Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

October 27, 2020 updated by: Chunlan Jin, China Academy of Chinese Medical Sciences

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Chunlan Jin, MD
  • Phone Number: +8613051207195
  • Email: kimcl@sina.com

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Dongzhimen Hospital
        • Contact:
      • Beijing, Beijing, China
        • Institute of Acupuncture and Moxibustion
        • Contact:
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Kyung Hee University Hospital at Gangdong
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: Acupuncture+Usual care

Acupuncture intervention Disposable, sterilized needles (0.25×40 mm and 0.30×50 mm) will be used and selected acupoints will include GV20, CV4, and bilateral BL32, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9. Subject will be prone position first and BL32 will be inserted with an angle of 30-45° in an inferomedial direction and a depth of 30-50 mm. Once the subject has a needle sensation ('De-qi'), the needle will be removed immediately. Then the subject will be supine position, and GV20, CV4, ST25, ST29, EX-CA1, LI4, LR3, SP6, SP9 will be needled with a depth of 10-40mm. After subject feel 'De-qi', the needles will be placed for 20 min to maintain the stimulation.

Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise.

Behavioral: Usual care Usual care intervention The subjects will receive the health advice including diet with regular meal, enough sleep, and appropriate exercise.
Active Comparator: Usual care
Subjects in control group will receive usual care only.
Behavioral: Usual care
Usual care intervention The subjects will receive the health advice

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Menstrual Period
Time Frame: 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.
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Estradiol (E2)
Time Frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in the level of serum estradiol in pg/mL
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Luteinizing Hormone (LH)
Time Frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in the level of serum luteinizing hormone (LH) in mIU/mL
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Serum Follicle Stimulating Hormone (FSH)
Time Frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in the level of serum follicle stimulating hormone (FSH) in mIU/mL
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Free Testosterone (T)
Time Frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in the level of serum free testosterone (T) in ng/mL
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in LH/FSH Ratio
Time Frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
The ratio is calculated based on the value of LH and FSH.
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Antral Follicle Count (AFC) in the Ovary and Ovarian Volume
Time Frame: 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.
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Body mass index (BMI)
Time Frame: 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.
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in Waist Hip Ratio (WHR)
Time Frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
The ratio is calculated based on the length of waist and hip.
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in acne severity evaluated by Pillsbury acne grading system
Time Frame: 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).
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Change in quality of life evaluated by the 36-Item Short Form Health Survey (SF-36)
Time Frame: 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.
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Adverse events
Time Frame: 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.
up to 32 weeks
Incidence of abnormal complete blood count
Time Frame: 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 %.
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Incidence of abnormal erythrocyte sedimentation rate
Time Frame: Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Incidence of patients with abnormal erythrocyte sedimentation rate in mm/h.
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Incidence of abnormal renal function
Time Frame: 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.
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Incidence of abnormal liver function
Time Frame: 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.
Baseline, post-intervention (16 weeks), follow-up (32 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Academy of Chinese Medical Sciences

Collaborators

Dongzhimen Hospital, Beijing
Kyung Hee University Hospital at Gangdong
Korea Institute of Oriental Medicine

Investigators

  • Principal Investigator: Chunlan Jin, MD, Institute of Acupuncture and Moxibustion, CACMS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2020

Primary Completion (Anticipated)

December 31, 2021

Study Completion (Anticipated)

March 31, 2022

Study Registration Dates

First Submitted

July 1, 2020

First Submitted That Met QC Criteria

August 10, 2020

First Posted (Actual)

August 12, 2020

Study Record Updates

Last Update Posted (Actual)

October 29, 2020

Last Update Submitted That Met QC Criteria

October 27, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GH201802
  • KHNMCOH 2017-12-003 (Other Identifier: Kyung Hee University Hospital at Gangdong)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The agreement for sharing IPD is not designed to be signed in informed consent form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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