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Polycystic ovary syndrome (PCOS) is a common endocrine and reproductive disorder in which insulin resistance (IR) is proposed as a key pathophysiological feature of the disease's symptoms and consequences. Diabetes and rediabetes, a significant consequence of IR, are related to a higher risk of diabetes mellitus, future cardiovascular events, and adverse pregnancy outcomes.
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All Vietnamese infertile women with PCOS, according to the Rotterdam criteria present at IVFMD, will be enrolled in the study. Phenotypes of PCOS are classified into A, B, C, and D due to hyperandrogenism (HA), ovulatory dysfunction (OD), and polycystic ovarian morphology (PCOM)
All patients enrolled in this study will have:
A fasting blood sample was obtained. Luteinizing hormone (LH) (with a coefficient of variation [CV] 2.3%), follicle-stimulating hormone (FSH) (CV 3.5%), estradiol (CV 2.7%), progesterone (CV: 6.2%), prolactin (CV: 5.2%), sex hormone binding globulin (SHBG) (CV 5.6%), total testosterone (CV 8.4%) were measured by Elesys technique, Cobas e411 system. FAI was calculated using the formula: FAI = serum testosterone in nmol/L/serum SHBG in nmol/L × 100. Thyroid stimulating hormone (TSH) (CV 6.0%), free thyroxin (fT4) (CV 5.05%) were measured by Access 2 immunoassay system. High-density lipoprotein cholesterol (HDL-C) (CV 2.4%), low-density lipoprotein cholesterol (LDL-C) (CV 2.0%), and triglyceride (CV 1.76%) were measured by Beckman Coulter AU480 system. Fasting serum insulin (CV 2.8%) was measured by Elesys technique, Cobas e411 system. The Homeostasis Model Assessment of Insulin Resistance Index (HOMA-IR) was used to estimate insulin sensitivity. HOMA-IR was calculated as FPG in mmol/L × fasting insulin in mIU/mL/22.5 (Matthews et al., 1985). A 2 mL blood sample was withdrawn and stored in a vacutainer with nature oxalate and EDTA additive.
Diagnosis of diabetes mellitus will be made when fasting glucose ≥126 mg/dL (7 nmol/L) or HbA1C ≥6.5% (48 mmol/mol) (American Diabetes Association, 2018). When glucose ≥126 mg/dL (7 nmol/L) or HbA1C ≥6.5% (48 mmol/mol) (American Diabetes Association, 2018).
Oral glucose tolerance test with 75 g glucose (75 g OGTT) will be performed on those with normal fasting glucose and HbA1C levels. Women will be recommended to have a normal diet for three days and overnight fasting for at least 8 hours. The blood withdrawal will be performed twice: (i) fasting and (2i) 2 hours after solution administration. The volume of blood for each test is 2 ml. Impaired glucose tolerance will be diagnosed when two-hour glucose levels of 140 to 199 mg/dL (7.8 to 11.0 mmol/l) (American Diabetes Association, 2018).
Clinical hyperandrogenism: Hirsutism using the modified Ferriman Gallwey score (mFG) and severe acne
Biochemical hyperandrogenism: free testosterone (normal range below 2,53nmol/ml), free testosterone index, SHBG
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1,208 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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