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

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT05987995

Collaborator

(none)

Enrollment

Location

Arms

4.3

Actual Duration (Months)

13.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Infertility	Procedure: Endometrial injury	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 11, 2022

Actual Primary Completion Date :

Jan 20, 2023

Actual Study Completion Date :

Jan 20, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Endometrial injury group 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.	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
No Intervention: Control group no thing is done for this group

Arm

Intervention/Treatment

Experimental: Endometrial injury group

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.

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

No Intervention: Control group

no thing is done for this group

Outcome Measures

Primary Outcome Measures

pregnancy rate [15 days after HCG administration]
Quantitative beta HCG test is done

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tamer	Alexandria		Egypt

Sponsors and Collaborators

Alexandria University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Alexandria University

ClinicalTrials.gov Identifier:

NCT05987995

Other Study ID Numbers:

0105711

First Posted:

Aug 14, 2023

Last Update Posted:

Aug 14, 2023

Last Verified:

Sep 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Alexandria University

Additional relevant MeSH terms:

Infertility

Study Results

No Results Posted as of Aug 14, 2023