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Completed

NCT Number: NCT03108157

Endometrial Scratch Effect on Pregnancy Rates 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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Procreatec

Madrid, 28036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female undergoing IVF treatment with donor eggs

Exclusion criteria

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

Treatment and study plan

Endometrial scratch

Procedure

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

Primary outcomes

  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 outcomes

  1. Live Birth

    Time frame: Pregnancy beyond 24 weeks

    Birth after 24 weeks of pregnancy

Sponsors and collaborators

Lead sponsor

Procreatec

Other

Collaborators

  • Hospital Universitario 12 de Octubre

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Apr 11, 2017
Registry last updated
Jun 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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