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