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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04197167
Enrollment
120
Registered
2019-12-12
Start date
2019-12-12
Completion date
2022-12-31
Last updated
2022-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometritis, IVF

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.

Interventions

PROCEDUREHysteroscopy

Diagnostic procedure

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

Sponsors

Hillel Yaffe Medical Center
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Single Group Assignment

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Comparison of infrared spectroscopy (ATR-FTIR technique) with routine histopathology2 YearsUsing 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).

Countries

Israel

Contacts

Primary ContactEinat Shalom-Paz, Prof
EinatS@hy.health.gov.il+972-47744750
Backup ContactAsaf Bilgory, MD
asaf_bil@hotmail.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026