NCT01955356

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 28, 2013

Completed
3 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 7, 2013

Completed
9.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2022

Completed
Last Updated

January 11, 2023

Status Verified

January 1, 2023

Enrollment Period

9.1 years

First QC Date

September 28, 2013

Last Update Submit

January 9, 2023

Conditions

Sterility

Keywords

ScratchingEndometrial biopsyOngoing embryo implantationAssisted reproductive techniques

Outcome Measures

Primary Outcomes (1)

  • Ongoing implantation rate (OIR)

    12 weeks of pregnancy

Secondary Outcomes (1)

  • Live born rate (LBR)

    9 months after embryo transfer

Study Arms (2)

Scratching

EXPERIMENTAL

induced endometrial injury

Procedure: Scratching

No scratching

NO INTERVENTION

None intervention

Interventions

ScratchingPROCEDURE

Endometrial biopsy

Also known as: Endometrial induced injury
Scratching

Eligibility Criteria

Age19 Years - 44 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • aged women
  • Kg/m2.
  • st or 2nd fresh embryo transfer ( egg donation).
  • or 2 blastocysts available.
  • written agreement.
  • \> or = 6 mms endometrial thickness.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Valencia

Valencia, 46015, Spain

Location

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • Carmina Vidal, MD

    IV VALENCIA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Obstetrics and Gynecology

Study Record Dates

First Submitted

September 28, 2013

First Posted

October 7, 2013

Study Start

October 1, 2013

Primary Completion

November 21, 2022

Study Completion

November 21, 2022

Last Updated

January 11, 2023

Record last verified: 2023-01

Locations

ES(1)