Endometrial Injury In Recurrent Implantation Failure

Sponsor

Gurgan Clinic (Other)

Overall Status

Unknown status

CT.gov ID

NCT03748238

Collaborator

(none)

230

Enrollment

Location

Arms

Anticipated Duration (Months)

114.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Infertility Endometrial Diseases	Procedure: Endometrial Injury with Hysteroscopy	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

230 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2018

Anticipated Primary Completion Date :

Jan 1, 2019

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Positive Pregnancy [1month]
Blood concentration of beta-hcg

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gurgan Clinic IVF and Women Health Center	Ankara	Cankaya	Turkey	06640

Sponsors and Collaborators

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