Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hyp… (NCT07675317) | Clinical Trial Compass
RecruitingNot Applicable
Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy'
Italy156 participantsStarted 2025-08-04
Plain-language 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.
Who can participate
Age range
48 Years – 75 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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'
Timeframe: During hysteroscopy
Trial details
NCT IDNCT07675317
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna