Skip to main content Accessibility help
×
Hostname: page-component-76fb5796d-x4r87 Total loading time: 0 Render date: 2024-04-26T09:33:06.732Z Has data issue: false hasContentIssue false

Chapter 7 - From Identification to Witnessing

Traceability to Ensure the Safety of the Embryo during Culture

Published online by Cambridge University Press:  15 April 2021

Kersti Lundin
Affiliation:
Sahlgrenska University Hospital, Gothenburg
Aisling Ahlström
Affiliation:
Livio Fertility Center, Gothenburg
Get access

Summary

The most important purpose of embryo culture in the IVF lab is to make sure that the embryo can develop to its full potential in a safe and secure environment, and to prevent any errors that can lead to cancellation of the IVF cycle, or risk of other adverse outcomes. In a study by Sakkas et al. (2018),1 including data from over 10 years and more than 35,000 fresh and frozen IVF cycles from more than 180,000 individual laboratory procedures, it was shown that the rate of moderate nonconformances was 0.23%. These failures are described as problems that negatively affect a cycle but not to the extent that the cycle is lost or severely compromised. Although the data from this study is reassuring and shows a very low rate of nonconformance during treatment, the most undesirable and catastrophic event that can occur in an IVF laboratory is a misidentification and mix-up of sperm, egg, or embryo. Embryo culture is a lengthy process that can last up to 6 or even 7 days in which the culture dish is manipulated regularly, sometimes on a daily basis, for purposes such as fertilization, embryo quality assessment, transfer, and cryopreservation. During these manipulations stringent procedures and protocols have to be in place in order to track and trace each and every embryo throughout the embryo culture. The ESHRE guideline for good practice in IVF laboratories includes a section on identification of patients and traceability of their reproductive cells.2 Although traceability is part of the quality management systems in IVF laboratories today, there is not one system that is fail-safe.

Type
Chapter
Information
Publisher: Cambridge University Press
Print publication year: 2021

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Sakkas, D, Barrett, CB, Alper, MM. Types and frequency of non-conformances in an IVF laboratory. Hum Reprod. 2018;12:21962204.Google Scholar
ESHRE guideline group on Good Practice in IVF labs, De los Santos, MJ, Apter, S. et al. Revised guidelines for good practice in IVF laboratories (2015). Hum Reprod. 2016;4:685686Google Scholar
Ishikawa, K. Guide to Quality Control. Tokyo: Asian Productivity Organization. 1976.Google Scholar
De Los Santos, MJ, Amparo, R. Protocols for tracking and witnessing samples and patients in ART. Fertil Steril. 2013;6 :14991502.CrossRefGoogle Scholar
Rienzi, L, Bariani, F, Dalla Zorza, M, et al. Comprehensive protocol of traceability during IVF: the result of a multicentre failure mode and effect analysis. Hum Reprod. 2017;8:16121620.Google Scholar
Rienzi, L, Bariani, F, Dalla Zorza, M, et al. Failure mode and effect analysis of witnessing protocols for ensuring traceability during IVF. Reprod Biomed Online. 2015;31:516522.Google Scholar
Intra, G, Alteri, A, Corti, L, et al. Application of failure mode and effect analysis in assisted reproduction technology laboratory. Reprod Biomed Online. 2016;33:132139.CrossRefGoogle ScholarPubMed
Forte, M, Faustini, F, Maggiulli, R, et al. Electronic witness system in IVF – patients perspective. J Assist Reprod Genet. 2016; 3:12151222.Google Scholar
Novo, S, Nogués, C, Penon, O, et al. Barcode tagging of human oocytes and embryos to prevent mix-ups in assisted reproduction technologies. Hum Reprod. 2014;29:1828.Google Scholar
Ilina, IV, Khramova, YV, Filatov, MA, Sitnikov, DS. Application of femtosecond laser surgery in assisted reproductive technologies for preimplantation embryo tagging. Biomed Opt Express. 2019;6:29852995.Google Scholar
Dyer, C. Human error and system failures caused IVF mix up. BMJ. 2004;328:1518.Google Scholar
Dyer, C. Biological father declared the legal father in IVF mix up. BMJ. 2003;326: 518.CrossRefGoogle ScholarPubMed
Rohde, D. Black parents prevail in embryo mix-up. NY Times Web. 1999;17:3.Google Scholar
Spriggs, M. IVF Mixup: white couple have black babies. J Med Ethics. 2001;2:65.Google Scholar
Mortimer, ST, Mortimer, D. Quality and Risk Management in the IVF Laboratory. 2nd edn. Cambridge:Cambridge University Press; 2015.CrossRefGoogle Scholar
European Directorate for the Quality of Medicines & Healthcare (EDQM). Council of Europe. The Guide to Quality and Safety of Tissues and Cells for Human Application. 4th ed. www.edqm.eu.Google Scholar

Save book to Kindle

To save this book to your Kindle, first ensure coreplatform@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×