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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05987995
Enrollment
60
Registered
2023-08-14
Start date
2022-09-11
Completion date
2023-01-20
Last updated
2023-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

Endometrial injury, ICSI, infertility, pregnancy rate

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.

Interventions

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 The inner piston of the catheter was withdrawn to create suction, and injury (scratching) of the endometrium was done by moving the pipelle catheter up and down within the uterine cavity

Sponsors

Alexandria University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 40 Years
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

Design outcomes

Primary

MeasureTime frameDescription
pregnancy rate15 days after HCG administrationQuantitative beta HCG test is done

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026