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A simple look inside the uterus may reveal hidden inflammation — no lab needed

NCT ID NCT07733713

Knowledge-focused Sponsor: Centro A.M.B.R.A. (Associazione Medici e Biologi per la Riproduzione Assistita) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time

Summary

This study asks whether visual signs seen during a hysteroscopy — a camera exam of the uterus — can reliably detect chronic endometritis, a long-term inflammation of the uterine lining. About 100 women already scheduled for hysteroscopy as part of their fertility care will take part. Researchers will compare the visual findings with a lab count of CD138-positive immune cells from a tissue sample to see if the two methods agree closely enough to skip the lab test.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If hysteroscopic signs correlate well with lab results, doctors might diagnose chronic endometritis faster and less invasively during routine exams.
What could go wrong
This is an observational study, not a treatment trial. The correlation may be weak, meaning lab tests would still be needed for reliable diagnosis.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Women aged 18-46 years referred for office hysteroscopy with endometrial biopsy at Centro A.M.B.R.A. (Palermo, Italy), for any clinical indication including recurrent implantation failure, recurrent pregnancy loss, or other reasons. All examinations are performed during the early-to-mid proliferative phase (cycle days 6-12) of a spontaneous, non-progestin-exposed menstrual cycle. Approximately 100 participants will be prospectively enrolled and registered; an additional approximately 20 patients evaluated before study initiation constitute a separate pilot cohort and are not included in this population.

Ages

18 to 46 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Woman aged 18-46 years undergoing office hysteroscopy with endometrial biopsy as part of her clinical work-up (including assisted reproduction/PMA pathways), for any indication (recurrent implantation failure, recurrent pregnancy loss, or other). * Examination performed during the early-to-mid proliferative phase (cycle days 6-12) of a spontaneous cycle not exposed to exogenous progestins * Written informed consent to participation and to data processing Exclusion Criteria: * Current or suspected pregnancy * Postmenopausal status * Clinically active pelvic or lower genital tract infection * Systemic antibiotic use within the preceding 4 weeks * Use of exogenous progestins or other hormonal therapy within the preceding 4 weeks * Submucous myoma, endometrial polyp, or synechiae precluding reliable * assessment of the endometrial surface * Inability to obtain adequate endometrial tissue for immunohistochemistry

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Conditions

The condition(s) this trial relates to.

chronic endometritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic endometritis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

More trials for these conditions

Other studies related to the condition(s) this trial covers.