EndometriosisNCT07164196
Endometriosis-Angiopoietin-like Protein-4
An observational study of Endometriosis and Angiopoietin-like Protein-4, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial summary
Endometriosis is a chronic inflammatory disease associated with pelvic pain, dyspareunia, and impaired ovarian reserve. Cancer antigen-125 (CA-125) is widely studied but limited by low specificity, while angiopoietin-like protein-4 (ANGPTL4) has emerged as a potential biomarker due to its role in angiogenesis and… Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometriosis, Angiopoietin-like Protein-4, Pelvic Pain
- What is being tested?
- Angiopoietin-like protein-4 (ANGPTL4) Peritoneal Fluid Level, Cancer Antigen 125 (CA-125) Serum Level and Angiopoietin-like protein-4 (ANGPTL4) Serum Level
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jun 2025to 2 Sep 2025
- Phase
- Observational
- 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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Study population includes a total of 80 participants. The study group consists of 40 women with the diagnosis of endometriosis, and the control group consists of 40 healthy women.
Who may be able to join
- Diagnosis of endometriosis for study group who underwent laparoscopic endometriosis surgery
- Healthy women for control group
Who cannot join
- Cardiovascular diseases including hypertension
- Type 1 or type 2 diabetes mellitus
- Morbid obesity
- Primary adrenal insufficiency
- Uterine fibroids
- Thyroid dysfunctions including Hashimoto thyroiditis and Grave's disease
Show all 14Show fewer
- Hepatic dysfunctions
- Renal insufficiency
- Genetic disorders in chromosome constitution or karyotype analysis including monosomy X, trisomy X and gene mutations as BMP15, FMR I, POFIB, and GDF9
- Neurologic diseases
- Psychiatric disorders
- Autoimmune diseases or syndromes including Addison's disease, autoimmune syndromes, scleroderma, Sjogren's syndrome, myasthenia gravis, inflammatory bowel diseases, multiple sclerosis, rheumatoid arthritis, systemic lupus erythematosus and familial Mediterranean fever
- History of any malignancy
- History of exposure to chemotherapeutic agents or radiotherapy
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Bilkent City Hospital
Ankara, Not Valid, 06100
About this study
Official title: Evaluation of Angiopoietin-like Protein 4 Levels in Patients With Endometriosis
Endometriosis is a chronic inflammatory disease associated with pelvic pain, dyspareunia, and impaired ovarian reserve. Cancer antigen-125 (CA-125) is widely studied but limited by low specificity, while angiopoietin-like protein-4 (ANGPTL4) has emerged as a potential biomarker due to its role in angiogenesis and inflammation. In the current study it was aimed to investigate serum and peritoneal fluid ANGPTL4 levels in women with endometriosis compared to healthy controls, and to evaluate their associations with clinical symptoms, serum CA-125, and anti-Müllerian hormone levels.
- Conditions
- Endometriosis, Angiopoietin-like Protein-4, Pelvic Pain
- Being tested
- Angiopoietin-like protein-4 (ANGPTL4) Peritoneal Fluid Level, Cancer Antigen 125 (CA-125) Serum Level, Angiopoietin-like protein-4 (ANGPTL4) Serum Level
- Keywords
- Endometriosis, Angiopoietin-like protein-4, Peritoneal fluid, Inflammation
- Medical subject headings
- Endometriosis, Pelvic Pain, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Angiopoietin-like protein-4 (ANGPTL4) Peritoneal Fluid LevelOther
Measurement of peritoneal fluid levels of Angiopoietin-like protein-4 (ANGPTL4) level by ELISA method.
Cancer Antigen 125 (CA-125) Serum LevelOther
Measurement of venous blood serum level of CA-125 level by ELISA method.
