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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03108157
Recruitment Status : Completed
First Posted : April 11, 2017
Results First Posted : December 4, 2019
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
Hospital Universitario 12 de Octubre
Information provided by (Responsible Party):
ALEXANDRA IZQUIERDO RODRIGUEZ, Procreatec

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
EMBRYO IMPLANTATION Procedure: Endometrial scratch Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 352 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endometrial Scratch Effect on Pregnancy Rates When Performed During the Previous Cycle of Embryo Transfer in Patients Undergoing Egg-donation IVF
Actual Study Start Date : January 12, 2017
Actual Primary Completion Date : November 30, 2018
Actual Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Arms and Interventions
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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.
 Procedure: Endometrial scratch
Patients included in the study group will be performed an endometrial scratch with Pipelle Cournier 3 to 4 weeks before embryo transfer.
Other Name: Scratching
No Intervention: GROUP B: no intervention group
Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.


Outcome Measures
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Primary Outcome Measures :
  1. Positive Pregnancy Test [ Time Frame: 12 to 14 days after embryo transfer ]
    Positive test (hcG>10 UI/ml)

  2. Clinical Pregnancy [ Time Frame: 5 weeks of pregnancy ]
    Ultrasound confirmation of intrauterine pregnancy


Secondary Outcome Measures :
  1. Live Birth [ Time Frame: Pregnancy beyond 24 weeks ]
    Birth after 24 weeks of pregnancy


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female undergoing IVF treatment with donor eggs

Exclusion Criteria:

  • Severe male factor ( less tan 2 million spermatozoa per ml )
  • Uterine abnormalities
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03108157


Locations
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Spain
Procreatec
Madrid, Spain, 28036
Sponsors and Collaborators
Procreatec
Hospital Universitario 12 de Octubre
Investigators
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Study Director: Alberto Galindo, PhD Hospital Universitario 12 Octubre
Study Chair: Laura De la Fuente, PhD Hospital Universitario 12 Octubre
  Study Documents (Full-Text)

Documents provided by ALEXANDRA IZQUIERDO RODRIGUEZ, Procreatec:
Statistical Analysis Plan  [PDF] July 25, 2019
Study Protocol  [PDF] January 12, 2017

More Information
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Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ALEXANDRA IZQUIERDO RODRIGUEZ, MD, Procreatec
ClinicalTrials.gov Identifier: NCT03108157    
Other Study ID Numbers: ENDOSCRATCH
First Posted: April 11, 2017    Key Record Dates
Results First Posted: December 4, 2019
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by ALEXANDRA IZQUIERDO RODRIGUEZ, Procreatec:
IVF
DONOR EGGS
ENDOMETRIAL SCRATCH
PIPELLE
ONGOING PREGNANCY