Effects of Metformin on Metabolic and Reproductive Outcomes in Chinese PCOS Patients

Shanghai Jiao Tong University

Status: Unknown

Conditions: Metformin; Polycystic Ovary Syndrome

Treatments: Drug: Metformin

Study type: Observational

Funder types: Other

Identifiers

NCT05463627

KY2021-184-B

Details and patient eligibility

About

Polycystic ovary syndrome (PCOS) is a reproductive endocrine disease characterized by reproductive and metabolic abnormalities, which is a crucial cause of female infertility and an essential risk factor for type 2 diabetes. At present, there exist several clinical trials and studies on the usage of metformin in the treatment of PCOS patients in prediabetes, and the practical application of metformin in clinical practice has years of history. The treatment plan of metformin is of great significance in preventing type 2 diabetes in PCOS patients and assisting pregnancy in PCOS infertile patients.

Full description

The purpose of this study is to conduct a real world study on effects of metformin on the improvement of metabolism and reproductive outcome in Chinese prediabetic PCOS patients by collecting relevant medical system records from Renji Hospital affiliated to Shanghai Jiao Tong University School of Medicine as real world data and a significant supplement to clinical trial studies. At the same time, obese and non-obese PCOS patients may have different mechanisms of insulin resistance, so this study stratified PCOS patients to analyze whether metformin can improve treatment results for PCOS patients with prediabetes according to different body mass index (BMI).The investigator's study is the first real world study to investigate Chinese pre-diabetes PCOS patients treated by metformin and the metabolic and reproductive outcomes, which is innovative. The investigator's research also has a guiding significance for the practical application of metformin in improving glucose metabolism and reproductive outcomes in patients with different body weight in clinical practice, and has great relevance for PCOS patients to reduce long-term complications and improve quality of life.

Enrollment: 1,440 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Females at the age of 18-45years old;
2. Diagnosed with PCOS or/and impaired glucose regulation (IGR)/diabetes(DM)
3. Metformin regimens were used without other metabolic agents
4. The diagnosis of PCOS is based on the 2003 Rotterdam criteria and the diagnostic criteria for impaired glucose regulation (IGR) and type 2 diabetes are based on the 2021 American Diabetes Association(ADA) diagnosis criteria.

Exclusion criteria

1. Severe liver and kidney dysfunction (ALT is greater than 2.5 times the upper limit of normal, or Cr>132umol/l, or eGFR <60 mL/min/1.73m2), psychosis, accompanied by severe infection, severe anemia, neutropenia disease;
2. Participated in clinical trials of other drugs within 3 months;
3. In the past 5 years, there have been treated or untreated organ system tumors (except local skin basal cell carcinoma), regardless of whether there is evidence of local recurrence or metastasis;
4. A history of psychoactive substance abuse, including alcohol and a history of alcohol-related illnesses in the past 2 years;
5. Any conditions judged by the investigator that affect enrollment.

Trial design

1,440 participants in 3 patient groups

BMI<24 kg/m2

Description:

women diagnosed with PCOS with BMI\<24 kg/m2

Treatment:

Drug: Metformin

BMI24-28 kg/m2

Description:

women diagnosed with PCOS with BMI24-28 kg/m2

Treatment:

Drug: Metformin

BMI>28 kg/m2

Description:

women diagnosed with PCOS with BMI\>28kg/m2

Treatment:

Drug: Metformin