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Clinical Trials/NCT04197167
NCT04197167
Unknown
Not Applicable

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

Hillel Yaffe Medical Center1 site in 1 country120 target enrollmentDecember 12, 2019
ConditionsEndometritisIVF

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometritis
Sponsor
Hillel Yaffe Medical Center
Enrollment
120
Locations
1
Primary Endpoint
Comparison of infrared spectroscopy (ATR-FTIR technique) with routine histopathology
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 12, 2019
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Comparison of infrared spectroscopy (ATR-FTIR technique) with routine histopathology

Time Frame: 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).

Study Sites (1)

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