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

Turtle Health

Status

Completed

Conditions

Fertility Risk

Treatments

Diagnostic Test: Blood draw through standard venipuncture

Diagnostic Test: Blood draw through TAP II

Diagnostic Test: Blood draw through ADx cardT

Study type

Interventional

Funder types

Industry

Identifiers

NCT04784325

009

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

Female

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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