Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis

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.

Study Overview

• Status: Recruiting
• Conditions: IVF; Endometritis
• Intervention / Treatment: Procedure: Hysteroscopy; Device: Infrared Spectroscopy

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.

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Einat Shalom-Paz, Prof; Phone Number: +972-47744750; Email: EinatS@hy.health.gov.il
• Study Contact Backup: Name: Asaf Bilgory, MD; Email: asaf_bil@hotmail.com

Study Locations

• Israel
  • Hadera, Israel, 3810101
    • Recruiting
    • Hillel Yaffe Medical Center
    • Contact: Osnat Palgi, BSc.; Phone Number: +972-47744602; Email: osnatp@hymc.gov.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Women undergoing hysteroscopy; Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.	Procedure: Hysteroscopy; Diagnostic procedure; Device: Infrared Spectroscopy; This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of Chronic Endometritis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	2 Years

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Investigators: Principal Investigator: Einat Shalom-Paz, Prof, Hillel Yaffe Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 12, 2019
• Primary Completion (ANTICIPATED): December 31, 2022
• Study Completion (ANTICIPATED): December 31, 2022

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 11, 2019
• First Posted (ACTUAL): December 12, 2019

Study Record Updates

• Last Update Posted (ACTUAL): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Uterine Diseases; Adnexal Diseases; Pelvic Inflammatory Disease; Endometritis
• Other Study ID Numbers: 0122-19-HYMC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No