Endometrial Injury In Recurrent Implantation Failure

Gurgan Clinic230 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

230

Conditions

Infertility Endometrial Diseases

Interventions

Endometrial Injury with HysteroscopyPROCEDURE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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

Locations (1)

Gurgan Clinic IVF and Women Health Center

Ankara, Cankaya, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Positive Pregnancy

Blood concentration of beta-hcg

Time frame: 1month

Central Contacts

Timur Gurgan, MD,Professor

CONTACT

0905322317706 tgurgan@gurganclinic.com.tr

Muberra Namlı Kalem, MD

CONTACT

Data from ClinicalTrials.gov

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