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Clinical Trials/NCT03748238
NCT03748238
Unknown
Not Applicable

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

Gurgan Clinic1 site in 1 country230 target enrollmentNovember 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Infertility
Sponsor
Gurgan Clinic
Enrollment
230
Locations
1
Primary Endpoint
Positive Pregnancy
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 1, 2018
End Date
January 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Gurgan Clinic
Responsible Party
Principal Investigator
Principal Investigator

Muberra Namlı Kalem

Assoc Professor, MD

Gurgan Clinic

Eligibility Criteria

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

Outcomes

Primary Outcomes

Positive Pregnancy

Time Frame: 1month

Blood concentration of beta-hcg

Study Sites (1)

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