Comparing calorie-restriction diet and Metformin for infertility in obese women with PCOS
Comparison of Live Birth Rates Between Calorie-restricted Diets and Metformin Interventions Prior to Ovulation Induction Therapy in Patients With Overweight/Obese Polycystic Ovary Syndrome Combined With Infertility
This study is testing whether a calorie-restriction diet or Metformin can help overweight women with PCOS improve their chances of getting pregnant and having a baby.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 406 (estimated) |
| Ages | 20 Years to 40 Years |
| Sex | Female |
| Sponsor | Shanghai First Maternity and Infant Hospital Academic / other |
| Locations | 1 site (Shanghai, Shanghai) |
| Trial ID | NCT06049186 on ClinicalTrials.gov |
What this trial studies
This research evaluates the effectiveness of a calorie-restriction diet (CRD) compared to Metformin in improving reproductive health and live birth rates in overweight or obese women diagnosed with polycystic ovary syndrome (PCOS). The study focuses on women aged 20-35 who meet the Rotterdam criteria for PCOS and have fertility requirements. By implementing a CRD prior to ovulation induction therapy, the study aims to provide evidence-based nutritional advice for clinical practice and assess its impact on fertility outcomes. The trial is conducted at Shanghai First Maternity and Infant Hospital and involves collaboration with other local hospitals.
Who should consider this trial
Good fit: Ideal candidates are women aged 20-35 with a diagnosis of PCOS, a body mass index over 23, and fertility requirements.
Not a fit: Patients with serious underlying health conditions or those currently using medications that affect weight or hormonal balance may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective dietary intervention to enhance fertility in obese women with PCOS.
How similar studies have performed: While weight loss interventions have been studied in PCOS, the specific comparison of CRD and Metformin in this context is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 is less than 10 million; 11. any other situations that might affect the trial.
Where this trial is running
Shanghai, Shanghai
- Shanghai First Maternity and Infant Hospital — Shanghai, Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Miaoxin Chen, Dr
- Email: chenmiaoxin@51mch.com
- Phone: 20261000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.