An interventional study of hysteroscopic repair of cesarean section defect and Diagnostic Hysteroscopy in Infertility and Complications; Cesarean Section, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to female participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2016-10-14.
Sponsored by Sheba Medical Center · Not applicable, Interventional, and Treatment
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.
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
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 150 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Sheba Medical Center is the lead sponsor of 660 studies on the registry; 63 are open to participants now.
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Exclusion Criteria:
Interventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. hysteroscopic repair of cesarean section defect 4. IVF cycle
Procedure: hysteroscopic repair of cesarean section defect · Procedure: Diagnostic Hysteroscopy · Procedure: Ultrasound Scan · Procedure: IVF Cycle
Interventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED
Procedure: Diagnostic Hysteroscopy · Procedure: Ultrasound Scan · Procedure: IVF Cycle
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
Also known as: hysteroscopic metroplasty, niche repair
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.
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.
Also known as: Internal ultrasound
Controlled ovarian hyperstimulation, followed by Human chorionic Gonadotropin ( hCG) administration, Ovum Pickup and Embryo transfer
Also known as: IVF Treatment
Embryo implantation rate
Embryo implantation rate during IVF
Time frame: completion of two IVF cycles after randomization - approx. 2 months
Fluid in Uterus
Detection of fluid in the uterine cavity during menotropin stimulation in IVF treatment
Time frame: 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
Time frame: 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
Time frame: completion of two IVF cycles after randomization - approx. 2 months
This study is status unknown, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Sheba Medical Center