| CTRI Number |
CTRI/2024/03/064928 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
29/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To study the association between Endometriosis and Thyroid disorder and to find if Thyroid disorder causes significant endometriosis symptoms. Patient between age of 18-55 with endometriosis will be included in the study. |
|
Scientific Title of Study
|
To study the association between Endometriosis and Thyroid disorder. |
| 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 AMRITA JENA |
| Designation |
Junior Resident |
| Affiliation |
KMC, Manipal |
| Address |
Dept. Of Obstetrics and Gynaecology, KMC Manipal, Karnataka
Udupi KARNATAKA 576104 India |
| Phone |
9583890032 |
| Fax |
|
| Email |
dramritajena@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Rajeshwari G Bhat |
| Designation |
Professor |
| Affiliation |
KMC. Manipal |
| Address |
Dept. Of Obstetrics and Gynaecology, KMC Manipal, Karnataka
Udupi KARNATAKA 576104 India |
| Phone |
9448624379 |
| Fax |
|
| Email |
bhat.rajeshwari@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Rajeshwari G Bhat |
| Designation |
Professor |
| Affiliation |
KMC. Manipal |
| Address |
Dept. Of Obstetrics and Gynaecology, KMC Manipal, Karnataka
KARNATAKA 576104 India |
| Phone |
9448624379 |
| Fax |
|
| Email |
bhat.rajeshwari@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology, KMC Manipal, Karnataka |
|
|
Primary Sponsor
|
| Name |
Department of Obstetrics and Gynaecology KMC Manipal Karnataka |
| Address |
Kasturba Medical College, Manipal, Karnataka, 576104 |
| 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 |
| Dr Amrita Jena |
Kasturba Medical College, Manipal |
Department of Obstetrics and Gynaecology Udupi KARNATAKA |
9583890032
dramritajena@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N80-N98||Noninflammatory disorders of female genital tract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Female |
| Details |
Inclusion criteria for Study Group:
Patient willing to participate in the study.
Within the age group of 18-55 years.
Patient diagnosed with Endometriosis {clinical (Any 5 symptoms)/USG/laparoscopy}
Inclusion criteria for Control Group:
Age between 18-55
Willing to participate in the study
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria for Study Group:
Malignancy
Pregnancy
Exclusion Criteria for Control Group
Endometriosis/adenomyosis
Pregnancy
Malignancy |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To study the association between patients diagnosed with Endometriosis (Diagnosed by clinically or ultrasound imaging or surgically) with Thyroid Dysfunction (Hypothyroidism/hyperthyroidism/ Anti-TPO antibodies positivity).
|
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the severity association with the help of ASRM scoring system in diagnosed Endometriosis cases with thyroid dysfunction. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="156" Sample Size from India="156"
Final Enrollment numbers achieved (Total)= "156"
Final Enrollment numbers achieved (India)="156" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/04/2024 |
| Date of Study Completion (India) |
31/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/12/2024 |
|
Estimated Duration of Trial
|
Years="1" Months="1" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Endometriosis is characterised by presence of benign ectopic endometrial cells outside of uterine cavity affecting up to 10% of reproductive age group. Leading to severe inflammation, pelvic pain and infertility. Endometriosis is associated with presence of variety of autoantibodies and fulfils most of classification criteria for autoimmune disease such as tissue damage, polyclonal B lymphocytes activation, B lymphocytes immunological abnormalities, female preponderance, multi-organ involvement, possible genetic and environmental factors, beside association with other autoimmune diseases. Thyroid autoimmunity and dysfunction is the most common autoimmune disease in women of reproductive age and affects 5–20% of the female population. There may be a potential link between autoimmune disease and Endometriosis, but the available data has been contradictory making it difficult to establish a cause-effect relationship. While studies have been done looking for association in between these two diseases there is a gap of such study in the South Asian population. And there is a need for severity association in patients of Endometriosis with Thyroid Disorder, to look for any association of Thyroid disorder leading to increased severity and if controlled is there any improvement in patient quality of life. |