Does Cesarean Section Scar Defect (Niche) Affect Implantation Rate?
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Embryo implantation rate
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing IVF after cesarean section
排除标准
- •Patients who underwent CSD repair
- •Patients with low ovarian reserve
- •Patients with hydrosalpinges, endometriosis, adenomyosis, submucous fibroids or polyps
研究组 & 干预措施
Nich Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- hysteroscopic repair of cesarean section defect
- IVF cycle
干预措施: IVF Cycle (Procedure)
No Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED
干预措施: Diagnostic Hysteroscopy (Procedure)
No Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED
干预措施: Ultrasound Scan (Procedure)
No Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED
干预措施: IVF Cycle (Procedure)
Nich Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- hysteroscopic repair of cesarean section defect
- IVF cycle
干预措施: 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
干预措施: Diagnostic Hysteroscopy (Procedure)
Nich Repair
Interventions to be administered:
- Ultrasound Scan
- Diagnostic Hysteroscopy
- hysteroscopic repair of cesarean section defect
- IVF cycle
干预措施: Ultrasound Scan (Procedure)
结局指标
主要结局
Embryo implantation rate
时间窗: completion of two IVF cycles after randomization - approx. 2 months
Embryo implantation rate during IVF
次要结局
- 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)
研究者
Roy Mashiach, M.D.
Vice Chairman Gynecological Department
Sheba Medical Center