Different effectiveness of closed embryo culture system with time-lapse imaging (EmbryoScopeTM) in comparison to standard manual embryology in good and poor prognosis patients: a prospectively randomized pilot study

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Abstract

Background

Previously manual human embryology in many in vitro fertilization (IVF) centers is rapidly being replaced by closed embryo incubation systems with time-lapse imaging. Whether such systems perform comparably to manual embryology in different IVF patient populations has, however, never before been investigated.

We, therefore, prospectively compared embryo quality following closed system culture with time-lapse photography (EmbryoScope™) and standard embryology.

We performed a two-part prospectively randomized study in IVF (clinical trial # NCT92256309). Part A involved 31 infertile poor prognosis patients prospectively randomized to EmbryoScope™ and standard embryology. Part B involved embryos from 17 egg donor-recipient cycles resulting in large egg/embryo numbers, thus permitting prospectively alternative embryo assignments to EmbryoScope™ and standard embryology.

We then compared pregnancy rates and embryo quality on day-3 after fertilization and embryologist time utilized per processed embryo.

Results

Part A revealed in poor prognosis patients no differences in day-3 embryo scores, implantation and clinical pregnancy rates between EmbryoScope™ and standard embryology. The EmbryoScope™, however, more than doubled embryology staff time ( P < 0.0001). In Part B, embryos grown in the EmbyoScope™ demonstrated significantly poorer day-3 quality (depending on embryo parameter between P = 0.005 and P = 0.01). Suspicion that conical culture dishes of the EmbryoScope™ (EmbryoSlide™) may be the cause was disproven when standard culture dishes demonstrated no outcome difference in standard incubation.

Conclusions

Though due to small patient numbers preliminary, this study raises concerns about the mostly uncontrolled introduction of closed incubation systems with time lapse imaging into routine clinical embryology. Appropriately designed and powered prospectively randomized studies appear urgently needed in well-defined patient populations before the uncontrolled utilization of these instruments further expands.

Trial registration

NCT02246309 Registered September 18, 2014.

Related collections

Most cited references 33

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Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage.

Connie Wong, Kevin E. Loewke, Nancy L. Bossert … (2010)

We report studies of preimplantation human embryo development that correlate time-lapse image analysis and gene expression profiling. By examining a large set of zygotes from in vitro fertilization (IVF), we find that success in progression to the blastocyst stage can be predicted with >93% sensitivity and specificity by measuring three dynamic, noninvasive imaging parameters by day 2 after fertilization, before embryonic genome activation (EGA). These parameters can be reliably monitored by automated image analysis, confirming that successful development follows a set of carefully orchestrated and predictable events. Moreover, we show that imaging phenotypes reflect molecular programs of the embryo and of individual blastomeres. Single-cell gene expression analysis reveals that blastomeres develop cell autonomously, with some cells advancing to EGA and others arresting. These studies indicate that success and failure in human embryo development is largely determined before EGA. Our methods and algorithms may provide an approach for early diagnosis of embryo potential in assisted reproduction.

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Embryo incubation and selection in a time-lapse monitoring system improves pregnancy outcome compared with a standard incubator: a retrospective cohort study.

Marcos Meseguer, Irene Rubio, Maria Eduarda Cruz … (2012)

To quantify the effect on reproductive outcome of culturing and selecting embryos using a novel time-lapse monitoring system (TMS). Retrospective observational cohort study. University-affiliated private center. Donation and autologous intracytoplasmic sperm injection (ICSI) cycles from ten IVF clinics using similar procedures, cultured in TMS (n = 1,390) or in a standard incubator (SI; n = 5,915). None. Clinical pregnancy rate confirmed by ultrasound in week 7. A logistic regression analysis, which included all significant confounding factors, was used to evaluate the effect of culturing and selecting embryos with the use of TMS. Comparing clinical pregnancy rates per oocyte retrieval with TMS and SI treatments gave a crude effect of odds ratio [OR] 1.190 (95% confidence interval [CI] 1.058-1.337). Oocyte source, maternal age, day of transfer, and number of retrieved oocytes were identified as significant confounding factors. After accounting for confounding factors, the effect of TMS culture was OR 1.201 (95% CI 1.059-1.363). Limiting analysis to treatments with embryo transfer and including number of transferred embryos as a confounding factor likewise gave a significant effect of TMS with OR 1.157 (95% CI 1.018-1.315). Analysis of retrospective data indicated that culturing and selecting embryos by TMS significantly improved the relative probability of clinical pregnancy (+20.1% per oocyte retrieval, +15.7% per embryo transfer). The elevated clinical pregnancy rate was attributed to a combination of stable culture conditions and the use of morphokinetic parameters for embryo selection. Copyright © 2012 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

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Improving embryo selection using a computer-automated time-lapse image analysis test plus day 3 morphology: results from a prospective multicenter trial.

