Self-operated endovaginal telemonitoring: a prospective, clinical validation study
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Published on: April 6, 2015
Isabel Pereira1, Kyra von Horn1, Marion Depenbusch1
1Department of Gynecological Endocrinology and Reproductive Medicine, University Hospital of Schleswig-Holstein, Campus Luebeck, Luebeck, Germany.
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.
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