| CTRI Number |
CTRI/2026/04/107833 [Registered on: 08/04/2026] Trial Registered Prospectively |
| Last Modified On: |
07/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of Uterus Lining Changes and Hormone Receptors in Women with Abnormal Uterine Bleeding” |
|
Scientific Title of Study
|
To correlate the histopathological features with expression of estrogen and progesterone receptors in endometrium of patients of Abnormal uterine bleeding at tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sambarto Bhadra |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Junior Resident Department of pathology Datta Meghe Institute of Higher Education and Research Wardha Maharashtra 442005 India
Wardha
MAHARASHTRA
442005
India |
| Phone |
9564827682 |
| Fax |
|
| Email |
sambarto99bhadra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunita Vagha |
| Designation |
Head of Department ,Department of Pathology Datta Meghe Institute of Higher Education and Research |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pathology Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442005
India |
| Phone |
9860244638 |
| Fax |
|
| Email |
sunitavagha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunita Vagha |
| Designation |
Head of Department ,Department of Pathology Datta Meghe Institute of Higher Education and Research |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Pathology Datta Meghe Institute of Higher Education and Research
Wardha
MAHARASHTRA
442005
India |
| Phone |
9860244638 |
| Fax |
|
| Email |
sunitavagha@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sambarto Bhadra |
| Address |
MS Bungalow near ESI Hospital Asansol-713305, West Bengal |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sambarto Bhadra |
Acharya Vinobha Bhave Rural Hospital |
Department of Obstetrics and Gynaecology and Department of Pathology Acharya Vinobha Bhave Rural Hospital,Datta Meghe Institute of Higher Education and Research (DMIHER)Wardha, 442107 Maharashtra
Wardha
MAHARASHTRA |
9564827682
sambarto99bhadra@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N939||Abnormal uterine and vaginal bleeding, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Female |
| Details |
Study will include all the patients presenting with abnormal uterine bleeding undergoing endometrial biopsy or hysterectomy received to the surgical Pathology section of Department of Pathology at AVBRH Hospital of tertiary care hospital. |
|
| ExclusionCriteria |
| Details |
Abnormal Uterine Bleeding with other than endometrial cause. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To predict the role of Estrogen ,Progesterone receptor for the management of patient of Abnormal Uterine Bleeding |
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background:
Abnormal uterine bleeding (AUB) is a common gynecological complaint affecting
women of reproductive and perimenopausal age. It significantly impacts quality
of life and may be associated with various endometrial pathologies ranging from
normal cyclical changes to hyperplasia and carcinoma. Estrogen and progesterone
regulate endometrial proliferation and differentiation through their respective
receptors. Alterations in estrogen receptor (ER) and progesterone receptor (PR)
expression may play a role in the pathogenesis of AUB and may influence
therapeutic response. Histopathological examination of endometrial tissue
remains the gold standard for diagnosis, and evaluation of ER/PR expression
using immunohistochemistry may provide additional insights into hormonal
responsiveness and disease progression.
Research Question:
Is there a correlation between histopathological patterns of the endometrium
and the expression of estrogen and progesterone receptors in patients
presenting with abnormal uterine bleeding?
Methodology:
This will be a cross-sectional prospective study conducted in the Department of
Pathology at Jawaharlal Nehru Medical College and AVBRH Hospital, Wardha. The
study will include patients presenting with abnormal uterine bleeding who
undergo endometrial biopsy or hysterectomy. The study duration will be 24
months with an estimated sample size of 45 cases. Endometrial specimens will be
fixed in 10% neutral buffered formalin, processed routinely, and stained with
hematoxylin and eosin for histopathological evaluation. Immunohistochemical
staining for estrogen receptor (ER) and progesterone receptor (PR) will be
performed on selected cases, and their expression will be correlated with
histopathological findings. Patients with abnormal uterine bleeding due to
causes other than endometrial pathology will be excluded from the study.
Conclusion:
The study aims to determine the correlation between histopathological features
of the endometrium and ER/PR expression in patients with abnormal uterine
bleeding. Understanding this relationship may help in predicting hormonal
responsiveness and guiding appropriate management strategies for patients with
AUB.
|