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Fertility RiskSELF-GYN1NCT05443698

SELF-GYN1 (Sonograms Enable Looking Forward- Get Your iNformation 1 Trial)

A study testing Transvaginal ultrasound in people with Fertility Risk, run by Turtle Health, Inc. at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This clinical trial will 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… Read more about this study

Who is it for?
Ages 22 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Fertility Risk
What is being tested?
Transvaginal ultrasound
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
365 participants
Where
2 sitesUnited States
Study dates
25 Jul 2022to 14 Jul 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 22 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Woman, as defined by sex at birth
  • Age 22 years or older at the time of eligibility screening
  • Premenopausal
  • BMI < 40 kg/m2
  • Unlikely to be pregnant during home scan, based on either current intrauterine device (IUD) or other birth control use or recent menstruation, defined as the home scan occurring between day 3 and 10 of the menstrual cycle based on patient self-report
  • English-speaking and able to follow verbal instructions of the remote ultrasound technologist as determined by the ability to complete the consent process unassisted
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  • Ability to manipulate a 1 lb. weight by hand
  • Residence in state where a PI holds a valid license to practice medicine
  • Ability to receive signature delivery of the investigational ultrasound device
  • Ability to return the investigational ultrasound device by specified instructions

Who cannot join

  • Pregnant or may be pregnant
  • Has recently given birth, and has had fewer than 3 postpartum menstrual cycles
  • Has 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
  • Has changed birth control within the current menstrual cycle (one 'washout' cycle is required)
  • Turtle Health employees
  • Has known cancer of a pelvic organ, not currently in remission
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  • Not able to schedule a scan while meeting the requirements above prior to the end of the trial. For example, women who change birth control within the last cycle of the trial (and would require a 'washout cycle' that would delay trial close) or who are unable to schedule within the last few weeks of the trial after reasonable scheduling efforts have been made
  • Previous hysterectomy or oophorectomy
  • Does not have one or more of the following anatomic organs: vagina, left ovary, right ovary, or uterus
  • Subjects with prior scanning experience are included in the trial (as they would be in the real world) but excluded from the primary image quality endpoint (due to experience potentially influencing that endpoint) and analyzed separately as a subgroup for that endpoint only. This sub-population is capped at 200 subjects (~20% of trial)

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Virtual Site

    Boston, Massachusetts, 02110

  • Mayo Clinic

    Rochester, Minnesota, 55902

Other trials in United States

About this study

Official title: Sonograms Enable Looking Forward- Get Your iNformation 1 Trial

This clinical trial will 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.

Read the detailed description

Those images will be assessed for their image quality by qualified Independent Readers. The study is intended to assess the ability of at home imaging performed with the Turtle Health Ultrasound Scanner to reliably produce quality images as compared to objective performance criteria set by the American Institute of Ultrasound in Medicine (AIUM).

The clinical investigation is intended to extend the findings of a published trial (SELF-HELP) to real-world performance.

Each participant will have imaging performed at-home. The at-home imaging will be conducted using the Turtle Health Ultrasound Scanner, manipulated by the participant and guided in real time by a remote ultrasound technologist that has received special training with the device. Home imaging will follow the procedures included in planned device labeling. Imaging obtained will include, at minimum, each of the specific imaging views and components defined in the "American Institute of Ultrasound in Medicine (AIUM) Case Study Submission Requirements: Gynecologic Ultrasound".

Imaging Scans will be assessed by at least two (2) independent readers who are physicians expert in the interpretation of transvaginal ultrasound gynecologic imaging studies. Images will have participant name redacted and each independent reader will be blinded to any participant information other than the images themselves. They will also be blinded to the assessments of the other readers. In-clinic Imaging Scans obtained from either or both of previous trials and in-clinic scans will be included in rating batches for calibration.

Conditions
Fertility Risk
Being tested
Transvaginal ultrasound

What participants receive

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

  • Transvaginal ultrasoundDevice

    Adult women in the U.S. who are eligible for the ultrasound trial on the basis of the inclusion/exclusion criteria will complete an at home transvaginal ultrasound guided by real-time remote supervision from a qualified and specially trained ultrasound technologist.

Study groups in NCT05443698
Study groupRoleWhat they receive
Ultrasound DeviceOtherAll women who choose to enroll in the trial will undergo an at home transvaginal ultrasound guided by real-time remote supervision from a qualified and specially trained ultrasound technologist.
Receives: Device: Transvaginal ultrasound

What is being measured

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

  1. Image Quality

    Each Independent Reader will make a determination of whether each Imaging Scan is of 'diagnostic quality' or 'not diagnostic quality', in its totality, for the purpose of a diagnostic gynecological ultrasound examination.

    Measured: 6 weeks

  2. Net Promoter Score (NPS)

    All subjects will be asked to complete the question 'How likely are you to recommend the experience to a friend or colleague?.' It is expected that a high share of patients will report a positive NPS.

