Self-operated endovaginal telemonitoring: a prospective, clinical validation study

Abstract

Objective: To study the comparability of self-operated endovaginal telemonitoring (SOET) with conventional two-dimensional transvaginal sonography (2D-TVS) monitoring during assisted reproductive technology (ART) cycles.

Design: Single center, observational, single-blinded cohort study.

Setting: University-affiliated in vitro fertilization center.

Patient(s): A total of 60 women undergoing ART cycles.

Intervention(s): Explanation, training, and use of SOET system, and measurements of follicular and endometrial diameter with SOET and 2D-TVS.

Main outcome measure(s): Correlation of the total number of follicles >10 mm measured by SOET versus conventional 2D-TVS.

Result(s): In 16 cases (26.7%) the images were judged unsuitable for analysis. In these excluded cases the body mass index (BMI) was statistically significantly higher (29.3 vs. 24.4 kg/m(2)). The total number of follicles >10 mm was highly similar comparing SOET with conventional 2D-TVS (r = 0.91). For the concordance of whether more than 19 follicles or more than 25 follicles >10 mm were present, we found agreement between the methods in 43 of 44 cases (κ = 0.88) and 43 of 44 cases (κ = 0.85), respectively. For concordance on predefined human chorionic gonadotropin administration criteria, agreement was found in 39 of 44 cases (κ = 0.734).

Conclusion(s): The incidence of SOET videos not suitable for analysis seems to be associated with higher BMI. Otherwise, SOET showed good agreement with conventional 2D-TVS both for follicles and endometrium measurements. More importantly we also found good concordance regarding the cutoffs relevant for clinical decisions.

Keywords: ART cycles; self-operated endovaginal telemonitoring; telemonitoring; transvaginal sonography.