Atrophic or Hypotrophic EndometriumHYSTEBNCT07675317
Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy'
An observational study of Atrophic or Hypotrophic Endometrium, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 48 to 75 years, women only
- Conditions the study is for
- Atrophic or Hypotrophic Endometrium
- How many people
- 156 participants
- Where
- 1 siteItaly
- Study dates
- 4 Aug 2025to Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 48 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Paolo Casadio, MD, 0512144411, p.casadio@unibo.it
About this study
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
- Medical subject headings
- Atrophy
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: During hysteroscopy
Secondary outcomes (6)
To compare the safety of the procedure between the two endometrial biopsy techniques.
Adverse events (e.g., vasovagal syndromes, bleeding, uterine perforations, or other injuries to the uterus and surrounding organs)
Measured: During hysteroscopy
To compare the adequacy of the tissue obtained for histological analysis between the two endometrial biopsy techniques.
Pathologist's assessment regarding specific factors (e.g., tissue quantity, absence of crushing and/or tearing and/or electrocautery artifacts and/or improper fixation)
Measured: 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.
Number of instruments used
Measured: During hysteroscopy
Pain intensity assessed by Visual Analog Scale (VAS)
Pain intensity measured using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst possible pain.
Measured: administered after hysteroscopy (within 24 hours)
Pain quality assessed by McGill Pain Questionnaire (MPQ)
Pain quality measured using the McGill Pain Questionnaire (MPQ), with total scores ranging from 0 to 78, where higher scores indicate greater pain severity.
Measured: administered after hysteroscopy (within 24 hours)
Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS)
Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS), consisting of two subscales (anxiety and depression), each ranging from 0 to 21, where higher scores indicate greater symptom severity.
Measured: administered after hysteroscopy (within 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start4 Aug 2025
- Primary completionSep 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrophic or Hypotrophic EndometriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 156 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07675317
- Sponsor's protocol ID
- HYSTEB
- Acronym
- HYSTEB
- Status last verified
- Jul 2025
- First submitted
- 26 Nov 2025
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Two Hysteroscopic Biopsy Techniques in the Outpatient Setting for Sampling Hypotrophic or Atrophic Endometrium: 'Rail Biopsy' Versus 'Chip Biopsy'
- ClinicalTrials.gov ID
- NCT07675317
- Acronym / sponsor ID
- HYSTEB / HYSTEB
- Conditions
- Atrophic or Hypotrophic Endometrium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 156 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 4 Aug 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 48 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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 frame: During hysteroscopy
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
6 secondary outcomes
To compare the safety of the procedure between the two endometrial biopsy techniques.
Time frame: During hysteroscopy
To compare the adequacy of the tissue obtained for histological analysis between the two endometrial biopsy techniques.
Time frame: 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.
Time frame: During hysteroscopy
Pain intensity assessed by Visual Analog Scale (VAS)
Time frame: administered after hysteroscopy (within 24 hours)
Pain quality assessed by McGill Pain Questionnaire (MPQ)
Time frame: administered after hysteroscopy (within 24 hours)
Anxiety and depression assessed by Hospital Anxiety and Depression Scale (HADS)
Time frame: administered after hysteroscopy (within 24 hours)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrophic or Hypotrophic Endometrium, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Casadio, MD (0512144411, p.casadio@unibo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 frame: During hysteroscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026; AzTrials last refreshed its copy on 1 Nov 2026.