Embryo Implantation After Induced Endometrial Injury

January 9, 2023 updated by: Carmina Vidal, MD, Instituto Valenciano de Infertilidad, IVI VALENCIA

Evaluation of Induced Endometrial Injury in the Subsequent IVF Cycle.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

600

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Valencia, Spain, 46015
        • IVI Valencia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 44 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Scratching
induced endometrial injury
Procedure: Scratching
Endometrial biopsy
Other Names:
  • Endometrial induced injury
No Intervention: No scratching
None intervention

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Collaborators

IVI Vigo
IVI Madrid
IVI Sevilla
IVI Barcelona
Instituto Valenciano de Infertilidad, IVI Alicante
IVI Bilbao
IVI Murcia

Investigators

  • Principal Investigator: Carmina Vidal, MD, IV VALENCIA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2013

Primary Completion (Actual)

November 21, 2022

Study Completion (Actual)

November 21, 2022

Study Registration Dates

First Submitted

September 28, 2013

First Submitted That Met QC Criteria

September 28, 2013

First Posted (Estimate)

October 7, 2013

Study Record Updates

Last Update Posted (Estimate)

January 11, 2023

Last Update Submitted That Met QC Criteria

January 9, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1306-C-119-CV/IVI Valencia

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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