Polycystic Ovary SyndromeNCT07027332
Liver Stiffness And Steatosis Assessment In Women With Polycystic Ovary Syndrome Using Fibroscan
An observational study of Polycystic Ovary Syndrome and Non-Alcoholic Fatty Liver Disease, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Polycystic Ovary Syndrome (PCOS) is a complex endocrine and metabolic disorder prevalent among women of reproductive age. It is closely associated with insulin resistance, obesity, and metabolic dysfunction, often leading to hepatic steatosis (fatty liver). 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
- Polycystic Ovary Syndrome, Non-Alcoholic Fatty Liver Disease
- What is being tested?
- FibroScan® (Echosens, Paris, France)
- How many people
- 36 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2024to 8 Mar 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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: This single-center, cross-sectional, comparative study was conducted at Bezmialem Vakif University Hospital. The study population consists of women aged 18 to 45 years diagnosed with PCOS according to Rotterdam criteria and age- and BMI-matched healthy controls without endocrine or metabolic disorders.
Who may be able to join
- Female participants aged 18 to 45 years
- Voluntary participation and signed informed consent
- For the PCOS group: diagnosis of Polycystic Ovary Syndrome (PCOS) based on the Rotterdam 2003 criteria, including at least two of the following: (1) oligo- or anovulation, (2) clinical or biochemical hyperandrogenism, (3) polycystic ovarian morphology on ultrasound
- For the control group: regular menstrual cycles in the past two years and absence of clinical or biochemical hyperandrogenism
- No history of endocrine, metabolic, hepatic, renal, cardiovascular, or oncologic disease
- Willingness and ability to undergo blood sampling, ultrasound, and FibroScan evaluations
- Ability to comply with study procedures and availability throughout the study period
Who cannot join
- Pregnancy or lactation
- Use of hormonal contraceptives, insulin sensitizers, or hepatotoxic medications within the past 3 months
- Diagnosis of diabetes mellitus, thyroid dysfunction, Cushing's syndrome, or congenital adrenal hyperplasia
- ALT ≥2 times the upper limit of normal (ULN) or single ALT >80 U/L at screening
- Positive screening for hepatitis B surface antigen (HBsAg), hepatitis C virus RNA (HCV RNA), or HIV
- History or current diagnosis of liver disease, autoimmune hepatitis, Wilson's disease, or alpha-1 antitrypsin deficiency
Show all 10Show fewer
- Alcohol intake exceeding 20 grams per day
- Presence of ovarian cysts, endometriomas, or adnexal masses interfering with ultrasound interpretation
- Personal or first-degree family history of liver cancer or any malignancy
- Inability to understand or sign informed consent or to adhere to study requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assesment of Liver Functions in Women With Polycystic Ovary Syndrome Using Fibroscan
Polycystic Ovary Syndrome (PCOS) is a complex endocrine and metabolic disorder prevalent among women of reproductive age. It is closely associated with insulin resistance, obesity, and metabolic dysfunction, often leading to hepatic steatosis (fatty liver). This single-center, cross-sectional, case-control study evaluates liver function in PCOS patients using FibroScan, a non-invasive elastography technique. Eighteen women diagnosed with PCOS according to Rotterdam criteria and 18 age- and BMI-matched healthy controls aged 18-45 years were included. The study aims to determine whether PCOS independently affects hepatic steatosis and to assess the clinical applicability of FibroScan in this population. The results may inform early metabolic risk detection and improve multidisciplinary management strategies for PCOS.
Read the detailed description
This prospective, cross-sectional study was conducted at Bezmialem Vakif University Hospital. The study included 36 women between the ages of 18 and 45. Eighteen participants were diagnosed with Polycystic Ovary Syndrome (PCOS) according to the Rotterdam 2003 criteria, which require at least two of the following features: oligo- or anovulation, clinical or biochemical hyperandrogenism, or polycystic ovarian morphology, with other endocrine disorders excluded. The remaining 18 participants, matched for age and body mass index (BMI), constituted the healthy control group.
