Asymptomatic Women With Thick Endometrium: Hysteroscopic and Histopathological Report

NCT07695077 | Not Yet Recruiting

• 1 other identifier: Soh-Med-26-6-27MS
• Study Type: observational
• Target: 120
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Endometrial; Asymptomatic Post-menopause

Keywords

postmenopause; asymptomatic thick endometrium

Outcome Measures

Primary Outcomes (1)

• 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.

  2 weeks

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

sohag outpatient clinic patient

You may qualify if:

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

You may not qualify if:

• Postmenopausal bleeding , known endometrial pathology and contraindication to hysteroscopy.

Sponsors & Collaborators

• Sohag University: lead

Central Study Contacts

Esraa Mohamed mohamed elsayed Mohamed elsayed, resident

CONTACT

01067310520; esraaelsherif3000@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Esraa Mohamed Mohamed ELsayed

Study Record Dates

• First Submitted: July 4, 2026
• First Posted: July 10, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 10, 2026

Record last verified: 2026-07