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

IVF Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04197167
• Other study ID #: 0122-19-HYMC
• Status: Recruiting
• Phase: N/A
• Start date: December 12, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: June 2022
• Source: Hillel Yaffe Medical Center
• Contact: Einat Shalom-Paz, Prof
• Phone: +972-47744750
• Email: EinatS[@]hy.health.gov.il
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Endometritis
• IVF

Intervention

Procedure:
• Hysteroscopy
Diagnostic procedure

Device:
• Infrared Spectroscopy
This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of Chronic Endometritis

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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