Polycystic Ovary Syndrome
Conditions
Interventions
Experimental group:Cangfu Daotan Tang Granules
Blank control group:Placebo granules
Sponsors
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Eligibility
Sex/Gender
Female
Age
25 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Diagnostic Criteria for Polycystic Ovary Syndrome (PCOS) According to the Chinese Guidelines for the Diagnosis and Treatment of Polycystic Ovary Syndrome, the essential diagnostic criteria consist of irregular uterine bleeding, amenorrhea, or oligomenorrhea, which must be accompanied by at least one of the following: (1) Clinical manifestations of hyperandrogenism (e.g., acne, hirsutism, alopecia) or biochemical hyperandrogenemia; (2) Imaging examinations showing polycystic ovarian morphology (PCOM) in either bilateral or unilateral ovaries. Additionally, the diagnosis requires exclusion of the following conditions: (1) Cushing's syndrome, androgen-secreting ovarian or adrenal tumors, and other conditions presenting with symptoms or signs of elevated androgen levels; (2) Thyroid disorders, ovarian insufficiency, functional hypothalamic amenorrhea, hyperprolactinemia, and other diseases causing ovulatory dysfunction. 2. TCM Diagnostic Criteria for Phlegm-Dampness Syndrome According to Traditional Chinese Medicine Gynecology and Guidelines for Clinical Research of New Chinese Drugs, syndrome differentiation was performed by two chief physicians specialized in Traditional Chinese Medicine. Patients meeting the diagnostic criteria were enrolled, while those who did not match were excluded. The diagnostic criteria for phlegm-dampness syndrome are as follows: Main symptoms: Delayed menstruation or amenorrhea, obesity. Secondary symptoms: Scanty menstrual flow with pale or sticky phlegm-like discharge; prolonged infertility; chest tightness; fatigue with drowsiness and dizziness; nausea; thick excessive leukorrhea; loose stools; pale and swollen tongue with teeth marks, white or greasy tongue coating; deep, slippery or deep-slow pulse. The syndrome can be confirmed when all main symptoms are present along with 1-2 secondary symptoms, combined with corresponding tongue and pulse manifestations. 3. Diagnostic Criteria for Infertility According to the 9th edition of Obstetrics and Gynecology: 1) Couples cohabiting for at least one year; 2) Having normal sexual activity; 3) No contraception used but failing to conceive, meeting these criteria can be diagnosed as infertility. Patients who have never conceived are classified as primary infertility; those who had previous pregnancies but failed to conceive again within the past year are classified as secondary infertility. 4. Inclusion Criteria for the Experimental and Control Groups (1) Married women aged 25-40; (2) Meeting the aforementioned diagnostic criteria; (3) PCOS patients with phlegm-dampness pattern manifesting symptoms consistent with the syndrome differentiation criteria for phlegm-dampness; (4) Normal reproductive tract structure; (5) Fertility requirements complying with the ethics committee standards; (6) Routine semen analysis of the male partner showing essentially normal results; (7) Informed consent and willingness to participate in the study treatment, with suitability for follow-up. 5. Inclusion Criteria for the Blank Control Group (1) Married women aged 25-40; (2) Meeting the diagnostic criteria for infertility; (3) Male partners diagnosed with oligoasthenozoospermia; (4) History of =2 failed cycles of intrauterine insemination (IUI); (5) Informed consent and willingness to participate in the study treatment, with suitability for follow-up.
Exclusion criteria
Exclusion criteria: Participants meeting any of the following criteria will be excluded from the study: (1) History of recurrent pregnancy loss; (2) Diagnosed with ovarian dysfunction (e.g., premature ovarian failure, hyperprolactinemia), thyroid disorders, uterine fibroids, endometriosis, or similar conditions; (3) Uterine or systemic diseases that contraindicate or severely complicate pregnancy; (4) Abnormal peripheral blood karyotyping in either partner; (5) Cardiovascular, cerebrovascular, hepatic, or renal disorders; (6) Dysfunction of hematopoietic or coagulation systems; (7) Severe detrimental habits (e.g., substance abuse); (8) Recent (within 3 months) use of hormonal medications; (9) Incomplete medical records.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in phlegm-dampness syndrome scores;Cumulative pregnancy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| number of oocytes retrieved; number of 2PN fertilized oocytes;normal fertilization rate; number of usable embryos;high-quality embryo rate; | — |
Countries
China
Contacts
Public ContactFang Lian
The Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Outcome results
None listed