CRD vs. Met in Patients With Obese PCOS Infertility
NCT06049186
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
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 is less than 10 million; 11. any other situations that might affect the trial.
Conditions2
Interventions1
Related trials
- A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis — The Hospital for Sick Children
- A Phase IV Clinical Trial to Compare the Efficacy and Safety of Metformin+Sodium-Glucose Cotransporter 2 Inhibitor(SGLT2-i)+Thiazolidinedione (TZD) in Patients With Type 2 Diabetes — Boryung Pharmaceutical Co., Ltd
- Acupuncture or Metformin for Insulin Resistance in Women With PCOS — Karolinska Institutet
- Acute Portal Pressure Reduction by Metformin and Carvedilol Compared to Carvedilol Alone in Cirrhosis. — Institute of Liver and Biliary Sciences, India
- Anti-atherosclerotic Efficacy of Selected Antidiabetic Drugs in Patients With Coronary Artery Disease and Pre-diabetes — National Institute of Cardiology, Warsaw, Poland
- Comparative Clinical and Biochemical Study Evaluating the Effectiveness of Metformin Versus Febuxostat on Gouty Obese Non-Diabetic Patients — Mostafa Bahaa
- Effect of Metformin Use on Weight Loss in Obese, Non-diabetic People (MOWRI) — University Of Nigeria Teaching Hospital
- Effect of Tofogliflozin on UACR Compared to Metformin Hydrochloride in Diabetic Kidney Disease (TRUTH-DKD) — Shinshu University
Browse More Trials
Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.
This site does not provide medical advice. Always consult your doctor before considering enrollment in a clinical trial. Learn more on our About page.
NCT06049186