Endometrial Genomic Profile in Endometrial Priming | NCT01778452

Studies
Endometrial Genomic Profile in Endometrial Priming

NCT01778452

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status

Completed

Last Update Posted

Feb 15, 2013Estimated

Enrollment

6Actual

Phase

Not Applicable

Conditions

Genomic Human Endometrial Expression Profile

Interventions

endometrial biopsy

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

Feb 2013

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

Nov 2009

Primary Completion Date

Oct 2012Actual

Completion Date

Jan 2013Actual

First Submitted Date

Jan 25, 2013

First Submission Date that Met QC Criteria

Jan 28, 2013

First Posted Date

Jan 29, 2013Estimated

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

Feb 14, 2013

Last Update Posted Date

Feb 15, 2013Estimated

Name	Class
Igenomix	INDUSTRY

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 aim of this study is to analyse genomics profile expression in endometrium under different endometrial priming for recipients.

Detailed Description

We analyze the genomic profile of egg donors in different endometrial priming protocols, compared with natural cycle, including the conventional single long acting GnRH agonist injection in the mid luteal phase of the previous cycle of the endometrial priming and the single daily antagonist injection (Cetrorelix 0.25 mg) administered in the early follicular phase followed by endometrial priming. Endometrial biopsy will be taken in luteinizing hormone

7 or with P4 +5 in cases with endometrial priming with oestrogens therapy.

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

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Natural cycle	Active Comparator	Natural cycle endometrial biopsy, lh+7	Procedure: endometrial biopsy
Antagonist cycle + endometrial priming.	Experimental	Antagonist cycle + endometrial priming for egg donation program. endometrial biopsy, p4+5	Procedure: endometrial biopsy
Agonist cycle + endometrial priming.	Experimental	Agonist cycle + endometrial priming for egg donation program endometrial biopsy, p4+5	Procedure: endometrial biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
endometrial biopsy	Procedure	endometrial biopsy	Agonist cycle + endometrial priming. Antagonist cycle + endometrial priming. Natural cycle

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
genetic endometrial human profile expression	implantation related genes profile expression	Oocyte donors will be followed up for four to six months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

6 egg healthy volunteer egg donors.
Volunteers.
18-35 years old
Healthy.
BMI <28.

Exclusion Criteria:

- BMI > 28
Smokers-

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

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carmen Vidal, MDphD	IVI Valencia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ivi Valencia		Valencia	Valencia	46015	Spain