InfertilityNCT02371486
Does Cesarean Section Scar Defect (Niche) Affect Implantation Rate?
A study testing hysteroscopic repair of cesarean section defect, Diagnostic Hysteroscopy and Ultrasound Scan in people with Infertility and Complications; Cesarean Section, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Infertility, Complications; Cesarean Section
- What is being tested?
- hysteroscopic repair of cesarean section defect, Diagnostic Hysteroscopy and Ultrasound Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing IVF after cesarean section
Who cannot join
- Patients who underwent CSD repair
- Patients with low ovarian reserve
- Patients with hydrosalpinges, endometriosis, adenomyosis, submucous fibroids or polyps
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
The chaim sheba medical center,Tel Hashomer
Ramat Gan, 52503
Roy Mashiach, MD, +97236130077, roy.mashiach@gmail.com
About this study
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.
Read the 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
- Conditions
- Infertility, Complications; Cesarean Section
- Being tested
- hysteroscopic repair of cesarean section defect, Diagnostic Hysteroscopy, Ultrasound Scan, IVF Cycle
- Keywords
- cesarean section defect, implantation, ivf
- Medical subject headings
- Infertility, Long Qt Syndrome 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hysteroscopic repair of cesarean section defectProcedure or surgery
Also called hysteroscopic metroplasty, niche repair
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 HysteroscopyProcedure or surgery
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 ScanProcedure or surgery
Also called Internal ultrasound
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 CycleProcedure or surgery
Also called IVF Treatment
Controlled ovarian hyperstimulation, followed by Human chorionic Gonadotropin ( hCG) administration, Ovum Pickup and Embryo transfer
| Study group | Role | What they receive |
|---|---|---|
| Nich Repair | Experimental | Interventions to be administered:
1. Ultrasound Scan
2. Diagnostic Hysteroscopy
3. hysteroscopic repair of cesarean section defect
4. IVF cycle Receives: Procedure: hysteroscopic repair of cesarean section defect; Procedure: Diagnostic Hysteroscopy; Procedure: Ultrasound Scan; Procedure: IVF Cycle |
| No Repair | Sham comparator | Interventions to be administered:
1. Ultrasound Scan
2. Diagnostic Hysteroscopy
3. IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED Receives: Procedure: Diagnostic Hysteroscopy; Procedure: Ultrasound Scan; Procedure: IVF Cycle |
What is being measured
The primary outcome is the main question the study is designed to answer.
Embryo implantation rate
Embryo implantation rate during IVF
Measured: completion of two IVF cycles after randomization - approx. 2 months
Secondary outcomes (3)
Fluid in Uterus
Detection of fluid in the uterine cavity during menotropin stimulation in IVF treatment
Measured: completion of two IVF cycles after randomization - approx. 2 months
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
Measured: 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
Correlation between the size and type of the defect and implantation rate during IVF treatment
Measured: completion of two IVF cycles after randomization - approx. 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2015 (estimated)
- Study startApr 2016
- Primary completionFeb 2017 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Roy Mashiach, M.D., Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02371486
- Sponsor's protocol ID
- SHEBA-14-1399-RM-CTIL
- Status last verified
- Oct 2016
- First submitted
- 10 Feb 2015
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Cesarean Section Scar Defect (Niche) Affect Implantation Rate?
- ClinicalTrials.gov ID
- NCT02371486
- Acronym / sponsor ID
- SHEBA-14-1399-RM-CTIL
- Conditions
- Infertility, Complications; Cesarean Section
- Keywords
- cesarean section defect, implantation, ivf
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Apr 2016
- Primary completion
- Feb 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 25 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nich Repair | Experimental | Procedure: hysteroscopic repair of cesarean section defect, Procedure: Diagnostic Hysteroscopy, Procedure: Ultrasound Scan, Procedure: IVF CycleInterventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. hysteroscopic repair of cesarean section defect 4. IVF cycle |
| No Repair | Sham comparator | Procedure: Diagnostic Hysteroscopy, Procedure: Ultrasound Scan, Procedure: IVF CycleInterventions to be administered: 1. Ultrasound Scan 2. Diagnostic Hysteroscopy 3. IVF cycle Operative hysteroscopy WILL NOT BE PERFORMED |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing IVF after cesarean section
Key exclusion criteria (3 listed)
- Patients who underwent CSD repair
- Patients with low ovarian reserve
- Patients with hydrosalpinges, endometriosis, adenomyosis, submucous fibroids or polyps
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hysteroscopic repair of cesarean section defectAlso: hysteroscopic metroplasty, niche repairOperative 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 | Procedure or surgery | Nich Repair |
| Diagnostic HysteroscopyBetthochi'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 or surgery | Nich Repair, No Repair |
| Ultrasound ScanAlso: Internal ultrasoundScanning 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. | Procedure or surgery | Nich Repair, No Repair |
| IVF CycleAlso: IVF TreatmentControlled ovarian hyperstimulation, followed by Human chorionic Gonadotropin ( hCG) administration, Ovum Pickup and Embryo transfer | Procedure or surgery | Nich Repair, No Repair |
Primary outcome
Embryo implantation rate
Time frame: completion of two IVF cycles after randomization - approx. 2 months
Embryo implantation rate during IVF
3 secondary outcomes
Fluid in Uterus
Time frame: 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 implantation rate during IVF treatment
Time frame: completion of two IVF cycles after randomization - approx. 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hysteroscopic repair of cesarean section defect, Diagnostic Hysteroscopy and Ultrasound Scan in people with Infertility and Complications; Cesarean Section, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lilia Margolis-Dorfman, M.P.H (+972-3530-4948, lilia.mdorfman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Embryo implantation rate (time frame: completion of two IVF cycles after randomization - approx. 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2016.