Rail Biopsy vs Chip Biopsy for endometrial sampling in women with atrophic or hypotrophic endometrium
Official title: Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy'
Run by IRCCS Azienda Ospedaliero-Universitaria di Bologna · NCT07675317 · Data updated 2026-11-12
This study compares how long it takes to perform rail biopsy versus chip biopsy in menopausal- age women needing an endometrial biopsy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 48 Years to 75 Years |
| Sex | Women only |
| Enrollment | 156 (estimated) |
| Sponsor | IRCCS Azienda Ospedaliero-Universitaria di Bologna Academic / other |
| Locations | 1 site (Bologna, Bologna) |
| Status | Recruiting |
| Started | August 4, 2025 |
| Main results expected | September 2026 |
| Study ends | November 2026 |
| Registry record updated | June 30, 2026 |
| Trial ID | NCT07675317 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 48 to 75 with atrophic or hypotrophic endometrium who are candidates for endometrial biopsy and provide informed consent.
✕Probably not a fit
Patients with coexisting uterine fibroids, polyps, adhesions, active pelvic inflammation, or recent anticoagulant/SERM use may not experience a faster procedure or may not benefit from the comparison.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center, prospective observational study comparing two hysteroscopic biopsy techniques for sampling atrophic or hypotrophic endometrium. It is cross-sectional in design and aims to enroll about 156 participants over roughly 14 months. The primary focus is procedure duration, with safety and tolerability not being the explicit primary outcomes. Eligibility is limited to women aged 48 to 75 without certain uterine conditions or recent anticoagulant/SERM use, and who consent to participation and data processing. The lead sponsor is IRCCS Azienda Ospedaliero-Universitaria di Bologna.
Why it matters
Potential benefit: If one technique proves faster with similar safety, it could reduce procedure time and improve efficiency in outpatient gynecologic care.
How similar studies have gone: Other centers have explored endometrial biopsy techniques, but direct head-to-head comparisons for duration in atrophic/hypotrophic endometrium are limited, making this study relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
-
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, Italy Recruiting
Study contacts
- Study coordinator: Paolo Casadio, MD
- Email: p.casadio@unibo.it
- Phone: 0512144411
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using bone marrow stem cells to treat abnormal endometrium conditions
This study is testing if using a special treatment to help bone marrow stem cells can improve conditions like Asherman's Syndrome and help women get pregnant better than standard care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.