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Anti-Mullerian Hormone - At My Home (AMH^2)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04784325
Recruitment Status : Completed
First Posted : March 5, 2021
Last Update Posted : June 22, 2021
Sponsor:
Information provided by (Responsible Party):
Turtle Health, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Fertility Risk Diagnostic Test: Blood draw through TAP II Diagnostic Test: Blood draw through ADx cardT Diagnostic Test: Blood draw through standard venipuncture Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: AMH^2: Anti-Müllerian Hormone - At My Home
Actual Study Start Date : April 1, 2021
Actual Primary Completion Date : June 1, 2021
Actual Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hormones

Arms and Interventions
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Arm Intervention/treatment
Experimental: Women recruited from a general population subject to I/E criteria
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
Two self-administered blood draws through TAP II device

Diagnostic Test: Blood draw through ADx cardT
One self-administered ADx card blood draw

Diagnostic Test: Blood draw through standard venipuncture
One phlebotomist-performed standard venipuncture


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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 ]
    Evaluate the concordance of the TAP blood collection device without shipment with in-clinic blood collection for AMH for control versus venipuncture "ground truth".

  2. 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 ]
    Evaluate the concordance of the ADx card comparator device with in-clinic blood collection for AMH for control versus venipuncture "ground truth".

  3. Number of women changing risk bands [ Time Frame: 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.

  4. NPS superiority [ Time Frame: 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).

  5. Self-reported pain [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04784325


Locations
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United States, Massachusetts
Turtle Health Pop-up Clinic
Brookline, Massachusetts, United States, 02445
Sponsors and Collaborators
Turtle Health, Inc.
Investigators
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Principal Investigator: Anatte E Karmon, Harvard University Fertility Institute of Hawaii
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Turtle Health, Inc.
ClinicalTrials.gov Identifier: NCT04784325    
Other Study ID Numbers: 009
First Posted: March 5, 2021    Key Record Dates
Last Update Posted: June 22, 2021
Last Verified: June 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No