Endometrial Injury In Recurrent Implantation Failure

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

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

Study Overview

• Status: Unknown
• Conditions: Infertility; Endometrial Diseases
• Intervention / Treatment: Procedure: Endometrial Injury with Hysteroscopy

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 Type: Interventional
• Enrollment (Anticipated): 230
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Timur Gurgan, MD,Professor; Phone Number: 0905322317706; Email: tgurgan@gurganclinic.com.tr
• Study Contact Backup: Name: Muberra Namlı Kalem, MD

Study Locations

• Turkey
  • Cankaya
    • Ankara, Cankaya, Turkey, 06640
      • Recruiting
      • Gurgan Clinic IVF and Women Health Center
      • Contact: Ziya Kalem, MD; Phone Number: 0905326922383; Email: ziyakalem@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Injury group; Endometrial injury with hysteroscopy	Procedure: Endometrial Injury with Hysteroscopy; 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
No Intervention: Control group; No hysteroscopy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Gurgan Clinic
• Investigators: Principal Investigator: Ziya Kalem, MD, Gurgan Clinic IVF and Women Health Center; Principal Investigator: Halil Ruso, Embryologist, GurganClinic IVF and Women Health Center; Principal Investigator: Antonis Makrigiannakis, MD,Professor, Greek University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Anticipated): January 1, 2019
• Study Completion (Anticipated): January 1, 2019

Study Registration Dates

• First Submitted: November 14, 2018
• First Submitted That Met QC Criteria: November 17, 2018
• First Posted (Actual): November 20, 2018

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 13, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Hysteroscopy; Implantation; Recurrent implantation failure; Endometrial injury
• Additional Relevant MeSH Terms: Infertility; Uterine Diseases
• Other Study ID Numbers: 201871

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No