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Embryo Implantation After Induced Endometrial Injury

Primary Purpose

Sterility

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Scratching
Sponsored by
Instituto Valenciano de Infertilidad, IVI VALENCIA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sterility focused on measuring Scratching, Endometrial biopsy, Ongoing embryo implantation, Assisted reproductive techniques

Eligibility Criteria

19 Years - 44 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • IVI Valencia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Scratching

No scratching

Arm Description

induced endometrial injury

None intervention

Outcomes

Primary Outcome Measures

Ongoing implantation rate (OIR)

Secondary Outcome Measures

Live born rate (LBR)

Full Information

First Posted
September 28, 2013
Last Updated
January 9, 2023
Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Collaborators
IVI Madrid, IVI Barcelona, IVI Murcia, IVI Sevilla, IVI Bilbao, IVI Vigo, Instituto Valenciano de Infertilidad, IVI Alicante
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1. Study Identification

Unique Protocol Identification Number
NCT01955356
Brief Title
Embryo Implantation After Induced Endometrial Injury
Official Title
Evaluation of Induced Endometrial Injury in the Subsequent IVF Cycle.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
October 2013 (Actual)
Primary Completion Date
November 21, 2022 (Actual)
Study Completion Date
November 21, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Valenciano de Infertilidad, IVI VALENCIA
Collaborators
IVI Madrid, IVI Barcelona, IVI Murcia, IVI Sevilla, IVI Bilbao, IVI Vigo, Instituto Valenciano de Infertilidad, IVI Alicante

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sterility
Keywords
Scratching, Endometrial biopsy, Ongoing embryo implantation, Assisted reproductive techniques

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Scratching
Arm Type
Experimental
Arm Description
induced endometrial injury
Arm Title
No scratching
Arm Type
No Intervention
Arm Description
None intervention
Intervention Type
Procedure
Intervention Name(s)
Scratching
Other Intervention Name(s)
Endometrial induced injury
Intervention Description
Endometrial biopsy
Primary Outcome Measure Information:
Title
Ongoing implantation rate (OIR)
Time Frame
12 weeks of pregnancy
Secondary Outcome Measure Information:
Title
Live born rate (LBR)
Time Frame
9 months after embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
44 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmina Vidal, MD
Organizational Affiliation
IV VALENCIA
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVI Valencia
City
Valencia
ZIP/Postal Code
46015
Country
Spain

12. IPD Sharing Statement

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Embryo Implantation After Induced Endometrial Injury

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