NCT03748238

Endometrial Injury In Recurrent Implantation Failure

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: Gurgan Clinic · Network
• Sex: Female
• Age: 18 Years – 40 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2018-11-01
• Primary completion: 2019-01-01
• Completion: 2019-01-01
• First posted: 2018-11-20
• Last updated: 2019-01-15

Locations

1 site across 1 country: Turkey (Türkiye)