confirms a clinical pregnancy. Patients are followed for clinical pregnancy outcomes of FETs performed up to one year after oocyte retrieval, or until the pregnancy outcome of the last available embryo is known.
In both the study and control arm, all procedures follow the standard of care. The only difference between the groups is the method of embryo ranking-and therefore the order in which embryos will be transferred.
- Conditions
- Pregnancy
- Being tested
- AI algorithm
- Keywords
- iDA, AI, embryo ranking, transfer-to-pregnancy, time-lapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI algorithmDevice
Also called iDAScore
iDAScore® is a deep learning-based tool that provides fully automated analysis of embryo time-lapse images. It automatically generates a score (1-9.9) for each embryo in the patient's embryo cohort, which correlates to the likelihood of achieving a fetal heartbeat (clinical pregnancy).
| Study group | Role | What they receive |
|---|---|---|
| Embryologist ranking | No intervention | Embryologist ranks the embryos according to their appearance |
| iDA ranking | Experimental | AI tool ranks embryos based on fully automated analysis of time-lapse images Receives: Device: AI algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transfer to pregnancy
Number of embryo transfers performed until a clinical pregnancy is obtained
Measured: The patient is followed up for clinical pregnancy outcomes (7-week echo) up until 1 year after the oocyte retrieval date, or until the result of the last available embryo is known.
Secondary outcomes (4)
iDA-embryologist consensus
In how many cases do iDA and the embryologist prioritize the same embryo for the first embryo transfer?
Measured: Embryo ranking is done on day 5 and/or 6 of embryo development and can be immediately compared during ranking.
Embryo prioritization time
How long does it take to establish a ranking of all embryos from that cohort?
Measured: Measures the time elapsing between the start and end of embryo prioritisation (range of minutes). Is recorded on day 5 and day 6 of embryo development right after embryo evaluation.
Cumulative clinical pregnancy rate
Number of oocyte retrievals resulting in at least one clinical pregnancy within 1 year of the oocyte retrieval divided by total number of oocyte retrievals
Measured: Up until 1 year after oocyte retrieval
Clinical pregnancy rate after the first embryo transfer
Number of clinical pregnancies divided by number of embryo transfers performed
Measured: Clinical pregnancy is determined at the 7 week echo by detection of a fetal heart beat.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2025
- Study start11 Dec 2025
- Primary completion11 Dec 2028 (estimated)
- Study completion1 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomisation (1:1) based on a computer-generated randomisation list with block size 10.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 1,325 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julie Praet, M.D., Principal investigator, Brussels IVF, UZ Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187934
- Sponsor's protocol ID
- PRIDE_2025
- Acronym
- PRIDE
- Status last verified
- Dec 2025
- First submitted
- 4 Sep 2025
- Last updated
- 23 Dec 2025
- 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 23 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROSPECTIVE EVALUATION OF THE IDASCORE ALGORITHM FOR EMBRYO RANKING
- ClinicalTrials.gov ID
- NCT07187934
- Acronym / sponsor ID
- PRIDE / PRIDE_2025
- Conditions
- Pregnancy
- Keywords
- iDA, AI, embryo ranking, transfer-to-pregnancy, time-lapse
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,325 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- 11 Dec 2025 (actual)
- Primary completion
- 11 Dec 2028 (estimated)
- Study completion
- 1 Oct 2029 (estimated)
- First posted
- 23 Sep 2025 (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.
This study aims to investigate whether embryo ranking by a fully automated AI tool (iDAScore) results in a similar transfer-to-pregnancy compared to manual embryo ranking by an embryologist. IVF patients who are planned for a freeze-all approach (where all usable embryos are frozen and transferred in later transfer cycles) will be allocated to either the control (ranking by embryologist) or intervention arm (ranking by iDAScore). The frozen embryos will be warmed and transferred one by one, according to their assigned rank. We want to see if the average number of embryo transfers that is needed to achieve a clinical pregnancy (transfer-to-pregnancy) is similar in both groups.
Detailed description
The study population consists of IVF/ICSI patients scheduled for a freeze-all policy on day 5. Inclusion takes place on the day prior to oocyte retrieval, based on predefined inclusion criteria. Embryo culture is performed in an EmbryoScope+ time-lapse incubator. On day 5 of embryo development, the embryologist evaluates the embryos using the Gardner criteria, assessing expansion stage, inner cell mass (ICM), and trophectoderm (TE). All embryos meeting our in-house cryopreservation criteria are vitrified. Embryos not yet meeting the criteria remain in culture and are re-evaluated on day 6. Once at least two blastocysts meet the cryopreservation criteria on day 5 and/or day 6, the patient is randomized in the control or study arm.
