Clinical Performance Evaluation of AMH Assay

Completed

Conditions studied: Anti-Mullerian Hormone

In brief

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.

Key facts

Study ID

NCT03131388

Run by

Beckman Coulter, Inc.

People needed

277

Starts

2016-09-01

Expected to finish

2018-04-30

Last updated by the study team

2018-07-13

Who can join

Age: 21 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• BRI — Phoenix, Arizona, United States
• Stanford — Palo Alto, California, United States
• FSMG — San Diego, California, United States
• RAD — Newark, Delaware, United States
• WRMG — Clearwater, Florida, United States
• Vios Fertility — Swansea, Illinois, United States
• BIVF — Waltham, Massachusetts, United States
• Mainline Fertility — Bryn Mawr, Pennsylvania, United States
• Univ Pennsylvania — Philadelphia, Pennsylvania, United States
• CARE — Dallas, Texas, United States
• CORM — Webster, Texas, United States
• PNWF — Seattle, Washington, United States
• Clinique Ovo — Montreal, Quebec, Canada

Full record on ClinicalTrials.gov

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