Pregnancy
Conditions
Keywords
iDA, AI, embryo ranking, transfer-to-pregnancy, time-lapse
Brief 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. 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.
Interventions
DEVICEAI algorithm
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).
Sponsors
Universitair Ziekenhuis Brussel
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Randomisation (1:1) based on a computer-generated randomisation list with block size 10.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Transfer to pregnancy | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| iDA-embryologist consensus | Embryo ranking is done on day 5 and/or 6 of embryo development and can be immediately compared during ranking. | In how many cases do iDA and the embryologist prioritize the same embryo for the first embryo transfer? |
| Embryo prioritization time | 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. | How long does it take to establish a ranking of all embryos from that cohort? |
| Cumulative clinical pregnancy rate | Up until 1 year after oocyte retrieval | 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 |
| Clinical pregnancy rate after the first embryo transfer | Clinical pregnancy is determined at the 7 week echo by detection of a fetal heart beat. | Number of clinical pregnancies divided by number of embryo transfers performed |
Countries
Belgium
Contacts
Primary ContactElsie Nulens
Backup ContactTine Bosman, Msc
Outcome results
None listed