Anti-Mullerian Hormone - At My Home

NCT04784325 | Completed

• 1 other identifier: 009
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Fertility Risk

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Correlation (r-squared) of AMH levels from stored TAP II samples and venipuncture samples

  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.

  Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery

• Number of women changing risk bands

  Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery

• NPS superiority

  Survey collected within 3 days of blood draw

• Self-reported pain

  Survey collected within 3 days of blood draw

Study Arms (1)

Women recruited from a general population subject to I/E criteria

EXPERIMENTAL

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; Diagnostic Test: Blood draw through ADx cardT; Diagnostic Test: Blood draw through standard venipuncture

Interventions

Blood draw through TAP II DIAGNOSTIC_TEST

Two self-administered blood draws through TAP II device

Women recruited from a general population subject to I/E criteria

Blood draw through ADx cardT DIAGNOSTIC_TEST

One self-administered ADx card blood draw

Women recruited from a general population subject to I/E criteria

Blood draw through standard venipuncture DIAGNOSTIC_TEST

One phlebotomist-performed standard venipuncture

Women recruited from a general population subject to I/E criteria

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Turtle Health, Inc.: lead

Study Sites (1)

Turtle Health Pop-up Clinic

Brookline, Massachusetts, 02445, United States

Location

Related Publications (1)

• 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.

  PMID: 36050723 DERIVED

Study Officials

• Anatte E Karmon, Harvard University

  Fertility Institute of Hawaii

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 5, 2021
• Study Start: April 1, 2021
• Primary Completion: June 1, 2021
• Study Completion: June 1, 2021
• Last Updated: June 22, 2021

Record last verified: 2021-06

Locations

US (1)