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NCT Number: NCT07675317

Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy'

Hysteroscopic endometrial biopsy is one of the most common procedures in gynecology. For patients with atrophic or hypotrophic endometrium, typical of menopausal women, the "chip biopsy" technique is often preferred as it provides adequate tissue samples for accurate histological examination. Recently, the "rail biopsy" technique has also been adopted at IRCCS AOUBO for biopsies in similar cases. Currently, the choice between these techniques depends largely on operator preference and experience, as there is no strong evidence favoring one over the other in terms of efficacy, safety, or tolerability.

This observational, single-center, cross-sectional, prospective, non-profit study aims to compare the procedure duration of "chip biopsy" versus "rail biopsy" in patients requiring endometrial biopsy of atrophic or hypotrophic endometrium. The study is expected to last approximately 14 months. Approximately 156 patients will be enrolled.

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Key information

Conditions

Atrophic or Hypotrophic Endometrium Atrophy Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

48 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, 40138, Italy

Location status: Recruiting

Location contact

Paolo Casadio, MD

CONTACT

[email protected]

0512144411

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. To compare the duration of procedures performed using two different techniques for endometrial biopsy in patients requiring sampling of hypotrophic or atrophic endometrium: 'chip biopsy' and 'rail biopsy'

    Time frame: During hysteroscopy

    Time required to perform the hysteroscopic endometrial biopsy technique, measured in seconds from entry into the uterine cavity to completion of the procedure itself (excluding the time needed for removal of the resected tissue), during hysteroscopy

Secondary outcomes

  1. To compare the safety of the procedure between the two endometrial biopsy techniques.

    Time frame: During hysteroscopy

    Adverse events (e.g., vasovagal syndromes, bleeding, uterine perforations, or other injuries to the uterus and surrounding organs)

  2. To compare the adequacy of the tissue obtained for histological analysis between the two endometrial biopsy techniques.

    Time frame: Upon delivery of the histological report (within 1 month from hysteroscopy)

    Pathologist's assessment regarding specific factors (e.g., tissue quantity, absence of crushing and/or tearing and/or electrocautery artifacts and/or improper fixation)

  3. To compare the need for additional accessory instruments between the two endometrial biopsy techniques.

    Time frame: During hysteroscopy

    Number of instruments used

  4. Pain intensity assessed by Visual Analog Scale (VAS)

    Time frame: administered after hysteroscopy (within 24 hours)

    Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain.

  5. Pain quality assessed by McGill Pain Questionnaire (MPQ)

    Time frame: administered after hysteroscopy (within 24 hours)

    Pain quality measured using the McGill Pain Questionnaire (MPQ), with total scores ranging from 0 to 78, where higher scores indicate greater pain severity.

  6. Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS)

    Time frame: administered after hysteroscopy (within 24 hours)

    Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS), consisting of two subscales (anxiety and depression), each ranging from 0 to 21, where higher scores indicate greater symptom severity.

Study contacts

Contact information is provided by the study sponsor or research team.

Paolo Casadio, MD

CONTACT

[email protected]

0512144411

Sponsors and collaborators

Lead sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Other

Registry information

Acronym: HYSTEB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 30, 2026
Registry last updated
Jun 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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