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

Primary Purpose

Infertility, Complications; Cesarean Section

Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
hysteroscopic repair of cesarean section defect
Diagnostic Hysteroscopy
Ultrasound Scan
IVF Cycle
Sponsored by
Sheba Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring cesarean section defect, implantation, ivf

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • The chaim sheba medical center,Tel HashomerRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Nich Repair

No Repair

Arm Description

Interventions to be administered: Ultrasound Scan Diagnostic Hysteroscopy hysteroscopic repair of cesarean section defect IVF cycle

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

Outcomes

Primary Outcome Measures

Embryo implantation rate
Embryo implantation rate during IVF

Secondary Outcome Measures

Fluid in Uterus
Detection of fluid in the uterine cavity during menotropin stimulation in IVF treatment
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
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

Full Information

First Posted
February 10, 2015
Last Updated
October 12, 2016
Sponsor
Sheba Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02371486
Brief Title
Does Cesarean Section Scar Defect (Niche) Affect Implantation Rate?
Official Title
Does Cesarean Section Scar Defect (Niche) Affect Implantation Rate?
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
April 2016 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
February 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Complications; Cesarean Section
Keywords
cesarean section defect, implantation, ivf

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Nich Repair
Arm Type
Experimental
Arm Description
Interventions to be administered: Ultrasound Scan Diagnostic Hysteroscopy hysteroscopic repair of cesarean section defect IVF cycle
Arm Title
No Repair
Arm Type
Sham Comparator
Arm Description
Interventions to be administered: Ultrasound Scan Diagnostic Hysteroscopy IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED
Intervention Type
Procedure
Intervention Name(s)
hysteroscopic repair of cesarean section defect
Other Intervention Name(s)
hysteroscopic metroplasty, niche repair
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Diagnostic Hysteroscopy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound Scan
Other Intervention Name(s)
Internal ultrasound
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
IVF Cycle
Other Intervention Name(s)
IVF Treatment
Intervention Description
Controlled ovarian hyperstimulation, followed by Human chorionic Gonadotropin ( hCG) administration, Ovum Pickup and Embryo transfer
Primary Outcome Measure Information:
Title
Embryo implantation rate
Description
Embryo implantation rate during IVF
Time Frame
completion of two IVF cycles after randomization - approx. 2 months
Secondary Outcome Measure Information:
Title
Fluid in Uterus
Description
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
Title
Correlation between size and type of the defect fluid accumulation
Description
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
Title
Correlation between the size and type of the defect and implantation rate during IVF treatment
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lilia Margolis-Dorfman, M.P.H
Phone
+972-3530-4948
Email
lilia.mdorfman@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Roy Mashiach, M.D
Phone
+972-35302773
Email
Roy.mashiach@gmail.com
Facility Information:
Facility Name
The chaim sheba medical center,Tel Hashomer
City
Ramat Gan
ZIP/Postal Code
52503
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roy Mashiach, MD
Phone
+97236130077
Email
roy.mashiach@gmail.com

12. IPD Sharing Statement

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

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