Polycystic Ovary SyndromeNCT04509817
Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome
A study of Polycystic Ovary Syndrome and Oligomenorrhea, run by China Academy of Chinese Medical Sciences at 3 sites in 2 countries.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Polycystic Ovary Syndrome, Oligomenorrhea
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 1 Nov 2020to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
China2 sites
Dongzhimen Hospital
Beijing, Beijing Municipality
Jiping Zhao, MD, +8613621382136, zjp7883@sina.com
Institute of acupuncture and moxibustion
Beijing, Beijing Municipality
Chunlan Jin, MD, +8613051207195, kimcl@sina.com
South Korea1 site
Kyung Hee University Hospital at Gangdong
Seoul
Jin-Moo Lee, KMD, PhD., 82-2-440-7128, hanbang9597@hanmail.net
About this study
Official title: Efficacy and Safety of Acupuncture on Oligomenorrhea Due to Polycystic Ovary Syndrome: an International Multicenter, Pilot Randomized Controlled Trial
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).
Read the detailed description
A total of 60 subjects will be recruited and randomly allocated into experimental or control group with 30 subjects respectively. The subjects in experimental group will receive a standardized acupuncture treatment plus usual care, whereas the ones in control group will be managed only with usual care.
- Conditions
- Polycystic Ovary Syndrome, Oligomenorrhea
- Being tested
- Acupuncture+Usual care, Usual care
- Keywords
- Polycystic ovary syndrome, Oligomenorrhea, Acupuncture
- Medical subject headings
- Polycystic Ovary Syndrome, Oligomenorrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acupuncture+Usual careDevice
Acupuncture intervention Disposable, sterilized needles (0.25×40 mm and 0.30×50 mm) will be used and selected acupoints will include GV20, CV4, and bilateral BL32, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9. Subject will be prone position first and BL32 will be inserted with an angle of 30-45° in an inferomedial direction and a depth of 30-50 mm. Once the subject has a needle sensation ('De-qi'), the needle will be removed immediately. Then the subject will be supine position, and GV20, CV4, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9 will be needled with a depth of 10-40mm. After subject feel 'De-qi', the needles will be placed for 20 min to maintain the stimulation.
Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise.
Behavioral: Usual care Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise.
Usual careBehavioural
Usual care intervention The subjects will receive the health advice
| Study group | Role | What they receive |
|---|---|---|
| Acupuncture+Usual care | Experimental | 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. Receives: Device: Acupuncture+Usual care |
| Usual care | Active comparator | Subjects in control group will receive usual care only. Receives: Behavioral: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Menstrual Frequency (cycles/month)
Menstrual cycle improvement will be assessed by menstrual frequency (cycle/month).
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary outcomes (16)
Change in Menstrual Period
Menstrual period is assessed in days from the 1st day of menstruation cycle to 1st day of the next menstruation cycle.
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Estradiol (E2)
Change in the level of serum estradiol in pg/mL
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Luteinizing Hormone (LH)
Change in the level of serum luteinizing hormone (LH) in mIU/mL
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Serum Follicle Stimulating Hormone (FSH)
Change in the level of serum follicle stimulating hormone (FSH) in mIU/mL
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Free Testosterone (T)
Change in the level of serum free testosterone (T) in ng/mL
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in LH/FSH Ratio
The ratio is calculated based on the value of LH and FSH.
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Antral Follicle Count (AFC) in the Ovary and Ovarian Volume
Change in the number of antral follicles of the ovary and ovarian volume by ultrasound imaging.
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Body mass index (BMI)
Body Mass Index (BMI) is defined as the body weight divided by the square of height, and expressed in kg/m2.
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Waist Hip Ratio (WHR)
The ratio is calculated based on the length of waist and hip.
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in acne severity evaluated by Pillsbury acne grading system
Acne severity is assessed by Pillsbury acne grading system. The grade of Pillsbury acne grading system ranges from 0 to 4. The high-scored grade means the more severe acne (i.e., grade 0 is considered to be normal, and grade 4 is considered severe).
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in quality of life evaluated by the 36-Item Short Form Health Survey (SF-36)
SF-36 is a 36-item, patient-reported survey of patient health, which consists of eight sections. The score of SF36 ranges from 0 to 100. The higher the score, the less disability, i.e., a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Adverse events
All expected or unexpected adverse events in both groups will be measured at every study visit.
- Assessment of severity: mild, moderate, severe
- Assessment of relation: definitely related, probably related, possibly related, probably not related, definitely not related, unknown.
Measured: up to 32 weeks
Incidence of abnormal complete blood count
The incidence of patients with abnormal complete blood count which includes the white blood cells count in ×10^9/L, the red blood cells count in ×10^12/L, platelets count in number ×10^9/L, and hemoglobin in g/L, and hematocrit in %.
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Incidence of abnormal erythrocyte sedimentation rate
Incidence of patients with abnormal erythrocyte sedimentation rate in mm/h.
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Incidence of abnormal renal function
Incidence of abnormal lactate dehydrogenase and creatine phosphokinase. Incidence of patients with abnormal lactate dehydrogenase in U/L, and creatinine phosphokinase in U/L.
