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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Infertility, Complications; Cesarean Section

Intervention / Treatment
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* Procedure: hysteroscopic repair of cesarean section defect
* Procedure: Diagnostic Hysteroscopy
* Procedure: Ultrasound Scan
* Procedure: IVF Cycle


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nich Repair<br>Interventions to be administered: Ultrasound Scan Diagnostic Hysteroscopy hysteroscopic repair of cesarean section defect IVF cycle | Procedure: hysteroscopic repair of cesarean section defect<br>* Operative hysteroscopy for the repair of cesarean section defect is performed under general anesthesia. the cervix is dilated and the cesarean section defect opened. polypoid tissue is ablated<br>* Other names: hysteroscopic metroplasty, niche repair;Procedure: Diagnostic Hysteroscopy<br>* Betthochi's method for diagnostic hysteroscopy: No anesthesia will be used. vaginoscopy will be performed, followed by diagnostic hysteroscopy. saline will be used as a distension media. 4.2 mm Storz hysteroscope will be used.<br>Procedure: Ultrasound Scan<br>* Scanning the uterus with the ultrasound probe . Transvaginal ultrasound usually produces better and clearer images of the female pelvic organs, because the ultrasound probe lies closer to these structures. The transvaginal ultrasound probe is thin, about 2cm diameter. The probe is covered with a disposable protective sheath. A small amount of ultrasound gel is placed on the end of this probe. The probe is then gently inserted a short distance into the vagina.<br>* Other names: Internal ultrasound;Procedure: IVF Cycle<br>* Controlled ovarian hyperstimulation, followed by Human chorionic Gonadotropin ( hCG) administration, Ovum Pickup and Embryo transfer<br>* Other names: IVF Treatment;|
| Sham Comparator: No Repair<br>Interventions to be administered: Ultrasound Scan Diagnostic Hysteroscopy IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED | Procedure: Diagnostic Hysteroscopy<br>* Betthochi's method for diagnostic hysteroscopy: No anesthesia will be used. vaginoscopy will be performed, followed by diagnostic hysteroscopy. saline will be used as a distension media. 4.2 mm Storz hysteroscope will be used.<br>Procedure: Ultrasound Scan<br>* Scanning the uterus with the ultrasound probe . Transvaginal ultrasound usually produces better and clearer images of the female pelvic organs, because the ultrasound probe lies closer to these structures. The transvaginal ultrasound probe is thin, about 2cm diameter. The probe is covered with a disposable protective sheath. A small amount of ultrasound gel is placed on the end of this probe. The probe is then gently inserted a short distance into the vagina.<br>* Other names: Internal ultrasound;Procedure: IVF Cycle<br>* Controlled ovarian hyperstimulation, followed by Human chorionic Gonadotropin ( hCG) administration, Ovum Pickup and Embryo transfer<br>* Other names: IVF Treatment;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Embryo implantation rate | Embryo implantation rate during IVF | completion of two IVF cycles after randomization - approx. 2 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ivf, cesarean section defect, implantation