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Which biopsy technique is best for a thin uterine lining? a Head-to-Head comparison

NCT ID NCT07675317

Knowledge-focused Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 30, 2026 · Last updated Jul 01, 2026 · Updated 1 time

Summary

This study compares two ways to take a tissue sample from the lining of the uterus in menopausal women whose lining is thin (atrophic or hypotrophic). The 'chip biopsy' and 'rail biopsy' techniques are both used in practice, but it is not clear which is faster, safer, or provides better tissue for diagnosis. Researchers will measure procedure time, side effects, and sample quality in about 156 women to help guide future choices.

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 one technique proves faster or safer, it could become the preferred method for endometrial biopsy in menopausal women, improving patient comfort and diagnostic accuracy.
What could go wrong
This is a small, single-center observational study, not a large randomized trial. Results may not apply to all patients or settings, and neither technique may show a clear advantage.

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 156 people

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

Started

Aug 2025

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

The recruitment of the study population will take place at the Hysteroscopy Outpatient Clinic of the Unit of Gynecology and Human Reproduction Physiopathology, IRCCS AOUBO. Patients referred to this clinic with an indication for diagnostic and/or operative hysteroscopy will undergo a thorough preliminary clinical evaluation to assess their eligibility for study enrollment (women with atrophic or hypotrophic endometrium requiring endometrial biopsy).

Ages

48 to 75 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: * Age ≥ 48 years and ≤ 75 years * Women with atrophic endometrium, candidates for endometrial biopsy * Informed consent obtained for participation in the study and for the processing of personal data Exclusion Criteria: * Presence of intrauterine fibroids, polyps, and adhesions; * Current or recent (\< 3 months) use of anticoagulant drugs and/or Selective Estrogen Receptor Modulators (SERMs); * Previous confirmed diagnosis of endometrial cancer; * Suspected active pelvic inflammation or history of recent pelvic inflammation (\< 6 months); * Presence of severe stenosis or obliteration of the cervical canal.

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Conditions

The condition(s) this trial relates to.

Atrophy

As listed by the trial registrant

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

Atrophic or hypotrophic endometrium

How to take part

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

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    RECRUITING

    Bologna, Bologna, 40138, Italy