An observational study in Endometrial and Asymptomatic Post-menopause, sponsored by Sohag University. Not yet recruiting. Open to female participants aged 40 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-10.
Sponsored by Sohag University · Observational
The primary objective of this study is to determine the histopathological diagnosis of endometrial tissue obtained from asymptomatic postmenopausal women with incidentally detected thickened endometrium, and to evaluate the diagnostic correlation between hysteroscopic findings and final histopathological results.
The secondary objectives are to describe the hysteroscopic findings in asymptomatic postmenopausal women with thickened endometrium. Estimate the prevalence of premalignant and malignant endometrial lesions in this population. Evaluate the diagnostic accuracy of hysteroscopy using histopathology as the gold standard. Assess the relationship between endometrial thickness and histopathological outcomes , create a structure risk assessment for predictors of pathological endometrium.
Patients who are fulfilling the eligible criteria of the current study after signing informed consent will undergo complete history taking, examination, and investigations such as (CBC-PT-PC-INR-LFTs-KFTs-electrolytes).
Transvaginal sonography will be performed with an expert gynaecologist using a 5-9 MHz probe (Vulson S8). Endometrial thickness will be measured in sagittal plane as double-layer thickness. Thickest point will be recorded in addition to assessment of echogenicity, patteren and vascularity.
Then operative hysteroscopy (Storze,) will be performed under regional anesthesia (spinal/epidural). Uterine cavity systematically examined using a 5-mm, 30° scope with continuous flow. Findings classified per ESGE criteria: normal, atrophic, polyp, fibroid, endometrial hyperplasia (regular or irregular thickening), or suspicious (friable, irregular vascularity, necrosis). All procedures will be video-recorded for offline blinded review.
Targeted biopsies will be performed from focal lesions using 3-mm grasping forceps. For diffuse thickening (>50% cavity or uniform thickening ≥5 mm without focal lesion), systematic sampling using a 3-mm mechanical resector or Pipelle curette. Separate specimens from each uterine horn and lower segment.
Histopathological evaluation will be performed blindly irrespective to results of ultrasonography and hysteroscopy. Specimens will be fixed in 10% neutral buffered formalin, paraffin-embedded, sectioned at 4 μm, H\&E-stained. Reviewed by two consultant pathologists blinded to hysteroscopy findings. In patients with inadequate biopsy with no risk factor or bleeding, ultrasonography will be repeated after 4 months.
Sohag University is the lead sponsor of 1,183 studies on the registry; 612 are open to participants now.
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sohag outpatient clinic patient
Postmenopausal asymptomatic women ≥40 years with incidentally detected endometrial thickness ≥5 mm.
Exclusion criteria:
Postmenopausal bleeding , known endometrial pathology and contraindication to hysteroscopy.
Findings classified per ESGE criteria: normal, atrophic, polyp, fibroid, endometrial hyperplasia (regular or irregular thickening), or suspicious (friable, irregular vascularity, necrosis). All procedures will be video-recorded for offline blinded review
Findings classified per ESGE criteria: normal, atrophic, polyp, fibroid, endometrial hyperplasia (regular or irregular thickening), or suspicious (friable, irregular vascularity, necrosis). All procedures will be video-recorded for offline blinded review. Targeted biopsies will be performed from focal lesions using 3-mm grasping forceps. For diffuse thickening (\>50% cavity or uniform thickening ≥5 mm without focal lesion), systematic sampling using a 3-mm mechanical resector or Pipelle curette. Separate specimens from each uterine horn and lower segment. Histopathological evaluation will be performed blindly irrespective to results of ultrasonography and hysteroscopy. Specimens will be fixed in 10% neutral buffered formalin, paraffin-embedded, sectioned at 4 μm, H\&E-stained. Reviewed by two consultant pathologists blinded to hysteroscopy findings. In patients with inadequate biopsy with no risk factor or bleeding, ultrasonography will be repeated after 4 months.
Time frame: 2 weeks
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Sohag University