Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

Not Applicable

• Conditions: Polycystic Ovary Syndrome; Oligomenorrhea
• Interventions: Device: Acupuncture+Usual care; Behavioral: Usual care

• Registration Number: NCT04509817
• Lead Sponsor: China Academy of Chinese Medical Sciences

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 Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-08-10
• Study First Posted: 2020-08-12
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29
• Study Start: 2020-11-01
• Primary Completion: 2021-12-31
• Study Completion: 2022-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Acupuncture+Usual care	Acupuncture+Usual care	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.
Usual care	Usual care	Subjects in control group will receive usual care only.

Primary Outcome Measures

Name	Time	Method
Change in Menstrual Frequency (cycles/month)	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Menstrual cycle improvement will be assessed by menstrual frequency (cycle/month).

Secondary Outcome Measures

Name	Time	Method
Change in Menstrual Period	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Menstrual period is assessed in days from the 1st day of menstruation cycle to 1st day of the next menstruation cycle.
Change in Estradiol (E2)	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Change in the level of serum estradiol in pg/mL
Change in Luteinizing Hormone (LH)	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Change in the level of serum luteinizing hormone (LH) in mIU/mL
Change in Serum Follicle Stimulating Hormone (FSH)	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Change in the level of serum follicle stimulating hormone (FSH) in mIU/mL
Change in Free Testosterone (T)	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Change in the level of serum free testosterone (T) in ng/mL
Change in LH/FSH Ratio	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	The ratio is calculated based on the value of LH and FSH.
Change in Antral Follicle Count (AFC) in the Ovary and Ovarian Volume	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Change in the number of antral follicles of the ovary and ovarian volume by ultrasound imaging.
Change in Body mass index (BMI)	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Body Mass Index (BMI) is defined as the body weight divided by the square of height, and expressed in kg/m2.
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)	SF-36 is a 36-item, patient-reported survey of patient health, which consists of eight sections. The score of SF36 ranges from 0 to 100. The higher the score, the less disability, i.e., a score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.
Incidence of abnormal complete blood count	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	The incidence of patients with abnormal complete blood count which includes the white blood cells count in ×10\^9/L, the red blood cells count in ×10\^12/L, platelets count in number ×10\^9/L, and hemoglobin in g/L, and hematocrit in %.
Change in Waist Hip Ratio (WHR)	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	The ratio is calculated based on the length of waist and hip.
Change in acne severity evaluated by Pillsbury acne grading system	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Acne severity is assessed by Pillsbury acne grading system. The grade of Pillsbury acne grading system ranges from 0 to 4. The high-scored grade means the more severe acne (i.e., grade 0 is considered to be normal, and grade 4 is considered severe).
Adverse events	up to 32 weeks	All expected or unexpected adverse events in both groups will be measured at every study visit.; * Assessment of severity: mild, moderate, severe; * Assessment of relation: definitely related, probably related, possibly related, probably not related, definitely not related, unknown.
Incidence of abnormal erythrocyte sedimentation rate	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Incidence of patients with abnormal erythrocyte sedimentation rate in mm/h.
Incidence of abnormal renal function	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Incidence of abnormal lactate dehydrogenase and creatine phosphokinase. Incidence of patients with abnormal lactate dehydrogenase in U/L, and creatinine phosphokinase in U/L.
Incidence of abnormal liver function	Baseline, post-intervention (16 weeks), follow-up (32 weeks)	Incidence of patients with abnormal liver function evaluated by serum aspartate aminotransferase in U/L, alanine aminotransferase in U/L, and γ-glutamyl-transpeptidase in U/L, alkaline phosphatase U/L, total protein in g/L, and albumin in g/L.

Trial Locations

Locations (3)

Dongzhimen Hospital; 🇨🇳 Beijing, Beijing, China

Institute of acupuncture and moxibustion; 🇨🇳 Beijing, Beijing, China

Kyung Hee University Hospital at Gangdong; 🇰🇷 Seoul, Korea, Republic of