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

NCT04197167 | Unknown DMC

• 1 other identifier: 0122-19-HYMC
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Endometritis; IVF

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Women undergoing hysteroscopy

EXPERIMENTAL

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

Procedure: Hysteroscopy; Device: Infrared Spectroscopy

Interventions

Hysteroscopy PROCEDURE

Diagnostic procedure

Women undergoing hysteroscopy

Infrared Spectroscopy DEVICE

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

Women undergoing hysteroscopy

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Pregnant women, minors and lack of judgment women will not included
• At the request of the examined woman

Sponsors & Collaborators

• Hillel Yaffe Medical Center: lead

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, 3810101, Israel

RECRUITING

MeSH Terms

Conditions

Endometritis

Interventions

Hysteroscopy

Condition Hierarchy (Ancestors)

Pelvic Inflammatory Disease; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Uterine Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Einat Shalom-Paz, Prof

  Hillel Yaffe Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Einat Shalom-Paz, Prof

CONTACT

+972-47744750; EinatS@hy.health.gov.il

Asaf Bilgory, MD

CONTACT

asaf_bil@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: December 4, 2019
• First Posted: December 12, 2019
• Study Start: December 12, 2019
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: June 23, 2022

Record last verified: 2022-06

Locations

IL (1)