Clinical trial NCT04509817: Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome
Official title: Efficacy and Safety of Acupuncture on Oligomenorrhea Due to Polycystic Ovary Syndrome: an International Multicenter, Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polycystic Ovary Syndrome
Oligomenorrhea
Keywords: Polycystic ovary syndrome
Oligomenorrhea
Acupuncture
Lead sponsor: China Academy of Chinese Medical Sciences
Sponsor class: OTHER
Collaborators: name: Korea Institute of Oriental Medicine
name: Dongzhimen Hospital, Beijing
name: Kyung Hee University Hospital at Gangdong
First posted: 2020-08-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Menstrual Frequency (cycles/month)
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary outcomes:
measure: Change in Menstrual Period
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Change in Estradiol (E2)
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Change in Luteinizing Hormone (LH)
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Change in Serum Follicle Stimulating Hormone (FSH)
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Change in Free Testosterone (T)
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Change in LH/FSH Ratio
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Change in Antral Follicle Count (AFC) in the Ovary and Ovarian Volume
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Change in Body mass index (BMI)
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Change in Waist Hip Ratio (WHR)
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Change in acne severity evaluated by Pillsbury acne grading system
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Change in quality of life evaluated by the 36-Item Short Form Health Survey (SF-36)
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Adverse events
timeFrame: up to 32 weeks
measure: Incidence of abnormal complete blood count
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Incidence of abnormal erythrocyte sedimentation rate
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Incidence of abnormal renal function
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
measure: Incidence of abnormal liver function
timeFrame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Dongzhimen Hospital
state: Beijing
city: Beijing
country: China
facility: Institute of acupuncture and moxibustion
state: Beijing
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
Study officials:
affiliation: Institute of acupuncture and moxibustion, CACMS
name: Chunlan Jin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.