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临床试验/CTRI/2024/03/064928
CTRI/2024/03/064928
已完成
不适用

To study the association between Endometriosis and Thyroid disorder.

Department of Obstetrics and Gynaecology KMC Manipal Karnataka1 个研究点 分布在 1 个国家目标入组 156 人开始时间: 2024年4月5日最近更新:

概览

阶段
不适用
状态
已完成
发起方
Department of Obstetrics and Gynaecology KMC Manipal Karnataka
入组人数
156
试验地点
1
主要终点
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).

概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 55.00 Year(s)(—)
性别
Female

入选标准

  • 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.

排除标准

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

结局指标

主要结局

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).

时间窗: At baseline

次要结局

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

研究者

发起方
Department of Obstetrics and Gynaecology KMC Manipal Karnataka
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

DR AMRITA JENA

KMC, Manipal

研究点 (1)

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