A Multi-Center Evaluation of a Novel IVF Cryostorage Device in an Active Clinical Setting

Abstract Purpose To evaluate the safety, function, and integration of a novel automated software-guided cryostorage system in an active IVF laboratory setting. Methods The Investigational Device (ID) was installed at 3 IVF laboratories (sites: α, β, and γ). A total of 15 embryologists were trained to use the ID. Mock patient specimens containing mirrored live patient data were handled using the ID. Temperature readings were recorded every minute. Successful identification, storage, and retrieval of patient specimens by the ID were evaluated. To assess an LN2 pressure builder, the frequency of use and events of workflow interruption were logged. Student’s t-test was used to determine statistical significance. Results The ID was in active use for 164 days total. During this time, 329 mock patient egg and embryo cohorts were handled by the ID. The mean ± SD temperatures during active use were: α, -176.57 ± 1.83OC; β, -178.21 ± 2.75OC; γ, -178.98 ± 1.74 and did not differ significantly. The highest recorded temperatures were: α, -165.14OC; β, -157.41OC; γ, -164.45OC. A total of 1064 automation transactions on 409 specimen vessels were performed. Data was managed on 1501 eggs and embryos. The ID did not lose or misplace any specimen data or vessels, and no specimen was exposed to a detrimental (>-150OC) temperature excursion. Over the 25 LN2 pressure builder usages during 99 total days, there was 1 occurrence where usage interrupted workflow due to a lack of LN2 pressure. Conclusions The ID has advantages over the current manual-based cryostorage systems, including radio frequency identification (RFID) tracking, automation of manual tasks, and software guidance to ensure accurate specimen storage and retrieval. The results of this study indicate that the ID can be easily integrated into active IVF laboratories.