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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infertility

Intervention / Treatment
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* Procedure: Endometrial injury


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endometrial injury group<br>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<br>* 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<br>|
| No Intervention: Control group<br>no thing is done for this group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pregnancy rate | Quantitative beta HCG test is done | 15 days after HCG administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endometrial injury, ICSI, infertility, pregnancy rate