Clinical Performance Evaluation of AMH Assay

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03131388

Enrollment

277

Registered

2017-04-27

Start date

2016-09-30

Completion date

2018-04-30

Last updated

2018-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anti-Mullerian Hormone

Brief summary

The Access AMH Assay is an in vitro diagnostic assay intended as an aid for fertility assessment. The purpose of the study is to evaluate the clinical performance of the Access AMH Assay in the intended use population.

Detailed description

same as brief summary

Interventions

DIAGNOSTIC_TESTAccess AMH Assay

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Age

21 Years to 45 Years

Inclusion criteria

* ≥ 21 and \< 46 years of age * Regular menstrual cycle * Both ovaries present

Exclusion criteria

* Evidence of PCOS * Confirmed ovarian endometrioma * Ovarian surgery prior to enrollment * Being treated for cancer * Hormonal contraceptive use prior to enrollment * Currently pregnant

Design outcomes

Primary

Measure	Time frame	Description
Measurement of AMH as an aid for fertility assessment	Day 2 to 4 of menstrual cycle	Comparison of AMH levels in women at different levels of AFC to aid in assessing ovarian reserve

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026