Clinical Performance Evaluation of AMH Assay

NCT ID: NCT03131388

Last Updated: 2018-07-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

277 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2018-04-30

Brief Summary

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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

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same as brief summary

Conditions

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Anti-Mullerian Hormone

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Interventions

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Access AMH Assay

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Beckman Coulter, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Fred Siebert

Role: STUDY_DIRECTOR

Beckman Coulter

Locations

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BRI

Phoenix, Arizona, United States

Site Status

Stanford

Palo Alto, California, United States

Site Status

FSMG

San Diego, California, United States

Site Status

RAD

Newark, Delaware, United States

Site Status

WRMG

Clearwater, Florida, United States

Site Status

Vios Fertility

Swansea, Illinois, United States

Site Status

BIVF

Waltham, Massachusetts, United States

Site Status

Mainline Fertility

Bryn Mawr, Pennsylvania, United States

Site Status

Univ Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

CARE

Dallas, Texas, United States

Site Status

CORM

Webster, Texas, United States

Site Status

PNWF

Seattle, Washington, United States

Site Status

Clinique Ovo

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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AMH 2.7.1

Identifier Type: -

Identifier Source: org_study_id

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