Clinical trial · Interventional
Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome
Efficacy and Safety of Acupuncture on Oligomenorrhea Due to Polycystic Ovary Syndrome: an International Multicenter, Pilot Randomized Controlled Trial
NCT04509817CI-TRIAL-00047991unknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This study is an international multicenter, pilot randomized, assessor-blind, controlled trial, which is aimed to preliminarily investigate the efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome (PCOS).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oligomenorrhea | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Acupuncture+Usual care | Device | — | UNRESOLVED |
| Usual care | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Acupuncture+Usual care
- description
- Subjects in experimental group will receive a standardized acupuncture treatment, 10 times per 4 weeks for 16 weeks with a total of 40 sessions in addition to usual care.
- interventionNames
- Device: Acupuncture+Usual care
- type
- ACTIVE_COMPARATOR
- label
- Usual care
- description
- Subjects in control group will receive usual care only.
- interventionNames
- Behavioral: Usual care
Primary outcomes (1)
- measure
- Change in Menstrual Frequency (cycles/month)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Oligomenorrhea (menstrual cycle\> 35 days or less than 8 cycles per year) plus at least one of the following two criteria; hyperandrogenism (clinical, biochemical, or both) and/or polycystic ovarian morphologic features \[12 or more antral follicles (2 to 9 mm in diameter) in either ovary, an ovarian volume that is greater than 10 ml in either ovary, or both\] * 20-40 years of age * Voluntary agreement to participate in this trial Exclusion Criteria: * Pregnancy, labor or breastfeeding within the past 3 months * Intake of oral contraceptive or ovulation inducing agent within the past 3 months * Severe oligomenorrhea with menstrual period over 3 months * Menstruation during more than 8 days * Premature ovarian failure * Resistant thyroid disease, Cushing's disease, congenital adrenal hyperplasia, or hyperprolactinemia * Ovarian tumor or adrenal tumor that cause hyperandrogenemia * Hemorrhagic disease * Severe cardiac, pulmonary, hepatic, or renal diseases, central nervous system disorders, or intake of psychoactive drug * Acupuncture treatment within the past one month * Participation in other clinical trial within the past 3 months * Other conditions judged to be inappropriate for the clinical study by the investigators
References
Publications (1)
- DERIVEDPark KS, Gang W, Kim PW, Yang C, Jun P, Jung SY, Kwon O, Lee JM, Lee HJ, Lee SJ, Jing X, Zhang N, Hu J, Zhao J, Pang R, Jin C, Lee JH. Efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome: An international multicenter, pilot randomized controlled trial. Medicine (Baltimore). 2022 Feb 18;101(7):e28674. doi: 10.1097/MD.0000000000028674. PMID 35363161