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

Area of Science:

• Reproductive Medicine
• Medical Imaging
• Gynecology

Background:

• Assisted reproductive technology (ART) cycles require precise monitoring of follicular and endometrial development.
• Conventional two-dimensional transvaginal sonography (2D-TVS) is the standard method for this monitoring.
• Exploring alternative monitoring methods like self-operated endovaginal telemonitoring (SOET) can improve patient experience and accessibility.

Purpose of the Study:

• To compare the accuracy and comparability of SOET with standard 2D-TVS for monitoring ART cycles.
• To evaluate the agreement between SOET and 2D-TVS in measuring follicular and endometrial parameters.
• To assess the clinical relevance of SOET in decision-making during ART.

Main Methods:

• A single-center, observational, single-blinded cohort study was conducted with 60 women undergoing ART.
• Participants were trained to use the SOET system for follicular and endometrial measurements.
• Measurements obtained via SOET were compared with those from conventional 2D-TVS.

Main Results:

• The total number of follicles >10 mm showed high similarity between SOET and 2D-TVS (r = 0.91).
• High concordance was observed for follicle count cutoffs (κ = 0.88 and κ = 0.85) and hCG administration criteria (κ = 0.734).
• SOET images were unsuitable for analysis in 26.7% of cases, associated with a statistically significant higher BMI.

Conclusions:

• SOET demonstrates good agreement with 2D-TVS for follicular and endometrial measurements in ART cycles.
• Higher BMI may be a factor in SOET image suitability for analysis.
• SOET shows promise as a comparable monitoring tool in ART, with good concordance for clinically relevant decision-making criteria.