Endometrial Injury In Recurrent Implantation Failure

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03748238
• Other study ID #: 201871
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: January 2019

Study information

• Verified date: January 2019
• Source: Gurgan Clinic
• Contact: Timur Gurgan, MD,Professor
• Phone: 0905322317706
• Email: tgurgan[@]gurganclinic.com.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 230
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Diseases
• Infertility
• Uterine Diseases

Intervention

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

Locations

Country	Name	City	State
Turkey	Gurgan Clinic IVF and Women Health Center	Ankara	Cankaya

Sponsors (1)

Lead Sponsor	Collaborator
Gurgan Clinic

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive Pregnancy	Blood concentration of beta-hcg	1month