Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis
Primary Purpose
Endometritis, IVF
Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Hysteroscopy
Infrared Spectroscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Endometritis
Eligibility Criteria
Inclusion Criteria:
- Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.
- Patients scheduled for any histological evaluation including endometrial biopsy, dilatation and curettage (D&C), biopsy/excision of uterine polyp or fibroid or any other cervical or uterine lesion.
- Age 18 and over.
Exclusion Criteria:
- Pregnant women, minors and lack of judgment women will not included
- At the request of the examined woman
Sites / Locations
- Hillel Yaffe Medical CenterRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Women undergoing hysteroscopy
Arm Description
Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.
Outcomes
Primary Outcome Measures
Comparison of infrared spectroscopy (ATR-FTIR technique) with routine histopathology
Using ATR-FTIR technique of impression smears obtained from CE tissue during standard hysteroscopy procedure will provide a new diagnostic tool for fast diagnosis of CE inflammation and thus assist in the clinical decision process leading to assisted reproductive treatment (ART).
Secondary Outcome Measures
Full Information
NCT ID
NCT04197167
First Posted
December 4, 2019
Last Updated
June 22, 2022
Sponsor
Hillel Yaffe Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04197167
Brief Title
Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis
Official Title
Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 12, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hillel Yaffe Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The Investigator propose to develop an in-vitro technique for the measurement and analysis of freshly excised biopsies during hysteroscopy procedure in patients with suspected Chronic Endometritis (CE) condition. Furthermore, the investigator propose to develop a discrimination model between the CE and inflammatory CE types using the measured spectroscopic data from freshly excised biopsies.
Detailed Description
It is common practice that, following hysteroscopy, the clinician needs to wait for about two weeks before the results of the histology are returned and the clinical treatment is initiated. In this research, the investigator intent to show that the mid infrared ATR (Assisted Reproductive Treatment) spectroscopy method will provide the physician with sufficient information about the CE inflammation status in a considerably shorter period of time to allow immediate initiation of the appropriate treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometritis, IVF
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Women undergoing hysteroscopy
Arm Type
Experimental
Arm Description
Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopy
Intervention Description
Diagnostic procedure
Intervention Type
Device
Intervention Name(s)
Infrared Spectroscopy
Intervention Description
This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of Chronic Endometritis
Primary Outcome Measure Information:
Title
Comparison of infrared spectroscopy (ATR-FTIR technique) with routine histopathology
Description
Using ATR-FTIR technique of impression smears obtained from CE tissue during standard hysteroscopy procedure will provide a new diagnostic tool for fast diagnosis of CE inflammation and thus assist in the clinical decision process leading to assisted reproductive treatment (ART).
Time Frame
2 Years
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.
Patients scheduled for any histological evaluation including endometrial biopsy, dilatation and curettage (D&C), biopsy/excision of uterine polyp or fibroid or any other cervical or uterine lesion.
Age 18 and over.
Exclusion Criteria:
Pregnant women, minors and lack of judgment women will not included
At the request of the examined woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Einat Shalom-Paz, Prof
Phone
+972-47744750
Email
EinatS@hy.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Asaf Bilgory, MD
Email
asaf_bil@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Einat Shalom-Paz, Prof
Organizational Affiliation
Hillel Yaffe Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hillel Yaffe Medical Center
City
Hadera
ZIP/Postal Code
3810101
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Osnat Palgi, BSc.
Phone
+972-47744602
Email
osnatp@hymc.gov.il
12. IPD Sharing Statement
Learn more about this trial
Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis
We'll reach out to this number within 24 hrs