Fertility Risk
Conditions
Brief 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 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.
Interventions
DIAGNOSTIC_TESTBlood draw through TAP II
Two self-administered blood draws through TAP II device
DIAGNOSTIC_TESTBlood draw through ADx cardT
One self-administered ADx card blood draw
DIAGNOSTIC_TESTBlood draw through standard venipuncture
One phlebotomist-performed standard venipuncture
Sponsors
Turtle Health, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Correlation (r-squared) of the AMH levels resulting from the shipped TAP II samples and venipuncture samples. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation (r-squared) of AMH levels from stored TAP II samples and venipuncture samples | Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery | Evaluate the concordance of the TAP blood collection device without shipment with in-clinic blood collection for AMH for control versus venipuncture ground truth. |
| Correlation (r-squared) of AMH levels from stored ADx samples and venipuncture samples. | Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery | Evaluate the concordance of the ADx card comparator device with in-clinic blood collection for AMH for control versus venipuncture ground truth. |
| Number of women changing risk bands | Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery | 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. |
| NPS superiority | Survey collected within 3 days of blood draw | 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). |
| Self-reported pain | Survey collected within 3 days of blood draw | Self-reported pain of different draw methods as measured by a post-draw using the Stanford Pain Scale. |
Countries
United States
Outcome results
None listed