Fertility RiskAMH^2NCT04784325
Anti-Mullerian Hormone - At My Home
A study testing Blood draw through TAP II, Blood draw through ADx cardT and Blood draw through standard venipuncture in people with Fertility Risk, run by Turtle Health, Inc. at 1 site in United States.
Trial summary
The AMH^2 (Anti-Mullerian Hormone - At My Home) study is a head-to-head-to-head validation study aiming to evaluate the concordance of AMH levels found in blood collected via three different routes: collected at-home using the TAP II device, drawn through standard venipuncture techniques, and collected with the ADx… Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Fertility Risk
- What is being tested?
- Blood draw through TAP II, Blood draw through ADx cardT and Blood draw through standard venipuncture
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2021to 1 Jun 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 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women between the ages of 20 and 39, inclusive (two age brackets above)
- 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
- Women who are in driving distance from Boston
Who cannot join
- Turtle Health employees
- 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 wait 2 cycles
- Women who are currently pregnant or may be pregnant
- Women who have known blood hypo- or hypercoagulability disorders or known blood clotting issues
- Any woman the PI believes is not capable of giving independent, informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Turtle Health Pop-up Clinic
Brookline, Massachusetts, 02445
About this study
Official title: AMH^2: Anti-Müllerian Hormone - At My Home
The AMH^2 (Anti-Mullerian Hormone - At My Home) study is a head-to-head-to-head validation study aiming to evaluate the concordance of AMH levels found in blood collected via three different routes: collected at-home using the TAP II device, drawn through standard venipuncture techniques, and collected with the ADx card, another at-home collection device widely available on the market for commercial use.
Read the detailed description
Today, information regarding fertility potential is challenging to obtain for healthy women; clinically meaningful in-clinic testing is limited by physician availability and patient willingness to undergo testing in-clinic. Meanwhile, at-home hormonal bloodwork relies on the use of an ADx card, and is not widely accepted as clinically reliable by the medical community. The Sponsor is developing a comprehensive home fertility assessment to enable couples to proactively estimate and manage their fertility and family building options. Accurate and reliable at-home AMH testing is necessary to reach this goal.
This study aims to validate the clinical excellence and medical accuracy of blood drawn via the TAP II device relative to a standard in-clinic venipuncture draw and other options available on the market to support emerging telemedicine care models. In doing so, the Sponsor may receive CLIA validation for the TAP II in AMH testing and commercialize a Lab Developed Test.
- Conditions
- Fertility Risk
- Being tested
- Blood draw through TAP II, Blood draw through ADx cardT, Blood draw through standard venipuncture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood draw through TAP IIDiagnostic test
Two self-administered blood draws through TAP II device
Blood draw through ADx cardTDiagnostic test
One self-administered ADx card blood draw
Blood draw through standard venipunctureDiagnostic test
One phlebotomist-performed standard venipuncture
| Study group | Role | What they receive |
|---|---|---|
| Women recruited from a general population subject to I/E criteria | Experimental | All study participants will administer three blood collection modalities (2 TAP II, 1 ADx card, and phlebotomist-performed venipuncture). Receives: Diagnostic Test: Blood draw through TAP II; Diagnostic Test: Blood draw through ADx cardT; Diagnostic Test: Blood draw through standard venipuncture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation (r-squared) of the AMH levels resulting from the shipped TAP II samples and venipuncture samples.
Evaluate the concordance of the TAP blood collection device after shipment with in-clinic blood collection for AMH.
Measured: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
Secondary outcomes (5)
Correlation (r-squared) of AMH levels from stored TAP II samples and venipuncture samples
Evaluate the concordance of the TAP blood collection device without shipment with in-clinic blood collection for AMH for control versus venipuncture "ground truth".
Measured: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
Correlation (r-squared) of AMH levels from stored ADx samples and venipuncture samples.
Evaluate the concordance of the ADx card comparator device with in-clinic blood collection for AMH for control versus venipuncture "ground truth".
Measured: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
Number of women changing risk bands
The number of participants who move to a different risk strata for their age and hormonal birth control status. This will be defined by changing to a different row for their AMH concentration range, treating venipuncture as the "Gold Standard" and comparing the number of women who move rows utilizing their TAP draws or ADx card draw.
Measured: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
NPS superiority
Superiority of net promoter score of TAP II device compared to venipuncture as measured by a post-draw survey (calculated as a standard NPS: 9/10 scores - 0-6 scores).
Measured: Survey collected within 3 days of blood draw
Self-reported pain
Self-reported pain of different draw methods as measured by a post-draw using the Stanford Pain Scale.