In the control group, the embryologist manually ranks all freezable embryos according to the assigned Gardner scores, applying a standard prioritization scheme: day of cryopreservation > expansion stage > TE score > ICM score.
If multiple embryos share the same Gardner score, the embryologist looks at the full morphokinetics to establish a final ranking. The order of warming for subsequent frozen embryo transfer (FET) cycles follows this ranking: the embryo ranked 1 is transferred first. If no clinical pregnancy results, the embryo ranked 2 is transferred in the next FET cycle, and so on.
In the study group, the iDA score is retrieved for each freezable embryo. Embryos are ranked solely based on their iDA score, with the highest score assigned rank 1, and so on. The order of warming for subsequent FET cycles is determined exclusively by this ranking. As in the embryologist group, the embryo ranked 1 is transferred first, followed by rank 2 in case of no clinical pregnancy, and so on.
+/- 10 days after embryo transfer, an hCG blood test is performed. In case of a positive result, the pregnancy is monitored until the 7-week ultrasound, at which the presence of fetal heartbeat confirms a clinical pregnancy. Patients are followed for clinical pregnancy outcomes of FETs performed up to one year after oocyte retrieval, or until the pregnancy outcome of the last available embryo is known.
In both the study and control arm, all procedures follow the standard of care. The only difference between the groups is the method of embryo ranking-and therefore the order in which embryos will be transferred.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Randomisation (1:1) based on a computer-generated randomisation list with block size 10.
| Arm | Type | Receives |
|---|---|---|
| Embryologist ranking | No intervention | –Embryologist ranks the embryos according to their appearance |
| iDA ranking | Experimental | Device: AI algorithmAI tool ranks embryos based on fully automated analysis of time-lapse images |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- patients undergoing an ICSI/IVF treatment (with donor or own oocytes) that are planned for a 'freeze-all' strategy on day 5
- all types of sperm samples (ejaculated or testicular, fresh or frozen, partner or donor origin)
- Minimum 8 follicles (≥ 12 mm) on last follicular measurement before oocyte retrieval
- 18 ≤ Age ≤ 42 years
- 18 ≤ BMI ≤ 35 kg/m²
Key exclusion criteria (6 listed)
- Embassy patients
- Use of frozen oocytes
- In vitro maturation (IVM) cycles
- Pre-implantation genetic Testing (PGT) cycles
- Proven untreated intra-uterine pathologies (e.g. Asherman syndrome, adenomysosis)
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 |
|---|---|---|
| AI algorithmAlso: iDAScoreiDAScore® is a deep learning-based tool that provides fully automated analysis of embryo time-lapse images. It automatically generates a score (1-9.9) for each embryo in the patient's embryo cohort, which correlates to the likelihood of achieving a fetal heartbeat (clinical pregnancy). | Device | iDA ranking |
Primary outcome
Transfer to pregnancy
Time frame: The patient is followed up for clinical pregnancy outcomes (7-week echo) up until 1 year after the oocyte retrieval date, or until the result of the last available embryo is known.
Number of embryo transfers performed until a clinical pregnancy is obtained
4 secondary outcomes
iDA-embryologist consensus
Time frame: Embryo ranking is done on day 5 and/or 6 of embryo development and can be immediately compared during ranking.
Embryo prioritization time
Time frame: Measures the time elapsing between the start and end of embryo prioritisation (range of minutes). Is recorded on day 5 and day 6 of embryo development right after embryo evaluation.
Cumulative clinical pregnancy rate
Time frame: Up until 1 year after oocyte retrieval
Clinical pregnancy rate after the first embryo transfer
Time frame: Clinical pregnancy is determined at the 7 week echo by detection of a fetal heart beat.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2025.
- iDAScore webpageLink provided by the sponsor.
- 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.
Julie Praet, M.D. principal investigator
Brussels IVF, UZ Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI algorithm in people with Pregnancy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 23 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elsie Nulens (+32 2 477 66 48, elsie.nulens@uzbrussel.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transfer to pregnancy (time frame: The patient is followed up for clinical pregnancy outcomes (7-week echo) up until 1 year after the oocyte retrieval date, or until the result of the last available embryo is known.). 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 23 Dec 2025.