A multi-center evaluation of a novel IVF cryostorage device in an active clinical setting

被引：0

作者：

Collins, Michael G. ^{[1
]}

Bailey, Jessica ^{[2
]}

Tremont, Jordan ^{[2
]}

Laasch, Natalee ^{[2
]}

Mcdonough, Cali ^{[2
]}

Dufault, Andrea ^{[2
]}

Martin, Jessica ^{[2
]}

Li, Albert ^{[3
]}

Pitts, Stefan ^{[3
]}

Kontaxis, Emma ^{[3
]}

Slifkin, Richard E. ^{[3
]}

Lee, Joseph A. ^{[3
]}

Reed, Laura ^{[4
]}

Swain, Jason E. ^{[5
]}

Schoolcraft, William B. ^{[4
]}

Stringfellow, Ellen ^{[1
]}

Woodhull, Robert ^{[1
]}

Souza, Ashley ^{[1
]}

机构：

[1] TMRW Life Sci, 250 Hudson St,6th Floor, New York, NY 10013 USA

[2] Boston IVF Eugin Grp, Waltham, MA USA

[3] Reprod Med Associates New York, New York, NY USA

[4] CCRM Colorado, Lonetree, CO USA

[5] CCRM Fertil, Lonetree, CO USA

来源：

SCIENTIFIC REPORTS | 2024年 / 14卷 / 01期

关键词：

Cryostorage; Automation; Embryo; Digital chain of custody; IVF; ASSISTED REPRODUCTIVE TECHNOLOGIES; IN-VITRO FERTILIZATION; STORAGE; TRANSPORT; ANDROLOGY; FATIGUE;

D O I：

10.1038/s41598-024-69877-4

中图分类号：

O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];

学科分类号：

07 ; 0710 ; 09 ;

摘要：

The objective of this study was to evaluate the function, and usability of a novel automated software-guided cryostorage system in an active IVF laboratory setting. The investigational device (ID) was installed at 3 IVF laboratories (sites: alpha, beta, and gamma). 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 mock 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. 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: alpha, - 176.57 +/- 1.83 degrees C; beta, - 178.21 +/- 2.75 degrees C; gamma, - 178.98 +/- 1.74 and did not differ significantly. The highest recorded temperatures were: alpha, - 165.14 degrees C; beta, - 157.41 degrees C; gamma, - 164.45 degrees C. 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 mock specimen was exposed to a detrimental (> - 150 degrees C) 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. 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 integrated into active IVF laboratories.

引用

页数：6