Polycystic ovary syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: PCOS was diagnosed according to the 2003 European Society for Human Reproduction and Embryology of Rotterdam and the American Society for Reproductive Medicine (ESHRE/ASRM) diagnostic criteria, which stipulates that any two of the following 3 items are required for a diagnosis: 1.Rare ovulation and/or anovulation; 2.Clinical manifestations and/or hyperandrogenism; 3.Ultrasound detection of polycystic changes in the ovaries, i.e., >=12 follicles of 2-9 mm in diameter in one or both ovaries and/or ovarian volume >=10 ml. All patients were evaluated using the euglycaemic hyperinsulinaemic clamp (EHC) technique; an M value (glucose metabolic rate) less than 6.286 mg/kg/min indicated IR, and an M value greater than or equal to 6.286 mg/kg/min indicated non-IR. Patients with other known endocrine system-related gonadal diseases (such as congenital adrenal hyperplasia, an androgen-secreting tumour and Cushings syndrome) were excluded.
Exclusion criteria
Exclusion criteria: 1.Older than 40 years; 2.Body mass index (BMI) greater than 35 kg/m^2; 3.The presence of other diseases that cause infertility; 4.Obvious signs or symptoms of liver or kidney disease, ALT higher than 2 times the upper limit of normal, serum creatinine level above normal, severe gallstones, triglycerides greater than 5 mmol/L, congestive heart failure, thyroid disease, or a history of diabetes; 5.The use of drugs that affect glycolipid metabolism within the previous 3 months; 6.A mental disorder or a history of alcohol or drug abuse in the past 3 years; 7.A history of allergies or contraindications to the study drug [exenatide (EX) injection]; 8.A positive urine HCG test or unwillingness to follow strict contraceptive measures during the study; and 9.Participation in other drug trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone morphogenetic protein-9; | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood glucose;Insulin;Blood lipid;Follicle-stimulating hormone;Total testosterone;Free testosterone index;Dehydroepiandrosterone sulfate;Sex hormone binding globulin;Estradiol;Prolactin;Progesterone; | — |
Countries
China
Contacts
Affiliated Hospital of Zunyi Medical University