Non Invasive Diagnostic of Endometrial Receptivity | NCT01588223

Studies
Non Invasive Diagnostic of Endometrial Receptivity

NCT01588223

Sponsor

Igenomix

Status

Completed

Last Update Posted

Mar 27, 2014Estimated

Enrollment

40Actual

Phase

Not Applicable

Conditions

Endometrial Receptivity Failure

Interventions

Lipid identification

Countries

Spain

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

Mar 2014

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

Jan 2011

Primary Completion Date

May 2012Actual

Completion Date

May 2012Actual

First Submitted Date

Apr 26, 2012

First Submission Date that Met QC Criteria

Apr 27, 2012

First Posted Date

Apr 30, 2012Estimated

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

Mar 26, 2014

Last Update Posted Date

Mar 27, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carlos Simon, Prof. Carlos Simon, MD PhD, Instituto Valenciano de Infertilidad, IVI VALENCIAPrincipal Investigator

Lead Sponsor

IgenomixINDUSTRY

Collaborators

Not provided

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to determine a lipidomic profile on the endometrial fluid, that can predict endometrial receptivity.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Lipids	Experimental		Other: Lipid identification

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lipid identification	Other	The lipids are identified using Mass Spectrometry	Lipids

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Levels of lipids in the endometrial fluid as a diagnostic factor.		1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Oocyte donors undergoing controlled ovarian stimulation
Regular menstrual cycles
no abnormal karyotype
generally healthy
BMI 19-29 Kg/m2 (both inclusive)
18 to 35 years old.

Exclusion criteria:

-patients diagnosed with endometriosis and/or endometritis.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided