PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesNCT06066034
Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance
An observational study of PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Gui Xiaoting at 1 site in China.
Trial summary
Polycystic ovary syndrome (PCOS) is a common reproductive endocrine and metabolic disease that affects 6-20% of women of childbearing age worldwide. Due to changes in modern lifestyles such as low fiber, high fat diets, sedentary lifestyles, smoking, and alcohol consumption, the risk of developing this disease has… Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
- What is being tested?
- HOMA-IR，ESHRE/ASRM
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2022to 30 Apr 2024
- How long will I take part?
- 1 Month
- 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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Sterile female
Who may be able to join
- Clinical diagnosis of Polycystic Ovary Syndrome
Who cannot join
- Congenital adrenal cortical hyperplasia Adrenocortical carcinoma Cushing syndrome.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Affiliated Hospital of Zunyi Medical University
Zunyi, Guizhou, 563000
Xiaoting Gui, bachelor, +8618882041247, 2302264437@qq.com
About this study
Polycystic ovary syndrome (PCOS) is a common reproductive endocrine and metabolic disease that affects 6-20% of women of childbearing age worldwide. Due to changes in modern lifestyles such as low fiber, high fat diets, sedentary lifestyles, smoking, and alcohol consumption, the risk of developing this disease has increased. Its clinical manifestations are heterogeneous, with typical clinical manifestations being oligomenorrhea or amenorrhea, infertility, hirsutism, and polycystic ovarian changes under ultrasound. Women affected by PCOS face significant reproductive challenges, seriously affecting their quality of life and increasing their psychological burden.LRG1 has various regulatory functions, including glucose and lipid metabolism, IR, angiogenesis, organ fibrosis, and inflammation. LRG1 can activate the transcription factor SREBP1 and participate in liver lipid synthesis in obese mice. SREBP1c is the active form of SREBP1. Research has shown that SREBP1c can directly or indirectly participate in the development of IR. Therefore, the investigators speculate that LRG1 may play a certain role in the progression of PCOS through SREBP1c.Understanding the local changes or metabolic characteristics of follicular fluid in patients with PCOS can help elucidate the pathogenesis of PCOS. Therefore, in this study,the investigators aim to detect changes in serum and follicular fluid LRG1, SREBP1c, and related hormone levels, and explore their role in the pathogenesis of PCOS from a systemic and ovarian perspective, providing new ideas for the prevention and treatment of PCOS and IR.
Read the detailed description
- The diagnostic criteria for all participants with polycystic ovary syndrome included in the study were based on the 2003 European Society for Human Reproductive and Embryonic Medicine and American Society for Reproductive Medicine (ESHRE/ASRM) diagnostic criteria in Rotterdam.
- Collect basic data of all participants.
- After informed consent, all participants were evaluated for insulin sensitivity(the degree of insulin resistance), using the insulin resistance index of the steady-state model. All participants were conducted after signing an informed consent form.
- After informed consent, all participants were given fasting venous blood samples in the morning for measuring blood sugar, blood lipids, insulin, C-peptide, glycosylated hemoglobin (HbA1c), and a complete set of sex hormones.
- After collecting follicular fluid from all participants, centrifuge at 1000xg for 20 minutes, filter and precipitate, and freeze in a refrigerator at -80 ° C for the determination of LRG1, SREBP1c, and related hormone levels in follicular fluid.
- Use SPSS 22.0 statistical software for data analysis.
