Clinical trial NCT04784325: Anti-Mullerian Hormone - At My Home
Official title: AMH^2: Anti-Müllerian Hormone - At My Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fertility Risk
Lead sponsor: Turtle Health, Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-05
Enrollment: 41
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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

Primary outcomes:
measure: Correlation (r-squared) of the AMH levels resulting from the shipped TAP II samples and venipuncture samples.
timeFrame: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
Secondary outcomes:
measure: Correlation (r-squared) of AMH levels from stored TAP II samples and venipuncture samples
timeFrame: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
measure: Correlation (r-squared) of AMH levels from stored ADx samples and venipuncture samples.
timeFrame: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
measure: Number of women changing risk bands
timeFrame: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
measure: NPS superiority
timeFrame: Survey collected within 3 days of blood draw
measure: Self-reported pain
timeFrame: Survey collected within 3 days of blood draw
Other outcomes:
Locations:
city: Brookline
country: United States
facility: Turtle Health Pop-up Clinic
state: Massachusetts
Study officials:
affiliation: Fertility Institute of Hawaii
name: Anatte E Karmon, Harvard University
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.