Abstract Study question Can patient self-scans with a home ultrasound device, with or without professional remote online guidance, be used for ovarian and endometrial monitoring during for ART? Summary answer Follicle number/size and endometrial thickness recorded from patients’ home ultrasound self-acquired scans, especially when guided online, corresponded with standard sonographies and aspirated oocyte yield. What is known already Follicle number and size are a key parameter for monitoring the ovarian stimulation and determining the time for triggering and OPU. The endometrial thickness (EMT) and pattern are important parameters associated with implantation and pregnancy. Both are measured repeatedly in serial sonographies during the ART cycles, imposing a significant burden of time, travel and cost on patients, while adding to the clinic’s workload. Patient self-scans with a home ultrasound device can potentially relief patient travel discomfort and the clinic’s patient congestion. Study design, size, duration Open label study performed during one IVF cycle. Participants were trained to visualize uterus and ovaries using the Pulsenmore FC device. After training the patients were randomized to two groups: independent use (IU-scans) or remote online guidance by a clinical sonographer (CG-scans). Before each in-clinic scan patients obtained and recorded their pelvic scan, which were read blindly and compared to the in-clinic scans for ovaries and uterus visualization, follicles number and size, and EMT. Participants/materials, setting, methods Patients without Mullerian or pelvic pathologies undergoing stimulation for IVF. Clinical decisions and triggering were based on individual considerations and the standard in-clinic ultrasound measurements. OPU was performed 36-38h after triggering. All ultrasound scans were analyzed for image quality, number and size of follicles and EMT and compared to the in-clinic scans as the gold standard (GS). Correlation was calculated based on the Spearman Correlation Factor (SCF). Patient satisfaction was measured using a questionnaire. Main results and the role of chance Twenty-four patients completed the study, 11-CG and 13-IU. Image quality score was>3 and adequate uterine visualization was achieved in 100% of the CG-scans and in 87% of the IU-scans. The right ovary was imaged in 100% of the CG-scans and 85.7% of the IU-scans. The left ovary in 97.4% of the CG-scans and 85.7% of the IU-scans. CG-scans AFC correlated better with the GS than IU-scans AFC (SCF 0.85vs.0.12). Correct identification of the first follicle>14mm was achieved in 100% of the CG-scans and in 92% of the IU-patients. Maximal EMT from CG-scans was better correlated with the GS than the IU-scans (SCF 0.64vs.0.46), with a clinically insignificant difference (0.4mm). The number of stimulated follicles obtained from CG-scans was better correlated with the GS than IU-scans (SCF 0.94 vs.0.43). The oocytes/stimulated follicles ratio was 1.19 for the GS and 1.28 for the self scans (1.06 for CG-scans, 1.9 for IU-scans). The MII/follicles>14mm ratio was 1.12 for the GS and 1.49 for the self scans (1.27 for CG-scans,1.69 for IU-scans). Patients’ questionnaire revealed that 89% of patients felt comfortable to self-scan themselfs, 86.5% were interested to use the device and 75% will recommend it to their friends. Limitations, reasons for caution Self vaginal ultrasound scanning is not suitable for all patients and online support by a sonographer is required. Inter-observer differences in scan measurements should be taken into consideration. Since participation in the study was limited to one cycle, no patient learning curve for IU-scans could be evaluated. Wider implications of the findings Reliable folliculometry and endometrial measurements can be obtained from patient self-use vaginal ultrasound scans. Online assistance enhances scanning accuracy. Together with near/home lab tests, safe remote management of ovarian stimulation can be realized, reducing costs, discomfort and travel time, ultimately reducing workload for fertility clinics, and improving workforce flexibility. Trial registration number NCT05485623
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Oct 24, 2024
Yang Wu + 3
Open Access
Just Published
