Endometrial Injury In Recurrent Implantation Failure

NCT ID: NCT03748238

Last Updated: 2019-01-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 230 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-01-31

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.

Conditions

Infertility; Endometrial Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Injury group

Endometrial injury with hysteroscopy

Group Type: EXPERIMENTAL

Endometrial Injury with Hysteroscopy

Intervention Type: PROCEDURE

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

Control group

No hysteroscopy

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Gurgan Clinic

NETWORK

Sponsor Role: lead

Responsible Party

Muberra Namlı Kalem

Assoc Professor, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ziya Kalem, MD

Role: PRINCIPAL_INVESTIGATOR

Gurgan Clinic IVF and Women Health Center

Halil Ruso, Embryologist

Role: PRINCIPAL_INVESTIGATOR

GurganClinic IVF and Women Health Center

Antonis Makrigiannakis, MD,Professor

Role: PRINCIPAL_INVESTIGATOR

Greek University

Locations

Gurgan Clinic IVF and Women Health Center

Ankara, Cankaya, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Timur Gurgan, MD,Professor

Role: CONTACT

tgurgan@gurganclinic.com.tr

0905322317706

Muberra Namlı Kalem, MD

Role: CONTACT

Facility Contacts

Ziya Kalem, MD

Role: primary

ziyakalem@hotmail.com

0905326922383

Other Identifiers

201871

Identifier Type: -

Identifier Source: org_study_id