Complications; Cesarean Section, Infertility
Conditions
Keywords
cesarean section defect, implantation, ivf
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
Interventions
PROCEDUREhysteroscopic repair of cesarean section defect
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
PROCEDUREDiagnostic Hysteroscopy
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.
PROCEDUREUltrasound Scan
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.
PROCEDUREIVF Cycle
Controlled ovarian hyperstimulation, followed by Human chorionic Gonadotropin ( hCG) administration, Ovum Pickup and Embryo transfer
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 35 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Embryo implantation rate | completion of two IVF cycles after randomization - approx. 2 months | Embryo implantation rate during IVF |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 |
| 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 |
Countries
Israel
Contacts
Primary ContactLilia Margolis-Dorfman, M.P.H
Backup ContactRoy Mashiach, M.D
Outcome results
None listed