Endometrial Injury In Recurrent Implantation Failure

Gurgan Clinic

Status: Unknown

Conditions: Infertility; Endometrial Diseases

Treatments: Procedure: Endometrial Injury with Hysteroscopy

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT03748238

201871

Details and patient eligibility

About

The aim of this study is to investigate that the efficacy of the endometrial injury before IVF in recurrent implantation failure patients.

Full description

This is a prospective and randomized controlled trial investigating the effect of hysteroscopic endometrial injury for treatment of recurrent implantation failure. Approximately 230 patients who had failed to achieve a clinical pregnancy after the transfer of at least four good-quality embryos in a minimum of three fresh or frozen cycles to a woman under the age of 40 years will be randomized into two groups. Injury group will receive endometrial injury during their hysteroscopic procedure, whereas the control group (n=115) did not. This study will investigate that, whether the endometrial injury is beneficial in recurrent implantation failure patients to increase the odds of clinical pregnancy rates, live birth rates, and implantation rates.

Enrollment: 230 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women under the age of 40 who met the RIF definition
• Patients whose follicle-stimulating hormone (FSH) levels were ≤ 15 IU/mL

Exclusion criteria

• Patients with congenital uterine anomalies
• Patients with Asherman's syndrome
• Patients with uterine cavity distorted by myoma or endometrial polyps
• Patients with confirmed endometriosis or endometrioma
• Patients with BMI of <18.5 and >29.9

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Injury group

Experimental group

Description:

Endometrial injury with hysteroscopy

Treatment:

Procedure: Endometrial Injury with Hysteroscopy

Control group

No Intervention group

Description:

No hysteroscopy