Clinical Performance Evaluation of AMH Assay

July 11, 2018 updated by: Beckman Coulter, Inc.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

same as brief summary

Study Type

Observational

Enrollment (Actual)

277

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada
        • Clinique OVO
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85258
        • BRI
    • California
      • Palo Alto, California, United States, 94305
        • Stanford
      • San Diego, California, United States, 92123
        • FSMG
    • Delaware
      • Newark, Delaware, United States, 19713
        • RAD
    • Florida
      • Clearwater, Florida, United States, 33759
        • WRMG
    • Illinois
      • Swansea, Illinois, United States, 62226
        • Vios Fertility
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • BIVF
    • Pennsylvania
      • Bryn Mawr, Pennsylvania, United States, 19010
        • Mainline Fertility
      • Philadelphia, Pennsylvania, United States, 19104
        • Univ Pennsylvania
    • Texas
      • Dallas, Texas, United States, 76022
        • CARE
      • Webster, Texas, United States, 77598
        • CORM
    • Washington
      • Seattle, Washington, United States, 98104
        • PNWF

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Adult women presenting to fertility clinics for fertility assessment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measurement of AMH as an aid for fertility assessment
Time Frame: Day 2 to 4 of menstrual cycle
Comparison of AMH levels in women at different levels of AFC to aid in assessing ovarian reserve
Day 2 to 4 of menstrual cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beckman Coulter, Inc.

Investigators

  • Study Director: Fred Siebert, BECKMAN COULTER

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2016

Primary Completion (Actual)

April 30, 2018

Study Completion (Actual)

April 30, 2018

Study Registration Dates

First Submitted

April 17, 2017

First Submitted That Met QC Criteria

April 24, 2017

First Posted (Actual)

April 27, 2017

Study Record Updates

Last Update Posted (Actual)

July 13, 2018

Last Update Submitted That Met QC Criteria

July 11, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • AMH 2.7.1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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