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

NCT02371486 | Unknown

• 1 other identifier: SHEBA-14-1399-RM-CTIL
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Complications; Cesarean Section

Keywords

cesarean section defect; implantation; ivf

Outcome Measures

Primary Outcomes (1)

• Embryo implantation rate

  Embryo implantation rate during IVF

  completion of two IVF cycles after randomization - approx. 2 months

Secondary Outcomes (3)

• Fluid in Uterus

  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

• 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

Study Arms (2)

Nich Repair

EXPERIMENTAL

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

No Repair

SHAM COMPARATOR

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

Interventions

hysteroscopic repair of cesarean section defect PROCEDURE

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

Nich Repair

Diagnostic Hysteroscopy PROCEDURE

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.

Nich Repair; No Repair

Ultrasound Scan PROCEDURE

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

Nich Repair; No Repair

IVF Cycle PROCEDURE

Controlled ovarian hyperstimulation, followed by Human chorionic Gonadotropin ( hCG) administration, Ovum Pickup and Embryo transfer

Also known as: IVF Treatment

Nich Repair; No Repair

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing IVF after cesarean section

You may not qualify if:

• Patients who underwent CSD repair
• Patients with low ovarian reserve
• Patients with hydrosalpinges, endometriosis, adenomyosis, submucous fibroids or polyps

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

The chaim sheba medical center,Tel Hashomer

Ramat Gan, 52503, Israel

RECRUITING

MeSH Terms

Conditions

Infertility; Long Qt Syndrome 3

Interventions

Hysteroscopy; High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Lilia Margolis-Dorfman, M.P.H

CONTACT

+972-3530-4948; lilia.mdorfman@gmail.com

Roy Mashiach, M.D

CONTACT

+972-35302773; Roy.mashiach@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chairman Gynecological Department

Study Record Dates

• First Submitted: February 10, 2015
• First Posted: February 25, 2015
• Study Start: April 1, 2016
• Primary Completion: February 1, 2017
• Study Completion: February 1, 2018
• Last Updated: October 14, 2016

Record last verified: 2016-10

Locations

IL (1)