Does Cesarean Section Scar Defect (Niche) Affect Implantation Rate?
- Conditions
- InfertilityComplications; Cesarean Section
- Interventions
- Procedure: hysteroscopic repair of cesarean section defectProcedure: Diagnostic HysteroscopyProcedure: Ultrasound ScanProcedure: IVF Cycle
- 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 150
- Patients undergoing IVF after cesarean section
- 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
- Arm && Interventions
Group Intervention Description Nich Repair hysteroscopic repair of cesarean section defect Interventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. hysteroscopic repair of cesarean section defect 4. IVF cycle Nich Repair Ultrasound Scan Interventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. hysteroscopic repair of cesarean section defect 4. IVF cycle No Repair IVF Cycle Interventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED No Repair Ultrasound Scan Interventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED Nich Repair Diagnostic Hysteroscopy Interventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. hysteroscopic repair of cesarean section defect 4. IVF cycle Nich Repair IVF Cycle Interventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. hysteroscopic repair of cesarean section defect 4. IVF cycle No Repair Diagnostic Hysteroscopy Interventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED
- 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