Fertility RiskSELF-HELPNCT04687189
Sonograms Enable Looking Forward - Home Examinations Led by Providers Validation Study
A study testing Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) in people with Fertility Risk, run by Turtle Health, Inc. at 1 site in United States.
Trial 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 interpretable by physicians with sufficient clarity to estimate approximate antral follicle count (i.e., appropriate for… Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Risk
- 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
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Feb 2021to 30 Apr 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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: SELF-HELP Validation Study: Sonograms Enable Looking Forward - Home Examinations Led by Providers
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 interpretable by physicians with sufficient clarity to estimate approximate antral follicle count (i.e., appropriate for age) and to observe submucosal fibroids. Study aims to prove that images taken when ultrasound is performed by a woman herself (with HCP supervision via telemedicine) and images taken when ultrasound is administered by an HCP are of comparable quality. Study population reflects real-world patient characteristics and includes both general-population and submucosal fibroid positive controls.
Read the 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-clinic, while home testing is limited to hormonal bloodwork which is insufficient on its own and has high false positives. Sponsor is developing home telemedicine transvaginal ultrasound as part of a home fertility assessment. Sponsor wishes to demonstrate the ability to obtain interpretable images, in women of varying body habitus, reproductive age, and reproductive status.
- Conditions
- Fertility Risk
- Being tested
- Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine)
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
Imaging performed by woman on herself with remote healthcare professional (HCP) supervision compared to images taken when same ultrasound is administered in person by HCP. 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 | Experimental | Not described Receives: Device: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) |
| Women recruited from a general population subject to I/E criteria | 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.
Clinically comparable video quality of supervised self-performed scan
As assessed by two experienced, qualified independent raters on a 4 point scale for each organ visualized and each modality (supervised versus HCP). 4 point scale consists of: 4=excellent image quality; 3=acceptable image quality; 2=below clinical quality; 1=nondiagnostic. Scale is translated into binary outcome to assess if image is clinically comparable. 'Clinical-quality image' of an organ requires a score of '3' or greater on the scale.
Measured: Day 1 (self-performed scan)
Clinically comparable video quality of HCP-performed scan
As assessed by two experienced, qualified independent raters on a 4 point scale for each organ visualized and each modality (supervised versus HCP). 4 point scale consists of: 4=excellent image quality; 3=acceptable image quality; 2=below clinical quality; 1=nondiagnostic. Scale is translated into binary outcome to assess if image is clinically comparable. 'Clinical-quality image' of an organ requires a score of '3' or greater on the scale.
Measured: Day 2 (HCP-performed scan)
Secondary outcomes (4)
Change in net promoter score (NPS) between supervised self-performed and HCP-performed scans
Evaluated by survey post ultrasound administration. Calculated as a standard NPS: 9/10 scores = 1; 7/8 scores = 0; 0-6 scores = -1, missing = 0.
Measured: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
Change in antral follicle count (AFC) between supervised self-performed and HCP-performed scans
Difference between antral follicle count (AFC) identified in both ovaries among exams in two modalities (supervised self-performed and HCP-performed), conducted proximately (within 24-48 hours of each other)
Measured: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
Change in detection accuracy for major submucosal fibroids between supervised self-performed and HCP-performed scans in the known history of submucosal fibroids arm
Difference between accurate identification of submucosal fibroids among exams in two modalities (supervised self-performed and HCP-performed), conducted proximately (within 24-48 hours of each other)
Measured: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
Change in all-cause false positive rate between supervised self-performed and HCP-performed scans in the general population arm
Difference between false positive rate among exams in two modalities (supervised self-performed and HCP-performed), conducted proximately (within 24-48 hours of each other). An all-cause false positive will be defined as a subject where pathology requiring in-person follow-up is identified on the supervised self-performed exam, but not substantiated by identification by the HCP-administered exam.
Measured: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start27 Feb 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Fertility RiskStudies 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
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turtle Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Aaron Styer, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04687189
- Sponsor's protocol ID
- 008
- Acronym
- SELF-HELP
- Status last verified
- May 2021
- First submitted
- 4 Dec 2020
- Last updated
- 18 May 2021
- 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
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SELF-HELP Validation Study: Sonograms Enable Looking Forward - Home Examinations Led by Providers
- ClinicalTrials.gov ID
- NCT04687189
- Acronym / sponsor ID
- SELF-HELP / 008
- Conditions
- Fertility Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Turtle Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Feb 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 29 Dec 2020 (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 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 interpretable by physicians with sufficient clarity to estimate approximate antral follicle count (i.e., appropriate for age) and to observe submucosal fibroids. Study aims to prove that images taken when ultrasound is performed by a woman herself (with HCP supervision via telemedicine) and images taken when ultrasound is administered by an HCP are of comparable quality. Study population reflects real-world patient characteristics and includes both general-population and submucosal fibroid positive controls.
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-clinic, while home testing is limited to hormonal bloodwork which is insufficient on its own and has high false positives. Sponsor is developing home telemedicine transvaginal ultrasound as part of a home fertility assessment. Sponsor wishes to demonstrate the ability to obtain interpretable images, in women of varying body habitus, reproductive age, and reproductive status.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women with a known history of submucosal fibroids | Experimental | Device: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) |
| Women recruited from a general population subject to I/E criteria | Experimental | Device: Transvaginal ultrasound performed by a woman herself (with HCP supervision via telemedicine) |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
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)Imaging performed by woman on herself with remote healthcare professional (HCP) supervision compared to images taken when same ultrasound is administered in person by HCP. 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 recruited from a general population subject to I/E criteria, Women with a known history of submucosal fibroids |
Primary outcome
Clinically comparable video quality of supervised self-performed scan
Time frame: Day 1 (self-performed scan)
As assessed by two experienced, qualified independent raters on a 4 point scale for each organ visualized and each modality (supervised versus HCP). 4 point scale consists of: 4=excellent image quality; 3=acceptable image quality; 2=below clinical quality; 1=nondiagnostic. Scale is translated into binary outcome to assess if image is clinically comparable. 'Clinical-quality image' of an organ requires a score of '3' or greater on the scale.
Clinically comparable video quality of HCP-performed scan
Time frame: Day 2 (HCP-performed scan)
As assessed by two experienced, qualified independent raters on a 4 point scale for each organ visualized and each modality (supervised versus HCP). 4 point scale consists of: 4=excellent image quality; 3=acceptable image quality; 2=below clinical quality; 1=nondiagnostic. Scale is translated into binary outcome to assess if image is clinically comparable. 'Clinical-quality image' of an organ requires a score of '3' or greater on the scale.
4 secondary outcomes
Change in net promoter score (NPS) between supervised self-performed and HCP-performed scans
Time frame: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
Change in antral follicle count (AFC) between supervised self-performed and HCP-performed scans
Time frame: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
Change in detection accuracy for major submucosal fibroids between supervised self-performed and HCP-performed scans in the known history of submucosal fibroids arm
Time frame: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
Change in all-cause false positive rate between supervised self-performed and HCP-performed scans in the general population arm
Time frame: Day 1 (self-performed scan) and Day 2 (HCP-performed scan)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Derived from this study: PubMed 35271530Chung 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.
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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.
Aaron Styer principal investigator
Harvard University
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 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 7 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: finished, as of the sponsor's last update on 18 May 2021. 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 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?
Clinically comparable video quality of supervised self-performed scan (time frame: Day 1 (self-performed scan)). 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 NCT04687189, which also lists 1 linked publication.
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 18 May 2021; AzTrials last refreshed its copy on 1 Nov 2026.