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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02371486
• Other study ID #: SHEBA-14-1399-RM-CTIL
• Status: Recruiting
• Phase: N/A
• First received: February 10, 2015
• Last updated: October 12, 2016
• Start date: April 2016
• Est. completion date: February 2018

Study information

• Verified date: October 2016
• Source: Sheba Medical Center
• Contact: Lilia Margolis-Dorfman, M.P.H
• Phone: +972-3530-4948
• Email: lilia.mdorfman[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: February 2018
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complications; Cesarean Section
• Infertility

Intervention

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

Locations

Country	Name	City	State
Israel	The chaim sheba medical center,Tel Hashomer	Ramat Gan

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryo implantation rate	Embryo implantation rate during IVF	completion of two IVF cycles after randomization - approx. 2 months	No
Secondary	Fluid in Uterus	Detection of fluid in the uterine cavity during menotropin stimulation in IVF treatment	completion of two IVF cycles after randomization - approx. 2 months	No
Secondary	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	completion of two IVF cycles after randomization - approx. 2 months	No
Secondary	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	completion of two IVF cycles after randomization - approx. 2 months	No