All British people, with no exceptions, will soon be able to opt-in to store their sperm, eggs, and embryos for up to 55 years instead of ten thanks to a landmark campaign by leading fertility experts, patient advocacy organisations, several members of the UK Parliament, the Human Fertilisation and Embryology Authority and the Progress Educational Trust (see BioNews 1111). With enhanced flexibility to decide when to start a family, and increasing demand for freeze-all procedures, however, fertility clinics and patients are faced with a more pressing question of how to keep these precious specimens safe for over a half-century.
While assisted reproductive technology/IVF clinics have long adopted cutting-edge and dependable bench techniques, the specimen storage and maintenance systems used date back decades, relying on manually operated equipment, analogue labelling, and record management tools developed for animal husbandry in the 1940s, with few decades-old upgrades. Confronted by trends of shifting life priorities, ageing population, and rising demands for IVF, clinics are coming up against a proportionate rise in scale, reliability, and safety issues, as evidenced by the recurrent storage failure(s) and specimen mix-ups, the last tragic examples of which became public in November 2021.
In one case, a California couple realised they delivered another couple's baby, while theirs was carried to term by that couple (see BioNews 1121). In another, a Utah couple learned that their son was conceived from the sperm of another man whose family was undergoing IVF treatment in the same clinic 11 years previously (see BioNews 1121). Alarmingly, cases like theirs are not isolated – but they are easily preventable by using software-guided, automated management of frozen specimens to maintain a digital chain of custody. By bringing together clinicians, scientists, engineers, and embryologists, the IVF community now has an opportunity to lead a generational change through technology and automation, which aim to provide long-term assurances for future families.
Innovations in automation, robotics, and artificial intelligence have proven to lead to dramatic improvements in safety and reliability – one can simply look across multiple sectors for proof points. In the aviation industry, investment in automation led to a 78 percent decline in airline fatalities; and in the pharmaceutical space, software and robotics decreased prescription dispensing errors by 52 percent compared with manual method(s). Drawing from those successes, IVF clinics should embrace the power of automation and technology to keep pace with the ongoing growth and management of millions of frozen specimens, taking a step in the same direction as a biobanking community at large. However, it is not only the adoption of new technology that matters – innovations must also maintain expected clinical outcomes and must demonstrate improvements in overall process and risk.
To ensure specimens remain fully capable of their purpose when using a modern, automated platform, scientists at the Colorado Centre for Reproductive Medicine set forth to evaluate if the management of frozen specimens using automation and robotics would have any deleterious effects when compared to the decades-old conventional cryostorage setup. In this study, donated human blastocysts were shipped and stored in either manually operated liquid nitrogen (traditional) or automated vapour phase liquid nitrogen (modern) systems. After a predefined period of storage, scientists used an extended culture system to evaluate the blastocyst formation for up to 11 days through peri-implantation development. The authors concluded the TMRW® automated platform provided a robustly safe environment for the shipment and storage of frozen reproductive specimens with the advantage of '… continuous telemetry, digital specimen inventory, and management (as) distinct improvements over current systems.'
When investigating these advantages further, several leading US clinics opined that the current process of managing each frozen specimen requires an embryologist to perform 26 critical manual steps and checks, making it vulnerable to 87 points of failure. Remarkably, upon evaluation of the fully automated TMRW platform, clinics were able to reduce 84 percent of the embryologist's workload associated with sample management and minimise the potential points of risks by 94 percent, all while maintaining the viability of the stored specimens. Given the grave challenges with current methods for long-term sample management, modern technology in the IVF setting safeguards for the expected specimen viability and quality, meaningfully reduces the potential for human error, and significantly increases safety and reliability.
Now is the time for clinics and patients to embrace a new standard of care when it comes to the long-term prosperity of future families. The challenges already existed but the recent UK legislation extending sample management to 55 years is the catalysing force. Automated platforms with a digital chain of custody bridge the requirement to eliminate the potential of a mix-up or loss with next-generation technology, such as 24/7, always-on monitoring, which gives patients and clinicians the much-needed peace of mind. The IVF industry now has a clear 21st-century technology-enabled solution to overcome the risks of 20th-century manual tool – a breakthrough for the standard of care demanded by both patients and clinicians.