NCT04784325

Anti-Mullerian Hormone - At My Home

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Turtle Health, Inc. · Industry
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

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.

Conditions

• Fertility Risk

Interventions

Type	Name	Description
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

Timeline

• Start date: 2021-04-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2021-03-05
• Last updated: 2021-06-22

Locations

1 site across 1 country: United States