Endometrial Injury In Recurrent Implantation Failure

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

Detailed Description
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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.

Official Title
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Systematic And Standardized Hysteroscopic Endometrial Injury For Treatment Of Recurrent Implantation Failure

Conditions
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Infertility, Endometrial Diseases

Intervention / Treatment
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* Procedure: Endometrial Injury with Hysteroscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Injury group<br>Endometrial injury with hysteroscopy | Procedure: Endometrial Injury with Hysteroscopy<br>* All office hysteroscopy procedures will be done transvaginally under sedation with a 5 mm 30 degree lens supplied with a 5 F working channel continuous flow office hysteroscope (Bettocchi office hysteroscope, Karl Storz, Tuttlingen, Germany) without speculum or tenaculum. Briefly, following cervical passage and initial endometrial cavity investigation endometrial injury will be performed without energy modality (i.e. with scissors). Endometrial injury will perform first on the fundus by cutting into the endometrium (without injuring the myometrium) transversally. Later, vertical incisions will perform 0,5 cm apart each other, on the anterior and posterior walls of the uterus, 1-1.5 cm away from the fundus and one cut for each lateral wall<br>|
| No Intervention: Control group<br>No hysteroscopy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive Pregnancy | Blood concentration of beta-hcg | 1month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Recurrent implantation failure, Endometrial injury, Implantation, Hysteroscopy