P1.237: Advocating for National Regulation of Embryo Storage Facilities: Addressing Social, Legal, and Economic Impact

Background: Embryo cryopreservation remains a critical component of assisted reproductive technologies (ART), extending fertility preservation options for patients in the context of medical diagnoses, infertility, or personal life choice. The Centers for Disease Control and Prevention (CDC) reported 98,289 ART live births across 457 clinics in the United States in 2022, underscoring widespread utilization. However, the embryo storage landscape is inconsistently regulated, exposing a variety of stakeholders to serious social and economic risks. The notable 2018 failure of a storage tank, resulting in the loss of over 4,000 embryos and eggs, impacting more than 950 patients, has brought attention to poor regulatory standards. Between 2009 and 2019, 133 legal cases were filed related to the loss or damage of embryos, with 11 directly caused by storage tank failures.

Project Description: This advocacy project integrates quantitative data and published legal and clinical research to emphasize the need for national oversight of embryo storage facilities (ESFs). Sources include: CDC, ART outcome reports, the American Society for Reproductive Medicine (ASRM) guidelines, and peer-reviewed legal literature. This review incorporates litigation trends, failure mechanisms, and access disparities that impact equitable ART participation. This analysis also addresses issues such as unclaimed embryos, cryopreservation safety, and counseling quality.

Discussion: The findings reveal that regulatory failure in ESFs poses legal, psychological, and financial consequences. ARSM guidelines recommend standardized alarm systems, stronger cryotank monitoring, and locked storage rooms, but these are not federally mandated. Many documented lawsuits cite negligence, improper maintenance, and equipment failure. Data demonstrates that a significant portion of cryopreserved embryos may remain in storage long-term, and clinics lack standard protocols for disposition. Furthermore, access to ART is inequitable: geography was noted as a barrier in 11 of 19 public health studies, and insurance coverage limitations in 37%. Minority patients receive disproportionately low rates of fertility counseling before treatment.

Conclusion: This advocacy project demonstrates that without national regulation, ESFs operate with inadequate safety standards and oversight, placing patients and stakeholders at risk. We advocate for federal protocols mandating cryotank monitoring systems, closed vitrification systems, and disaster planning. Broader insurance coverage and culturally sensitive counseling are essential. With ART usage expanding rapidly nationwide, there is a public health and ethical imperative to safeguard stored reproductive material.