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

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.

Study Overview

• Status: Completed
• Conditions: Fertility Risk
• Intervention / Treatment: Diagnostic test: Blood draw through TAP II; Diagnostic test: Blood draw through ADx cardT; Diagnostic test: Blood draw through standard venipuncture

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Brookline, Massachusetts, United States, 02445
      • Turtle Health Pop-up Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Turtle Health, Inc.
• Investigators: Principal Investigator: Anatte E Karmon, Harvard University, Fertility Institute of Hawaii

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2021
• Primary Completion (Actual): June 1, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: March 2, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 5, 2021

Study Record Updates

• Last Update Posted (Actual): June 22, 2021
• Last Update Submitted That Met QC Criteria: June 21, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No