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Incidence of abnormal liver function
Incidence of patients with abnormal liver function evaluated by serum aspartate aminotransferase in U/L, alanine aminotransferase in U/L, and γ-glutamyl-transpeptidase in U/L, alkaline phosphatase U/L, total protein in g/L, and albumin in g/L.
Measured: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start1 Nov 2020 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Polycystic Ovary SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine, Dongzhimen Hospital, Beijing, Kyung Hee University Hospital at Gangdong
- Responsible party
- Principal investigator, Chunlan Jin, China Academy of Chinese Medical Sciences
- Investigators
- Chunlan Jin, MD, Principal investigator, Institute of acupuncture and moxibustion, CACMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509817
- Sponsor's protocol ID
- GH201802
- Other IDs
- KHNMCOH 2017-12-003
- Status last verified
- Oct 2020
- First submitted
- 1 Jul 2020
- Last updated
- 29 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The agreement for sharing IPD is not designed to be signed in informed consent form.
Publications
Li J, Yang C, Zhang J, Yang L, Hang T, Wang X, An D, Kim PW, Jung SY, Jun P, Kwon O, Lee JM, Lee CH, Zhao J, Fang Y, Xu H, Lee JH. Effect of Acupuncture Plus Usual Care versus Usual Care Alone for Oligomenorrhea in Women with Polycystic Ovary Syndrome: A Pilot Randomized Controlled Trial. Int J Womens Health. 2026 Oct 22;18:638897. doi: 10.2147/IJWH.S638897. eCollection 2026.
PubMed 42936675Park 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.
PubMed 35363161
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Acupuncture on Oligomenorrhea Due to Polycystic Ovary Syndrome: an International Multicenter, Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04509817
- Acronym / sponsor ID
- GH201802
- Conditions
- Polycystic Ovary Syndrome, Oligomenorrhea
- Keywords
- Polycystic ovary syndrome, Oligomenorrhea, Acupuncture
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Korea Institute of Oriental Medicine, Dongzhimen Hospital, Beijing, Kyung Hee University Hospital at Gangdong
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 12 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
A total of 60 subjects will be recruited and randomly allocated into experimental or control group with 30 subjects respectively. The subjects in experimental group will receive a standardized acupuncture treatment plus usual care, whereas the ones in control group will be managed only with usual care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acupuncture+Usual care | Experimental | Device: Acupuncture+Usual careSubjects 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. |
| Usual care | Active comparator | Behavioral: Usual careSubjects in control group will receive usual care only. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acupuncture+Usual careAcupuncture intervention Disposable, sterilized needles (0.25×40 mm and 0.30×50 mm) will be used and selected acupoints will include GV20, CV4, and bilateral BL32, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9. Subject will be prone position first and BL32 will be inserted with an angle of 30-45° in an inferomedial direction and a depth of 30-50 mm. Once the subject has a needle sensation ('De-qi'), the needle will be removed immediately. Then the subject will be supine position, and GV20, CV4, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9 will be needled with a depth of 10-40mm. After subject feel 'De-qi', the needles will be placed for 20 min to maintain the stimulation. Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise. Behavioral: Usual care Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise. | Device | Acupuncture+Usual care |
| Usual careUsual care intervention The subjects will receive the health advice | Behavioural | Usual care |
Primary outcome
Change in Menstrual Frequency (cycles/month)
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Menstrual cycle improvement will be assessed by menstrual frequency (cycle/month).
16 secondary outcomes
Change in Menstrual Period
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Estradiol (E2)
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Luteinizing Hormone (LH)
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Serum Follicle Stimulating Hormone (FSH)
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Free Testosterone (T)
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in LH/FSH Ratio
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Antral Follicle Count (AFC) in the Ovary and Ovarian Volume
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Body mass index (BMI)
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Waist Hip Ratio (WHR)
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in acne severity evaluated by Pillsbury acne grading system
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in quality of life evaluated by the 36-Item Short Form Health Survey (SF-36)
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Adverse events
Time frame: up to 32 weeks
Incidence of abnormal complete blood count
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Incidence of abnormal erythrocyte sedimentation rate
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Incidence of abnormal renal function
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Incidence of abnormal liver function
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2020.
- Derived from this study: PubMed 42936675Li J, Yang C, Zhang J, Yang L, Hang T, Wang X, An D, Kim PW, Jung SY, Jun P, Kwon O, Lee JM, Lee CH, Zhao J, Fang Y, Xu H, Lee JH. Effect of Acupuncture Plus Usual Care versus Usual Care Alone for Oligomenorrhea in Women with Polycystic Ovary Syndrome: A Pilot Randomized Controlled Trial. Int J Womens Health. 2026 Oct 22;18:638897. doi: 10.2147/IJWH.S638897. eCollection 2026.
- Derived from this study: PubMed 35363161Park 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.
- Individual participant dataSharing planned: No. The agreement for sharing IPD is not designed to be signed in informed consent form.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chunlan Jin, MD principal investigator
Institute of acupuncture and moxibustion, CACMS
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Polycystic Ovary Syndrome and Oligomenorrhea, run by China Academy of Chinese Medical Sciences at 3 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in China, South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chunlan Jin, MD (+8613051207195, kimcl@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Menstrual Frequency (cycles/month) (time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04509817, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2020.