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

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ClinicalTrials.gov Identifier: NCT03108157
Recruitment Status : Recruiting
First Posted : April 11, 2017
Last Update Posted : April 11, 2017
Sponsor:
Collaborator:
Hospital Universitario 12 de Octubre
Information provided by (Responsible Party):
ALEXANDRA IZQUIERDO RODRIGUEZ, Procreatec

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 332 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 30, 2017
Estimated Primary Completion Date : December 31, 2017
Estimated Study Completion Date : June 30, 2018

Arm Intervention/treatment
Experimental: STUDY 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: CONTROL GROUP
Patients will receive the conventional preparation protocol to receive embryos coming from an egg donation treatment.



Primary Outcome Measures :
  1. Pregnancy Rate [ Time Frame: 12 to 14 days after the embryo transfer ]
    Positive pregnancy test in blood


Secondary Outcome Measures :
  1. Ongoing Pregnancy Rate [ Time Frame: 15 days after the pregnancy test ]
    US confirmation of evolutive pregnancy

  2. Miscarriage Rate [ Time Frame: Before week 12 of pregnancy ]
    Pregnancy loss



Information from the National Library of Medicine

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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

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


Contacts
Contact: Alexandra Izquierdo, MD 0034914585804 ext 28 alexandraizquierdo@procreatec.com
Contact: Katharina Spies, MD 0034914585804 ext 28 katharina.spies@procreatec.com

Locations
Spain
Procreatec Recruiting
Madrid, Spain, 28036
Contact: Alexandra Izquierdo, MD    0034914585804 ext 28    alexandraizquierdo@procreatec.com   
Contact: Katharina Spies, MD    0034914585804 ext 28    katharina.spies@procreatec.com   
Sponsors and Collaborators
Procreatec
Hospital Universitario 12 de Octubre
Investigators
Study Director: Alberto Galindo, PhD Hospital Universitario 12 Octubre
Study Chair: Laura De la Fuente, PhD Hospital Universitario 12 Octubre

Publications:

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

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