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Asymptomatic Women With Thick Endometrium: Hysteroscopic and Histopathological Report

Postmenopausal Asymptomatic Women With Thick Endometrium: Hysteroscopic and Histopathological Report

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07695077
Enrollment
120
Registered
2026-07-10
Start date
2026-08-01
Completion date
2027-07-01
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asymptomatic Post-menopause, Endometrial

Keywords

postmenopause, asymptomatic thick endometrium

Brief summary

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.

Detailed description

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.

Interventions

None listed

Sponsors

Sohag University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

Postmenopausal asymptomatic women ≥40 years with incidentally detected endometrial thickness ≥5 mm.

Exclusion criteria

Postmenopausal bleeding , known endometrial pathology and contraindication to hysteroscopy.

Design outcomes

Primary

MeasureTime frameDescription
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 review2 weeksFindings 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.

Contacts

CONTACTEsraa Mohamed mohamed elsayed Mohamed elsayed, resident
esraaelsherif3000@gmail.com01067310520

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026