Does Cesarean Section Scar Defect (Niche) Affect Implantation Rate?
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Sheba Medical Center
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Embryo implantation rate
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Nich Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- hysteroscopic repair of cesarean section defect
- IVF cycle
Intervention: IVF Cycle (Procedure)
No Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED
Intervention: Diagnostic Hysteroscopy (Procedure)
No Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED
Intervention: Ultrasound Scan (Procedure)
No Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED
Intervention: IVF Cycle (Procedure)
Nich Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- hysteroscopic repair of cesarean section defect
- IVF cycle
Intervention: hysteroscopic repair of cesarean section defect (Procedure)
Nich Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- hysteroscopic repair of cesarean section defect
- IVF cycle
Intervention: Diagnostic Hysteroscopy (Procedure)
Nich Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- hysteroscopic repair of cesarean section defect
- IVF cycle
Intervention: Ultrasound Scan (Procedure)
Outcomes
Primary Outcomes
Embryo implantation rate
Time Frame: completion of two IVF cycles after randomization - approx. 2 months
Embryo implantation rate during IVF
Secondary Outcomes
- Fluid in Uterus(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(completion of two IVF cycles after randomization - approx. 2 months)
- Correlation between size and type of the defect fluid accumulation(completion of two IVF cycles after randomization - approx. 2 months)
Investigators
Roy Mashiach, M.D.
Vice Chairman Gynecological Department
Sheba Medical Center