An observational study in Atrophic or Hypotrophic Endometrium, sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna. Recruiting at 1 site in Italy. Open to female participants aged 48 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-06-30.
Sponsored by IRCCS Azienda Ospedaliero-Universitaria di Bologna · Observational
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.
125 studies on the registry are indexed under Atrophy; 21 are open to participants now.
This study's planned enrollment of 156 is above the median of 66 across 18 observational studies indexed under Atrophy.
Browse Atrophy studies →IRCCS Azienda Ospedaliero-Universitaria di Bologna is the lead sponsor of 511 studies on the registry; 287 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Time frame: During hysteroscopy
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)
Time frame: 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)
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.
Number of instruments used
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: administered after hysteroscopy (within 24 hours)
Plan to share: No
No publications or documents are linked to this record.
Started Aug 2025 (actual). Primary completion is estimated for Sep 2026, 13 months after the start.
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