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AzTrials

Fertility RiskCARENCT05509322

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

A study testing Subsidy for fertility consult and Invitation to purchase fertility consult in people with Fertility Risk, run by Turtle Health, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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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. Read more about this study

Who is it for?
Ages 25 to 35 years, women only
Conditions the study is for
Fertility Risk
What is being tested?
Subsidy for fertility consult and Invitation to purchase fertility consult
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
1 Jan 2023to 10 Apr 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 35 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • All exclusion criteria from the SELF-GYN1 trial apply
  • Planning to move away from MN in the next year

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic

    Rochester, Minnesota, 55902

Other trials in United States

About this study

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

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.

Read the detailed 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.

Conditions
Fertility Risk
Being tested
Subsidy for fertility consult, Invitation to purchase fertility consult

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Subsidy for fertility consultOther

    Some participants will receive a subsidy when they purchase the fertility consult.

  • Invitation to purchase fertility consultOther

    Some participants will receive an invitation from their health center to purchase an at-home fertility consult.

Study groups in NCT05509322
Study groupRoleWhat they receive
Invitation to fertility consult with subsidyExperimentalThis group will be invited to purchase a fertility consult, and will be offered a subsidy if they choose to purchase the consult.
Receives: Other: Subsidy for fertility consult; Other: Invitation to purchase fertility consult
Invitation to fertility consult without subsidyActive comparatorThis group will be invited to purchase a fertility consult at full price.
Receives: Other: Invitation to purchase fertility consult
Control (no invitation)No interventionThis group will not receive invitations to purchase a fertility consult.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Image quality

    Percent of women whose stills are clinical quality, in each of 3 populations of interest.

    Measured: 6 weeks

Secondary outcomes (22)

  1. False positives

    Rate of false positives of 'significant findings'

    Measured: 6 weeks

  2. 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.

    Measured: 6 weeks

  3. Number of patients opening box at correct time

    Confirming patient opens box at correct time (not early)

    Measured: 6 weeks

  4. Number of correct patients identified

    Correct patient is identified by tech and tests (not wrong patient)

    Measured: 6 weeks

  5. 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

    Measured: 6 weeks

  6. Number of patients placing probe in correct cavity

    Patient places probe in correct cavity (vaginal vs. anal)

    Measured: 6 weeks

  7. Rate of return packages sent

    Patient ships product back in a timely fashion

    Measured: 6 weeks

  8. Rate of probes that crack

    Probe does not crack on out-return trip

    Measured: 6 weeks

  9. Rate of working probes

    Probe remains in working condition

    Measured: 6 weeks

  10. Rate of probes being reprocessed

    Probe is reprocessed properly per internal SOPs

    Measured: 6 weeks

  11. Adverse events

    Number and type of adverse events that occur

    Measured: 6 weeks

  12. Number of participants per subsidy

    Level of participation (purchase and completion of consult) per subsidy level within each cohort of interest

    Measured: 6 months

  13. 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

    Measured: 6 months

  14. Clinically significant findings

    Percentage of patients in which clinically significant findings are identified

    Measured: 6 weeks

  15. Number of IVF cycles

    Number of IVF cycles conducted

    Measured: 6 months

  16. Percentage of IVF cycles

    Percentage of IVF cycles considered clinically necessary based on treating physician survey

    Measured: 6 months

  17. Number of gynecological surgeries

    Number of gynecological surgeries conducted

    Measured: 6 months

  18. Percentage of minimally invasive gynecological surgeries

    Percentage of those surgeries that are considered minimally invasive based on treating physician survey

    Measured: 6 months

  19. Percentage of gynecological surgeries

    Percentage of those surgeries that are considered clinically necessary within next 12 months based on treating physician survey

    Measured: 12 months

  20. Number of additional TVUS

    Number of additional transvaginal ultrasounds conducted to monitor findings identified during at-home consult

    Measured: 6 months

  21. Number of other follow-up care

    Number of other follow-up care sought based on findings identified during at-home consult

    Measured: 6 months

  22. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2022
  2. Study start1 Jan 2023 (estimated)
  3. Primary completion10 Apr 2023
  4. Study completion10 Apr 2023

Why it stopped: Study is no longer going to be occurring- no subjects were enrolled at any point.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, interventional, multi-arm real-world study
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05509322
Sponsor's protocol ID
016a
Acronym
CARE
Status last verified
Apr 2023
First submitted
10 Aug 2022
Last updated
12 Apr 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes

Publications

  • 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.

    PubMed 35271530

  • 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.

    PubMed 27990627

  • 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.

    PubMed 12780419

Questions about this trial

What is this clinical trial studying?

A study testing Subsidy for fertility consult and Invitation to purchase fertility consult in people with Fertility Risk, run by Turtle Health, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 12 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Image quality (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05509322, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2023.

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