All evaluations were conducted according to a standardized protocol approved by the university ethics committee. Each participant underwent physical examination and anthropometric assessment, including measurement of height, weight, waist and hip circumferences, and calculation of BMI and waist-to-hip ratio. Clinical hyperandrogenism was assessed using the modified Ferriman-Gallwey score by an experienced gynecologist. Participants were also evaluated for acne and androgenic alopecia. Pelvic ultrasonography was performed transabdominally or transvaginally between days 2 and 5 of the menstrual cycle, depending on anatomical and personal factors. Ovarian volume was calculated using the ellipsoid formula, and participants with structural abnormalities or dominant follicles larger than 10 mm were excluded.
Fasting venous blood samples were collected after a 13-hour overnight fast. Biochemical tests included fasting glucose, insulin, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), liver function tests including AST (aspartate aminotransferase), ALT (alanine aminotransferase), ALP (alkaline phosphatase), GGT (gamma-glutamyl transferase), and bilirubin fractions. Renal function markers included creatinine, blood urea nitrogen, and estimated glomerular filtration rate. Additional measurements included albumin, uric acid, and platelet count. Thyroid function was assessed with thyroid-stimulating hormone (TSH), free triiodothyronine (free T3), and free thyroxine (free T4). Hormonal assays, performed between days 3 and 5 of the menstrual cycle, included follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), anti-Müllerian hormone (AMH), total and free testosterone, sex hormone-binding globulin (SHBG), prolactin, and the free androgen index. Insulin resistance was calculated using the HOMA-IR formula.
Liver steatosis and stiffness were measured using Vibration-Controlled Transient Elastography (FibroScan®, Echosens, Paris) following at least 12 hours of fasting. All procedures were performed by a senior hepatologist blinded to the clinical and laboratory findings. CAP (Controlled Attenuation Parameter) values were used to evaluate hepatic fat content, and liver stiffness was measured in kilopascals (kPa). Measurements followed strict quality control standards including a minimum of 10 valid acquisitions, a success rate of 60% or higher, and an interquartile-to-median ratio of 0.30 or lower. CAP and stiffness cut-off values were applied according to published clinical thresholds.
To exclude secondary hepatic or endocrine conditions, all participants were screened for viral hepatitis (HBsAg, Anti-HCV, HCV RNA), HIV (Anti-HIV ELISA), and abnormal thyroid or renal function. Individuals with a history of liver disease, viral hepatitis, hepatotoxic drug use, ALT levels greater than twice the upper limit of normal for more than three months, or a personal or first-degree family history of liver cancer or autoimmune liver disorders were excluded. Pregnant or breastfeeding women were also not included.
The aim of this study is to evaluate whether PCOS independently contributes to hepatic steatosis, beyond known factors such as obesity and insulin resistance, and to assess the clinical utility of FibroScan as a non-invasive liver assessment tool in this patient population.
- Being tested
- FibroScan® (Echosens, Paris, France)
- Keywords
- fibroscan, infertility, Polycystic Ovary Syndrome, Hepatic Steatosis
- Medical subject headings
- Polycystic Ovary Syndrome, Non-alcoholic Fatty Liver Disease, Infertility, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FibroScan® (Echosens, Paris, France)Diagnostic test
A non-invasive liver elastography device used for clinical assessment. Liver steatosis and stiffness are measured in participants using the FibroScan device.
| Study group | Role | What they receive |
|---|---|---|
| PCOS Group | Women aged 18 to 45 diagnosed with Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria. Participants presented with symptoms such as menstrual irregularities, acne, or hirsutism. Exclusion criteria included alcohol consumption >20 g/day, liver disease history, pregnancy, lactation, and medication affecting liver/metabolism. Evaluations included anthropometric measurements (BMI, waist and hip circumference, waist-to-hip ratio), laboratory analyses (fasting glucose, insulin, lipid profile, liver enzymes, bilirubin fractions), hormonal assays (FSH, LH, AMH, estradiol, total and free testosterone, SHBG), ovarian ultrasonography (transabdominal or transvaginal), and liver assessment via FibroScan elastography. No interventions were administered as this was an observational study. Receives: Diagnostic Test: FibroScan® (Echosens, Paris, France) | |
| Control Group ( Healthy, NON PCOS) | Age and BMI matched healthy women aged 18 to 45 with regular menstruation for at least two years, no clinical signs of hyperandrogenism, and no history of endocrine, hepatic, renal, cardiovascular, or oncologic diseases. Participants underwent the same evaluations as the PCOS group, including anthropometric measurements, laboratory and hormonal assays, ovarian ultrasonography, and FibroScan liver elastography. No interventions were administered. Receives: Diagnostic Test: FibroScan® (Echosens, Paris, France) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liver Steatosis Measured by Controlled Attenuation Parameter (CAP)
Non-invasive quantification of hepatic steatosis in women with PCOS and controls using FibroScan elastography.
