Endometrial Injury In Recurrent Implantation Failure

Not Applicable

• Conditions: Infertility; Endometrial Diseases
• Interventions: Procedure: Endometrial Injury with Hysteroscopy

• Registration Number: NCT03748238
• Lead Sponsor: Gurgan Clinic

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2018-11-14
• Study First Submitted QC: 2018-11-17
• Study First Posted: 2018-11-20
• Status Verified: 2019-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Last Update Submitted: 2019-01-13
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 230

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Injury group	Endometrial Injury with Hysteroscopy	Endometrial injury with hysteroscopy

Primary Outcome Measures

Name	Time	Method
Positive Pregnancy	1month	Blood concentration of beta-hcg

Trial Locations

Locations (1)

Gurgan Clinic IVF and Women Health Center; 🇹🇷 Ankara, Cankaya, Turkey