Clinical Performance Evaluation of AMH Assay
- Conditions
- Anti-Mullerian Hormone
- Registration Number
- NCT03131388
- Lead Sponsor
- Beckman Coulter, Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 277
- ≥ 21 and < 46 years of age
- Regular menstrual cycle
- Both ovaries present
- Evidence of PCOS
- Confirmed ovarian endometrioma
- Ovarian surgery prior to enrollment
- Being treated for cancer
- Hormonal contraceptive use prior to enrollment
- Currently pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (13)
CARE
🇺🇸Dallas, Texas, United States
RAD
🇺🇸Newark, Delaware, United States
Vios Fertility
🇺🇸Swansea, Illinois, United States
BIVF
🇺🇸Waltham, Massachusetts, United States
BRI
🇺🇸Phoenix, Arizona, United States
FSMG
🇺🇸San Diego, California, United States
WRMG
🇺🇸Clearwater, Florida, United States
Stanford
🇺🇸Palo Alto, California, United States
PNWF
🇺🇸Seattle, Washington, United States
Clinique Ovo
🇨🇦Montreal, Quebec, Canada
Mainline Fertility
🇺🇸Bryn Mawr, Pennsylvania, United States
Univ Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
CORM
🇺🇸Webster, Texas, United States