Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04509817
• Other study ID #: GH201802
• Secondary ID: KHNMCOH 2017-12-
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2020
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2020
• Source: China Academy of Chinese Medical Sciences
• Contact: Chunlan Jin, MD
• Phone: +8613051207195
• Email: kimcl[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Oligomenorrhea
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.

Behavioral:
• Usual care
Usual care intervention The subjects will receive the health advice

Locations

Country	Name	City	State
China	Dongzhimen Hospital	Beijing	Beijing
China	Institute of acupuncture and moxibustion	Beijing	Beijing
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul

Sponsors (4)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Dongzhimen Hospital, Beijing, Korea Institute of Oriental Medicine, Kyung Hee University Hospital at Gangdong

Countries where clinical trial is conducted

China,  Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	Change in Estradiol (E2)	Change in the level of serum estradiol in pg/mL	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	Change in Luteinizing Hormone (LH)	Change in the level of serum luteinizing hormone (LH) in mIU/mL	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	Change in Serum Follicle Stimulating Hormone (FSH)	Change in the level of serum follicle stimulating hormone (FSH) in mIU/mL	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	Change in Free Testosterone (T)	Change in the level of serum free testosterone (T) in ng/mL	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	Change in LH/FSH Ratio	The ratio is calculated based on the value of LH and FSH.	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	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.	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	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.	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	Change in Waist Hip Ratio (WHR)	The ratio is calculated based on the length of waist and hip.	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	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).	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	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.	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	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.	up to 32 weeks
Secondary	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 %.	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	Incidence of abnormal erythrocyte sedimentation rate	Incidence of patients with abnormal erythrocyte sedimentation rate in mm/h.	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	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.	Baseline, post-intervention (16 weeks), follow-up (32 weeks)
Secondary	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 ?-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)