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

NCT ID: NCT04687189

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-27
• Study Completion Date: 2021-04-30

Brief 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.

Detailed 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.

Conditions

Fertility Risk

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Women with a known history of submucosal fibroids

Group Type: EXPERIMENTAL

Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)

Intervention Type: DEVICE

Imaging performed by woman on herself with remote healthcare professional (HCP) supervision compared to images taken when same ultrasound is administered in person by HCP. The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study.

Women recruited from a general population subject to I/E criteria

Group Type: EXPERIMENTAL

Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)

Intervention Type: DEVICE

Imaging performed by woman on herself with remote healthcare professional (HCP) supervision compared to images taken when same ultrasound is administered in person by HCP. The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study.

Interventions

Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)

Imaging performed by woman on herself with remote healthcare professional (HCP) supervision compared to images taken when same ultrasound is administered in person by HCP. The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Women between the ages of 18 and 38 inclusive
• Women with BMI up to 40
• Women able to freely give consent electronically, given COVID. For the purposes of this study, this is defined as women who speak native or fluent English; and have a high school degree or equivalent, and who are otherwise, in the professional judgement of the PI, able to give informed consent
• N = 30 will be recruited from the general population, e.g., no known previous issues
• N = 15 will be positive controls with submucosal fibroids
• Women who are in driving distance from Boston (including Vermont and Connecticut); these states are covered by the PI's medical license during the COVID emergency
• Women between cycle days 3 and 10 at the time of testing; or IUD users who do not have a menses

Exclusion Criteria

• Women with expert ultrasound experience, e.g., ultrasound technologists, radiologists, OB/GYNs, Reproductive Endocrinologists
• Women with BMI over 40
• Women who do not speak English natively or fluently
• Women who have recently given birth, and have had fewer than 3 postpartum menstrual cycles
• Women who have recently had a stillbirth or abortion more than 20 weeks (subject to the 3 postpartum menstrual cycles above). Miscarriages or abortions less than 20 weeks are subject to two wait cycles
• Women who are currently pregnant or may be pregnant
• Any woman the PI believes is not capable of giving independent, informed consent
• Turtle Health employees

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 38 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Turtle Health, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aaron Styer

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

Virtual metasite

Boston, Massachusetts, United States

Countries

United States

References

Chung EH, Petishnok LC, Conyers JM, Schimer DA, Vitek WS, Harris AL, Brown MA, Jolin JA, Karmon A, Styer AK. Virtual Compared With In-Clinic Transvaginal Ultrasonography for Ovarian Reserve Assessment. Obstet Gynecol. 2022 Apr 1;139(4):561-570. doi: 10.1097/AOG.0000000000004698. Epub 2022 Mar 10.

Reference Type: DERIVED

PMID: 35271530 (View on PubMed)

Other Identifiers

008

Identifier Type: -

Identifier Source: org_study_id