IVIRMA Global Research Alliance, GENERA, Clinica Valle Giulia, Rome, Italy.
IVIRMA Global Research Alliance, 9.baby, Bologna, Italy.
Hum Reprod. 2023 Oct 3;38(10):1901-1909. doi: 10.1093/humrep/dead174.
Do embryologists from different European countries agree on embryo disposition decisions ('use' or 'discard') about Day 7 (>144 h post-insemination) and/or low-quality blastocysts (LQB; <Gardner's BB) (i.e. borderline quality blastocysts)?
The prevalence of 'discard' answers was 38.7%; nevertheless, embryologists' agreement was overall just fair (Fleiss-k = 0.26).
The utilization of LQBs and adoption of culture beyond 144 h post-insemination is increasing worldwide. Although morphology and morphokinetics are associated with embryo developmental competence, previous studies demonstrated significant interobserver variability among embryologists regarding embryo quality assessment and disposition decisions for borderline quality blastocysts.
STUDY DESIGN, SIZE, DURATION: An anonymous survey was run in a large network of IVF centers. A total of 117 embryologists from 6 European countries and 29 IVF centers filled in the survey. Randomly selected anonymous time-lapse videos of 50 Day 7 and/or LQB whole embryo preimplantation development were assessed by the embryologists. The key information on patients/cycles was provided along with each video. All cycles entailed preimplantation genetic testing for aneuploidies. Each embryologist specified whether he/she would have discarded or used ('transfer-fresh'/'cryopreserve'/'biopsy') any embryo. Inter-rater agreement was measured with Fleiss-k.
PARTICIPANTS/MATERIALS, SETTING, METHODS: Examiners were asked about their years of experience, center location, average number of cycles and average maternal age, number of colleagues, and use of time-lapse incubators at their centers. All participants were blinded to artificial intelligence (AI) scores generated by two commercially available software packages, chromosomal diagnosis (all blastocysts were tested for aneuploidies), and clinical outcomes after vitrified-warmed euploid single blastocyst transfer. These data were known only by one embryologist not involved in the survey.
Participants were Italian (40%, N = 47), Spanish (24%, N = 28), Portuguese (5%, N = 6), Czech (5%, N = 6), Swedish (23%, N = 27), and Icelandic (3%, N = 3). In total, 2263 (38.7%) 'discard' and 3587 (61.3%) 'use' decisions were recorded. Czech, Portuguese, and Italian embryologists expressed lower 'discard' decision rates (mean ± SD 17 ± 7%, range 8-24%; 23 ± 14% range 4-46%; and 27 ± 18% range 2-72%, respectively), while Spanish gave intermediate (37 ± 16% range 4-66%) and Nordic gave higher (67 ± 11% range 40-90%) rates. The prevalence of 'discard' answers was 38.7% out of 5850 choices (mean per embryologist: 39 ± 23% range 2-90%). Only embryologists' country and IVF group were associated with this rate. Overall agreement among embryologists was fair (Fleiss-k = 0.26). The prevalence of 'discard' responses per embryo was 37 ± 24% (range 2-87%). Only the number of sibling blastocysts influenced this rate (i.e. the larger the cohort, the higher the inclination to 'discard'). No difference was shown for the two scores between euploid and aneuploid borderline quality blastocysts, while the embryologists were, by chance, more prone to 'discard' the latter (28.3 ± 21% range 9-71% versus 41.6 ± 24.8% range 2-87%, respectively).
LIMITATIONS, REASONS FOR CAUTION: The survey included only private IVF clinics located in Europe. Moreover, a key variable is missing, namely patients' access to care. Indeed, all embryologists involved in the survey were part of the same network of private IVF clinics, while the embryo disposition decisions might be different in a public setting.
Decision-making by European embryologists regarding Day 7 embryos or LQBs is inconsistent with putative clinical consequences, especially in patients with low prognosis. Although the embryologists could make decisions independent from their local regulations, their mindset and clinical background influenced their choices. In the future, AI tools should be trained to assess borderline quality embryos and empowered with cost-effectiveness information to support embryologists' decisions with more objective assessments.
