CRD vs. Met in Patients With Obese PCOS Infertility
Trial Parameters
Brief Summary
Polycystic ovary syndrome (PCOS) is a common gynecological endocrine disease and a major cause of anovulatory infertility in reproductive-aged women. From 2010 to 2020, it was found that the prevalence of PCOS in reproductive-aged women in China reached 7.8%, an increase of 65% over 10 years ago. Many of them are overweight or obese. Weight loss including diet modifications can significantly reduce reproductive and metabolic disorders of PCOS and is recommended as a first step in the treatment of overweight or obese women with PCOS. Many weight loss programs have been proposed, including calorie-restriction diet (CRD) intervention. Whether CRD intervention prior to ovulation induction therapy could improve live birth rates in overweight/obese PCOS women has not been illustrated.
Eligibility Criteria
Inclusion Criteria: 1. a diagnosis of polycystic ovary syndrome (PCOS) based on the Rotterdam diagnostic criteria; 2. age 20-35 years old; 3. a body-mass index over 23; 4. have requirements for fertility. Exclusion Criteria: 1. acute or chronic viral hepatitis; 2. serious liver dysfunction or chronic kidney disease; 3. serious cardiovascular or cerebrovascular disease; 4. patients with a history of acute/chronic infection, severe cardiovascular and cerebrovascular diseases, and malignant tumors; 5. have drugs for PCOS such as glucocorticoids and anti-androgen drugs (spironolactone, cyproterone acetate, flutamide, etc.) within 3 months; 6. congenital or secondary uterine abnormalities; 7. use of medications that affect weight or energy balance such as Metformin within 3 months; 8. undergoing weight loss treatment (weight change greater than 5% in the past 3 months) or have a history of gastrointestinal surgery; 9. tubal obstruction; 10. the total number of motile sperm of male partner i