A Randomized Controlled Trial of Acupuncture for Insulin Resistance in Patients With Polycystic Ovary Syndrome
Department of Traditional Chinese Medicine (TCM), Center for Reproductive Medicine, Department of Obstetrics and Gynaecology, Peking University Third Hospital, Beijing 100191, China.
1 other identifier
interventional
144
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 28, 2023
CompletedFirst Submitted
Initial submission to the registry
February 19, 2024
CompletedFirst Posted
Study publicly available on registry
March 12, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2025
CompletedJune 22, 2025
January 1, 2024
1.6 years
February 19, 2024
June 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (29)
Hirsutism(FG score >4）, acne and early alopecia
baseline and after 4 months
AUC insulin
baseline and after 4 months
Follicle stimulating hormone (FSH)
baseline and after 4 months
luteinizing hormone (LH)
baseline and after 4 months
Progestin (P)
baseline and after 4 months
- +24 more secondary outcomes
Study Arms (2)
Experimental group
EXPERIMENTALacupuncture
control group
SHAM COMPARATORsham acupuncture
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking University third hospital
Beijing, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Haolin Zhang
Peking University Third Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 19, 2024
First Posted
March 12, 2024
Study Start
September 28, 2023
Primary Completion
April 30, 2025
Study Completion
April 30, 2025
Last Updated
June 22, 2025
Record last verified: 2024-01