AMH^2: Anti-Müllerian Hormone - At My Home
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Correlation (r-squared) of the AMH levels resulting from the shipped TAP II samples and venipuncture samples.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Correlation (r-squared) of the AMH levels resulting from the shipped TAP II samples and venipuncture samples.
时间窗: Lab analysis 72 hours after ADx card/venipuncture/TAP II hand delivery
Evaluate the concordance of the TAP blood collection device after shipment with in-clinic blood collection for AMH.
次要结局
- Self-reported pain(Survey collected within 3 days of blood draw)
- 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)