Measured: At baseline (single time point during study visit)
Secondary outcomes (4)
Liver Stiffness Measurement (E)
Assessment of liver fibrosis via liver stiffness measurement using FibroScan in PCOS and control groups.
Measured: At baseline (single time point during study visit)
Insulin Resistance Index (HOMA-IR)
Calculated insulin resistance based on fasting glucose and insulin levels in study participants.
Measured: At baseline (single time point during study visit)
Hormonal Profiles (FSH, LH, AMH, Total and Free Testosterone)
Measurement of key reproductive hormone levels by electrochemiluminescence immunoassay to assess endocrine function in PCOS and control groups.
Measured: At baseline (single time point during study visit)
Ovarian Volume
Ovarian volume measured by standardized transabdominal or transvaginal ultrasonography using the ellipsoid formula.
Measured: At baseline (single time point during study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2025
- Study start29 May 2024
- Primary completion30 Jan 2025
- Study completion8 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe 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
- Cross-sectional
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeynep Gayhan, Medicine, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07027332
- Sponsor's protocol ID
- E-54022451-050.04-153866
- Status last verified
- Jun 2025
- First submitted
- 28 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, a definitive plan for sharing individual participant data (IPD) has not been finalized. The study team acknowledges the importance of data sharing for scientific transparency and collaboration and will evaluate the feasibility and ethical considerations related to IPD sharing following study completion. Any future plans for data sharing will comply with applicable privacy regulations and institutional policies.
Publications
Kara O, Arsoy HA, Keskin M. Relationship between nonalcoholic fatty liver disease and hyperandrogenemia in adolescents with polycystic ovary syndrome. Clin Exp Pediatr. 2023 Sep;66(9):395-402. doi: 10.3345/cep.2023.00353. Epub 2023 Jun 14.
PubMed 37321582Macut D, Tziomalos K, Bozic-Antic I, Bjekic-Macut J, Katsikis I, Papadakis E, Andric Z, Panidis D. Non-alcoholic fatty liver disease is associated with insulin resistance and lipid accumulation product in women with polycystic ovary syndrome. Hum Reprod. 2016 Jun;31(6):1347-53. doi: 10.1093/humrep/dew076. Epub 2016 Apr 12.
PubMed 27076501Taranto DOL, Guimaraes TCM, Couto CA, Candido AL, Azevedo RCS, Mattos FS, Elias MLC, Reis FM, Rocha ALL, Faria LC. Nonalcoholic fatty liver disease in women with polycystic ovary syndrome: associated factors and noninvasive fibrosis staging in a single Brazilian center. Arch Endocrinol Metab. 2020 May-Jun;64(3):235-242. doi: 10.20945/2359-3997000000242.
PubMed 32555989Petta S, Ciresi A, Bianco J, Geraci V, Boemi R, Galvano L, Magliozzo F, Merlino G, Craxi A, Giordano C. Insulin resistance and hyperandrogenism drive steatosis and fibrosis risk in young females with PCOS. PLoS One. 2017 Nov 21;12(11):e0186136. doi: 10.1371/journal.pone.0186136. eCollection 2017.
PubMed 29161258Chen W, Pang Y. Metabolic Syndrome and PCOS: Pathogenesis and the Role of Metabolites. Metabolites. 2021 Dec 14;11(12):869. doi: 10.3390/metabo11120869.
PubMed 34940628Migacz M, Pluta D, Baranski K, Krajewski B, Madej P, Holecki M. Using non-invasive indicators to screen the PCOS population for liver disease - a single-centre study. Endokrynol Pol. 2025;76(1):94-99. doi: 10.5603/ep.101901.
PubMed 40071805Chakraborty S, Ganie MA, Masoodi I, Jana M; Shalimar; Gupta N, Sofi NY. Fibroscan as a non-invasive predictor of hepatic steatosis in women with polycystic ovary syndrome. Indian J Med Res. 2020 Apr;151(4):333-341. doi: 10.4103/ijmr.IJMR_610_18.
PubMed 32461397
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of Liver Functions in Women With Polycystic Ovary Syndrome Using Fibroscan
- ClinicalTrials.gov ID
- NCT07027332
- Acronym / sponsor ID
- E-54022451-050.04-153866
- Keywords
- fibroscan, infertility, Polycystic Ovary Syndrome, Hepatic Steatosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 29 May 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 8 Mar 2025 (actual)
- First posted
- 18 Jun 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.
Polycystic Ovary Syndrome (PCOS) is a complex endocrine and metabolic disorder prevalent among women of reproductive age. It is closely associated with insulin resistance, obesity, and metabolic dysfunction, often leading to hepatic steatosis (fatty liver). This single-center, cross-sectional, case-control study evaluates liver function in PCOS patients using FibroScan, a non-invasive elastography technique. Eighteen women diagnosed with PCOS according to Rotterdam criteria and 18 age- and BMI-matched healthy controls aged 18-45 years were included. The study aims to determine whether PCOS independently affects hepatic steatosis and to assess the clinical applicability of FibroScan in this population. The results may inform early metabolic risk detection and improve multidisciplinary management strategies for PCOS.
Detailed description
This prospective, cross-sectional study was conducted at Bezmialem Vakif University Hospital. The study included 36 women between the ages of 18 and 45. Eighteen participants were diagnosed with Polycystic Ovary Syndrome (PCOS) according to the Rotterdam 2003 criteria, which require at least two of the following features: oligo- or anovulation, clinical or biochemical hyperandrogenism, or polycystic ovarian morphology, with other endocrine disorders excluded. The remaining 18 participants, matched for age and body mass index (BMI), constituted the healthy control group.
All evaluations were conducted according to a standardized protocol approved by the university ethics committee. Each participant underwent physical examination and anthropometric assessment, including measurement of height, weight, waist and hip circumferences, and calculation of BMI and waist-to-hip ratio. Clinical hyperandrogenism was assessed using the modified Ferriman-Gallwey score by an experienced gynecologist. Participants were also evaluated for acne and androgenic alopecia. Pelvic ultrasonography was performed transabdominally or transvaginally between days 2 and 5 of the menstrual cycle, depending on anatomical and personal factors. Ovarian volume was calculated using the ellipsoid formula, and participants with structural abnormalities or dominant follicles larger than 10 mm were excluded.
Fasting venous blood samples were collected after a 13-hour overnight fast. Biochemical tests included fasting glucose, insulin, lipid profile (total cholesterol, LDL-C, HDL-C, triglycerides), liver function tests including AST (aspartate aminotransferase), ALT (alanine aminotransferase), ALP (alkaline phosphatase), GGT (gamma-glutamyl transferase), and bilirubin fractions. Renal function markers included creatinine, blood urea nitrogen, and estimated glomerular filtration rate. Additional measurements included albumin, uric acid, and platelet count. Thyroid function was assessed with thyroid-stimulating hormone (TSH), free triiodothyronine (free T3), and free thyroxine (free T4). Hormonal assays, performed between days 3 and 5 of the menstrual cycle, included follicle-stimulating hormone (FSH), luteinizing hormone (LH), estradiol (E2), anti-Müllerian hormone (AMH), total and free testosterone, sex hormone-binding globulin (SHBG), prolactin, and the free androgen index. Insulin resistance was calculated using the HOMA-IR formula.
Liver steatosis and stiffness were measured using Vibration-Controlled Transient Elastography (FibroScan®, Echosens, Paris) following at least 12 hours of fasting. All procedures were performed by a senior hepatologist blinded to the clinical and laboratory findings. CAP (Controlled Attenuation Parameter) values were used to evaluate hepatic fat content, and liver stiffness was measured in kilopascals (kPa). Measurements followed strict quality control standards including a minimum of 10 valid acquisitions, a success rate of 60% or higher, and an interquartile-to-median ratio of 0.30 or lower. CAP and stiffness cut-off values were applied according to published clinical thresholds.
To exclude secondary hepatic or endocrine conditions, all participants were screened for viral hepatitis (HBsAg, Anti-HCV, HCV RNA), HIV (Anti-HIV ELISA), and abnormal thyroid or renal function. Individuals with a history of liver disease, viral hepatitis, hepatotoxic drug use, ALT levels greater than twice the upper limit of normal for more than three months, or a personal or first-degree family history of liver cancer or autoimmune liver disorders were excluded. Pregnant or breastfeeding women were also not included.
The aim of this study is to evaluate whether PCOS independently contributes to hepatic steatosis, beyond known factors such as obesity and insulin resistance, and to assess the clinical utility of FibroScan as a non-invasive liver assessment tool in this patient population.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PCOS Group | – | Diagnostic Test: FibroScan® (Echosens, Paris, France)Women aged 18 to 45 diagnosed with Polycystic Ovary Syndrome (PCOS) according to Rotterdam criteria. Participants presented with symptoms such as menstrual irregularities, acne, or hirsutism. Exclusion criteria included alcohol consumption >20 g/day, liver disease history, pregnancy, lactation, and medication affecting liver/metabolism. Evaluations included anthropometric measurements (BMI, waist and hip circumference, waist-to-hip ratio), laboratory analyses (fasting glucose, insulin, lipid profile, liver enzymes, bilirubin fractions), hormonal assays (FSH, LH, AMH, estradiol, total and free testosterone, SHBG), ovarian ultrasonography (transabdominal or transvaginal), and liver assessment via FibroScan elastography. No interventions were administered as this was an observational study. |
| Control Group ( Healthy, NON PCOS) | – | Diagnostic Test: FibroScan® (Echosens, Paris, France)Age and BMI matched healthy women aged 18 to 45 with regular menstruation for at least two years, no clinical signs of hyperandrogenism, and no history of endocrine, hepatic, renal, cardiovascular, or oncologic diseases. Participants underwent the same evaluations as the PCOS group, including anthropometric measurements, laboratory and hormonal assays, ovarian ultrasonography, and FibroScan liver elastography. No interventions were administered. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- This single-center, cross-sectional, comparative study was conducted at Bezmialem Vakif University Hospital. The study population consists of women aged 18 to 45 years diagnosed with PCOS according to Rotterdam criteria and age- and BMI-matched healthy controls without endocrine or metabolic disorders.
Key inclusion criteria (7 listed)
- Female participants aged 18 to 45 years
- Voluntary participation and signed informed consent
- For the PCOS group: diagnosis of Polycystic Ovary Syndrome (PCOS) based on the Rotterdam 2003 criteria, including at least two of the following: (1) oligo- or anovulation, (2) clinical or biochemical hyperandrogenism, (3) polycystic ovarian morphology on ultrasound
- For the control group: regular menstrual cycles in the past two years and absence of clinical or biochemical hyperandrogenism
- No history of endocrine, metabolic, hepatic, renal, cardiovascular, or oncologic disease
Key exclusion criteria (10 listed)
- Pregnancy or lactation
- Use of hormonal contraceptives, insulin sensitizers, or hepatotoxic medications within the past 3 months
- Diagnosis of diabetes mellitus, thyroid dysfunction, Cushing's syndrome, or congenital adrenal hyperplasia
- ALT ≥2 times the upper limit of normal (ULN) or single ALT >80 U/L at screening
- Positive screening for hepatitis B surface antigen (HBsAg), hepatitis C virus RNA (HCV RNA), or HIV
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 |
|---|---|---|
| FibroScan® (Echosens, Paris, France)A non-invasive liver elastography device used for clinical assessment. Liver steatosis and stiffness are measured in participants using the FibroScan device. | Diagnostic test | Control Group ( Healthy, NON PCOS), PCOS Group |
Primary outcome
Liver Steatosis Measured by Controlled Attenuation Parameter (CAP)
Time frame: At baseline (single time point during study visit)
Non-invasive quantification of hepatic steatosis in women with PCOS and controls using FibroScan elastography.