- Being tested
- HOMA-IR，ESHRE/ASRM
- Keywords
- PCOS, Insulin resistance
- Medical subject headings
- Polycystic Ovary Syndrome, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOMA-IR，ESHRE/ASRMDiagnostic test
Grouping based on HOMA-IR and the diagnostic criteria of the European Society for Human Reproduction and Embryology and American Society for Reproductive Medicine (ESHRE/ASRM) in Rotterdam in 2003
| Study group | Role | What they receive |
|---|---|---|
| Normal group | With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle | |
| Insulin resistance group | With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle Receives: Diagnostic Test: HOMA-IR，ESHRE/ASRM | |
| PCOS group | With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle Receives: Diagnostic Test: HOMA-IR，ESHRE/ASRM | |
| PCOS with insulin resistance group | With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle Receives: Diagnostic Test: HOMA-IR，ESHRE/ASRM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum LRG1 levels
pg/ml
Measured: one years
follicular fluid LRG1 levels
pg/ml
Measured: one years
Serum SREBP1c levels
pmol/mL
Measured: one years
follicular SREBP1c levels
pmol/mL
Measured: one years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2023
- Study start1 Apr 2022
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PCOS (Polycystic Ovary Syndrome) of Bilateral OvariesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Gui Xiaoting
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gui Xiaoting, Zunyi Medical College
- Investigators
- Fa Sun, Principal investigator, Guizhou Provincial Health Commission
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06066034
- Sponsor's protocol ID
- KLLY-2022-041
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance
- ClinicalTrials.gov ID
- NCT06066034
- Acronym / sponsor ID
- KLLY-2022-041
- Keywords
- PCOS, Insulin resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Gui XiaotingUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 4 Oct 2023 (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 common reproductive endocrine and metabolic disease that affects 6-20% of women of childbearing age worldwide. Due to changes in modern lifestyles such as low fiber, high fat diets, sedentary lifestyles, smoking, and alcohol consumption, the risk of developing this disease has increased. Its clinical manifestations are heterogeneous, with typical clinical manifestations being oligomenorrhea or amenorrhea, infertility, hirsutism, and polycystic ovarian changes under ultrasound. Women affected by PCOS face significant reproductive challenges, seriously affecting their quality of life and increasing their psychological burden.LRG1 has various regulatory functions, including glucose and lipid metabolism, IR, angiogenesis, organ fibrosis, and inflammation. LRG1 can activate the transcription factor SREBP1 and participate in liver lipid synthesis in obese mice. SREBP1c is the active form of SREBP1. Research has shown that SREBP1c can directly or indirectly participate in the development of IR. Therefore, the investigators speculate that LRG1 may play a certain role in the progression of PCOS through SREBP1c.Understanding the local changes or metabolic characteristics of follicular fluid in patients with PCOS can help elucidate the pathogenesis of PCOS. Therefore, in this study,the investigators aim to detect changes in serum and follicular fluid LRG1, SREBP1c, and related hormone levels, and explore their role in the pathogenesis of PCOS from a systemic and ovarian perspective, providing new ideas for the prevention and treatment of PCOS and IR.
Detailed description
- The diagnostic criteria for all participants with polycystic ovary syndrome included in the study were based on the 2003 European Society for Human Reproductive and Embryonic Medicine and American Society for Reproductive Medicine (ESHRE/ASRM) diagnostic criteria in Rotterdam.
- Collect basic data of all participants.
- After informed consent, all participants were evaluated for insulin sensitivity(the degree of insulin resistance), using the insulin resistance index of the steady-state model. All participants were conducted after signing an informed consent form.
- After informed consent, all participants were given fasting venous blood samples in the morning for measuring blood sugar, blood lipids, insulin, C-peptide, glycosylated hemoglobin (HbA1c), and a complete set of sex hormones.
- After collecting follicular fluid from all participants, centrifuge at 1000xg for 20 minutes, filter and precipitate, and freeze in a refrigerator at -80 ° C for the determination of LRG1, SREBP1c, and related hormone levels in follicular fluid.
- Use SPSS 22.0 statistical software for data analysis.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Normal group | – | –With the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle |
| Insulin resistance group | – | Diagnostic Test: HOMA-IR，ESHRE/ASRMWith the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle |
| PCOS group | – | Diagnostic Test: HOMA-IR，ESHRE/ASRMWith the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle |
| PCOS with insulin resistance group | – | Diagnostic Test: HOMA-IR，ESHRE/ASRMWith the informed consent of the patient, venous blood was extracted on an empty stomach in the morning, and follicular fluid from multiple follicles was extracted during the 5-9 day menstrual cycle |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Sterile female
Key inclusion criteria (1 listed)
- Clinical diagnosis of Polycystic Ovary Syndrome
Key exclusion criteria (1 listed)
- Congenital adrenal cortical hyperplasia Adrenocortical carcinoma Cushing syndrome.
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 |
|---|---|---|
| HOMA-IR，ESHRE/ASRMGrouping based on HOMA-IR and the diagnostic criteria of the European Society for Human Reproduction and Embryology and American Society for Reproductive Medicine (ESHRE/ASRM) in Rotterdam in 2003 | Diagnostic test | Insulin resistance group, PCOS group, PCOS with insulin resistance group |
Primary outcome
Serum LRG1 levels
Time frame: one years
pg/ml
follicular fluid LRG1 levels
Time frame: one years
pg/ml
Serum SREBP1c levels
Time frame: one years
pmol/mL
follicular SREBP1c levels
Time frame: one years
pmol/mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2023.
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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.
Fa Sun principal investigator
Guizhou Provincial Health Commission
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 PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries, run by Gui Xiaoting at 1 site in China.
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 1 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: status not confirmed, as of the sponsor's last update on 4 Oct 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin LIao, Dr (+86 135 9520 8618, liaoxin8618@163.om), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum LRG1 levels (time frame: one years). The study lists 4 primary outcomes in all. 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 4 Oct 2023.