Does Cesarean Section Scar Defect (Niche) Affect Implantation Rate?

Not Applicable

• Conditions: Infertility; Complications; Cesarean Section

• Registration Number: NCT02371486
• Lead Sponsor: Sheba Medical Center

Brief Summary

Cesarean scar defects (CSDs), i.e. deficient uterine scars following a cesarean section, involve discontinuity at the site of a previous Cesarean section scar. These anatomical defects have been reported to be associated with postmenstrual spotting, chronic pelvic pain and infertility. Few case series have suggested improved fertility (most probably by improving implantation of embryos) The aim of this study is to prospectively record embryonal implantation rate during IVF in patients with CSDs, and to evaluate the effect of hysteroscopic repair of CSDs on fetal implantation during IVF.

Detailed Description

150 patients undergoing IVF after cesarean section will be recruited. demographic, clinical and treatment data will be collected. ultrasound and hysteroscopic evaluation of the CSD will be performed. IVF treatment will be provided. In case of failure of IVF treatment, patients will be randomized to hysteroscopic repair of CSD versus second IVF treatment

Study Timeline

• Study First Submitted: 2015-02-10
• Study First Submitted QC: 2015-02-19
• Study First Posted: 2015-02-25
• Study Start: 2016-04
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-12
• Last Update Posted: 2016-10-14
• Primary Completion: 2017-02
• Study Completion: 2018-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

• Patients undergoing IVF after cesarean section

Exclusion Criteria

• Patients who underwent CSD repair
• Patients with low ovarian reserve
• Patients with hydrosalpinges, endometriosis, adenomyosis, submucous fibroids or polyps

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Embryo implantation rate	completion of two IVF cycles after randomization - approx. 2 months	Embryo implantation rate during IVF

Secondary Outcome Measures

Name	Time	Method
Fluid in Uterus	completion of two IVF cycles after randomization - approx. 2 months	Detection of fluid in the uterine cavity during menotropin stimulation in IVF treatment
Correlation between the size and type of the defect and implantation rate during IVF treatment	completion of two IVF cycles after randomization - approx. 2 months	Correlation between the size and type of the defect and implantation rate during IVF treatment
Correlation between size and type of the defect fluid accumulation	completion of two IVF cycles after randomization - approx. 2 months	Correlation between the size and type of the defect and the detection of fluid in the uterine cavity during menotropin stimulation in IVF treatment

Trial Locations

Locations (1)

The chaim sheba medical center,Tel Hashomer; 🇮🇱 Ramat Gan, Israel