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Trial Title:
Changes in Serum, Follicular Fluid SREBP1c and LRG1 Levels in PCOS Patients and Correlation With Insulin Resistance
NCT ID:
NCT06066034
Condition:
PCOS (Polycystic Ovary Syndrome) of Bilateral Ovaries
Conditions: Official terms:
Polycystic Ovary Syndrome
Insulin Resistance
Conditions: Keywords:
PCOS
Insulin resistance
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
HOMA-IR，ESHRE/ASRM
Description:
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
Arm group label:
Insulin resistance group
Arm group label:
PCOS group
Arm group label:
PCOS with insulin resistance group
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 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:
1. 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.
2. Collect basic data of all participants.
3. 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.
4. 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.
5. 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.
6. Use SPSS 22.0 statistical software for data analysis.
Criteria for eligibility:
Study pop:
Sterile female
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
Clinical diagnosis of Polycystic Ovary Syndrome
Exclusion Criteria:
Congenital adrenal cortical hyperplasia Adrenocortical carcinoma Cushing syndrome.
Gender:
Female
Minimum age:
20 Years
Maximum age:
50 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Affiliated Hospital of Zunyi Medical University
Address:
City:
Zunyi
Zip:
563000
Country:
China
Status:
Recruiting
Contact:
Last name:
Xiaoting Gui, bachelor
Phone:
+8618882041247
Email:
2302264437@qq.com
Start date:
April 1, 2022
Completion date:
April 30, 2024
Lead sponsor:
Agency:
Gui Xiaoting
Agency class:
Other
Source:
Zunyi Medical College
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06066034
