Polycystic Ovary Syndrome Infertility
Conditions
Interventions
Treatment group:Oral administration of Letrozole for ovulation induction, acupuncture point embedding.
Control Group:Oral letrozole, sham acupoint implantation
Sponsors
Affiliated Hospital of Chinese Medicine of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1.Females aged between 20 and 40 years old who meet the above diagnostic criteria, with at least one fallopian tube patent; 2.Normal routine semen analysis in male partners (in compliance with WHO standards); 3.Have a clear intention of conception during the study period and agree to receive intervention and follow-up in accordance with the research protocol; 4.Complete case data, and be willing to cooperate with investigators to complete TCM syndrome score assessment, case report forms and other relevant questionnaires; 5.Voluntarily participate in the study and sign the written informed consent form.
Exclusion criteria
Exclusion criteria: (1) Other conditions causing hyperandrogenism or ovulatory dysfunction: such as congenital adrenal hyperplasia (non-classic type), Cushing's syndrome, androgen-secreting tumors, severe hyperprolactinemia, uncontrolled thyroid dysfunction, etc.; (2) Significant uterine or pelvic organic lesions affecting conception or pregnancy outcomes: such as submucosal uterine fibroids, severe intrauterine adhesions, uncorrected uterine malformations, untreated endometrial polyps, moderate to severe adenomyosis, severe endometriosis (Stage III–IV), etc.; (3) Unresolved hydrosalpinx; (4) History of allergy to suture materials (e.g., absorbable sutures, metal needles) or letrozole; (5) Bleeding tendency or coagulation disorders, currently using anticoagulant/antiplatelet drugs that cannot be discontinued, or significantly reduced platelet count; (6) Local skin infections, severe scar tendency, or skin lesions at the suture site that make the procedure unsuitable; (7) Presence of systemic diseases that contraindicate pregnancy, such as severe liver or kidney dysfunction (e.g., ALT/AST > 2–3 times the upper limit, significantly decreased eGFR) or other severe systemic diseases that make participation in the study inadvisable (e.g., heart failure, malignant tumors); (8) Mental or cognitive disorders affecting compliance or follow-up; (9) Use of treatments affecting reproductive endocrinology or metabolism in the past 3 months: such as ovulation induction drugs, oral contraceptives, glucocorticoids, anti-androgens, weight-loss medications, etc.; (10) Receipt of acupuncture, suture embedding, cupping, or other traditional Chinese medicine external therapies in the past 3 months that may affect weight, ovulation, or pregnancy; (11) Weight-loss surgery within the past 6 months or plans to undergo weight-loss surgery or major lifestyle interventions (e.g., forced nutritional replacement therapy) during the study period; (12) Plans to undergo assisted reproductive techniques (IUI/IVF-ET) during the study period or already pregnant.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pregnancy rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ovulation rate;Endometrial thickness;Sex hormone indicators;Glycemic Metabolism Indicators;Lipid metabolism indicators;Body Data;Menstrual Cycle Status;Quality of Life Rating;Traditional Chinese Medicine (TCM) Clinical Symptom Scoring; | — |
Countries
China
Contacts
Public ContactMing Kangman
Affiliated Hospital of Chinese Medicine of Guangzhou Medical University
Outcome results
None listed