Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

Not Applicable

• Conditions: Polycystic Ovary Syndrome; Oligomenorrhea

• 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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