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Disclosure
Tammie Roy Chief Scientific Officer Genea Biomedx Sydney, AUSTRALIA
Declared to be employee of Genea Biomedx
Automation and standardization in embryology lab
Tammie Roy
Australia
1. Review the technology changes that have occurred in IVF
2. What automated equipment is available to the IVF laboratory
3. Understand Electronic witness and traceability technologies
4. Understand how automation and standardisation can improve IVF outcomes
5. Introduction to Automated vitrification
Objectives
What is Standardization?
• The process of implementing and developing technical standards. Standardization can help to maximize compatibility, interoperability, safety, repeatability, or quality.
• Can be achieved through: – QMS/QC systems
– Accreditation and documentation
– Education
– Automation
Why standardize IVF processes?
Number of ART cycles and outcomes reported in America (Centers for disease Control and Prevention 2013 report)
Laboratory Environment
Past Today
• Small room • Manual processes
• Controlled environment • VOC management • Clean room environment
Witnessing
IVF Witnessing is the process of ensuring that embryos, gametes and patients are handled and mixed correctly.
On average embryologist check up to 6 movements per cycle.
Some errors reported:
• Wrong sperm used for ICSI
• Affected weaker embryos transferred
• Wrong embryos thawed
• Embryos implanted in wrong patient
• Occurs <1% of the time (Thornhill, 2013)
Legislative requirements:
• UK HFEA Guidance Note 18 (mandated in 2004)
• Australia/NZ RTAC (initiated in 2011)
• US is under review.
Witnessing
Manual
“double checking performed on all clinical and laboratory procedures”
Issues with Manual double witnessing:
• Time consuming and distraction
• Signage paperwork required
• Variable reliability in technique
• Prone to human error
• Involuntary automaticity Errors can occur because staff saw what they “expected to see”
Electronic
• Utilises barcodes or RFID tags to identify and match samples
• Increased peace of mind for our staff and patients
• Risk mitigation and traceability
• Efficiency
IVF Culture Media
Past
• Individual clinics manufactured
• Non-defined ingredients used
• Variable across labs
• Use of cell culture media not developed for embryos
Today
• Commercially manufactured
• Defined ingredients e.g. HSA, Dipeptide Glutamine
• Quality controlled – Sterility
– MEA tested
– Endotoxin tested
• Additional supplements • Vitamins
• Growth factors
• Sequential and single step
Embryo Culture Environment
Large Box
• Slow Temp and CO2 recovery
• Large volume
• Temperature stratifications
Benchtop
• Quick recovery of Temp and CO2
• Smaller footprint
• Control and consistency of temp
Individual Patient Benchtop
• Optimal environment
• Controlled exposure
Embryo Selection
Subjective • Morphology
– single-point morphology is subjective
– low predictive value for embryo implantation potential
– relatively high inter-observer variability (even within the same centre)
(Braude 2013, Wang 2011).
Standardized • Timelapse
– Objective
– Uninterrupted culture
– Algorithms
• Pre-implantation genetic screening – Objective
• Mitochondrial analysis
• Proteomics
Cryopreservation
Slow Freezing
• Low cryoprotectants
• Controlled slow freezing rate
• Alignment of ice crystals to aid in damage prevention
Vitrification
• Higher cryoprotectant concentrations
• Rapid cooling and warming rates
• Prevention of ice crystal formation
• Improved embryo survival and outcomes
Automation
• Standardised
• Controlled variables
• Reduced learning curve
Why Automate Vitrification?
• Automate to attempt to control variables:
– Vitrification/warming solutions
• Cryopreservatives
• Sucrose v’s Trehalose
• Exposure
– Timing
– Temperature
– Device usability
– Open v’s Closed
Outcomes From Automated Vitrification
P-172 First pregnancies from human
embryos vitrified-warmed using the
semi-automated Gavi closed
vitrification system. ESHRE; 3-6 July
2016; Helsinki, Finland
Hobson, N.1; Filipovits, J.1; Roy, T. 2; Brandi, S.2; Woolcott, R.2; Bowman, M.1; McArthur, S.1
1.Genea Fertility, Sydney Australia 2. Genea Biomedx, Sydney Australia
Gavi Cryotop P value
Embryos vitrified 321 346
Maternal age
36.8
(33.9-39.6)
36.5
(33.9-39.4) .631
Embryos warmed 52 63
Embryo recovery
rate
100%
(52/52)
100%
(63/63) .999
Embryo survival
rate
100%
(52/52)
98.4%
(62/63) 1
Embryo transfers 52 62
Maternal age
35.9
(33.0-38.4)
35.4
(34.0-38.4) .512
Biochemical
pregnancy rate
65.4%
(34/52)
67.7%
(42/62) .791
Fetal heart
pregnancy rate
57.7%
(30/52)
58.1%
(36/62) 1
Subclinical
miscarriage rate
11.8%
(4/34)
14.3%
(6/42) 1
Implementing Automation
• Introducing automation into an IVF lab involves:
– Planning
– Training
– Assessment of workflows
– Lab restructure
– Evaluation of technology
– Ongoing monitoring
• Microfluidics – Embryo Culture
– Potential to allow culture from oocyte, through insemination and development (Han 2010 & Ma 2011, Swain 2013)
– Dynamic culture may improve development (Heo, 2010)
– Costs can be prohibitive
From: Ma et al, Anal. Chem., 2011, 83 (8), pp 2964–2970
From, Heo. Et al, Human Reproduction, Vol.25, No.3 pp. 613–622, 2010
IVF Laboratories of the Future
• Microfluidics – Sperm Preparations
– Can increase motility
– Reduced DNA fragmentation (Wasim, et al 2013)
– More efficient
IVF Laboratories of the Future
IVF Laboratories of the Future
• New dynamic culturing methods – Microfluidics – Co-culture – Next generation culture media
• Automated ICSI – Tested in animal models – 90% survival (Sun 2011)
• Real time measurements of embryo viability – Metabolism – mRNA
• Sperm Selection – New methods to identify and isolate most viable sperm
• Data mining – Personlised IVF
Take-home message
• The future is bright!!!
• Automation and standardisation will allow each step of the IVF process to be optimised resulting in a gold-standard of care and an overall increase in the take home baby rate from IVF.
Thank you
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