O-123 Time lapse incubation and morphokinetic embryo evaluation are not enough. Results from a Randomized controlled PILOT study

Abstract Study question Does the TLI have an added value in reproductive outcome when separating system’s two components, undisturbed culturing, and morphokinetic embryo grading? Summary answer The system itself does not a significant value. More advanced algorithms should be applied to aid selection process. What is known already technology has been widely used for over decades culturing. A Cochrane meta-analysis found no difference clinical pregnancy rate using compared conventional incubators. Another RCT concluded that addition of data did significantly improve outcomes. On other hand, benefit identification abnormal cleavage dynamics analysis parameters although proven increase was shown. Several Artificial intelligence use design, size, duration prospective, randomized, double-blinded, single-center, controlled study. After applying inclusion criteria, 102 women were included analysis, 34, 32, 36 arms 1,2, 3 respectively, with total 1061 embryos evaluated, 420 arm 1, 285 2, 356 3. Patients recruited between November 2017- July 2020. Participants/materials, setting, methods University-affiliated Medical Centre vitro fertilization (IVF) clinic. randomized into groups: 1) incubator morphological evaluation only; 2) both evaluation; 3) incubation only. All cultured MIRI ESCO primary live birth rates. Secondary outcomes rates cumulative Embryo quality scores. Main results role chance No differences rated day 2 top (TQE), TQE or blastocyst stage TQE, similar number suitable either transfer cryopreservation groups. higher multinucleation group 1 (31.9±6 vs. 16.6±5 vs.14.9±5, p = 0.03 groups 1,2 respectively). Regarding outcome, we find any groups, neither single cycles (SET) (35% 31.6% 24%, 0.708) nor double (DET) (41.7% 38.5% 36.4%, 0.966 Also, noted concluding first part study, retrospectively reevaluated, gaining additional In more than half selected transfer, morphologic evaluations similar. For 32 from 12 cycles, there discrepancy grades. cases, scoring would changed end point pregnancy. Limitations, reasons caution pandemic affected patient recruitment smaller numbers intended achieved leaving study sample underpowered endpoint. Both 5 transfers performed, always restricted designed as such. Wider implications findings This underlines maybe unjustified morphkinetic grading which requires much time attention embryologist view annotate reconsidered especially rise substitute software-assisted assessment showing advantage implantation rate. Trial registration ClinicalTrials.gov Identifier: NCT02657811.