131 Validation Strategy In vitro and in vivo validations were performed to test the ability of the proposed method to measure and characterise UP. In vitro, we optimized the parameterization and verified the accuracy of the OF with the data acquired by a dedicated setup with an ex vivo uterus introduced in [17]. In vivo, the proposed method was validated with TVUS recordings acquired in healthy volunteers during their normal menstrual cycle and in patients undergoing IVF treatment. A. Validation in Healthy Volunteers According to previous studies [9], [25], the uterus presents different behaviour in different phases of the menstrual cycle, showing different contraction frequencies and velocities. Therefore, we validated our proposed method for its ability to characterize and distinguish different UP patterns along the natural menstrual cycle. Feature Extraction: After deriving the RSR from the tracking results, UP velocities in both C2F and F2C directions were calculated inside the moving window. After that, median velocities (MVs) in C2F and F2C directions were calculated by averaging velocities over time in the corresponding directions. The MSE, CC, and Hd between ERant and ERpos were also estimated from each RSR signal to assess the UP coordination in each phase. The global propagation direction represented by ER metric was explicitly calculated on the full recording without the moving window. Intra-observer and Inter-observer Study: To validate the reproducibility of our method, we conducted an intra-observer study. The TMs were positioned by the same operator in two subsequent 4-min recordings acquired from the same healthy volunteer. To further analyse the intra-observer variability, the TMs were positioned three times by the same operator in the same set of recordings. In addition, two clinicians were also asked to place the TMs on the same set of recordings to perform an interobserver variability test after a 10-min training.
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