Clinical Performance Evaluation of AMH Assay

Beckman Coulter, Inc.277 enrolled

Overview

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.

same as brief summary

Study Type

OBSERVATIONAL

Enrollment

277

Conditions

Anti-Mullerian Hormone

Interventions

Access AMH AssayDIAGNOSTIC_TEST

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (13)

BRI

Phoenix, Arizona, United States

Stanford

Palo Alto, California, United States

FSMG

San Diego, California, United States

Outcomes

Primary Outcomes

Measurement of AMH as an aid for fertility assessment

Comparison of AMH levels in women at different levels of AFC to aid in assessing ovarian reserve

Time frame: Day 2 to 4 of menstrual cycle

Data from ClinicalTrials.gov

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