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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06306417
Other study ID # PKUTH TCM
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 28, 2023
Est. completion date August 30, 2025

Study information

Verified date January 2024
Source Peking University Third Hospital
Contact Haolin Zhang, PHD
Phone 15611963539
Email zoe@bjmu.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

A prospective, randomized controlled trial design was used to select women with polycystic ovary syndrome as the research subjects. 144 subjects who met the inclusion and exclusion criteria were randomly divided into an acupuncture plus lifestyle intervention group (treatment group) and a placebo plus lifestyle intervention group (control group). The differences in glucose metabolism and reproductive endocrinology were compared between the two groups. 1. To verify the efficacy and safety of acupuncture intervention on insulin resistance in PCOS; 2. To explore the effects of acupuncture on androgen and lipid levels, ovarian function, reproductive dysfunction, mood and quality of life in women with PCOS.


Recruitment information / eligibility

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.

Study Design


Intervention

Other:
lifestyle intervention
lifestyle intervention
Device:
acupuncture
acupuncture
Sham acupuncture
Sham acupuncture

Locations

Country Name City State
China Peking University third hospital Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

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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