Anti-Mullerian Hormone - At My Home

Study Overview
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Brief Summary
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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
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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.

Official Title
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AMH^2: Anti-Müllerian Hormone - At My Home

Conditions
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Fertility Risk

Intervention / Treatment
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* Diagnostic Test: Blood draw through TAP II
* Diagnostic Test: Blood draw through ADx cardT
* Diagnostic Test: Blood draw through standard venipuncture


Participation Criteria
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Eligibility Criteria
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Study Participants Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women recruited from a general population subject to I/E criteria<br>All study participants will administer three blood collection modalities (2 TAP II, 1 ADx card, and phlebotomist-performed venipuncture). | Diagnostic Test: Blood draw through TAP II<br>* Two self-administered blood draws through TAP II device<br>Diagnostic Test: Blood draw through ADx cardT<br>* One self-administered ADx card blood draw<br>Diagnostic Test: Blood draw through standard venipuncture<br>* One phlebotomist-performed standard venipuncture<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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). | 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. | Survey collected within 3 days of blood draw |