Abstract

Abstract Study question Is the intelligent Data Analysis Score (iDAScore) reliable in predicting a positive pregnancy test, clinical pregnancy and miscarriage rate after single vitrified-warmed blastocyst transfer (SVBT)? Summary answer There is a significant increase in positive pregnancy test and clinical pregnancy rates as iDAScore increases. The miscarriage rate is lower with increased iDAScore. What is known already With the improvement of assisted reproductive technology (ART), elective single embryo transfer has become a standard. Optimizing embryo selection is a major challenge to increase reproductive outcomes. The Gardner embryo grading system is widely adopted for the evaluation of blastocyst quality, but this tool is subject to inter- and intra-variability. In recent years, artificial intelligence has found diverse applications in healthcare. Based on time-laps sequences of > 180’000 developing embryos, iDAScore is a new deep-learning model for objective and standardized blastocyst scoring. However, its reliability in predicting pregnancy and miscarriage rates remains unknown. Study design, size, duration This monocentric retrospective pilot study was conducted from May 2023 to December 2023. A total of 206 homologous SVBT cycles from 206 patients were analyzed (one patient, one cycle). Exclusion criteria included: cycles involving preimplantation genetic testing, multiple and/or fresh blastocyst transfer, and blastocysts obtained after testicular sperm extraction. All vitrified-warmed blastocysts were scored using iDAScore version 1.0 model, ranging from 1 – 9.9. Participants/materials, setting, methods Scores were stratified into 3 groups: high-score (9.9 – 7.7), medium-score (7.6 – 5.5) and low-score (5.4 – 3.1). For each group, positive pregnancy test, clinical pregnancy and miscarriage rates were analyzed. SVBT cycles were then stratified into four maternal age groups (< 35, 35-37, 38-40, >41 years) and the same outcomes were analyzed. χ2 was used for statistics analysis. Main results and the role of chance Mean maternal age was 36.8 ± 4.9. Among the 206 vitrified-warmed blastocysts, 122 were scored as high-score, 57 as medium-score and 27 as low-score. Positive pregnancy test rate was significantly higher with increased iDAScore with 58% in the high-score group, 36.8% in the medium-score group and 17% in the low-score group (p < 0.0001). Clinical pregnancy rate, defined as the visualization of a fetal heartbeat at ultrasound scan, was also significantly higher with increased iDAScore, with 51.6% in the high-score group, 31.6% in the medium-score group and 17% in the low-score group (p < 0.0001). The miscarriage rate was lower with increased iDAScore, with 8.1% in the high-score group, 16.6% in the medium-score group and 50% in the low-score group, but this difference was not statistically significative (p 0.032). When adjusted to age group however, the miscarriage rate was found to be significantly lower in the high-score group when compared to the medium-score group (p < 0.0001); statistical analysis was not achieved in the low-score group due to the small sample size. Limitations, reasons for caution The major limitation of our study is its small sample size. Data collection is ongoing, to increase the study power. Additionally, many other factors, such as genetic, hormonal, metabolic and/or immunological, may play a role in achieving pregnancy. Wider implications of the findings Our results indicate that iDAScore may be a strong predictor of pregnancy and could be used as a complementary tool to the Gardner embryo grading system in the decision-making process of which blastocyst to transfer. Trial registration number N/A

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