NCT05323539

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 20, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 12, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2022

Completed
Last Updated

August 1, 2023

Status Verified

July 1, 2023

Enrollment Period

8 months

First QC Date

April 5, 2022

Last Update Submit

July 28, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Patients with endometrioma

ACTIVE COMPARATOR

Patients having a prediagnosis of surgically planned endometrioma occured this group.

Other: Evaluating Thyroid Volumes by ultrasonography

Control group

ACTIVE COMPARATOR

Patients who had planned gynecological surgery for a reason (ovarian cycts) other than endometrioma

Other: Evaluating Thyroid Volumes by ultrasonography

Interventions

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.

Also known as: routine blood tests, pathology data reports
Control groupPatients with endometrioma

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailshaving a prediagnosis of surgically planned endometrioma
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Prediagnosis of surgically planned endometrioma

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adana City Education and Research Hospital

Adana, Merkez, 01100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

EndometriosisThyroid Diseases

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine System Diseases

Study Officials

  • Gulsum Uysal

    University of Heath and Sciences Adana City Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor Gulsum Uysal

Study Record Dates

First Submitted

April 5, 2022

First Posted

April 12, 2022

Study Start

September 20, 2021

Primary Completion

May 20, 2022

Study Completion

July 20, 2022

Last Updated

August 1, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations