Comparison of Thyroid Volumes in Patients With and Without Endometrioma
Primary Purpose
Endometrioma, Thyroid
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Evaluating Thyroid Volumes by ultrasonography
Sponsored by
About this trial
This is an interventional screening trial for Endometrioma
Eligibility Criteria
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.
Sites / Locations
- Adana City Education and Research Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Patients with endometrioma
Control group
Arm Description
Patients having a prediagnosis of surgically planned endometrioma occured this group.
Patients who had planned gynecological surgery for a reason (ovarian cycts) other than endometrioma
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05323539
First Posted
April 5, 2022
Last Updated
July 28, 2023
Sponsor
Adana City Training and Research Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05323539
Brief Title
Comparison of Thyroid Volumes in Patients With and Without Endometrioma
Official Title
Comparison of Thyroid Volumes by Ultrasonography in Patients With and Without Endometrioma
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2021 (Actual)
Primary Completion Date
May 20, 2022 (Actual)
Study Completion Date
July 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Adana City Training and Research Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Endometrioma, Thyroid
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with endometrioma
Arm Type
Active Comparator
Arm Description
Patients having a prediagnosis of surgically planned endometrioma occured this group.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients who had planned gynecological surgery for a reason (ovarian cycts) other than endometrioma
Intervention Type
Other
Intervention Name(s)
Evaluating Thyroid Volumes by ultrasonography
Other Intervention Name(s)
routine blood tests, pathology data reports
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measuring Thyroid Volumes by ultrasonography
Description
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.
Time Frame
6 months
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
having a prediagnosis of surgically planned endometrioma
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gulsum Uysal
Organizational Affiliation
University of Heath and Sciences Adana City Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adana City Education and Research Hospital
City
Adana
State/Province
Merkez
ZIP/Postal Code
01100
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of Thyroid Volumes in Patients With and Without Endometrioma
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