An interventional study of Acupuncture+Usual care and Usual care in Polycystic Ovary Syndrome and Oligomenorrhea, sponsored by China Academy of Chinese Medical Sciences. Status unknown at 3 sites in 2 countries. Open to female participants aged 20 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-10-29.
Sponsored by China Academy of Chinese Medical Sciences · Not applicable, Interventional, and Treatment
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.
944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.
This study's planned enrollment of 60 is below the median of 70 across 685 interventional studies indexed under Polycystic Ovary Syndrome.
Browse Polycystic Ovary Syndrome studies →China Academy of Chinese Medical Sciences is the lead sponsor of 61 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Device: Acupuncture+Usual care
Subjects in control group will receive usual care only.
Behavioral: Usual care
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 care intervention The subjects will receive the health advice
Change in Menstrual Frequency (cycles/month)
Menstrual cycle improvement will be assessed by menstrual frequency (cycle/month).
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
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.
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Estradiol (E2)
Change in the level of serum estradiol in pg/mL
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
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)
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.
Time frame: 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.
Time frame: 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 %.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Plan to share: No — The agreement for sharing IPD is not designed to be signed in informed consent form.
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China Academy of Chinese Medical Sciences