Angiopoietin-like protein-4 (ANGPTL4) Serum LevelOther
Measurement of venous blood serum level of Angiopoietin-like protein-4 (ANGPTL4) Level level by ELISA method.
| Study group | Role | What they receive |
|---|---|---|
| Endometriosis group (Study group) | The study group included women with endometriosis. The study group consisted of women diagnosed with endometriosis who consecutively underwent laparoscopic endometriosis surgery. Receives: Other: Angiopoietin-like protein-4 (ANGPTL4) Peritoneal Fluid Level; Other: Cancer Antigen 125 (CA-125) Serum Level; Other: Angiopoietin-like protein-4 (ANGPTL4) Serum Level | |
| Healthy women (Control group) | Control group consisted of healthy women. The control group consisted of women who consecutively visited the outpatient clinic for routine gynecologic examinations and had no known diseases. Receives: Other: Cancer Antigen 125 (CA-125) Serum Level; Other: Angiopoietin-like protein-4 (ANGPTL4) Serum Level |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum and peritoneal fluid Angiopoietin-like protein-4 level
Nanogram/milliliter
Measured: day 1
Secondary outcomes (1)
Serum cancer antigen 125 level
Unit/milliliter
Measured: day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2025
- Study start5 Jun 2025
- Primary completion21 Aug 2025
- Study completion2 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for EndometriosisStudies of the same condition, open and under way.
- More trials run by Ankara City Hospital BilkentThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Merve Didem Eşkin Tanrıverdi, Ankara City Hospital Bilkent
- Investigators
- Merve Didem Eşkin Tanrıverdi, MD, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07164196
- Sponsor's protocol ID
- TABED 1-25-1372
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 10 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD are available which may be shared in necessary conditions.
Publications
Campara K, Rodrigues P, Viero FT, da Silva B, Trevisan G. A systematic review and meta-analysis of advanced oxidative protein products levels (AOPP) levels in endometriosis: Association with disease stage and clinical implications. Eur J Pharmacol. 2025 Jun 5;996:177434. doi: 10.1016/j.ejphar.2025.177434. Epub 2025 Feb 28.
PubMed 40024324Makoui MH, Fekri S, Makoui RH, Ansari N, Esmaeilzadeh A. The Role of Mast Cells in the Development and Advancement of Endometriosis. Am J Reprod Immunol. 2025 Mar;93(3):e70019. doi: 10.1111/aji.70019.
PubMed 40028674Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469.
PubMed 29420391Brown R, Imran SA, Wilkinson M. Lipopolysaccharide (LPS) stimulates adipokine and socs3 gene expression in mouse brain and pituitary gland in vivo, and in N-1 hypothalamic neurons in vitro. J Neuroimmunol. 2009 Apr 30;209(1-2):96-103. doi: 10.1016/j.jneuroim.2009.02.001. Epub 2009 Mar 3.
PubMed 19261336
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Angiopoietin-like Protein 4 Levels in Patients With Endometriosis
- ClinicalTrials.gov ID
- NCT07164196
- Acronym / sponsor ID
- TABED 1-25-1372
- Conditions
- Endometriosis, Angiopoietin-like Protein-4, Pelvic Pain
- Keywords
- Endometriosis, Angiopoietin-like protein-4, Peritoneal fluid, Inflammation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 5 Jun 2025 (actual)
- Primary completion
- 21 Aug 2025 (actual)
- Study completion
- 2 Sep 2025 (actual)
- First posted
- 10 Sep 2025 (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.
