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Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse
The aim of this study is to determine inter-laboratory variability on embryo assessment using time-lapse platform and conventional morphological assessment. This study compares the data obtained from a pilot study of external quality control (EQC) of time lapse, performed in 2014, with the classical...
Autores principales: | , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2017
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5571938/ https://www.ncbi.nlm.nih.gov/pubmed/28841654 http://dx.doi.org/10.1371/journal.pone.0183328 |
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author | Martínez-Granados, Luis Serrano, María González-Utor, Antonio Ortíz, Nereyda Badajoz, Vicente Olaya, Enrique Prados, Nicolás Boada, Montse Castilla, Jose A. |
author_facet | Martínez-Granados, Luis Serrano, María González-Utor, Antonio Ortíz, Nereyda Badajoz, Vicente Olaya, Enrique Prados, Nicolás Boada, Montse Castilla, Jose A. |
author_sort | Martínez-Granados, Luis |
collection | PubMed |
description | The aim of this study is to determine inter-laboratory variability on embryo assessment using time-lapse platform and conventional morphological assessment. This study compares the data obtained from a pilot study of external quality control (EQC) of time lapse, performed in 2014, with the classical EQC of the Spanish Society for the Study of Reproductive Biology (ASEBIR) performed in 2013 and 2014. In total, 24 laboratories (8 using EmbryoScope™, 15 using Primo Vision™ and one with both platforms) took part in the pilot study. The clinics that used EmbryoScope™ analysed 31 embryos and those using Primo Vision™ analysed 35. The classical EQC was implemented by 39 clinics, based on an analysis of 25 embryos per year. Both groups were required to evaluate various qualitative morphological variables (cell fragmentation, the presence of vacuoles, blastomere asymmetry and multinucleation), to classify the embryos in accordance with ASEBIR criteria and to stipulate the clinical decision taken. In the EQC time-lapse pilot study, the groups were asked to determine, as well as the above characteristics, the embryo development times, the number, opposition and size of pronuclei, the direct division of 1 into 3 cells and/or of 3 into 5 cells and false divisions. The degree of agreement was determined by calculating the intra-class correlation coefficients and the coefficient of variation for the quantitative variables and the Gwet index for the qualitative variables. For both EmbryoScope™ and Primo Vision™, two periods of greater inter-laboratory variability were observed in the times of embryo development events. One peak of variability was recorded among the laboratories addressing the first embryo events (extrusion of the second polar body and the appearance of pronuclei); the second peak took place between the times corresponding to the 8-cell and morula stages. In most of the qualitative variables analysed regarding embryo development, there was almost-perfect inter-laboratory agreement among conventional morphological assessment (CMA), EmbryoScope™ and Primo Vision™, except for false divisions, vacuoles and asymmetry (users of all methods) and multinucleation (users of Primo Vision™), where the degree of agreement was lower. The inter-laboratory agreement on embryo classification according to the ASEBIR criteria was moderate-substantial (Gwet 0.41–0.80) for the laboratories using CMA and EmbryoScope™, and fair-moderate (Gwet 0.21–0.60) for those using Primo Vision™. The inter-laboratory agreement for clinical decision was moderate (Gwet 0.41–0.60) on day 5 for CMA users and almost perfect (Gwet 0.81–1) for time-lapse users. In conclusion, time-lapse technology does not improve inter-laboratory agreement on embryo classification or the analysis of each morphological variable. Moreover, depending on the time-lapse platform used, inter-laboratory agreement may be lower than that obtained by CMA. However, inter-laboratory agreement on clinical decisions is improved with the use of time lapse, regardless of the platform used. |
format | Online Article Text |
id | pubmed-5571938 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2017 |
publisher | Public Library of Science |
record_format | MEDLINE/PubMed |
spelling | pubmed-55719382017-09-09 Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse Martínez-Granados, Luis Serrano, María González-Utor, Antonio Ortíz, Nereyda Badajoz, Vicente Olaya, Enrique Prados, Nicolás Boada, Montse Castilla, Jose A. PLoS One Research Article The aim of this study is to determine inter-laboratory variability on embryo assessment using time-lapse platform and conventional morphological assessment. This study compares the data obtained from a pilot study of external quality control (EQC) of time lapse, performed in 2014, with the classical EQC of the Spanish Society for the Study of Reproductive Biology (ASEBIR) performed in 2013 and 2014. In total, 24 laboratories (8 using EmbryoScope™, 15 using Primo Vision™ and one with both platforms) took part in the pilot study. The clinics that used EmbryoScope™ analysed 31 embryos and those using Primo Vision™ analysed 35. The classical EQC was implemented by 39 clinics, based on an analysis of 25 embryos per year. Both groups were required to evaluate various qualitative morphological variables (cell fragmentation, the presence of vacuoles, blastomere asymmetry and multinucleation), to classify the embryos in accordance with ASEBIR criteria and to stipulate the clinical decision taken. In the EQC time-lapse pilot study, the groups were asked to determine, as well as the above characteristics, the embryo development times, the number, opposition and size of pronuclei, the direct division of 1 into 3 cells and/or of 3 into 5 cells and false divisions. The degree of agreement was determined by calculating the intra-class correlation coefficients and the coefficient of variation for the quantitative variables and the Gwet index for the qualitative variables. For both EmbryoScope™ and Primo Vision™, two periods of greater inter-laboratory variability were observed in the times of embryo development events. One peak of variability was recorded among the laboratories addressing the first embryo events (extrusion of the second polar body and the appearance of pronuclei); the second peak took place between the times corresponding to the 8-cell and morula stages. In most of the qualitative variables analysed regarding embryo development, there was almost-perfect inter-laboratory agreement among conventional morphological assessment (CMA), EmbryoScope™ and Primo Vision™, except for false divisions, vacuoles and asymmetry (users of all methods) and multinucleation (users of Primo Vision™), where the degree of agreement was lower. The inter-laboratory agreement on embryo classification according to the ASEBIR criteria was moderate-substantial (Gwet 0.41–0.80) for the laboratories using CMA and EmbryoScope™, and fair-moderate (Gwet 0.21–0.60) for those using Primo Vision™. The inter-laboratory agreement for clinical decision was moderate (Gwet 0.41–0.60) on day 5 for CMA users and almost perfect (Gwet 0.81–1) for time-lapse users. In conclusion, time-lapse technology does not improve inter-laboratory agreement on embryo classification or the analysis of each morphological variable. Moreover, depending on the time-lapse platform used, inter-laboratory agreement may be lower than that obtained by CMA. However, inter-laboratory agreement on clinical decisions is improved with the use of time lapse, regardless of the platform used. Public Library of Science 2017-08-25 /pmc/articles/PMC5571938/ /pubmed/28841654 http://dx.doi.org/10.1371/journal.pone.0183328 Text en © 2017 Martínez-Granados et al http://creativecommons.org/licenses/by/4.0/ This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/) , which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited. |
spellingShingle | Research Article Martínez-Granados, Luis Serrano, María González-Utor, Antonio Ortíz, Nereyda Badajoz, Vicente Olaya, Enrique Prados, Nicolás Boada, Montse Castilla, Jose A. Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse |
title | Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse |
title_full | Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse |
title_fullStr | Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse |
title_full_unstemmed | Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse |
title_short | Inter-laboratory agreement on embryo classification and clinical decision: Conventional morphological assessment vs. time lapse |
title_sort | inter-laboratory agreement on embryo classification and clinical decision: conventional morphological assessment vs. time lapse |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5571938/ https://www.ncbi.nlm.nih.gov/pubmed/28841654 http://dx.doi.org/10.1371/journal.pone.0183328 |
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