4 secondary outcomes
Liver Stiffness Measurement (E)
Time frame: At baseline (single time point during study visit)
Insulin Resistance Index (HOMA-IR)
Time frame: At baseline (single time point during study visit)
Hormonal Profiles (FSH, LH, AMH, Total and Free Testosterone)
Time frame: At baseline (single time point during study visit)
Ovarian Volume
Time frame: At baseline (single time point during study visit)
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 18 Jun 2025.
- Background: PubMed 37321582Kara O, Arsoy HA, Keskin M. Relationship between nonalcoholic fatty liver disease and hyperandrogenemia in adolescents with polycystic ovary syndrome. Clin Exp Pediatr. 2023 Sep;66(9):395-402. doi: 10.3345/cep.2023.00353. Epub 2023 Jun 14.
- Background: PubMed 27076501Macut D, Tziomalos K, Bozic-Antic I, Bjekic-Macut J, Katsikis I, Papadakis E, Andric Z, Panidis D. Non-alcoholic fatty liver disease is associated with insulin resistance and lipid accumulation product in women with polycystic ovary syndrome. Hum Reprod. 2016 Jun;31(6):1347-53. doi: 10.1093/humrep/dew076. Epub 2016 Apr 12.
- Background: PubMed 32555989Taranto DOL, Guimaraes TCM, Couto CA, Candido AL, Azevedo RCS, Mattos FS, Elias MLC, Reis FM, Rocha ALL, Faria LC. Nonalcoholic fatty liver disease in women with polycystic ovary syndrome: associated factors and noninvasive fibrosis staging in a single Brazilian center. Arch Endocrinol Metab. 2020 May-Jun;64(3):235-242. doi: 10.20945/2359-3997000000242.
- Background: PubMed 29161258Petta S, Ciresi A, Bianco J, Geraci V, Boemi R, Galvano L, Magliozzo F, Merlino G, Craxi A, Giordano C. Insulin resistance and hyperandrogenism drive steatosis and fibrosis risk in young females with PCOS. PLoS One. 2017 Nov 21;12(11):e0186136. doi: 10.1371/journal.pone.0186136. eCollection 2017.
- Background: PubMed 34940628Chen W, Pang Y. Metabolic Syndrome and PCOS: Pathogenesis and the Role of Metabolites. Metabolites. 2021 Dec 14;11(12):869. doi: 10.3390/metabo11120869.
- Background: PubMed 40071805Migacz M, Pluta D, Baranski K, Krajewski B, Madej P, Holecki M. Using non-invasive indicators to screen the PCOS population for liver disease - a single-centre study. Endokrynol Pol. 2025;76(1):94-99. doi: 10.5603/ep.101901.
- Results publication: PubMed 32461397Chakraborty S, Ganie MA, Masoodi I, Jana M; Shalimar; Gupta N, Sofi NY. Fibroscan as a non-invasive predictor of hepatic steatosis in women with polycystic ovary syndrome. Indian J Med Res. 2020 Apr;151(4):333-341. doi: 10.4103/ijmr.IJMR_610_18.
- Study examining the relationship between nonalcoholic fatty liver disease and hyperandrogenemia in adolescents with PCOS.Link provided by the sponsor.
- Research on the association of NAFLD with insulin resistance and lipid accumulation in women with PCOS.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At this time, a definitive plan for sharing individual participant data (IPD) has not been finalized. The study team acknowledges the importance of data sharing for scientific transparency and collaboration and will evaluate the feasibility and ethical considerations related to IPD sharing following study completion. Any future plans for data sharing will comply with applicable privacy regulations and institutional policies.
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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.
Zeynep Gayhan, Medicine principal investigator
Bezmialem Vakif University
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 Polycystic Ovary Syndrome and Non-Alcoholic Fatty Liver Disease, run by Bezmialem Vakif University 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 7 inclusion and 10 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 18 Jun 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?
Liver Steatosis Measured by Controlled Attenuation Parameter (CAP) (time frame: At baseline (single time point during study visit)). 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 NCT07027332, which also lists 7 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 18 Jun 2025.