Fertility IssuesHER-USENCT05004870
Home Examinations Researching and Understanding Submucosal Evaluations
A study testing Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) in people with Fertility Issues, run by Turtle Health, Inc. at 1 site in United States.
Trial summary
To demonstrate that imaging via home ultrasound can identify submucosal fibroids. The image quality and submucosal fibroid detection specificity of the home imaging has already been demonstrated; the aim of this study is to generate further data for sensitivity. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Fertility Issues
- What is being tested?
- Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2021to 17 Dec 2021
- 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 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women with one or more submucosal fibroid, with appropriate attestation (see more detail below)
- Women between the ages of 18 and 49 inclusive (women 38 and younger can also receive their antral follicle count, or AFC; 39 and older will participate in uterine scanning only)
- Women with BMI up to 40
- Women located in states where the PI or sub-PI licensure is valid
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Home Examinations Researching and Understanding Submucosal Evaluations: Prospective, Virtual Study to Demonstrate Sensitivity of Submucosal Fibroids on At-home Ultrasound (Follow up to SELF-HELP Study)
To demonstrate that imaging via home ultrasound can identify submucosal fibroids. The image quality and submucosal fibroid detection specificity of the home imaging has already been demonstrated; the aim of this study is to generate further data for sensitivity. This will be a single visit study, with participants scanning themselves at home with healthcare professional (HCP) supervision. Targeted population is women with previously diagnosed submucosal fibroids that have not been removed. The study will be single-blinded to the image raters.
- Conditions
- Fertility Issues
- Being tested
- Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)Device
The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study.
| Study group | Role | What they receive |
|---|---|---|
| Women with a known history of submucosal fibroids (that have not been surgically removed) | Experimental | Not described Receives: Device: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of the at-home ultrasound for submucosal fibroids
Qualified independent raters will be asked if they see a submucosal fibroid on the uterine videos. Answer options are: Yes, definitely; Almost certain; Possibly; Unlikely; No; N/A. In order to consider a fibroid present, either (1) two raters must answer "Almost certain" to having seen a submucosal fibroid or (2) one must answer "Yes definitely" to having seen a submucosal fibroid
Measured: Up to 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start16 Dec 2021 (estimated)
- Primary completion17 Dec 2021 (estimated)
- Study completion17 Dec 2021 (estimated)
Why it stopped: Study objective embedded into future study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fertility IssuesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turtle Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004870
- Sponsor's protocol ID
- 010
- Acronym
- HER-USE
- Status last verified
- Apr 2022
- First submitted
- 6 Aug 2021
- Last updated
- 29 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home Examinations Researching and Understanding Submucosal Evaluations: Prospective, Virtual Study to Demonstrate Sensitivity of Submucosal Fibroids on At-home Ultrasound (Follow up to SELF-HELP Study)
- ClinicalTrials.gov ID
- NCT05004870
- Acronym / sponsor ID
- HER-USE / 010
- Conditions
- Fertility Issues
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study objective embedded into future study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Turtle Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2021 (estimated)
- Primary completion
- 17 Dec 2021 (estimated)
- Study completion
- 17 Dec 2021 (estimated)
- First posted
- 13 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To demonstrate that imaging via home ultrasound can identify submucosal fibroids. The image quality and submucosal fibroid detection specificity of the home imaging has already been demonstrated; the aim of this study is to generate further data for sensitivity. This will be a single visit study, with participants scanning themselves at home with healthcare professional (HCP) supervision. Targeted population is women with previously diagnosed submucosal fibroids that have not been removed. The study will be single-blinded to the image raters.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women with a known history of submucosal fibroids (that have not been surgically removed) | Experimental | Device: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Women with one or more submucosal fibroid, with appropriate attestation (see more detail below)
- Women between the ages of 18 and 49 inclusive (women 38 and younger can also receive their antral follicle count, or AFC; 39 and older will participate in uterine scanning only)
- Women with BMI up to 40
- Women located in states where the PI or sub-PI licensure is valid
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)The ultrasound device used is cleared for HCP-supervised use in environments where healthcare is provided by trained HCPs. No changes to the design or manufacture have been made for this study. | Device | Women with a known history of submucosal fibroids (that have not been surgically removed) |
Primary outcome
Sensitivity of the at-home ultrasound for submucosal fibroids
Time frame: Up to 20 minutes
Qualified independent raters will be asked if they see a submucosal fibroid on the uterine videos. Answer options are: Yes, definitely; Almost certain; Possibly; Unlikely; No; N/A. In order to consider a fibroid present, either (1) two raters must answer "Almost certain" to having seen a submucosal fibroid or (2) one must answer "Yes definitely" to having seen a submucosal fibroid
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2022.
Related trials for Fertility Issues
Active, not recruitingObservational study
Fresh Versus Vitrified-Warmed Donor Oocytes: Embryological and Clinical Outcomes
Infertility, Donor Oocyte Assisted Reproduction
RecruitingPhase 3
A Study to Compare the Efficacy and Safety of Follitropin Alfa/Lutropin Alfa Versus hMG in Japanese Participants With LH and FSH Deficiency Undergoing ART (HINATA)
Infertility
RecruitingObservational study
Safety and Efficacy of Corifollitropin Alfa N02 Injection in Elderly Women Undergoing Assisted Reproductive Technology (ART)
Infertility
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
Not yet recruiting
Implementing IVM for Fertility Treatment in Clinical Practice
Infertility
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) in people with Fertility Issues, 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 8 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 29 Apr 2022. 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?
Sensitivity of the at-home ultrasound for submucosal fibroids (time frame: Up to 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Apr 2022.