NCT04509817

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).

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2020

Geographic Reach
2 countries

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2020

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

October 29, 2020

Status Verified

October 1, 2020

Enrollment Period

1.2 years

First QC Date

July 1, 2020

Last Update Submit

October 27, 2020

Conditions

Polycystic Ovary SyndromeOligomenorrhea

Keywords

Polycystic ovary syndromeOligomenorrheaAcupuncture

Outcome Measures

Primary Outcomes (1)

  • Change in Menstrual Frequency (cycles/month)

    Menstrual cycle improvement will be assessed by menstrual frequency (cycle/month).

    Baseline, post-intervention (16 weeks), follow-up (32 weeks)

Secondary Outcomes (16)

  • Change in Menstrual Period

    Baseline, post-intervention (16 weeks), follow-up (32 weeks)

  • Change in Estradiol (E2)

    Baseline, post-intervention (16 weeks), follow-up (32 weeks)

  • Change in Luteinizing Hormone (LH)

    Baseline, post-intervention (16 weeks), follow-up (32 weeks)

  • Change in Serum Follicle Stimulating Hormone (FSH)

    Baseline, post-intervention (16 weeks), follow-up (32 weeks)

  • Change in Free Testosterone (T)

    Baseline, post-intervention (16 weeks), follow-up (32 weeks)

  • +11 more secondary outcomes

Study Arms (2)

Acupuncture+Usual care

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

Subjects in control group will receive usual care only.

Behavioral: Usual care

Interventions

Acupuncture+Usual careDEVICE

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.

Acupuncture+Usual care
Usual careBEHAVIORAL

Usual care intervention The subjects will receive the health advice

Usual care

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 \[12 or more antral follicles (2 to 9 mm in diameter) in either ovary, an ovarian volume that is greater than 10 ml in either ovary, or both\]
  • years of age
  • Voluntary agreement to participate in this trial

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dongzhimen Hospital

Beijing, Beijing Municipality, China

Location

Institute of acupuncture and moxibustion

Beijing, Beijing Municipality, China

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 35363161DERIVED

MeSH Terms

Conditions

Polycystic Ovary SyndromeOligomenorrhea

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesMenstruation DisturbancesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Chunlan Jin, MD

    Institute of acupuncture and moxibustion, CACMS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunlan Jin, MD

CONTACT

+8613051207195kimcl@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The assessor will be masked.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated professor

Study Record Dates

First Submitted

July 1, 2020

First Posted

August 12, 2020

Study Start

November 1, 2020

Primary Completion

December 31, 2021

Study Completion

March 31, 2022

Last Updated

October 29, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

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

Locations

CN(2)KR(1)