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      Evaluation of the Clinical Efficacy and Trust in AI-Assisted Embryo Ranking: Survey-Based Prospective Study

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          Abstract

          Background

          Current embryo assessment methods for in vitro fertilization depend on subjective morphological assessments. Recently, artificial intelligence (AI) has emerged as a promising tool for embryo assessment; however, its clinical efficacy and trustworthiness remain unproven. Simulation studies may provide additional evidence, provided that they are meticulously designed to mitigate bias and variance.

          Objective

          The primary objective of this study was to evaluate the benefits of an AI model for predicting clinical pregnancy through well-designed simulations. The secondary objective was to identify the characteristics of and potential bias in the subgroups of embryologists with varying degrees of experience.

          Methods

          This simulation study involved a questionnaire-based survey conducted on 61 embryologists with varying levels of experience from 12 in vitro fertilization clinics. The survey was conducted via Google Forms (Google Inc) in three phases: (1) phase 1, an initial assessment (December 23, 2022, to January 22, 2023); (2) phase 2, a validation assessment (March 6, 2023, to April 5, 2023); and (3) phase 3 an AI-guided assessment (March 6, 2023, to April 5, 2023). Inter- and intraobserver assessments and the accuracy of embryo selection from 360 day-5 embryos before and after AI guidance were analyzed for all embryologists and subgroups of senior and junior embryologists.

          Results

          With AI guidance, the interobserver agreement increased from 0.355 to 0.527 and from 0.440 to 0.524 for junior and senior embryologists, respectively, thus reaching similar levels of agreement. In a test of accurate embryo selection with 90 questions, the numbers of correct responses by the embryologists only, embryologists with AI guidance, and AI only were 34 (38%), 45 (50%), and 59 (66%), respectively. Without AI, the average score (accuracy) of the junior group was 33.516 (37%), while that of the senior group was 35.967 (40%), with P<.001 in the t test. With AI guidance, the average score (accuracy) of the junior group increased to 46.581 (52%), reaching a level similar to that of the senior embryologists of 44.833 (50%), with P=.34. Junior embryologists had a higher level of trust in the AI score.

          Conclusions

          This study demonstrates the potential benefits of AI in selecting embryos with high chances of pregnancy, particularly for embryologists with 5 years or less of experience, possibly due to their trust in AI. Thus, using AI as an auxiliary tool in clinical practice has the potential to improve embryo assessment and increase the probability of a successful pregnancy.

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          Most cited references32

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          The Measurement of Observer Agreement for Categorical Data

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            The Istanbul consensus workshop on embryo assessment: proceedings of an expert meeting.

            Many variations in oocyte and embryo grading make inter-laboratory comparisons extremely difficult. This paper reports the proceedings of an international consensus meeting on oocyte and embryo morphology assessment. Background presentations about current practice were given. The expert panel developed a set of consensus points to define the minimum criteria for oocyte and embryo morphology assessment. It is expected that the definition of common terminology and standardization of laboratory practice related to embryo morphology assessment will result in more effective comparisons of treatment outcomes. This document is intended to be referenced as a global consensus to allow standardized reporting of the minimum data set required for the accurate description of embryo development.
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              Deep learning enables robust assessment and selection of human blastocysts after in vitro fertilization

              Visual morphology assessment is routinely used for evaluating of embryo quality and selecting human blastocysts for transfer after in vitro fertilization (IVF). However, the assessment produces different results between embryologists and as a result, the success rate of IVF remains low. To overcome uncertainties in embryo quality, multiple embryos are often implanted resulting in undesired multiple pregnancies and complications. Unlike in other imaging fields, human embryology and IVF have not yet leveraged artificial intelligence (AI) for unbiased, automated embryo assessment. We postulated that an AI approach trained on thousands of embryos can reliably predict embryo quality without human intervention. We implemented an AI approach based on deep neural networks (DNNs) to select highest quality embryos using a large collection of human embryo time-lapse images (about 50,000 images) from a high-volume fertility center in the United States. We developed a framework (STORK) based on Google’s Inception model. STORK predicts blastocyst quality with an AUC of >0.98 and generalizes well to images from other clinics outside the US and outperforms individual embryologists. Using clinical data for 2182 embryos, we created a decision tree to integrate embryo quality and patient age to identify scenarios associated with pregnancy likelihood. Our analysis shows that the chance of pregnancy based on individual embryos varies from 13.8% (age ≥41 and poor-quality) to 66.3% (age <37 and good-quality) depending on automated blastocyst quality assessment and patient age. In conclusion, our AI-driven approach provides a reproducible way to assess embryo quality and uncovers new, potentially personalized strategies to select embryos.
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                Author and article information

                Contributors
                Journal
                J Med Internet Res
                J Med Internet Res
                JMIR
                Journal of Medical Internet Research
                JMIR Publications (Toronto, Canada )
                1439-4456
                1438-8871
                2024
                3 June 2024
                : 26
                : e52637
                Affiliations
                [1 ] AI Lab Kai Health Seoul Republic of Korea
                [2 ] IVF Clinic Miraewaheemang Hospital Seoul Republic of Korea
                [3 ] IVF Clinic Seoul Rachel Fertility Center Seoul Republic of Korea
                [4 ] Department of Obstetrics & Gynecology Ajou University School of Medicine Suwon Republic of Korea
                [5 ] IVF Clinic HI Fertility Center Seoul Republic of Korea
                [6 ] Kai Health Seoul Republic of Korea
                Author notes
                Corresponding Author: Hye Jun Lee hyejunlee@ 123456gmail.com
                Author information
                https://orcid.org/0000-0003-2824-0535
                https://orcid.org/0009-0005-2846-6069
                https://orcid.org/0009-0001-6466-5699
                https://orcid.org/0009-0004-8009-2255
                https://orcid.org/0000-0001-5270-2723
                https://orcid.org/0000-0001-5553-5334
                https://orcid.org/0009-0001-7408-6498
                https://orcid.org/0009-0008-6758-9944
                Article
                v26i1e52637
                10.2196/52637
                11184268
                38830209
                64ce9e2c-c779-45b4-8bfb-61e49ad8cd26
                ©Hyung Min Kim, Hyoeun Kang, Chaeyoon Lee, Jong Hyuk Park, Mi Kyung Chung, Miran Kim, Na Young Kim, Hye Jun Lee. Originally published in the Journal of Medical Internet Research (https://www.jmir.org), 03.06.2024.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in the Journal of Medical Internet Research (ISSN 1438-8871), is properly cited. The complete bibliographic information, a link to the original publication on https://www.jmir.org/, as well as this copyright and license information must be included.

                History
                : 12 September 2023
                : 12 October 2023
                : 23 October 2023
                : 6 May 2024
                Categories
                Original Paper
                Original Paper

                Medicine
                assisted reproductive technology,in vitro fertilization,artificial intelligence,intraobserver and interobserver agreements,embryos,embryologists

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