A Strategy To Validate The Introduction Of Time-Lapse Incubator In The Laboratory.

To present a strategy to validate the introduction of time-lapse technology in the laboratory for clinical use. Retrospective case-control study performed at an assisted reproduction clinic in southern Brazil. The data refers to a period from January to February 2020 and was collected from electronic records. Inclusion criteria: patients undergoing in vitro fertilization (IVF), with at least two fertilized oocytes. A total of 39 patients were included in the analysis. Embryos from the same patient were then divided into two groups: Group 1, embryos cultured in the Time-lapse technology, and Group 2: embryos cultured in a conventional incubator. A total of 417 inseminated oocytes (G1=210; G2: 207) and 188 blastocysts (G1=111; G2=77) were included. Fertilization rate, embryo development and blastocyst rate were analyzed between groups. Mann–Whitney U-test test was applied. Variables was expressed in median [25th-75th], and statistical significance was defined as p<0.05. The mean maternal age was 34.6 ± 4.4. When compared Group 1 with Group 2 the following results were observed: inseminated oocytes (5 [4-6] vs. 5 [4-7], p=0.800); fertilized oocytes (5 [3-6] vs. 4 [3-5], p=0.334); fertilized oocytes rate (fertilized/inseminated) (83.3% [71.4-100.0] vs 83.3 % [66.7-100], p=0.657); D3 embryos with more than 6 cells (4 [2-5] vs. 2 [1-5] (p=0.028); number of blastocysts (D5 plus D6) (3 [1-4] vs. 1.5 [1-3], p=0.039) and blastocysts rate (60.0% [33.3-75.0] vs 45% [18,6-61.7], p=0.038). In this study, data from 39 patients and 188 blastocysts was sufficient for demonstrating statistical difference regarding to embryo development in different incubators. Hence, the applied methodology in this study may be a strategy to validate the introduction of time-lapse technology in the laboratory for clinical use.