P J Conaghan, Kevin E. Loewke, S Willman … (2013)

To assess the first computer-automated platform for time-lapse image analysis and blastocyst prediction and to determine how the screening information may assist embryologists in day 3 (D3) embryo selection. Prospective, multicenter, cohort study. Five IVF clinics in the United States. One hundred sixty women ≥ 18 years of age undergoing fresh IVF treatment with basal antral follicle count ≥ 8, basal FSH <10 IU/mL, and ≥ 8 normally fertilized oocytes. A noninvasive test combining time-lapse image analysis with the cell-tracking software, Eeva (Early Embryo Viability Assessment), was used to measure early embryo development and generate usable blastocyst predictions by D3. Improvement in the ability of experienced embryologists to select which embryos are likely to develop to usable blastocysts using D3 morphology alone, compared with morphology plus Eeva. Experienced embryologists using Eeva in combination with D3 morphology significantly improved their ability to identify embryos that would reach the usable blastocyst stage (specificity for each of three embryologists using morphology vs. morphology plus Eeva: 59.7% vs. 86.3%, 41.9% vs. 84.0%, 79.5% vs. 86.6%). Adjunctive use of morphology plus Eeva improved embryo selection by enabling embryologists to better discriminate which embryos would be unlikely to develop to blastocyst and was particularly beneficial for improving selection among good-morphology embryos. Adjunctive use of morphology plus Eeva also reduced interindividual variability in embryo selection. Previous studies have shown improved implantation rates for blastocyst transfer compared with cleavage-stage transfer. Addition of Eeva to the current embryo grading process may improve the success rates of cleavage-stage ETs. Copyright © 2013 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

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Author and article information

Contributors

Yan-Guang Wu: ywu@thechr.com

Emanuela Lazzaroni-Tealdi: elazzaroni@thechr.com

Qi Wang: vqwang@thechr.com

Lin Zhang: lzhang@thechr.com

David H. Barad: dbarad@thechr.com

Vitaly A. Kushnir: vkushnir@thechr.com

Sarah K. Darmon: sdarmon@thechr.com

David F. Albertini: dalbertini@thechr.com

Norbert Gleicher: ngleicher@thechr.com , ngleicher@rockefeller.edu

Journal

Journal ID (nlm-ta): Reprod Biol Endocrinol

Journal ID (iso-abbrev): Reprod. Biol. Endocrinol

Title: Reproductive Biology and Endocrinology : RB&E

Publisher: BioMed Central (London )

ISSN (Electronic): 1477-7827

Publication date (Electronic): 24 August 2016

Publication date PMC-release: 24 August 2016

Publication date Collection: 2016

Volume: 14

Issue: 1

Electronic Location Identifier: 49

Affiliations

[1 ]The Center for Human Reproduction, 21 East 69th Street, New York, NY 10021 USA

[2 ]The Foundation for Reproductive Medicine, New York, NY 10021 USA

[3 ]Department of Obstetrics and Gynecology, Albert Einstein College of Medicine, Bronx, NY 10461 USA

[4 ]Department of Obstetrics and Gynecology, Wake Forest University, Winston Salem, NC 27106 USA

[5 ]Department of Molecular and Integrative Physiology, The University of Kansas School of Medicine, Wichita, KS 64109 USA

[6 ]Stem Cell Biology and Molecular Embryology Laboratory, The Rockefeller University, New York, NY 10065 USA

Article

Publisher ID: 181

DOI: 10.1186/s12958-016-0181-x

PMC ID: 4995783

PubMed ID: 27553622

SO-VID: ae0dba20-7619-47c6-8b47-4216bf1bacc8

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 24 May 2016

Date accepted : 4 August 2016

Funding

Funded by: Foundation for Reproductive Medicine

Award ID: N/A

Funded by: Center for Human Reproduction

Award ID: N/A

Custom metadata

ScienceOpen disciplines: Human biology

Keywords: in vitro fertilization (ivf),time laps photography,closed incubation systems,embryology,embryo quality,cost-effectiveness

Data availability:

ScienceOpen disciplines: Human biology

Keywords: in vitro fertilization (ivf), time laps photography, closed incubation systems, embryology, embryo quality, cost-effectiveness