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Clinical Trials/CTRI/2024/03/064928
CTRI/2024/03/064928
Completed
Not Applicable

To study the association between Endometriosis and Thyroid disorder.

Department of Obstetrics and Gynaecology KMC Manipal Karnataka1 site in 1 country156 target enrollmentStarted: April 5, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Department of Obstetrics and Gynaecology KMC Manipal Karnataka
Enrollment
156
Locations
1
Primary Endpoint
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).

Overview

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.

Study Design

Study Type
Observational

Eligibility Criteria

Ages
18.00 Year(s) to 55.00 Year(s) (—)
Sex
Female

Inclusion Criteria

  • 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.

Exclusion Criteria

  • for Study Group: Malignancy Pregnancy Exclusion Criteria for Control Group Endometriosis/adenomyosis Pregnancy Malignancy.

Outcomes

Primary Outcomes

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).

Time Frame: At baseline

Secondary Outcomes

  • To assess the severity association with the help of ASRM scoring system in diagnosed Endometriosis cases with thyroid dysfunction.(1 year)

Investigators

Sponsor
Department of Obstetrics and Gynaecology KMC Manipal Karnataka
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

DR AMRITA JENA

KMC, Manipal

Study Sites (1)

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