Status:
UNKNOWN
Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome
Lead Sponsor:
China Academy of Chinese Medical Sciences
Collaborating Sponsors:
Korea Institute of Oriental Medicine
Dongzhimen Hospital, Beijing
Conditions:
Polycystic Ovary Syndrome
Oligomenorrhea
Eligibility:
FEMALE
20-40 years
Phase:
NA
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...
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 acupunc...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04509817
Start Date
November 1 2020
End Date
March 31 2022
Last Update
October 29 2020
Active Locations (3)
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1
Dongzhimen Hospital
Beijing, Beijing Municipality, China
2
Institute of acupuncture and moxibustion
Beijing, Beijing Municipality, China
3
Kyung Hee University Hospital at Gangdong
Seoul, South Korea