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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05987995
• Other study ID #: 0105711
• Status: Completed
• Phase: N/A
• Start date: September 11, 2022
• Est. completion date: January 20, 2023

Study information

• Verified date: September 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 20, 2023
• Est. primary completion date: January 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• Endometrial injury
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

Locations

Country	Name	City	State
Egypt	Tamer	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pregnancy rate	Quantitative beta HCG test is done	15 days after HCG administration