| CTRI Number |
CTRI/2021/08/035806 [Registered on: 19/08/2021] Trial Registered Prospectively |
| Last Modified On: |
10/05/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Other |
|
Public Title of Study
|
To show relation of Hysteroscopy findings With tissue microscopy Findings Of uterus In Infertile Women |
|
Scientific Title of Study
|
Correlation Of Hysteroscopy With Histopathological Findings Of Endometrium In PCOS Infertile Women: A Prospective Interventional Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kanchan Rani |
| Designation |
Professor |
| Affiliation |
erthankar Mahaveer Medical College and research centre, Moradabad |
| Address |
Department of Obstetric and Gynaecology
TMU Campus
Moradabad
UTTARPRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India |
| Phone |
7017621406 |
| Fax |
|
| Email |
drkanchanrani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kanchan Rani |
| Designation |
Professor |
| Affiliation |
erthankar Mahaveer Medical College and research centre, Moradabad |
| Address |
Department of Obstetric and Gynaecology
TMU Campus
Moradabad
UTTARPRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India
Department of Obstetric and Gynaecology
TMU Campus
Moradabad
UTTARPRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India
UTTAR PRADESH
244001
India |
| Phone |
7017621406 |
| Fax |
|
| Email |
drkanchanrani@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kanchan Rani |
| Designation |
Professor |
| Affiliation |
erthankar Mahaveer Medical College and research centre, Moradabad |
| Address |
Department of Obstetric and Gynaecology
TMU Campus
Moradabad
UTTARPRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India
Department of Obstetric and Gynaecology
TMU Campus
Moradabad
UTTARPRADESH
244001
India
Moradabad
UTTAR PRADESH
244001
India
UTTAR PRADESH
244001
India |
| Phone |
7017621406 |
| Fax |
|
| Email |
drkanchanrani@gmail.com |
|
|
Source of Monetary or Material Support
|
| Teerthankar Mahaveer Medical college and research centre |
|
|
Primary Sponsor
|
| Name |
Teerthankar Mahaveer Medical college and research centre |
| Address |
Bagadpur
Moradabad
UTTAR PRADESH
244001
India |
| Type of Sponsor |
Private medical college |
|
|
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 |
| Kanchan Rani |
Teerthankar MahaveerMedical college andresearch centre |
Room no. 206,Department of Obstetrics and Gynaecology,
Teerthankar Mahaveer Medical college,
Moradabad
Uttar Pradesh
244001
India
Moradabad
UTTAR PRADESH |
7017621406
drkanchanrani@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: E282||Polycystic ovarian syndrome, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Histopathology Of Endometrium |
Histopathological Findings Of Endometrium In PCOS Infertile Women |
| Intervention |
Hysteroscopy |
Hysteroscopy of Infertile PCOS women with normal endometrial thickness on USG |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
Infertile PCOS women with normal endometrial thickness on USG.
|
|
| ExclusionCriteria |
| Details |
Any other uterine lesion on USG
PID
Tubal Infertility
Endometrial polyp on USG
Progesterone intake in last 3 months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare hysteroscopic findings with histological findings
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| compare hormonal and demographic variable |
6 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/08/2021 |
| Date of Study Completion (India) |
28/02/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This prospective, randomized, study will be conducted in Teerthanker Mahaveer Medical College and Research Centre at Moradabad. Patient will be defined PCOS as per Rotterdam criteria Patient will be recruited as per inclusion and exclusion criteria Duration of infertility Demographic profile and hormonal profile will be noted Patient will be posted for hysteroscopic evaluation Each patient will be explained the entire procedure in English/Hindi language. Written informed consent for the procedure will be taken from all the patients and participation sheet will be filled out. Hysteroscopy will be done with karl storz 30 degree rigid hysteroscope with 4.3mm inner sheath and 5 mm outer sheath with working channel with Normal Saline distension media. Entire uterine cavity will be examined and findings will be noted Endometrial biopsy will be taken from the abnormal area and if no abnormal area is noted then endometrial biopsy will be taken from random sites under hysteroscopic guidance Endometrial sample will be sent for histopathological examination Findings of hysteroscopic and histopathological examination will be compared with appropriate statistical tests. |