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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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