Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Syndrome

Polycystic Ovary Syndrome

Oligomenorrhea

Cysts

Ovarian Cysts

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Gonadal Disorders

Endocrine System Diseases

Menstruation Disturbances

Central Nervous System Depressants

All Drugs and Chemicals

Other Dietary Supplements

Benzocaine

Tannic Acid

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.

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 care intervention The subjects will receive the health advice

Usual care

Chunlan Jin, MD

Jiping Zhao, MD

Jin-Moo Lee, KMD, PhD.

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).

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.

Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome

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

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

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

Menstrual period is assessed in days from the 1st day of menstruation cycle to 1st day of the next menstruation cycle.

Change in the level of serum estradiol in pg/mL

Change in the level of serum luteinizing hormone (LH) in mIU/mL

Change in the level of serum follicle stimulating hormone (FSH) in mIU/mL

Change in the level of serum free testosterone (T) in ng/mL

The ratio is calculated based on the value of LH and FSH.

Change in the number of antral follicles of the ovary and ovarian volume by ultrasound imaging.

Body Mass Index (BMI) is defined as the body weight divided by the square of height, and expressed in kg/m2.

The ratio is calculated based on the length of waist and hip.

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).

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.

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.

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 patients with abnormal erythrocyte sedimentation rate in mm/h.

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 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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome	NCT04509817	Polycystic Ovar... Oligomenorrhea	Acupuncture+Usu... Usual care	20 Years - 40 Years	China Academy of Chinese Medical Sciences
Acupuncture for Oligomenorrhea Due to Polycystic Ovary Syndrome	NCT04509817	Polycystic Ovar... Oligomenorrhea	Acupuncture+Usu... Usual care	20 Years - 40 Years	China Academy of Chinese Medical Sciences

Spots Global Cancer Trial Database for acupuncture+usual care