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OpenTrials
Completed

NCT Number: NCT05987995

Is it Safe to do Endometrial Injury in the Same ICSI Cycle: A Randomized Controlled Trial

Endometrial injury is one of the interventions suggested to improve the endometrial receptivity by enhancing the decidualization process, and so increasing the pregnancy rate

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Age range

Up to 40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tamer

Alexandria, Egypt

About this study

In assisted reproductive techniques , specially ICSI, several approaches have been put forward to improve the endometrium, including endometrial injection of granulocyte colony-stimulating factor or platelet-rich plasma. Endometrial injury is one of the interventions suggested to improve the endometrial receptivity.

Endometrial injury, also known as endometrial scratching, is the intentional damage of the endometrium, usually using a pipelle, aiming at increasing the implantation rate. The exact mechanism of action is still vague ,many hypotheses have been advocated, including enhanced decidualization, which is stimulated by the local injury. Moreover, endometrial injury stimulates an inflammatory response, which in turn adjusts gene expression.

The value of endometrial injury is a controversial issue, there is no agreement on the exact time to perform endometrial scratching, so in the current study, we investigated the safety and efficacy of performing endometrial injury in the follicular phase of the same ICSI cycle.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age <40 year.
  • BMI 20-35 kg/m2.

Exclusion criteria

  • Age >40 year
  • BMI > 35
  • Uterine cavity abnormalities
  • poor quality embryos
  • Poor responders
  • Diagnosed sever endometriosis
  • Sever male factor
  • Declined to participate

Treatment and study plan

Endometrial injury

Procedure

A pipelle endometrial sampler was introduced gently into the uterine cavity. The inner piston of the catheter was withdrawn to create suction, and injury (scratching) of the endometrium was done by moving the pipelle catheter up and down within the uterine cavity

Primary outcomes

  1. pregnancy rate

    Time frame: 15 days after HCG administration

    Quantitative beta HCG test is done

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Aug 14, 2023

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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