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Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

Primary Purpose

Polycystic Ovary Syndrome, Oligomenorrhea

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Acupuncture+Usual care
Usual care
Sponsored by
China Academy of Chinese Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Polycystic ovary syndrome, Oligomenorrhea, Acupuncture

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • Dongzhimen Hospital
  • Institute of acupuncture and moxibustion
  • Kyung Hee University Hospital at Gangdong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Acupuncture+Usual care

Usual care

Arm 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.

Subjects in control group will receive usual care only.

Outcomes

Primary Outcome Measures

Change in Menstrual Frequency (cycles/month)
Menstrual cycle improvement will be assessed by menstrual frequency (cycle/month).

Secondary Outcome Measures

Change in Menstrual Period
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)
Change in the level of serum estradiol in pg/mL
Change in Luteinizing Hormone (LH)
Change in the level of serum luteinizing hormone (LH) in mIU/mL
Change in Serum Follicle Stimulating Hormone (FSH)
Change in the level of serum follicle stimulating hormone (FSH) in mIU/mL
Change in Free Testosterone (T)
Change in the level of serum free testosterone (T) in ng/mL
Change in LH/FSH Ratio
The ratio is calculated based on the value of LH and FSH.
Change in Antral Follicle Count (AFC) in the Ovary and Ovarian Volume
Change in the number of antral follicles of the ovary and ovarian volume by ultrasound imaging.
Change in Body mass index (BMI)
Body Mass Index (BMI) is defined as the body weight divided by the square of height, and expressed in kg/m2.
Change in Waist Hip Ratio (WHR)
The ratio is calculated based on the length of waist and hip.
Change in acne severity evaluated by Pillsbury acne grading system
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).
Change in quality of life evaluated by the 36-Item Short Form Health Survey (SF-36)
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.
Adverse events
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 complete blood count
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 %.
Incidence of abnormal erythrocyte sedimentation rate
Incidence of patients with abnormal erythrocyte sedimentation rate in mm/h.
Incidence of abnormal renal function
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
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.

Full Information

First Posted
July 1, 2020
Last Updated
October 27, 2020
Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Korea Institute of Oriental Medicine, Dongzhimen Hospital, Beijing, Kyung Hee University Hospital at Gangdong
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1. Study Identification

Unique Protocol Identification Number
NCT04509817
Brief Title
Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome
Official Title
Efficacy and Safety of Acupuncture on Oligomenorrhea Due to Polycystic Ovary Syndrome: an International Multicenter, Pilot Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Anticipated)
Primary Completion Date
December 31, 2021 (Anticipated)
Study Completion Date
March 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Academy of Chinese Medical Sciences
Collaborators
Korea Institute of Oriental Medicine, Dongzhimen Hospital, Beijing, Kyung Hee University Hospital at Gangdong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Oligomenorrhea
Keywords
Polycystic ovary syndrome, Oligomenorrhea, Acupuncture

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
The assessor will be masked.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acupuncture+Usual care
Arm Type
Experimental
Arm 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.
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Subjects in control group will receive usual care only.
Intervention Type
Device
Intervention Name(s)
Acupuncture+Usual care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Usual care intervention The subjects will receive the health advice
Primary Outcome Measure Information:
Title
Change in Menstrual Frequency (cycles/month)
Description
Menstrual cycle improvement will be assessed by menstrual frequency (cycle/month).
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary Outcome Measure Information:
Title
Change in Menstrual Period
Description
Menstrual period is assessed in days from the 1st day of menstruation cycle to 1st day of the next menstruation cycle.
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Change in Estradiol (E2)
Description
Change in the level of serum estradiol in pg/mL
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Change in Luteinizing Hormone (LH)
Description
Change in the level of serum luteinizing hormone (LH) in mIU/mL
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Change in Serum Follicle Stimulating Hormone (FSH)
Description
Change in the level of serum follicle stimulating hormone (FSH) in mIU/mL
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Change in Free Testosterone (T)
Description
Change in the level of serum free testosterone (T) in ng/mL
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Change in LH/FSH Ratio
Description
The ratio is calculated based on the value of LH and FSH.
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Change in Antral Follicle Count (AFC) in the Ovary and Ovarian Volume
Description
Change in the number of antral follicles of the ovary and ovarian volume by ultrasound imaging.
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Change in Body mass index (BMI)
Description
Body Mass Index (BMI) is defined as the body weight divided by the square of height, and expressed in kg/m2.
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Change in Waist Hip Ratio (WHR)
Description
The ratio is calculated based on the length of waist and hip.
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Change in acne severity evaluated by Pillsbury acne grading system
Description
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).
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Change in quality of life evaluated by the 36-Item Short Form Health Survey (SF-36)
Description
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.
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Adverse events
Description
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.
Time Frame
up to 32 weeks
Title
Incidence of abnormal complete blood count
Description
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 %.
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Incidence of abnormal erythrocyte sedimentation rate
Description
Incidence of patients with abnormal erythrocyte sedimentation rate in mm/h.
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Incidence of abnormal renal function
Description
Incidence of abnormal lactate dehydrogenase and creatine phosphokinase. Incidence of patients with abnormal lactate dehydrogenase in U/L, and creatinine phosphokinase in U/L.
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Title
Incidence of abnormal liver function
Description
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.
Time Frame
Baseline, post-intervention (16 weeks), follow-up (32 weeks)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunlan Jin, MD
Phone
+8613051207195
Email
kimcl@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunlan Jin, MD
Organizational Affiliation
Institute of acupuncture and moxibustion, CACMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dongzhimen Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jiping Zhao, MD
Phone
+8613621382136
Email
zjp7883@sina.com
Facility Name
Institute of acupuncture and moxibustion
City
Beijing
State/Province
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunlan Jin, MD
Phone
+8613051207195
Email
kimcl@sina.com
Facility Name
Kyung Hee University Hospital at Gangdong
City
Seoul
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Moo Lee, KMD, PhD.
Phone
82-2-440-7128
Email
hanbang9597@hanmail.net

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The agreement for sharing IPD is not designed to be signed in informed consent form.
Citations:
PubMed Identifier
35363161
Citation
Park KS, Gang W, Kim PW, Yang C, Jun P, Jung SY, Kwon O, Lee JM, Lee HJ, Lee SJ, Jing X, Zhang N, Hu J, Zhao J, Pang R, Jin C, Lee JH. Efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome: An international multicenter, pilot randomized controlled trial. Medicine (Baltimore). 2022 Feb 18;101(7):e28674. doi: 10.1097/MD.0000000000028674.
Results Reference
derived

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Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

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