Redefining Risk in IVF and Why Cryogovernance® Matters
Inspired by the recent International IVF Initiative (i3) Webinar, Cryogovernance® VIII, sponsored by Cryoport Systems.
Reproductive medicine is evolving faster than ever. The demand for in vitro fertilization (IVF) has surged across continents, driven by expanded access and new technologies as well as greater global mobility among patients. But that same growth has amplified the challenges (and risks) facing IVF programs worldwide.
The truth is that IVF success today depends as much on safe, reliable cryostorage and transport as it does on laboratory technique. Every embryo, egg, or sperm sample represents a family’s hope for their future. Yet as laboratories scale operations and manage increasingly complex storage networks, the systems in place to protect those sensitive materials haven’t always kept pace.
For many clinics, risk management has historically focused on what happens inside the lab. But as the panelists of the recent Cryogovernance VIII webinar highlighted, the boundaries of responsibility have expanded far beyond the cryotank.
In a landscape defined by data and automation alongside global movement of reproductive materials, the time has come to move from cryomanagement to cryogovernance.
From Management to Governance
In her opening remarks, Cynthia Hudson (VP Clinical Strategy, TMRW Life Sciences) captured the heart of the issue. “For decades, I’ve watched the same preventable challenges appear again and again,” she said. “Manual inventory tracking leading to confusion, fragmented custody chains during specimen transport, storage tanks without continuous monitoring. Gaps in accountability that leave everyone, patients, physicians, and embryologists, vulnerable when things go wrong.”
The industry, she argued, has outgrown piecemeal risk management. What’s needed now is governance. A framework that unites every component of the cryogenic lifecycle, from freezing and labeling to shipment and long-term storage.
Cryogovernance builds on established quality management systems but goes further, demanding visibility, traceability, and accountability across every touchpoint. It’s a mindset shift, transitioning from reacting to problems to designing systems that prevent them. It also demands new forms of collaboration between clinical teams, laboratory staff, and external partners who are responsible for critical functions like transportation and long-term storage.
The field is ready for a new standard, one that matches the sophistication of the science with equally advanced systems of protection.
Understanding the Risks that Define Modern IVF
The panelists painted a compelling picture of today’s cryogenic landscape. IVF clinics now manage exponentially more samples than they did a decade ago. Industry data predicts a rise from fewer than one million specimens in 2005 to more than 22 million by the end of 2025. Each of these specimens requires precise tracking and documentation in addition to safe storage, and the logistics of these samples are frequently managed across multiple locations.
Dr. Bec Holmes (Corporate Laboratory Director, CCRM Network) shared that her organization now oversees more than 20 laboratories, each with varying storage capacities and regulatory environments. Within that network alone, the team manages thousands of cryotanks and more than 900 shipments annually between sites. While scaling is a success story, it also introduces new forms of risk.
“One of our goals is always consistency between labs, from SOPs, media, reagents, storage, workflows, and somewhat the layout of the labs,” Holmes said. “And at the network level, one of our priorities is to build systems that reduce variability, increase predictability, and ensure traceability of every specimen across every lab…this is obviously essential.”
Those systems can no longer rely on manual logs or disconnected spreadsheets. As Holmes explained, true risk reduction requires digitized specimen inventories, standardized workflows, and a partnership approach to relationships with validated biorepositories and logistics providers. “We’re growing a network that can increase in size without compounding its risk exposure,” she noted. “We do have greater efficiency and transparency across sites and stronger resilience against both clinical risk and legal liability. So using our partners of Cryoport (Systems) and TMRW has really helped us to get to this reward state.”
The Legal Imperative for Stronger Governance
For Dr. Steven Katz (Founder, REI Protect), cryogovernance isn’t just best practice, it’s becoming a prerequisite for insurability.
The days of using non-specialized transport companies for reproductive materials are over, Katz emphasized, saying “…the future of IVF and fertility care really depends on safe cryostorage.” Professional liability carriers now expect IVF programs to demonstrate that they have robust cryogovernance protocols in place. “You cannot go another day without an electronic witnessing system,” Katz cautioned. “Your IVF lab needs track and trace technology in and out of the cryotank…the cryotank must be monitored with state of the alarm systems…you need a long-term offsite storage partner… And again, you need a proven, state-of-the-art shipping transport partner. (That’s) crucial.”
Katz warned that most claims in reproductive medicine are “low frequency but high severity.” A single mislabeled specimen or lost shipment can lead to devastating consequences for patients and clinics alike, from emotional trauma to reputational loss and legal exposure. “I’m sorry to say this,” he added, “but I think without these technologies and relationships, you’ll likely become uninsurable in the next year or so by any quality carrier. The risk is just too high to making a mistake.” He strongly encouraged modernization of lab and logistics systems to mitigate this risk.
Where Cryoport Systems fits in
As this conversation shows, the future of reproductive medicine requires collaboration, especially between clinical operations and logistics providers.
Cryoport Systems is proud to play a leading role in enabling cryogovernance worldwide. Our reproductive medicine platform delivers the infrastructure clinics need to maintain control and compliance in reproductive shipping from end-to-end, including:
- Validated cryogenic shipping systems engineered to safeguard sensitive reproductive materials across temperature extremes and transit durations
- Continuous GPS and condition monitoring for visibility into every shipment’s location and condition, with 24/7/365 support from our expert logistics team who stand ready to intervene should any deviations occur
- Comprehensive Chain of Compliance® that integrates with laboratory and biorepository workflows, ensuring full traceability for audits and quality systems
- Insurance-backed transport and quality assurance that help reduce risk exposure and support patient confidence
By integrating these logistics solutions into the broader framework of cryogovernance, IVF programs can transform a traditional weak point into one of their strongest safeguards.
A Shared Responsibility to Protect the Future
The takeaway from Cryogovernance® VIII was clear, protecting patients’ reproductive materials – and dreams for their future family-building – is a collective responsibility.
Laboratory directors, embryologists, administrators, biorepositories, and logistics providers must operate in partnership as one continuous chain of accountability. Cryogovernance is the bridge that connects them, an approach that elevates safety to a cross-organizational mandate.
At Cryoport Systems, we believe that every specimen deserves the same level of protection, whether it’s stored in a laboratory, a biorepository, or in transit between the two. By building validated systems with continuous monitoring, we add proven reliability into every shipment and help clinics deliver on the promise at the heart of IVF: giving patients confidence that their future is protected.
