Abstract
Now that ovarian tissue cryopreservation (OTC) has become standard of care for patients receiving gonadotoxic therapies, discussion has turned toward offering OTC to pediatric patients with Turner syndrome outside of research. Although patients with Turner syndrome have unmet fertility needs and the authors support efforts for fertility preservation in these individuals, safety and efficacy data about OTC in this population are limited. Building on longstanding debates around offering experimental therapies as research or outside of research (as "innovative therapy"), we considered the suitability of offering OTC for patients with Turner syndrome as innovative therapy. On the basis of pathophysiology and preliminary research data, we argue that there is significant uncertainty about whether the risk-benefit profile of OTC for patients with Turner syndrome is favorable. This reduces the weight of arguments in favor of offering it as innovative therapy. Furthermore, as Turner syndrome is rare, widespread availability of OTC could make it difficult to develop generalizable knowledge. The benefits of innovative therapy for acquiring experience from use in humans and avoiding research-related procedures are of limited importance too, as OTC is already an established procedure, and current studies involve limited procedures that restrict access. OTC should therefore only be offered to patients with Turner syndrome in research settings until additional data suggest that the risk-benefit profile is likely favorable.