Care Expansion Across Remote Environments - Sub-Study of the SELF-GYN1 Trial

Fertility Risk Clinical Trial

— CARE  

Official title:

Care Expansion Across Remote Environments - Substudy of the SELF-GYN [Sonograms Enable Looking Forward - Get Your iNformation] Extension - I Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05509322
• Other study ID #: 016a
• Status: Withdrawn
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: April 10, 2023

Study information

• Verified date: April 2023
• Source: Turtle Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This real-world, interventional sub-study will evaluate the impact of potential payer subsidies for Turtle Health at-home consults on subsequent interactions with the healthcare system within select sub-populations of interest.

Description:

The present study is a sub-study of the SELF-GYN1 study. The SELF-GYN1 study is a multicenter study designed to evaluate the efficacy and safety of the use of the Turtle Health Ultrasound Scanner for the acquisition of transvaginal ultrasound images by a study participant, with no previous training, in her home when guided by real-time remote supervision from a qualified and specially trained ultrasound technologist.

In addition to the main questions of the SELF-GYN1 study, additional questions related to patient decision-making and pricing dynamics for patients who purchase patient's decisions to purchase a fertility consult alongside enrolling in the SELF-GYN1 trial, will be studied at Mayo Clinic, through providing subsidies for the purchasing of the fertility consult.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 10, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

Inclusion Criteria:

• All inclusion criteria from the SELF-GYN1 trial apply

• Participant in Mayo Clinic health system

• Lives in MN

• Belongs to a sub-population targeted for enrollment that has not yet met its enrollment target

• Consent to participate in electronic health record monitoring and outreach

Exclusion Criteria:

• All exclusion criteria from the SELF-GYN1 trial apply

• Planning to move away from MN in the next year

Related Conditions & MeSH terms

• Fertility Risk

Intervention

Other:
• Subsidy for fertility consult
Some participants will receive a subsidy when they purchase the fertility consult.
• Invitation to purchase fertility consult
Some participants will receive an invitation from their health center to purchase an at-home fertility consult.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Turtle Health, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

Birch Petersen K, Maltesen T, Forman JL, Sylvest R, Pinborg A, Larsen EC, Macklon KT, Nielsen HS, Hvidman HW, Nyboe Andersen A. The Fertility Assessment and Counseling Clinic - does the concept work? A prospective 2-year follow-up study of 519 women. Acta Obstet Gynecol Scand. 2017 Mar;96(3):313-325. doi: 10.1111/aogs.13081. Epub 2017 Feb 3. — View 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. — View Citation

Farquhar C, Ekeroma A, Furness S, Arroll B. A systematic review of transvaginal ultrasonography, sonohysterography and hysteroscopy for the investigation of abnormal uterine bleeding in premenopausal women. Acta Obstet Gynecol Scand. 2003 Jun;82(6):493-504. doi: 10.1034/j.1600-0412.2003.00191.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Image quality	Percent of women whose stills are clinical quality, in each of 3 populations of interest.	6 weeks
Secondary	False positives	Rate of false positives of 'significant findings'	6 weeks
Secondary	Recalled Net Promoter Score	Difference between recalled in-clinic Net Promoter Score and at-home Net Promoter Score. The Net Promoter Score has a range of 0-10 with higher scores indicating more favorable responses.	6 weeks
Secondary	Number of patients opening box at correct time	Confirming patient opens box at correct time (not early)	6 weeks
Secondary	Number of correct patients identified	Correct patient is identified by tech and tests (not wrong patient)	6 weeks
Secondary	Number of patients who used probe cover	Patient correctly applies probe cover without either a) failing to apply it or b) ripping it, including in low light or other sub-optimal conditions	6 weeks
Secondary	Number of patients placing probe in correct cavity	Patient places probe in correct cavity (vaginal vs. anal)	6 weeks
Secondary	Rate of return packages sent	Patient ships product back in a timely fashion	6 weeks
Secondary	Rate of probes that crack	Probe does not crack on out-return trip	6 weeks
Secondary	Rate of working probes	Probe remains in working condition	6 weeks
Secondary	Rate of probes being reprocessed	Probe is reprocessed properly per internal SOPs	6 weeks
Secondary	Adverse events	Number and type of adverse events that occur	6 weeks
Secondary	Number of participants per subsidy	Level of participation (purchase and completion of consult) per subsidy level within each cohort of interest	6 months
Secondary	Number of couples who participate	Level of participation in couple consults where offered - i.e., purchase of both male and female consult, per subsidy level within each cohort of interest	6 months
Secondary	Clinically significant findings	Percentage of patients in which clinically significant findings are identified	6 weeks
Secondary	Number of IVF cycles	Number of IVF cycles conducted	6 months
Secondary	Percentage of IVF cycles	Percentage of IVF cycles considered clinically necessary based on treating physician survey	6 months
Secondary	Number of gynecological surgeries	Number of gynecological surgeries conducted	6 months
Secondary	Percentage of minimally invasive gynecological surgeries	Percentage of those surgeries that are considered minimally invasive based on treating physician survey	6 months
Secondary	Percentage of gynecological surgeries	Percentage of those surgeries that are considered clinically necessary within next 12 months based on treating physician survey	12 months
Secondary	Number of additional TVUS	Number of additional transvaginal ultrasounds conducted to monitor findings identified during at-home consult	6 months
Secondary	Number of other follow-up care	Number of other follow-up care sought based on findings identified during at-home consult	6 months
Secondary	Percentage of follow up care per arm	Percentage of patients in each arm seeking follow up care of any kind; fertility care in particular after consult	6 months