Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study — SELF-HELP  

Fertility Risk Clinical Trial

Official title: SELF-HELP Validation Study: Sonograms Enable Looking Forward - Home Examinations Led by Providers

Status Completed

Clinical Trial Summary

To demonstrate that clear, interpretable quality images of the ovaries and uterus can be generated using a portable transvaginal ultrasound scanner in the home environment, and that those images are interpretable by physicians with sufficient clarity to estimate approximate antral follicle count (i.e., appropriate for age) and to observe submucosal fibroids. Study aims to prove that images taken when ultrasound is performed by a woman herself (with HCP supervision via telemedicine) and images taken when ultrasound is administered by an HCP are of comparable quality. Study population reflects real-world patient characteristics and includes both general-population and submucosal fibroid positive controls.

Clinical Trial Description

Today, pro-fertility information is generally unavailable to healthy women; clinically meaningful in-clinic testing is limited by physician availability and patient willingness to undergo testing in-clinic, while home testing is limited to hormonal bloodwork which is insufficient on its own and has high false positives. Sponsor is developing home telemedicine transvaginal ultrasound as part of a home fertility assessment. Sponsor wishes to demonstrate the ability to obtain interpretable images, in women of varying body habitus, reproductive age, and reproductive status. ;

Related Conditions & MeSH terms

• Fertility Risk

• NCT number: NCT04687189
• Study type: Interventional
• Source: Turtle Health, Inc.
• Status: Completed
• Phase: N/A
• Start date: February 27, 2021
• Completion date: April 30, 2021