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

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

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-12

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Endometritis IVF

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single Group Assignment

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Women undergoing hysteroscopy

Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings.

Group Type EXPERIMENTAL

Hysteroscopy

Intervention Type PROCEDURE

Diagnostic procedure

Infrared Spectroscopy

Intervention Type DEVICE

This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of Chronic Endometritis

Interventions

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Hysteroscopy

Diagnostic procedure

Intervention Type PROCEDURE

Infrared Spectroscopy

This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of Chronic Endometritis

Intervention Type DEVICE

Eligibility Criteria

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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.