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ClinicalTrials.gov ID

NCT04509817

Lead Sponsor

China Academy of Chinese Medical SciencesOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

60Estimated

Last Update Posted

Oct 29, 2020Actual

Start Date

Nov 1, 2020Estimated

Primary Completion Date

Dec 31, 2021Estimated

Completion Date

Mar 31, 2022Estimated

Official Title

Efficacy and Safety of Acupuncture on Oligomenorrhea Due to Polycystic Ovary Syndrome: an International Multicenter, Pilot Randomized Controlled Trial

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.

• Polycystic Ovary Syndrome
• Oligomenorrhea

• Acupuncture+Usual care
• Usual care

Ages Eligible for Study

Adult (18-64)

Sexes Eligible for Study

Female

Accepts Healthy Volunteers

No

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 Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Single

Lead Sponsor

China Academy of Chinese Medical SciencesOTHER

Collaborators

Korea Institute of Oriental MedicineOTHER_GOV

Dongzhimen Hospital, BeijingOTHER

Kyung Hee University Hospital at GangdongOTHER

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