Embryo Implantation After Induced Endometrial Injury | NCT01955356

Studies
Embryo Implantation After Induced Endometrial Injury

NCT01955356

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status

Completed

Last Update Posted

Jan 11, 2023Actual

Enrollment

600Actual

Phase

Not Applicable

Conditions

Sterility

Interventions

Scratching

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

Jan 2023

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

Oct 2013Actual

Primary Completion Date

Nov 21, 2022Actual

Completion Date

Nov 21, 2022Actual

First Submitted Date

Sep 28, 2013

First Submission Date that Met QC Criteria

Sep 28, 2013

First Posted Date

Oct 7, 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

Jan 9, 2023

Last Update Posted Date

Jan 11, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Carmina Vidal, MD, Obstetrics and Gynecology, Instituto Valenciano de Infertilidad, IVI VALENCIAPrincipal Investigator

Lead Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIAOTHER

Collaborators

Name	Class
IVI Madrid	OTHER
IVI Barcelona	OTHER
IVI Murcia	OTHER
Vida Recoletas Sevilla

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Some studies have revealed that an induced endometrial injury could improve embryo human implantation in patients with implantation failure.

The purpose of this study is to determine whether the induced endometrial injury could be beneficial for regular patients undergoing IVF

Detailed Description

Endometrial induced injury has been suggested that could improve embryo implantation in cases of patients with recurrent implantation failure. The mechanisms that induce that improvement remain unknown.

We want to analyse if the endometrial induce injury could be useful in cases of standard patients who require assisted reproductive techniques.

For that purpose we will start a randomized controlled trial with the ideal background in implantation in ART, the egg donation programme.

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

600Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Scratching	Experimental	induced endometrial injury	Procedure: Scratching
No scratching	No Intervention	None intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Scratching	Procedure	Endometrial biopsy	Scratching	Endometrial induced injury

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Ongoing implantation rate (OIR)		12 weeks of pregnancy

Secondary Outcomes

Measure	Description	Time Frame
Live born rate (LBR)		9 months after embryo transfer

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

19-44 aged women
19-29.9 Kg/m2.
1st or 2nd fresh embryo transfer ( egg donation).
1 or 2 blastocysts available.
written agreement.
> or = 6 mms endometrial thickness.

Exclusion Criteria:

Premature ovarian failure.
Endometrial pathology.
Insufficient endometrial development.
Hydrosalpinx
Mullerian malformations.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Carmina Vidal, MD	IV VALENCIA	Principal Investigator

Locations

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

Condition Browse Module

MeSH Terms

ID	Term
D007246	Infertility

Ancestor Terms

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided