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

NCT ID: NCT02371486

Last Updated: 2016-10-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2018-02-28

Brief Summary

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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

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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

Conditions

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Infertility Complications; Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nich Repair

Interventions to be administered:

1. Ultrasound Scan
2. Diagnostic Hysteroscopy
3. hysteroscopic repair of cesarean section defect
4. IVF cycle

Group Type EXPERIMENTAL

hysteroscopic repair of cesarean section defect

Intervention Type 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

Diagnostic Hysteroscopy

Intervention Type 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.

Ultrasound Scan

Intervention Type 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.

IVF Cycle

Intervention Type PROCEDURE

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

No Repair

Interventions to be administered:

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

Group Type SHAM_COMPARATOR

Diagnostic Hysteroscopy

Intervention Type 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.

Ultrasound Scan

Intervention Type 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.

IVF Cycle

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

IVF Cycle

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

Intervention Type PROCEDURE

Other Intervention Names

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hysteroscopic metroplasty, niche repair Internal ultrasound IVF Treatment

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Roy Mashiach, M.D.

Vice Chairman Gynecological Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The chaim sheba medical center,Tel Hashomer

Ramat Gan, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Lilia Margolis-Dorfman, M.P.H

Role: CONTACT

+972-3530-4948

Roy Mashiach, M.D

Role: CONTACT

+972-35302773

Facility Contacts

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Roy Mashiach, MD

Role: primary

+97236130077

Other Identifiers

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SHEBA-14-1399-RM-CTIL

Identifier Type: -

Identifier Source: org_study_id

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