Abstract / Summary
Virtual histology is a method by which live magnified images of tissue’s upper layers are combined with computerized analysis to provide tissue diagnosis. It provides a useful two-fold view of both the tissue’s in-vivo appearance and morphological characteristics. The method is particularly efficient for the endometrium due to its rapid remodeling during the normal menstrual cycle. Endometrial dating is routinely assessed for embryo transfer timing in IVF, yet currently, it remains inaccurate and controversial. High magnification, safe and usable hysteroscopy, with minimal image deformation, can offer more accurate endometrial dating. Utilizing a mini-hysteroscopic system, we captured 363 high-quality images during 77 sessions performed on 20 participants, on different cycle days. With zero severe adverse events, physicians defined the use of the system to be “very easy” to “reasonable” in 95% of all sessions. Among participants, in all sessions, 86% did not report any pain. Image quality was evaluated “good” to “excellent” in > 65% of the sessions. Image-based endometrial dating compared to dating according to participant’s report and urine LH test, yields correlation coefficients of ≥ 0.9 ( P < 10 − 3 ). In this study we demonstrate that the mini-hysteroscope system is safe, highly usable and provides high-quality images for endometrial virtual histology assessment and dating. Trial registration : Registry number under clinicaltrials.gov is NCT05440019 (30.6.2022).