Monitoring Ovarian Stimulation for Assisted Reproduction With Patient Self-Scans Using a Home Vaginal Ultrasound Device: A Single-Center Interventional, Prospective Study.

Background: Ovarian follicles and endometrial thickness are monitored repeatedly for assisted reproduction, burdening patients and clinics. Self-scans with a home ultrasound device can relieve this. Objective: We aimed to evaluate the reliability of self-scans using the smartphone-based Pulsenmore follicle count vaginal self-scan device (FC) versus in-clinic (IC) sonographies, in ovarian stimulation for in-vitro fertilization or fertility preservation. Methods: This study is a single-center, interventional, controlled, prospective study including 44 patients without pelvic pathologies undergoing stimulation for in-vitro fertilization (2022-2024). Following training, patients used a vaginal home ultrasound device to scan their uterus and ovaries with remote guidance by a sonographer in each cycle check-point. Clinical decisions were based on standard IC sonographies. FC and IC results were compared for image quality, endometrial thickness, and follicle count or size. Aspirated oocyte numbers were compared to the follicles recorded at the last visit by home and IC scans. Absolute differences in follicular count and endometrial thickness between IC and FC scans were compared using means, SDs, and 95% CIs. The Spearman correlation (r) analyzed the relations between IC and FC outcomes. All tests applied were 2-tailed, with a P value of ≤5% considered statistically significant. Patient and sonographer satisfaction were assessed via surveys. Results: Of 44 patients, 34 completed this study. The mean age was 34.7 (SD 4.0) years, and BMI was 25.8 (SD 5.0) kg/m². A total of 65% (22/34) pursued fertility preservation and 35% (12/34) aimed to conceive. The image quality scores of all home scans were at a minimum suitable level, with most of better quality. FC measurements closely matched IC findings for key clinical parameters: antral follicle count (mean FC 11.94, SD 6.62 vs mean IC 15.23, SD 10.2, ρ=0.86, P<.001); number of stimulated follicles ≥10 mm (FC 12.19, SD 6.27 vs IC 13.5, SD 8.87, ρ=0.84, P<.001); identification of the leading follicle >14 mm (achieved in 87% of FC scans); and follicular number or size pretriggering. The aspirated oocyte or last-visit stimulated follicles (>10 mm; FC 1.12, SD 0.6 vs IC 1.06, SD 0.56, ρ=0.82, P<.001), mature oocytes or follicles >13 mm ratios (FC 1.28, SD 1.11 vs IC 1.04, SD 0.77, ρ=0.88, P<.001), and endometrial thickness pretriggering (FC 9.87, SD 2.2 mm vs IC 9.63, SD 2.7 mm, ρ=0.54, P=.002) were well-correlated between the home and standard scans, with 87.1% concordance in identifying endometrial adequacy (≥7 mm). In the patient survey, 82% (28/34) expressed interest in future use of the FC device. In the sonographer survey, 91% (31/34) demonstrated patient improvement. Conclusions: The home ultrasound device was feasible, comparable, and well-correlated with standard IC scans, laying the basis for remote home-based monitoring of follicular development during ovarian stimulation. We believe this also applies to monitoring milder stimulations and even natural cycles.