NCT04509817UnknownNot Applicable
Efficacy and Safety of Acupuncture on Oligomenorrhea Due to Polycystic Ovary Syndrome: an International Multicenter, Pilot Randomized Controlled Trial
China Academy of Chinese Medical Sciences3 sites in 2 countries60 target enrollmentStarted: November 1, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Enrollment
- 60
- Locations
- 3
- Primary Endpoint
- Change in Menstrual Frequency (cycles/month)
Study Overview
Brief 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).
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Masking Description
The assessor will be masked.
Eligibility Criteria
- Ages
- 20 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Acupuncture+Usual care (Device)
Usual care
Active Comparator
Subjects in control group will receive usual care only.
Intervention: Usual care (Behavioral)
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Change in LH/FSH Ratio(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Menstrual Period(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Estradiol (E2)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Luteinizing Hormone (LH)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Serum Follicle Stimulating Hormone (FSH)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Free Testosterone (T)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Antral Follicle Count (AFC) in the Ovary and Ovarian Volume(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Body mass index (BMI)(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)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Incidence of abnormal complete blood count(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in Waist Hip Ratio (WHR)(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Change in acne severity evaluated by Pillsbury acne grading system(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Adverse events(up to 32 weeks)
- Incidence of abnormal erythrocyte sedimentation rate(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Incidence of abnormal renal function(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
- Incidence of abnormal liver function(Baseline, post-intervention (16 weeks), follow-up (32 weeks))
Investigators
Chunlan Jin
Associated professor
China Academy of Chinese Medical Sciences
Study Sites (3)
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