    Measured: 6 weeks

Secondary outcomes (18)

  1. False Positives

    Rate of false positives of 'significant findings'

    Measured: 6 weeks

  2. Performance Task of Independent Readers

    Each Independent Reader will assess the suitability of the Imaging Study for use on each of ten specific imaging tasks defined by the AIUM practice parameters as required for a high quality two-dimensional gynecological ultrasound imaging study.

    Measured: 6 weeks

  3. Box Opening

    Patient opens box at correct time (not early)

    Measured: 6 weeks

  4. Patient Identifier

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

    Measured: 6 weeks

  5. Probe Cover

    Patient correctly applies probe cover and uses it successfully during the scan

    Measured: 6 weeks

  6. Correct Cavity

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

    Measured: 6 weeks

  7. Timely Return

    Patient ships product back in a timely fashion

    Measured: 6 weeks

  8. Shipping Damage

    Rate at which probe is damaged in transit

    Measured: 6 weeks

  9. Successful Return

    Rate at which probe remains in working condition and able to be reprocessed

    Measured: 6 weeks

  10. Minor Pain or Discomfort

    Rate at which subjects report minor pain, discomfort, or similarly mild symptoms lasting under 24 hours

    Measured: 6 weeks

  11. All Other Adverse Events

    Rate at which subjects report adverse events, side effects, or other sequelae other than minor pain, discomfort, or similarly mild symptoms lasting under 24 hours

    Measured: 6 weeks

  12. Successful Reprocessing

    Number of probes undergoing reprocessing that are reprocessed properly per internal standard operating procedures

    Measured: 6 weeks

  13. Ultrasound technologist satisfaction

    Difference in average weekly satisfaction between in-person and virtual settings based on survey responses

    Measured: 6 months

  14. Ultrasound technologist availability

    Estimation of weekly increase in personnel capacity enabled by device based on number of ultrasound technologists available.

    Measured: 6 months

  15. Ultrasound technologist safety

    Implied/potential estimation of injury reduction based on survey results

    Measured: 6 months

  16. Correct setting of care guess rate

    Including in-clinic 'control' data from previous study or from in-clinic scans with same device

    Measured: 6 months

  17. Sub-group exploratory endpoints: Endpoint 1

    Results from the primary end point "Image Quality" will also be reported by sub-populations of interest. The sub-populations are:

    1. Class I obese patients (BMI between 30 and 35, inclusive)
    2. Class II+ obese patients (BMI greater than 35)
    3. Aged 40 or older
    4. Residing in 'completely rural' or 'mostly rural' counties
    5. Symptoms indicating possible pathology (where available)
    6. No record of visiting a doctor in the 24 months prior to enrollment (where available)
    7. Educational attainment less than some college
    8. Identifying as Hispanic or Latino
    9. Identifying as
    • American Indian or Alaska Native
    • Asian
    • Black or African American
    • Native Hawaiian or Other Pacific Islander
    • White
    • Multiple identities selected

    Measured: 1 year

  18. Sub-group exploratory endpoints: Endpoint 2

    Results from the primary end point "Net Promoter Score (NPS)" will also be reported by sub-populations of interest. There sub-populations are:

    1. Class I obese patients (BMI between 30 and 35, inclusive)
    2. Class II+ obese patients (BMI greater than 35)
    3. Aged 40 or older
    4. Residing in 'completely rural' or 'mostly rural' counties
    5. Symptoms indicating possible pathology (where available)
    6. No record of visiting a doctor in the 24 months prior to enrollment (where available)
    7. Educational attainment less than some college
    8. Identifying as Hispanic or Latino
    9. Identifying as
    • American Indian or Alaska Native
    • Asian
    • Black or African American
    • Native Hawaiian or Other Pacific Islander
    • White
    • Multiple identities selected

    Measured: 1 year

Timeline

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

  1. First posted5 Jul 2022
  2. Study start25 Jul 2022
  3. Primary completion14 Jul 2023
  4. Study completion14 Jul 2023

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
Not applicable
Intervention model
Single group
Model description
Prospective, interventional, single arm clinical trial
Masking
None (open label)
Enrolment
365 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05443698
Sponsor's protocol ID
016
Acronym
SELF-GYN1
Status last verified
Jul 2023
First submitted
22 Jun 2022
Last updated
17 Jul 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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

  • Ainsworth AJ, Sacha C, Vagios S, Doke B, Vitek W, Fridman D, Islam T, Pecoriello J, Chelliah J, Martini A, Verrilli L, Brown M, Styer A. At-Home Transvaginal Pelvic Ultrasonography and Image Quality in Premenopausal Women: A Nonrandomized Clinical Trial. JAMA Netw Open. 2026 Jul 1;9(7):e2621476. doi: 10.1001/jamanetworkopen.2026.21476.

    PubMed 42406404

Questions about this trial

What is this clinical trial studying?

A study testing Transvaginal ultrasound in people with Fertility Risk, run by Turtle Health, Inc. at 2 sites 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 17 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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). The study lists 2 primary outcomes in all. 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 NCT05443698, which also lists 4 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 17 Jul 2023.

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