STUDY FUNDING/COMPETING INTEREST(S): No external funding was obtained for this study. The authors have no conflict of interest to declare.
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来自不同欧洲国家的胚胎学家是否同意关于第 7 天（>144 小时受精后）和/或低质量囊胚（LQB；<Gardner 的 BB）（即边缘质量囊胚）的胚胎处置决定（“使用”或“丢弃”）？
“丢弃”答案的流行率为 38.7%；然而，胚胎学家的总体一致性仅为一般（Fleiss-k=0.26）。
低质量囊胚的利用和超过 144 小时受精后培养的采用正在全球范围内增加。尽管形态学和形态动力学与胚胎发育能力相关，但之前的研究表明，对于边缘质量囊胚，胚胎学家在胚胎质量评估和处置决策方面存在显著的观察者间变异性。
研究设计、规模、持续时间：在一个大型 IVF 中心网络中进行了一项匿名调查。来自 6 个欧洲国家和 29 个 IVF 中心的 117 名胚胎学家填写了调查。胚胎学家评估了随机选择的 50 个第 7 天和/或 LQB 整个胚胎植入前发育的匿名时间推移视频。每个视频都提供了有关患者/周期的关键信息。所有周期都进行了非整倍体的植入前遗传检测。每个胚胎学家都指定了他们是否会丢弃或使用（“新鲜转移”/“冷冻保存”/“活检”）任何胚胎。使用 Fleiss-k 测量了评分者间的一致性。
参与者/材料、地点、方法：检查者被问及他们的工作年限、中心位置、平均周期数和平均产妇年龄、同事人数，以及他们中心是否使用时间推移孵化器。所有参与者都对两个商业上可用的软件包（所有囊胚都进行了非整倍体检测）和玻璃化冷冻解冻后的整倍体单个囊胚转移后的临床结果生成的人工智能（AI）评分一无所知。只有一名未参与调查的胚胎学家知道这些数据。
参与者包括意大利人（40%，N=47）、西班牙人（24%，N=28）、葡萄牙人（5%，N=6）、捷克人（5%，N=6）、瑞典人（23%，N=27）和冰岛人（3%，N=3）。总共记录了 2263 次（38.7%）“丢弃”和 3587 次（61.3%）“使用”决定。捷克、葡萄牙和意大利的胚胎学家表示，“丢弃”决策的发生率较低（平均±SD 17±7%，范围 8-24%；23±14%，范围 4-46%；27±18%，范围 2-72%），而西班牙人的发生率为中等（37±16%，范围 4-66%），北欧人的发生率较高（67±11%，范围 40-90%）。5850 次选择中有 38.7%（平均每位胚胎学家：39±23%，范围 2-90%）表示“丢弃”。只有胚胎学家的国家和 IVF 组与这一比率有关。胚胎学家之间的总体一致性是一般的（Fleiss-k=0.26）。每个胚胎的“丢弃”反应率为 37±24%（范围 2-87%）。只有同胞囊胚的数量影响了这一比率（即，队列越大，“丢弃”的倾向越高）。在整倍体和非整倍体边缘质量囊胚之间，两个评分之间没有差异，而胚胎学家偶然更倾向于“丢弃”后者（28.3±21%，范围 9-71%与 41.6±24.8%，范围 2-87%）。
局限性、谨慎的原因：该调查仅包括位于欧洲的私人 IVF 诊所。此外，一个关键变量缺失，即患者获得护理的机会。事实上，参与调查的所有胚胎学家都属于同一个私人 IVF 诊所网络，而胚胎处置决策在公共环境中可能会有所不同。
欧洲胚胎学家关于第 7 天胚胎或 LQB 的决策与推测的临床后果不一致，尤其是在预后较差的患者中。尽管胚胎学家可以独立于其当地法规做出决策，但他们的思维方式和临床背景影响了他们的选择。在未来，人工智能工具应该接受评估边缘质量胚胎的培训，并通过成本效益信息来支持胚胎学家的决策，以进行更客观的评估。
研究资助/利益冲突：本研究没有获得外部资金。作者没有利益冲突需要声明。
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