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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Endometrial injury
Sponsored by
Alexandria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Endometrial injury, ICSI, infertility, pregnancy rate

Eligibility Criteria

undefined - 40 Years (Child, Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Tamer

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Endometrial injury group

Control group

Arm Description

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 The inner piston of the catheter was withdrawn to create suction, and injury (scratching) of the endometrium was done by moving the pipelle catheter up and down within the uterine cavity.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

no thing is done for this group

Outcomes

Primary Outcome Measures

pregnancy rate
Quantitative beta HCG test is done

Secondary Outcome Measures

Full Information

First Posted
August 4, 2023
Last Updated
August 10, 2023
Sponsor
Alexandria University
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1. Study Identification

Unique Protocol Identification Number
NCT05987995
Brief Title
Is it Safe to do Endometrial Injury in the Same ICSI Cycle: A Randomized Controlled Trial
Official Title
Is it Safe to do Endometrial Injury in the Same ICSI Cycle: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 11, 2022 (Actual)
Primary Completion Date
January 20, 2023 (Actual)
Study Completion Date
January 20, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Endometrial injury, ICSI, infertility, pregnancy rate

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endometrial injury group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
no thing is done for this group
Intervention Type
Procedure
Intervention Name(s)
Endometrial injury
Intervention Description
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 Outcome Measure Information:
Title
pregnancy rate
Description
Quantitative beta HCG test is done
Time Frame
15 days after HCG administration

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
infertile females that seeking pregnancy
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Tamer
City
Alexandria
Country
Egypt

12. IPD Sharing Statement

Learn more about this trial

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

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