Clinical Performance Evaluation of AMH Assay

Beckman Coulter

Status: Completed

Conditions: Anti-Mullerian Hormone

Treatments: Diagnostic Test: Access AMH Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT03131388

AMH 2.7.1

Details and patient eligibility

About

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.

Full description

same as brief summary

Enrollment: 277 patients

Sex: Female

Ages: 21 to 45 years old

Volunteers: No Healthy Volunteers

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