ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02371486
Recruitment Status : Unknown
Verified October 2016 by Roy Mashiach, M.D., Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : February 25, 2015
Last Update Posted : October 14, 2016
Sponsor:
Information provided by (Responsible Party):
Roy Mashiach, M.D., Sheba Medical Center

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.

Condition or disease Intervention/treatment Phase
Infertility Complications; Cesarean Section Procedure: hysteroscopic repair of cesarean section defect Procedure: Diagnostic Hysteroscopy Procedure: Ultrasound Scan Procedure: IVF Cycle Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Does Cesarean Section Scar Defect (Niche) Affect Implantation Rate?
Study Start Date : April 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Internal ultrasound

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

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




Primary Outcome Measures :
  1. Embryo implantation rate [ Time Frame: completion of two IVF cycles after randomization - approx. 2 months ]
    Embryo implantation rate during IVF


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02371486


Contacts
Contact: Lilia Margolis-Dorfman, M.P.H +972-3530-4948 lilia.mdorfman@gmail.com
Contact: Roy Mashiach, M.D +972-35302773 Roy.mashiach@gmail.com

Locations
Israel
The chaim sheba medical center,Tel Hashomer Recruiting
Ramat Gan, Israel, 52503
Contact: Roy Mashiach, MD    +97236130077    roy.mashiach@gmail.com   
Sponsors and Collaborators
Sheba Medical Center

Responsible Party: Roy Mashiach, M.D., Vice Chairman Gynecological Department, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT02371486     History of Changes
Other Study ID Numbers: SHEBA-14-1399-RM-CTIL
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: October 14, 2016
Last Verified: October 2016

Keywords provided by Roy Mashiach, M.D., Sheba Medical Center:
cesarean section defect
implantation
ivf

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female