Polycystic Ovary Syndrome (PCOS) Clinical Trial
Official title:
Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.
NCT number | NCT04264832 |
Other study ID # | Peking TCM |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2016 |
Est. completion date | September 1, 2021 |
Verified date | March 2021 |
Source | Peking University Third Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
To investigate the body fat distribution in chinese women with polycystic ovary syndrome (PCOS) and the association of those distribution with metabolic parameters, microeconomics, hormone profiles and psychological state.
Status | Completed |
Enrollment | 733 |
Est. completion date | September 1, 2021 |
Est. primary completion date | May 1, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 45 Years |
Eligibility | Inclusion Criteria: - Age 18 to 45 years - For the PCOS group, PCOS diagnosis according to Rotterdam criteria 2003 with at least two of the following three symptoms: (1) infrequent ovulation or anovulation; (2) hyperandrogenism or clinical manifestations of high blood androgen; (3) ultrasound findings of polycystic ovaries in 1 or 2 ovaries, or =12 follicles measuring 2 to 9 mm in diameter, and/or ovarian volume =10 mL Exclusion Criteria: - Exclusion of other endocrine disorders such as androgen secreting tumors, suspected Cushing's syndrome and non-classic congenital adrenal hyperplasia (17-hydroxyprogesterone < 3nmol/L) thyroid dysfunction and hyperprolactinemia. - Type I diabetes or not well controlled type II diabetes - Stage 2 hypertension (resting blood pressure =160/100mmHg) - Psychiatric diagnoses or using psychiatric medications including antidepressants - Pharmacological treatment (cortizone, antidepressant, other antidiabetic treatment such as insulin and acarbose, hormonal contraceptives, hormonal ovulation induction or other drugs judged by discretion of investigator) within 12 weeks. Depo Provera or similar within 6 months. The control group are non- PCOS normal women (age 18-45) and meet the same exclusion criteria. |
Country | Name | City | State |
---|---|---|---|
China | Peking University third hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | body fat content and ratio | Examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) | Baseline | |
Secondary | Body mass index (BMI) | Weight in kilograms divided by the square of height in meters, reported in kg/m2 | Baseline | |
Secondary | Waist circumference(WC) | Waist circumference(WC)reported in cm, refers to the horizontal circumference along the midpoint of the connection line of the anterior superior iliac crest through the lower costal margin of the calm breathing state when standing. Recumbent position is the abdominal circumference through the girth of the navel. | Baseline | |
Secondary | Hip circumference | Hip circumference reported in cm, and when measured, the legs are upright and closed together, the arms are naturally pendulous, and the tape measure is placed horizontally on the pubic symphysis in front and the gluteus maximus in the back. | Baseline | |
Secondary | Waist-hip ratio (WHR) | Waist-to-hip ratio | Baseline | |
Secondary | Fat content and ratio of trunk | Examined with a body composition analyzer (Tanita Corporation, model MC-180, Japan) | Baseline | |
Secondary | Follicle stimulating hormone (FSH) | Examined with the blood sample | Baseline | |
Secondary | luteinizing hormone (LH) | Examined with the blood sample | Baseline | |
Secondary | Progestin (P) | Examined with the blood sample | Baseline | |
Secondary | Estrogen (E2) | Examined with the blood sample | Baseline | |
Secondary | Prolactin (PRL) | Examined with the blood sample | Baseline | |
Secondary | Androgen(T) | Examined with the blood sample | Baseline | |
Secondary | Androstenedione (A2) | Examined with the blood sample | Baseline | |
Secondary | Glucose | Examined with the blood sample | Baseline | |
Secondary | Insulin | Examined with the blood sample | Baseline | |
Secondary | HOMA-IR | calculation of HOMA-IR: [fasting insulin (µU/mL) × fasting glucose (mmol/L)] / 22.5) | Baseline | |
Secondary | HOMA- ß | calculation of HOMA-ß: 20 × fasting insulin (mU/mL) / (fasting plasma glucose (mmol/L) - 3.5) (%) | Baseline | |
Secondary | total cholesterol | examined with the blood sample | Baseline | |
Secondary | triglycerides | examined with the blood sample | Baseline | |
Secondary | high density lipoprotein (HDL) | examined with the blood sample | Baseline | |
Secondary | low density lipoprotein (LDL) | examined with the blood sample examined with the blood sample | Baseline | |
Secondary | ß-endorphin | examined with the blood sample | Baseline | |
Secondary | 5- hydroxytryptamine (5-HT) | examined with the blood sample | Baseline | |
Secondary | Dopamine(DA) | examined with the blood sample | Baseline | |
Secondary | lipometabonomics | examined with the blood sample | Baseline | |
Secondary | bile acid | examined with the blood sample (fasting plasma glucose (mmol/L) - 3.5) (%) | Baseline | |
Secondary | FerrimanGallwey (FG )value | To determine changes in women's hairy with FG rating scale (0-36 score), the higher, the worse | Baseline | |
Secondary | short form-36 (SF36) | determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better | Baseline | |
Secondary | Self-Rating Anxiety Scale (SAS) | determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse. | Baseline | |
Secondary | Self-Rating Depress Scale (SDS) | determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse | Baseline | |
Secondary | Preserved Stress Scale (PSS) | determine the stress level with the questionnaire of SDS (14-56 score), the higher, the worse | Baseline |
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