Clinical Performance Evaluation of AMH Assay | NCT03131388

Studies
Clinical Performance Evaluation of AMH Assay

NCT03131388

Sponsor

Beckman Coulter, Inc.

Status

Completed

Last Update Posted

Jul 13, 2018Actual

Enrollment

277Actual

Phase

Not provided

Conditions

Anti-Mullerian Hormone

Interventions

Access AMH Assay

Countries

United States
Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Apr 30, 2018Actual

Completion Date

Apr 30, 2018Actual

First Submitted Date

Apr 17, 2017

First Submission Date that Met QC Criteria

Apr 24, 2017

First Posted Date

Apr 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 11, 2018

Last Update Posted Date

Jul 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

277Actual

Name	Type	Description	Arm Group Labels	Other Names
Access AMH Assay	Diagnostic Test

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Not provided

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

21 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Adult women presenting to fertility clinics for fertility assessment

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Fred Siebert	Beckman Coulter	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
BRI		Phoenix	Arizona	85258	United States
Stanford

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided