Status:
COMPLETED
Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study
Lead Sponsor:
Turtle Health, Inc.
Conditions:
Fertility Risk
Eligibility:
FEMALE
18-38 years
Phase:
NA
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 i...
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-c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2021
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT04687189
Start Date
February 27 2021
End Date
April 30 2021
Last Update
May 18 2021
Active Locations (1)
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1
Virtual metasite
Boston, Massachusetts, United States, 02115