Measured: Survey collected within 3 days of blood draw
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Apr 2021
- Primary completion1 Jun 2021
- Study completion1 Jun 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Turtle Health, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anatte E Karmon, Harvard University, Principal investigator, Fertility Institute of Hawaii
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784325
- Sponsor's protocol ID
- 009
- Acronym
- AMH^2
- Status last verified
- Jun 2021
- First submitted
- 2 Mar 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Silliman E, Chung EH, Fitzpatrick E, Jolin JA, Brown M, Hotaling J, Styer AK, Karmon AE. Evaluation of at-home serum anti-Mullerian hormone testing: a head-to-head comparison study. Reprod Biol Endocrinol. 2022 Sep 1;20(1):131. doi: 10.1186/s12958-022-01004-2.
PubMed 36050723
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMH^2: Anti-Müllerian Hormone - At My Home
- ClinicalTrials.gov ID
- NCT04784325
- Acronym / sponsor ID
- AMH^2 / 009
- Conditions
- Fertility Risk
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Turtle Health, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 1 Jun 2021 (actual)
- First posted
- 5 Mar 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.
The AMH^2 (Anti-Mullerian Hormone - At My Home) study is a head-to-head-to-head validation study aiming to evaluate the concordance of AMH levels found in blood collected via three different routes: collected at-home using the TAP II device, drawn through standard venipuncture techniques, and collected with the ADx card, another at-home collection device widely available on the market for commercial use.
Detailed description
Today, information regarding fertility potential is challenging to obtain for healthy women; clinically meaningful in-clinic testing is limited by physician availability and patient willingness to undergo testing in-clinic. Meanwhile, at-home hormonal bloodwork relies on the use of an ADx card, and is not widely accepted as clinically reliable by the medical community. The Sponsor is developing a comprehensive home fertility assessment to enable couples to proactively estimate and manage their fertility and family building options. Accurate and reliable at-home AMH testing is necessary to reach this goal.
This study aims to validate the clinical excellence and medical accuracy of blood drawn via the TAP II device relative to a standard in-clinic venipuncture draw and other options available on the market to support emerging telemedicine care models. In doing so, the Sponsor may receive CLIA validation for the TAP II in AMH testing and commercialize a Lab Developed Test.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Women recruited from a general population subject to I/E criteria | Experimental | Diagnostic Test: Blood draw through TAP II, Diagnostic Test: Blood draw through ADx cardT, Diagnostic Test: Blood draw through standard venipunctureAll study participants will administer three blood collection modalities (2 TAP II, 1 ADx card, and phlebotomist-performed venipuncture). |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women between the ages of 20 and 39, inclusive (two age brackets above)
- 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
- Women who are in driving distance from Boston
Key exclusion criteria (7 listed)
- Turtle Health employees
- 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 wait 2 cycles
- Women who are currently pregnant or may be pregnant
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 |
|---|---|---|
| Blood draw through TAP IITwo self-administered blood draws through TAP II device | Diagnostic test | Women recruited from a general population subject to I/E criteria |
| Blood draw through ADx cardTOne self-administered ADx card blood draw | Diagnostic test | Women recruited from a general population subject to I/E criteria |
| Blood draw through standard venipunctureOne phlebotomist-performed standard venipuncture | Diagnostic test | Women recruited from a general population subject to I/E criteria |
Primary outcome
Correlation (r-squared) of the AMH levels resulting from the shipped TAP II samples and venipuncture samples.
Time frame: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
Evaluate the concordance of the TAP blood collection device after shipment with in-clinic blood collection for AMH.
5 secondary outcomes
Correlation (r-squared) of AMH levels from stored TAP II samples and venipuncture samples
Time frame: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
Correlation (r-squared) of AMH levels from stored ADx samples and venipuncture samples.
Time frame: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
Number of women changing risk bands
Time frame: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
NPS superiority
Time frame: Survey collected within 3 days of blood draw
Self-reported pain
Time frame: Survey collected within 3 days of blood draw
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 22 Jun 2021.
- Derived from this study: PubMed 36050723Silliman E, Chung EH, Fitzpatrick E, Jolin JA, Brown M, Hotaling J, Styer AK, Karmon AE. Evaluation of at-home serum anti-Mullerian hormone testing: a head-to-head comparison study. Reprod Biol Endocrinol. 2022 Sep 1;20(1):131. doi: 10.1186/s12958-022-01004-2.
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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.
Anatte E Karmon, Harvard University principal investigator
Fertility Institute of Hawaii
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood draw through TAP II, Blood draw through ADx cardT and Blood draw through standard venipuncture 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 3 inclusion and 7 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 22 Jun 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?
Correlation (r-squared) of the AMH levels resulting from the shipped TAP II samples and venipuncture samples. (time frame: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery). 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 NCT04784325, 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 22 Jun 2021.