Endometrial Scratch Effect on Pregnancy Rates in Patients Undergoing Egg-donation IVF

June 10, 2020 updated by: ALEXANDRA IZQUIERDO RODRIGUEZ, Procreatec

Endometrial Scratch Effect on Pregnancy Rates When Performed During the Previous Cycle of Embryo Transfer in Patients Undergoing Egg-donation IVF

Clinical trial about the effect of endometrial scratch on pregnancy rates in patients undergoing a treatment with in-vitro fertilization with donor eggs, when doing the endometrial biopsy during the cycle prior to the embryo transfer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this clinical trial is to investigate whether an endometrial scratch during the cycle prior to embryo transfer cycle is effective or not in increasing pregnancy rates. Previous studies about this issue have not shown clear conclusions about the effectiveness of this method.

The endometrial scratch is a simple technique that consists in performing a mild injury to all the internal walls of the uterus with a Pipelle Cournier.

To achieve the trial objective, all participating patients are randomly divided into two groups. Once patients decide to participate in the trial, they are assigned to each group according to the randomization list:

Group A: Patients with transfer of fresh embryos after taking an endometrium biopsy during the previous cycle and then following the conventional preparation protocol.

Group B: Patients with transfer of fresh embryos with the conventional preparation protocol.

Study Type

Interventional

Enrollment (Actual)

352

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

      • Madrid, Spain, 28036
        • ProcreaTec

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Female undergoing IVF treatment with donor eggs

Exclusion Criteria:

  • Severe male factor ( less tan 2 million spermatozoa per ml )
  • Uterine abnormalities

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: GROUP A: intervention group
Patients will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before the embryo transfer and then they will follow the conventional preparation protocol to receive embryos coming from an egg donation treatment.
Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.
Other Names:
  • Scratching
No Intervention: GROUP B: no intervention group
Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Positive Pregnancy Test
Time Frame: 12 to 14 days after embryo transfer
Positive test (hcG>10 UI/ml)
12 to 14 days after embryo transfer
Clinical Pregnancy
Time Frame: 5 weeks of pregnancy
Ultrasound confirmation of intrauterine pregnancy
5 weeks of pregnancy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Live Birth
Time Frame: Pregnancy beyond 24 weeks
Birth after 24 weeks of pregnancy
Pregnancy beyond 24 weeks

Collaborators and Investigators

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

Sponsor

Investigators

  • Study Director: Alberto Galindo, PhD, Hospital Universitario 12 Octubre
  • Study Chair: Laura De la Fuente, PhD, Hospital Universitario 12 Octubre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

January 12, 2017

Primary Completion (Actual)

November 30, 2018

Study Completion (Actual)

December 31, 2019

Study Registration Dates

First Submitted

April 5, 2017

First Submitted That Met QC Criteria

April 10, 2017

First Posted (Actual)

April 11, 2017

Study Record Updates

Last Update Posted (Actual)

June 23, 2020

Last Update Submitted That Met QC Criteria

June 10, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • ENDOSCRATCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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