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

Not Applicable

• Conditions: Endometritis; IVF
• Interventions: Procedure: Hysteroscopy; Device: Infrared Spectroscopy

• Registration Number: NCT04197167
• Lead Sponsor: Hillel Yaffe Medical Center

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.

Study Timeline

• Study First Submitted: 2019-12-04
• Study First Submitted QC: 2019-12-11
• Study Start: 2019-12-12
• Study First Posted: 2019-12-12
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-22
• Last Update Posted: 2022-06-23
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Women undergoing hysteroscopy	Infrared Spectroscopy	Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.
Women undergoing hysteroscopy	Hysteroscopy	Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.

Primary Outcome Measures

Name	Time	Method
Comparison of infrared spectroscopy (ATR-FTIR technique) with routine histopathology	2 Years	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).

Trial Locations

Locations (1)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel