JMIR Publications

ABSTRACT

Background:

Ovarian follicles and endometrial thickness are monitored repeatedly for assisted reproduction, imposing a significant burden on patients and clinics. Self-scans with a home ultrasound device can relieve this burden.

Objective:

We aimed to evaluate the real-life reliability and accuracy of patient self-scans using the smartphone-based Pulsenmore FC vaginal self-scan device (FC) in comparison to standard in-clinic (IC) sonographies, in patients undergoing ovarian stimulation and oocyte pick-up for assisted reproduction or fertility preservation.

Methods:

A single-center, interventional, controlled, prospective study including 44 patients without pelvic pathologies undergoing stimulation for in-vitro fertilization (IVF) (2022-2024). Patients were trained to use a vaginal home ultrasound device and scan their uterus and ovaries with remote guidance in each cycle check-point. Clinical decisions were based on standard IC sonographies. Image quality, endometrial thickness, number and size of follicles obtained from home scans were compared to those obtained IC. Aspirated oocytes numbers were compared to the follicles recorded at the last visit by home and IC scans. Differences in follicular count and endometrial thickness between IC and FC scans were compared with absolute differences using means, standard deviations and 95% confidence intervals. Relations between IC and FC outcomes were analyzed by the Spearman correlation. The time difference between the first and last self-scans was calculated using the T-test for dependent samples. All tests applied were two-tailed, and a p-value of 5% or less was considered statistically significant.

Results:

The image quality scores of all home scans were at minimum suitable, and most of them were of better quality. The endometrial measurements and follicular counts/measurements obtained from home scans were in correlation with IC scans in all the clinically significant parameters; antral follicle count, number of stimulated follicles, identification of the leading follicle>14mm, and follicular number/size pre-triggering. The aspirated oocyte/last visit stimulated follicles and mature oocytes/follicles>13mm ratios were well-correlated between the home and standard scans.

Conclusions:

The home ultrasound device, its method of operation and result interpretation were found to be comparable to conventional sonographies, laying the basis for remote home-base monitoring of follicular development during ovarian stimulation. We believe this also applies to monitoring milder stimulations and even natural cycles, helping those seeking to achieve or avoid natural fertility. Clinical Trial: The study was registered at ClinicalTrials.gov (NCT05485623).