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

NCT07675317 | Recruiting

• 1 other identifier: HYSTEB
• Study Type: observational
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Atrophic or Hypotrophic Endometrium

Outcome Measures

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 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

  During hysteroscopy

Secondary Outcomes (6)

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

  During hysteroscopy

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

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

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

  During hysteroscopy

• Pain intensity assessed by Visual Analog Scale (VAS)

  administered after hysteroscopy (within 24 hours)

• Pain quality assessed by McGill Pain Questionnaire (MPQ)

  administered after hysteroscopy (within 24 hours)

Eligibility Criteria

• Age: 48 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Atrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Paolo Casadio, MD

CONTACT

0512144411; p.casadio@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2025
• First Posted: June 30, 2026
• Study Start: August 4, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)