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| ID | Type | Description | Link |
|---|---|---|---|
| KHNMCOH 2017-12-003 | Other Identifier | Kyung Hee University Hospital at Gangdong |
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| Name | Class |
|---|---|
| Korea Institute of Oriental Medicine | OTHER_GOV |
| Dongzhimen Hospital, Beijing | OTHER |
| Kyung Hee University Hospital at Gangdong | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Usual care | Active Comparator | Subjects in control group will receive usual care only. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acupuncture+Usual care | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Menstrual Frequency (cycles/month) | Menstrual cycle improvement will be assessed by menstrual frequency (cycle/month). | Baseline, post-intervention (16 weeks), follow-up (32 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, post-intervention (16 weeks), follow-up (32 weeks) |
| Change in Estradiol (E2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chunlan Jin, MD | Contact | +8613051207195 | kimcl@sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Chunlan Jin, MD | Institute of acupuncture and moxibustion, CACMS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dongzhimen Hospital | Beijing | Beijing Municipality | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35363161 | Derived | Park 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. |
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The agreement for sharing IPD is not designed to be signed in informed consent form.
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D009839 | Oligomenorrhea |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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The assessor will be masked.
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| Usual care | Behavioral | Usual care intervention The subjects will receive the health advice |
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Change in the level of serum estradiol in pg/mL
| 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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). | 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. | 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.
| 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 %. | 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. | 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. | 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. | Baseline, post-intervention (16 weeks), follow-up (32 weeks) |
| Institute of acupuncture and moxibustion | Beijing | Beijing Municipality | China |
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| Kyung Hee University Hospital at Gangdong | Seoul | South Korea |
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| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D008599 | Menstruation Disturbances |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |