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

Not Applicable

Completed

• Conditions: Infertility
• Interventions: Procedure: Endometrial injury

• Registration Number: NCT05987995
• Lead Sponsor: Alexandria University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Status Verified: 2022-09
• Study Start: 2022-09-11
• Primary Completion: 2023-01-20
• Study Completion: 2023-01-20
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-10
• Last Update Submitted: 2023-08-10
• Study First Posted: 2023-08-14
• Last Update Posted: 2023-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endometrial injury group	Endometrial injury	Endometrial injury was done on day 3-5 of stimulation, just after the cessation of menstruation. After the insertion of a vaginal speculum, the cervix was cleaned using a sterile saline solution. 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. The obtained tissues were seen in a transparent tube. If no tissues were seen in the tube, the procedure was repeated.

Primary Outcome Measures

Name	Time	Method
pregnancy rate	15 days after HCG administration	Quantitative beta HCG test is done

Trial Locations

Locations (1)

Tamer; 🇪🇬 Alexandria, Egypt