Clinical Performance Evaluation of AMH Assay

Anti-Mullerian Hormone Clinical Trial

Official title:

Clinical Performance Evaluation of AMH Assay

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131388
• Other study ID #: AMH 2.7.1
• Status: Completed
• Start date: September 2016
• Est. completion date: April 30, 2018

Study information

• Verified date: July 2018
• Source: Beckman Coulter, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

same as brief summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Gender: Female
• Age group: 21 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Anti-Mullerian Hormone

Intervention

Diagnostic Test:
• Access AMH Assay

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Day 2 to 4 of menstrual cycle