Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy'
Recruiting now
Conditions studied: Atrophic or Hypotrophic Endometrium
In brief
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.
Key facts
- Study ID
- NCT07675317
- Run by
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- People needed
- 156
- Starts
- 2025-08-04
- Expected to finish
- 2026-11-01
- Last updated by the study team
- 2026-06-30
Who can join
Age: 48 and older, up to 75. Sex: female. Healthy volunteers: not accepted.
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.
Where it is running
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna, Bologna, Italy (enrolling)
Full record on ClinicalTrials.gov
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