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Lifestyle Intervention in Women with Polycystic Ovary Syndrome: A Multicenter Study

Lifestyle Intervention in Women with Polycystic Ovary Syndrome: A Multicenter Study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023823
Enrollment
Unknown
Registered
2019-06-13
Start date
2019-06-21
Completion date
Unknown
Last updated
2020-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Interventions

LE:Lifestyle education
ILI-F:Intensive lifestyle intervention with low-fat diet
ILI-C:Intensive lifestyle intervention with low-carbohydrate diet

Sponsors

Women's Hospital School of Medicine Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Aged 20 to 40 years; 2. BMI >= 25kg/m2; 3. Confirmed diagnosis of PCOS according to the 2011 Chinese criteria; 4. Patency of at least one tube and a normal uterine cavity; 5. Semen analysis: Sperm concentration >= 15 million/ml, and forward motility (a+b) >= 20%; Total motile sperm count >= 9 million. 6. Agree to visit the clinic according to the research timeline; 7. Didn't participate in other investigative studies within 3 months.

Exclusion criteria

Exclusion criteria: 1. Pregnancy, lactation or menopause; 2. Receive weight-loss drugs or surgery within 2 months; 3. Food allergy; 4. Patients with other diseases that may cause hyperandrogenism and anovulation; 5. Patients with diabetes; 6. Patients have routine to medication to treat chronic diseases such as hypertension, gout and hyperuricemia. 7. Patients use weight-loss medications and other medications that affect hormone levels, appetite, carbohydrate absorption and metabolism within 2 months. 8. Patients with cirrhosis and various serious liver diseases (ALT and/or AST exceed the upper limit of normal range three times); patients with abnormal renal function (serum creatinine exceeds the upper limit of normal range); patients with nephropathy and other diseases requiring control of protein intake; 9. Patients with severe cardiovascular and cerebrovascular diseases; 10. Patients with gastrointestinal diseases such as gastrointestinal ulcer bleeding, chronic diarrhea or gastrointestinal resection which affect nutrients absorption. 11. Patients with infectious diseases such as hepatitis B, active pulmonary tuberculosis and AIDS; 12. Patients with cancer or have received radiotherapy and chemotherapy within five years; 13. Patients with psychosis requiring medications; 14. Patients with a current history of alcohol abuse. Alcohol abuse is defined as more than 15 g of alcohol per day; 15. Smoking addiction; 16. Not willing to stop taking supplements which are not provided by this project; 17. Patients with hypoplasia, deformity or abnormality of reproductive organs (such as severe uterine adhesion, severe adenomyosis, giant submucous uterine leiomyoma) which seriously affect the environment of pregnancy.

Design outcomes

Primary

MeasureTime frame
body weight;

Secondary

MeasureTime frame
Ovulation rate;Glucose tolerance;sex hormone;lipid levels;menstrual cycle;Gynecological B ultrasonic;CRP;homocysteine;Blood pressure;Body composition;Clinical symptoms of hyperandrogenemia;Waist-to-hip ratio;

Countries

China

Contacts

Public ContactYimin Zhu

Women's Hospital School of Medicine Zhejiang University

Zhuyim@zju.edu.cn+86 13567106420

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026