NCT04193371Completed
Effects of Acupuncture on Body Mass Index in Overweight and Obese Women With Polycystic Ovary Syndrome (PCOS )
Department of Traditional Chinese Medicine (TCM), Peking University Third Hospital, Beijing, China
Source: ClinicalTrials.gov · Last updated 22 Jun 2025
Brief summary (registry, in English)
This is a cross-sectional case-control study combined with a randomised controlled trial (RCT) study. This study aims to compare the effect of acupuncture, with usual care (lifestyle management) for weight control, with BMI (Body Mass index) as main outcome along with improvement of reproductive and metabolic dysfunction in overweight and obese women with PCOS, and further exploring the alteration of lipidomics, bile acid omics, proteomics and branched-chain amino acids between PCOS and the normal controls, and before and after the acupuncture treatment in different gourps.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 106 (actual)
- First submitted
- 6 Nov 2019
- Start date
- 6 Dec 2019
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- Peking University Third Hospital
- Diseases
- Obesity
- NCT number
- NCT04193371
What you commit to
- Study type: Interventional
- Participants enrolled: 106
- From 6 Dec 2019 to the primary completion date, 1 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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
Other
- Pregnancy or breastfeeding the last 6 months
- Acupuncture last 3 months
- Daily smoking and alcoholic intake
Who the study is looking for
- Age 20 to 40 years
- BMI≥ 24 to \<40
- 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.
- Controls should have BMI\>25to\<40, regular cycles with 28 days±2 days and no signs of hyperandrogenism and PCO morphology on ultrasound
Age in the registry: 20 years to 40 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University Third Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.