Baseline visit

The baseline visit will take place around days 1–7 of a spontaneous menstruation cycle or after a withdrawal bleeding if a woman fulfills the inclusion criteria and has signed the consent form. Fasting blood samples will be obtained from the patients and will be shipped to the core laboratory for analysis and stored for a minimum of 5 years and may be further used in future studies, which is stated in the informed consent form (Supplementary file 2). Moreover, a urine or serum pregnancy test will be performed at this visit.

Women will complete the following questionnaires: the 36-item Short Form Health Survey (SF-36) of health-related quality of life (QOL), the Polycystic Ovary Syndrome Quality of Life Questionnaire (PCOS-QOL), the Chinese Quality of Life (ChQOL), the Pittsburgh Sleep Quality Index (PSQI), the Zung Self-Rating Anxiety Scale (SAS), and the Zung Self-Rating Depression Scale (SDS).

The symptoms of PCOS are mainly differentiated in TCM as a liver-kidney yin-type deficiency or a spleen-kidney yang-type deficiency. The TCM syndrome diagnosis will be made by the PI and acupuncturist in each participating site according to a standard questionnaire during the baseline visit and the end-of-treatment visit. If the diagnosis differs between the PI and acupuncturist, they will discuss this until reaching an agreement. Syndrome differentiation in TCM entails the comprehensive analysis of clinical information gained by the four main diagnostic TCM procedures: observation, listening, questioning, and pulse analysis. All baseline measures will be repeated in all subjects at the end-of-treatment visit.