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.
To determine the efficacy and safety of 2 different treatment modalities: 1) acupuncture plus lifestyle management (treatment group), 2) placebo plus lifestyle management (control group) in the treatment of insulin resistance in PCOS patients.
Status | Recruiting |
Enrollment | 144 |
Est. completion date | August 30, 2025 |
Est. primary completion date | April 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility | Inclusion Criteria: - 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: 1. 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. 2. Type I diabetes or not well controlled type II diabetes 3. Stage 2 hypertension (resting blood pressure =160/100mmHg) 4. Psychiatric diagnoses or using psychiatric medications including antidepressants 5. 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University third hospital | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University Third Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | HOMA-IR | calculation of HOMA-IR: [fasting insulin (µU/mL) × fasting glucose (mmol/L)] / 22.5)
[Time Frame: Baseline] |
baseline and after 4 months | |
Secondary | Hirsutism(FG score >4), acne and early alopecia | general condition | baseline and after 4 months | |
Secondary | AUC insulin | during oral glucose tolerance test (OGTT), AUCarea under the glucose tolerance curve | baseline and after 4 months | |
Secondary | Follicle stimulating hormone (FSH) | Examined with the blood sample | baseline and after 4 months | |
Secondary | luteinizing hormone (LH) | Examined with the blood sample | baseline and after 4 months | |
Secondary | Progestin (P) | Examined with the blood sample | baseline and after 4 months | |
Secondary | Estrogen (E2) | Examined with the blood sample | baseline and after 4 months | |
Secondary | Prolactin (PRL) | Examined with the blood sample | baseline and after 4 months | |
Secondary | Androgen(T) | Examined with the blood sample | baseline and after 4 months | |
Secondary | Anti-mullerian hormone (AMH) | Examined with the blood sample | baseline and after 4 months | |
Secondary | Sex hormone-binding globulin (SHBG) | Examined with the blood sample | baseline and after 4 months | |
Secondary | Free testosterone index (FAI) | testosterone (nmol/ml) ×100 / SHBG (nmol/ml). | baseline and after treatment | |
Secondary | total cholesterol | Examined with the blood sample | baseline and after 4 months | |
Secondary | triglycerides | Examined with the blood sample | baseline and after 4 months | |
Secondary | high density lipoprotein (HDL) | Examined with the blood sample | baseline and after 4 months | |
Secondary | low density lipoprotein (LDL) | Examined with the blood sample | baseline and after 4 months | |
Secondary | Bile acidomics | Quantitative detection of bile acids in blood and feces by targeted metabolomics (ultra-performance liquid chromatography-time-of-flight mass spectrometry). | baseline and after 4 months | |
Secondary | Metagenomics and 16S rDNA sequencing analysis | gDNA was extracted by fecal genomic DNA kit and sequenced by Illumina Hiseq 4000. | baseline and after 4 months | |
Secondary | short form-36 (SF36) | determine the health quality of life by the questionnaire of SF36 (0-100 score), the higher, the better | baseline and after 4 months | |
Secondary | Self-Rating Anxiety Scale (SAS) | determine the anxiety level with the questionnaire of SAS (20-100 score), the higher, the worse. | baseline and after 4 months | |
Secondary | Self-Rating Depress Scale (SDS) | determine the depress level with the questionnaire of SDS (20-100 score), the higher, the worse | baseline and after 4 months | |
Secondary | polycystic ovary syndrome questionnaire, PCOSQ | Mood, weight, body hair, acne, infertility, menstrual symptoms, and menstrual predictability in women with PCOS | baseline and after 4 months | |
Secondary | BMI | calculation:BMI=weight(kg)/height(m)^2 | baseline and after 4 months | |
Secondary | Fat% | examined by body composition analyzer | baseline and after 4 months | |
Secondary | waist to hip ratio(WHR) | calculation of WHR: waist circumference(cm)/ hip circumference(cm) | baseline and after 4 months | |
Secondary | glycosylated hemoglobin level | Examined with the blood sample | baseline and after 4 months | |
Secondary | ovarian size | baseline and after 4 months, explained by 3 diameters: length(cm) * width(cm) * height(cm) | baseline and after 4 months | |
Secondary | number of follicles | observed by B-ultrasound | baseline and after 4 months | |
Secondary | uterine size | observed by B-ultrasound | baseline and after 4 months | |
Secondary | endometrial thickness | observed by B-ultrasound | baseline and after 4 months |
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