Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

China Academy of Chinese Medical Sciences

Status: Unknown

Conditions: Polycystic Ovary Syndrome; Oligomenorrhea

Treatments: Behavioral: Usual care; Device: Acupuncture+Usual care

Study type: Interventional

Funder types: Other

Identifiers

NCT04509817

KHNMCOH 2017-12-003 (Other Identifier)

GH201802

Details and patient eligibility

About

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).

Full 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.

Enrollment: 60 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Acupuncture+Usual care

Experimental group

Description:

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.

Treatment:

Device: Acupuncture+Usual care

Usual care

Active Comparator group

Description:

Subjects in control group will receive usual care only.

Treatment:

Behavioral: Usual care