polycystic ovarian syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Patients meeting the Rotterdam diagnostic criteria [6] for PCOS, specifically defined by the presence of at least two of the following conditions: a. Oligo-ovulation (menstrual intervals > 35 days or 90 days); b. Clinical or biochemical hyperandrogenism (clinical manifestations such as hirsutism; biochemical findings such as total testosterone level > 60 ng/dL); c. Polycystic ovary morphology on ultrasound (=12 follicles per ovary measuring 2-9 mm in diameter; and/or ovarian volume > 10 mL). 2.All subjects must be diagnosed with PCOS and present with menstrual disturbances: a. Oligomenorrhea: Menstrual cycle length between 35 days and 6 months; b. Amenorrhea: Secondary amenorrhea: Cessation of menses for =6 months or for a duration equivalent to more than 3 previous cycle lengths. Primary amenorrhea: Absence of menarche by age 14 years with no development of secondary sexual characteristics, or absence of menarche by age 15 years regardless of the presence of secondary sexual characteristics. c. Frequent menstruation: Irregularities in menstrual cycle frequency, duration, or volume. 3.Age between 20 and 40 years. 4.Voluntary participation in the study and provision of signed informed consent.
Exclusion criteria
Exclusion criteria: 1.Ovarian tumors, pituitary adenoma, endometrial tuberculosis, post-abortion intrauterine adhesions, endometrial injury, hyperprolactinemia, congenital adrenal hyperplasia, Cushing's syndrome, premature ovarian failure, central amenorrhea, or thyroid dysfunction. 2.Severe cardiac, hepatic, or renal impairment; hematologic disorders; or any malignancy. 3.Use of estrogen/progestogen therapies, lipid-lowering agents, or glucose-lowering medications within the past 3 months. 4.Concurrent engagement in surgical or pharmacological weight-control interventions. 5.Participation in other clinical trials within the past 3 months. 6.Significant visual or hearing impairment, or diagnosed psychiatric disorders. 7.Known metal allergy or allergic constitution. 8.Current pregnancy or lactation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ovulation rate; ;Menstrual recovery rate;; | — |
Secondary
| Measure | Time frame |
|---|---|
| Conception rate; ;TCM syndrome score; ;Serum sex hormone levels; ;Glycolipid metabolism parameters; ;Ultrasonographic measures on the day of ovulation: Uterine dimensions, Endometrial thickness, Bilateral ovarian volume, Antral follicle count (AFC, 2-9 mm), Dominant follicle diameter; ;mFG score;; GAGS score; ;MPCOSQ; ;FertiQoL questionnaire; ;HADS; | — |
Countries
CHINA
Contacts
The First Affiliated Hospital of Guangzhou University of Chinese Medicine