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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age48-75
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

No trial groups listed