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

Sheba Medical Center

Status: Unknown

Conditions: Infertility; Complications; Cesarean Section

Treatments: Procedure: hysteroscopic repair of cesarean section defect; Procedure: IVF Cycle; Procedure: Ultrasound Scan; Procedure: Diagnostic Hysteroscopy

Study type: Interventional

Funder types: Other

Identifiers

NCT02371486

SHEBA-14-1399-RM-CTIL

Details and patient eligibility

About

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.

Full 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

Enrollment: 150 estimated patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Nich Repair

Experimental group

Description:

Interventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. hysteroscopic repair of cesarean section defect 4. IVF cycle

Treatment:

Procedure: Ultrasound Scan

Procedure: IVF Cycle

Procedure: Diagnostic Hysteroscopy

Procedure: hysteroscopic repair of cesarean section defect

No Repair

Sham Comparator group

Description:

Interventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED

Treatment:

Procedure: Ultrasound Scan

Procedure: IVF Cycle

Procedure: Diagnostic Hysteroscopy