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Electroacupuncture for Autonomic Nervous Balance in Polycystic Ovary Syndrome: A Randomized Controlled Trial

A Randomized Controlled Trial of Autonomic Nerve-Targeted Electroacupuncture Based on the "Qi Jie" Theory for Polycystic Ovary Syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001081
Enrollment
Unknown
Registered
2026-04-24
Start date
2026-05-08
Completion date
Unknown
Last updated
2026-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Interventions

Experimental group (autonomic nerve-targeted electroacupuncture group):Points: Left Yiming, Tianrong, Ear Jia, Ruto (vagus nerve)
bilateral T9, T10 Jiaji (sympathetic nerve).EA connection: Yiming-Tianrong & Ear Jia-Ruto (positive to Yiming & Ear Jia), dense-disperse wave (2/10 Hz), 0.5-1.0 mA
T9 & T10 Jiaji (positive to left, negative to right), continuous wave (100 Hz), 1.0-2.0 mA.Regimen: 30 min/session, 3 times/week (=1 day apart), for 12 weeks (36 sessions total).
Control Group: Conventional Acupoint Group (Traditional Electroacupuncture Group):Point selection: Guanyuan (CV4), Zhongji (CV3), bilateral Zigong (EX-CA1), bilateral Sanyinjiao (SP6), bilateral Taich
2) Guanyuan (positive) - Zhongji (negative). Continuous wave, 10 Hz, 1.0-2.5 mA. Sanyinjiao and Taichong are needled without electroacupuncture. Treatment course: Three times per week (at least one d

Sponsors

Tianjin Binhai New Area Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (1) Meet both the diagnostic criteria for PCOS and infertility as described above; (2) Aged 20 to 40 years (inclusive); (3) Oligomenorrhea (menstrual cycle > 35 days) or amenorrhea; (4) The subject has been informed of the study details, voluntarily signs the informed consent form, and agrees to participate in this study. Note: Patients who meet all of the above four criteria will be included in this study.

Exclusion criteria

Exclusion criteria: Exclusion Criteria (1) Presence of congenital adrenal hyperplasia, Cushing's syndrome, or other conditions that cause hyperandrogenism or ovulatory dysfunction; (2) Use of hormonal medications (e.g., contraceptives, ovulation-inducing drugs) or medications affecting the nervous or psychiatric system within the past 3 months; (3) Presence of severe heart, liver, or kidney diseases, uncontrolled diabetes, or thyroid disorders; (4) Presence of contraindications to acupuncture or a history of needle phobia; (5) Implanted cardiac pacemaker or claustrophobia (which would affect participation in the fMRI substudy); (6) Presence of severe mental illness or cognitive impairment that precludes cooperation with treatment and evaluation; (7) Current participation in another clinical trial. Note: Patients meeting any of the above criteria will be excluded.

Design outcomes

Primary

MeasureTime frame
Heart rate variability (HRV);Ovulation rate;

Secondary

MeasureTime frame
Menstrual status: Menstrual cycle recovery rate and average cycle length.;Clinical symptoms: Hirsutism score (mFG score) and acne score.;Psychological and quality of life measures: Fertility Problem Inventory (FPI), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), and Fertility Quality of Life Questionnaire (FertiQoL).;Central sympathetic tone: Resting pupil diameter.;Central neuroplasticity: Resting-state functional magnetic resonance imaging (fMRI).;Patient Global Assessment (PGA);Incidence of adverse events (AEs);

Countries

China

Contacts

Public ContactLianqi Geng

Tianjin Binhai New Area Hospital of Traditional Chinese Medicine

genglianqi@163.com13920956132

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026