Clinical trial NCT04687189: Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study
Official title: SELF-HELP Validation Study: Sonograms Enable Looking Forward - Home Examinations Led by Providers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Risk
Lead sponsor: Turtle Health, Inc.
Sponsor class: INDUSTRY
First posted: 2020-12-29
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Clinically comparable video quality of supervised self-performed scan
timeFrame: Day 1 (self-performed scan)
measure: Clinically comparable video quality of HCP-performed scan
timeFrame: Day 2 (HCP-performed scan)
Secondary outcomes:
measure: Change in net promoter score (NPS) between supervised self-performed and HCP-performed scans
timeFrame: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
measure: Change in antral follicle count (AFC) between supervised self-performed and HCP-performed scans
timeFrame: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
measure: Change in detection accuracy for major submucosal fibroids between supervised self-performed and HCP-performed scans in the known history of submucosal fibroids arm
timeFrame: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
measure: Change in all-cause false positive rate between supervised self-performed and HCP-performed scans in the general population arm
timeFrame: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Virtual metasite
state: Massachusetts
Study officials:
affiliation: Harvard University
name: Aaron Styer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.