EndometriomaNCT05323539
Comparison of Thyroid Volumes in Patients With and Without Endometrioma
A study testing Evaluating Thyroid Volumes by ultrasonography in people with Endometrioma and Thyroid, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrioma, Thyroid
- What is being tested?
- Evaluating Thyroid Volumes by ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Sep 2021to 20 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Prediagnosis of surgically planned endometrioma
Who cannot join
- Patients with goiteri,
- Patients with past or present autoimmune thyroid dysfunction,
- Patietns on treatment with thyroid hormones or drugs containing iodine.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Adana City Education and Research Hospital
Adana, Merkez, 01100
About this study
Official title: Comparison of Thyroid Volumes by Ultrasonography in Patients With and Without Endometrioma
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.
Read the 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.
- Conditions
- Endometrioma, Thyroid
- Being tested
- Evaluating Thyroid Volumes by ultrasonography
- Medical subject headings
- Endometriosis, Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluating Thyroid Volumes by ultrasonographyOther
Also called routine blood tests, pathology data reports
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.
| Study group | Role | What they receive |
|---|---|---|
| Patients with endometrioma | Active comparator | Patients having a prediagnosis of surgically planned endometrioma occured this group. Receives: Other: Evaluating Thyroid Volumes by ultrasonography |
| Control group | Active comparator | Patients who had planned gynecological surgery for a reason (ovarian cycts) other than endometrioma Receives: Other: Evaluating Thyroid Volumes by ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start20 Sep 2021
- Primary completion20 May 2022
- Study completion20 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Adana City Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gulsum Uysal, Adana City Training and Research Hospital
- Investigators
- Gulsum Uysal, Principal investigator, University of Heath and Sciences Adana City Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05323539
- Sponsor's protocol ID
- 1557/2021
- Status last verified
- Jul 2023
- First submitted
- 5 Apr 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Thyroid Volumes by Ultrasonography in Patients With and Without Endometrioma
- ClinicalTrials.gov ID
- NCT05323539
- Acronym / sponsor ID
- 1557/2021
- Conditions
- Endometrioma, Thyroid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Adana City Training and Research HospitalUniversity, hospital or other
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 20 May 2022 (actual)
- Study completion
- 20 Jul 2022 (actual)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with endometrioma | Active comparator | Other: Evaluating Thyroid Volumes by ultrasonographyPatients having a prediagnosis of surgically planned endometrioma occured this group. |
| Control group | Active comparator | Other: Evaluating Thyroid Volumes by ultrasonographyPatients who had planned gynecological surgery for a reason (ovarian cycts) other than endometrioma |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Prediagnosis of surgically planned endometrioma
Key exclusion criteria (3 listed)
- Patients with goiteri,
- Patients with past or present autoimmune thyroid dysfunction,
- Patietns on treatment with thyroid hormones or drugs containing iodine.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluating Thyroid Volumes by ultrasonographyAlso: routine blood tests, pathology data reportsThe 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. | Other | Control group, Patients with endometrioma |
Primary outcome
Measuring Thyroid Volumes by ultrasonography
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulsum Uysal principal investigator
University of Heath and Sciences Adana City Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluating Thyroid Volumes by ultrasonography in people with Endometrioma and Thyroid, run by Adana City Training and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measuring Thyroid Volumes by ultrasonography (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.