Ignite Creation Date:
2024-05-06 @ 3:52 PM
Last Modification Date:
2024-10-26 @ 1:58 PM
Study NCT ID:
NCT04784325
Status:
COMPLETED
Last Update Posted:
2021-06-22
First Post:
2021-03-02
Brief Title:
Anti-Mullerian Hormone - At My Home
Sponsor:
Turtle Health Inc
Organization:
Turtle Health Inc
Study Overview
Official Title:
AMH2 Anti-Müllerian Hormone - At My Home
Status:
COMPLETED
Status Verified Date:
2021-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMH2
Brief Summary:
The AMH2 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None