Endometriosis is a chronic inflammatory disease associated with pelvic pain, dyspareunia, and impaired ovarian reserve. Cancer antigen-125 (CA-125) is widely studied but limited by low specificity, while angiopoietin-like protein-4 (ANGPTL4) has emerged as a potential biomarker due to its role in angiogenesis and inflammation. In the current study it was aimed to investigate serum and peritoneal fluid ANGPTL4 levels in women with endometriosis compared to healthy controls, and to evaluate their associations with clinical symptoms, serum CA-125, and anti-Müllerian hormone levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometriosis group (Study group) | – | Other: Angiopoietin-like protein-4 (ANGPTL4) Peritoneal Fluid Level, Other: Cancer Antigen 125 (CA-125) Serum Level, Other: Angiopoietin-like protein-4 (ANGPTL4) Serum LevelThe study group included women with endometriosis. The study group consisted of women diagnosed with endometriosis who consecutively underwent laparoscopic endometriosis surgery. |
| Healthy women (Control group) | – | Other: Cancer Antigen 125 (CA-125) Serum Level, Other: Angiopoietin-like protein-4 (ANGPTL4) Serum LevelControl group consisted of healthy women. The control group consisted of women who consecutively visited the outpatient clinic for routine gynecologic examinations and had no known diseases. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Study population includes a total of 80 participants. The study group consists of 40 women with the diagnosis of endometriosis, and the control group consists of 40 healthy women.
Key inclusion criteria (2 listed)
- Diagnosis of endometriosis for study group who underwent laparoscopic endometriosis surgery
- Healthy women for control group
Key exclusion criteria (14 listed)
- Cardiovascular diseases including hypertension
- Type 1 or type 2 diabetes mellitus
- Morbid obesity
- Primary adrenal insufficiency
- Uterine fibroids
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 |
|---|---|---|
| Angiopoietin-like protein-4 (ANGPTL4) Peritoneal Fluid LevelMeasurement of peritoneal fluid levels of Angiopoietin-like protein-4 (ANGPTL4) level by ELISA method. | Other | Endometriosis group (Study group) |
| Cancer Antigen 125 (CA-125) Serum LevelMeasurement of venous blood serum level of CA-125 level by ELISA method. | Other | Endometriosis group (Study group), Healthy women (Control group) |
| Angiopoietin-like protein-4 (ANGPTL4) Serum LevelMeasurement of venous blood serum level of Angiopoietin-like protein-4 (ANGPTL4) Level level by ELISA method. | Other | Endometriosis group (Study group), Healthy women (Control group) |
Primary outcome
Serum and peritoneal fluid Angiopoietin-like protein-4 level
Time frame: day 1
Nanogram/milliliter
1 secondary outcome
Serum cancer antigen 125 level
Time frame: day 1
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 10 Sep 2025.
- Background: PubMed 40024324Campara K, Rodrigues P, Viero FT, da Silva B, Trevisan G. A systematic review and meta-analysis of advanced oxidative protein products levels (AOPP) levels in endometriosis: Association with disease stage and clinical implications. Eur J Pharmacol. 2025 Jun 5;996:177434. doi: 10.1016/j.ejphar.2025.177434. Epub 2025 Feb 28.
- Background: PubMed 40028674Makoui MH, Fekri S, Makoui RH, Ansari N, Esmaeilzadeh A. The Role of Mast Cells in the Development and Advancement of Endometriosis. Am J Reprod Immunol. 2025 Mar;93(3):e70019. doi: 10.1111/aji.70019.
- Background: PubMed 29420391Falcone T, Flyckt R. Clinical Management of Endometriosis. Obstet Gynecol. 2018 Mar;131(3):557-571. doi: 10.1097/AOG.0000000000002469.
- Background: PubMed 19261336Brown R, Imran SA, Wilkinson M. Lipopolysaccharide (LPS) stimulates adipokine and socs3 gene expression in mouse brain and pituitary gland in vivo, and in N-1 hypothalamic neurons in vitro. J Neuroimmunol. 2009 Apr 30;209(1-2):96-103. doi: 10.1016/j.jneuroim.2009.02.001. Epub 2009 Mar 3.
- Individual participant dataSharing planned: No. IPD are available which may be shared in necessary conditions.
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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.
Merve Didem Eşkin Tanrıverdi, MD principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometriosis and Angiopoietin-like Protein-4, run by Ankara City Hospital Bilkent 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 2 inclusion and 14 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 10 Sep 2025. 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?
Serum and peritoneal fluid Angiopoietin-like protein-4 level (time frame: day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07164196, which also lists 4 linked publications.
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 10 Sep 2025.