EndometritisNCT04197167
Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis
A study testing Hysteroscopy and Infrared Spectroscopy in people with Endometritis and IVF, run by Hillel Yaffe Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Endometritis, IVF
- What is being tested?
- Hysteroscopy and Infrared Spectroscopy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 12 Dec 2019to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Pregnant women, minors and lack of judgment women will not included
- At the request of the examined woman
Trial locations and contacts
1 site in 1 country.
Asaf Bilgory, MD contact
Israel1 site, 1 recruiting
- Recruiting
Hillel Yaffe Medical Center
Hadera, 3810101
Osnat Palgi, BSc., +972-47744602, osnatp@hymc.gov.il
About this study
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.
Read the 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.
- Conditions
- Endometritis, IVF
- Being tested
- Hysteroscopy, Infrared Spectroscopy
- Medical subject headings
- Endometritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HysteroscopyProcedure or surgery
Diagnostic procedure
Infrared SpectroscopyDevice
This device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of Chronic Endometritis
| Study group | Role | What they receive |
|---|---|---|
| Women undergoing hysteroscopy | Experimental | Patients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings. Receives: Procedure: Hysteroscopy; Device: Infrared Spectroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start12 Dec 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Einat Shalom-Paz, Prof, Principal investigator, Hillel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04197167
- Sponsor's protocol ID
- 0122-19-HYMC
- Status last verified
- Jun 2022
- First submitted
- 4 Dec 2019
- Last updated
- 23 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mid-Infrared Spectroscopy as a Real Time Diagnostic Tool for Chronic Endometritis
- ClinicalTrials.gov ID
- NCT04197167
- Acronym / sponsor ID
- 0122-19-HYMC
- Conditions
- Endometritis, IVF
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 12 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Women undergoing hysteroscopy | Experimental | Procedure: Hysteroscopy, Device: Infrared SpectroscopyPatients scheduled to undergo hysteroscopy for the evaluation of abnormal bleeding or abnormal cervical or uterine findings. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Pregnant women, minors and lack of judgment women will not included
- At the request of the examined woman
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HysteroscopyDiagnostic procedure | Procedure or surgery | Women undergoing hysteroscopy |
| Infrared SpectroscopyThis device uses spectral absorption of the tissue taken during hysteroscopy to determine immediate diagnosis of Chronic Endometritis | Device | Women undergoing hysteroscopy |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Asaf Bilgory, MD contact
Einat Shalom-Paz, Prof principal investigator
Hillel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hysteroscopy and Infrared Spectroscopy in people with Endometritis and IVF, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Einat Shalom-Paz, Prof (+972-47744750, EinatS@hy.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of infrared spectroscopy (ATR-FTIR technique) with routine histopathology (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2022.