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

October 12, 2016 updated by: Roy Mashiach, M.D., Sheba Medical Center
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel, 52503
        • Recruiting
        • The Chaim Sheba Medical Center,Tel Hashomer
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nich Repair

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
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
Other Names:
  • hysteroscopic metroplasty, niche repair
Procedure: Diagnostic 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.
Procedure: Ultrasound 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.

Other Names:
  • Internal ultrasound
Procedure: IVF Cycle
Controlled ovarian hyperstimulation, followed by Human chorionic Gonadotropin ( hCG) administration, Ovum Pickup and Embryo transfer
Other Names:
  • IVF Treatment
Sham Comparator: No Repair

Interventions to be administered:

  1. Ultrasound Scan
  2. Diagnostic Hysteroscopy
  3. IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED
Procedure: Diagnostic 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.
Procedure: Ultrasound 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.

Other Names:
  • Internal ultrasound
Procedure: IVF Cycle
Controlled ovarian hyperstimulation, followed by Human chorionic Gonadotropin ( hCG) administration, Ovum Pickup and Embryo transfer
Other Names:
  • IVF Treatment

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

February 1, 2017

Study Completion (Anticipated)

February 1, 2018

Study Registration Dates

First Submitted

February 10, 2015

First Submitted That Met QC Criteria

February 19, 2015

First Posted (Estimate)

February 25, 2015

Study Record Updates

Last Update Posted (Estimate)

October 14, 2016

Last Update Submitted That Met QC Criteria

October 12, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-14-1399-RM-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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