Comparison of Thyroid Volumes in Patients With and Without Endometrioma

Thyroid Clinical Trial

Official title:

Comparison of Thyroid Volumes by Ultrasonography in Patients With and Without Endometrioma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05323539
• Other study ID #: 1557/2021
• Status: Completed
• Phase: N/A
• Start date: September 20, 2021
• Est. completion date: July 20, 2022

Study information

• Verified date: July 2023
• Source: Adana City Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of our study is to evaluate whether there is a statistical difference between thyroid gland volume in patients with pathological diagnosis of endometriosis or endometrioma and in patients who underwent surgery for other gynecological reasons, and to reveal the presence of concomitant thyroid disease in these cases.

Description:

Transcripts and proteins involved in thyroid metabolism are dysregulated in the eutopic and ectopic endometrium of endometriotic patients, leading to triiodothyronine (T3) action, resistance, and local thyroxine (T4) accumulation of the ectopic endometrium. Thyroid stimulating hormone (TSH) acts as a proliferative and prooxidative hormone in all endometriums of endometriosis patients and controls. Mouse studies have confirmed that endometriotic implants are larger when thyroid hormones are increased. Since endometriosis is characterized by a chronic inflammatory process, the high prevalence of autoimmune thyroid diseases in patients with endometriosis may be the result of immune dysregulation observed in women with endometriosis (5). Thyroid involvement has already been described in the physiology of the endometrium and ovary, and thyroid diseases are often associated with gynecological and obstetric disorders such as infertility, miscarriage or preterm delivery. Despite all the links between thyroid diseases and endometriosis, there is no study related to thyroid volume in patients with endometriosis so far. Thyroid volume was studied in patients with diabetes mellitus, pregnant women, and scleroderma. We believe that the evaluation of thyroid volume in patients with endometriosis will contribute to the investigation of the relationship between these two pathogenesis, and to the treatment and follow-up approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: July 20, 2022
• Est. primary completion date: May 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Prediagnosis of surgically planned endometrioma

Exclusion Criteria:

• Patients with goiteri,
• Patients with past or present autoimmune thyroid dysfunction,
• Patietns on treatment with thyroid hormones or drugs containing iodine.

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Thyroid
• Thyroid Diseases

Intervention

Other:
• Evaluating Thyroid Volumes by ultrasonography
The inclusion criteria are ; having a prediagnosis of surgically planned endometrioma and to undergo gynecological surgery for a reason other than endometriosis (control group). Among the patients with pre-diagnosis of endometriosis, who applied to our clinic during the study period and accepted to participate in the study, thyroid volumes will be measured by ultrasonography during the preoperative hospitalization. The pathological diagnosis of the patients will be confirmed and patients with different results will be excluded from the study (such as malignancy, endometriosis prediagnosis but different pathology detected etc.) In the same period, gynecological surgery was planned for another reason and patients without endometriosis will form the control group.

Locations

Country	Name	City	State
Turkey	Adana City Education and Research Hospital	Adana	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Adana City Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measuring Thyroid Volumes by ultrasonography	Longitudinal and transverse scans are performed allowing the measurement of the depth, the width and the length of each lobe. The ellipsoid formula is used. The thyroid volume is the sum of the both lobes excluding isthmus. All measurements are performed bt one experienced radiologist.	6 months