Polycystic Ovary Syndrome (PCOS)
Conditions
Interventions
Control Group:Sham Acupuncture + Letrozole
Experimental Group:Tongyuan Acupuncture + Letrozole
Sponsors
Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)
Eligibility
Sex/Gender
Female
Age
21 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Female patients aged 21 to 40 years; 2. Diagnosed with PCOS based on Rotterdam criteria (meeting at least two of the following): a. Oligo-ovulation (menstrual interval > 35 days or 90 days); b. Clinical or biochemical hyperandrogenism (e.g. hirsutism or total testosterone > 60 ng/dL in biochemical tests); c. Polycystic ovarian morphology on ultrasound (= 12 follicles measuring 2-9 mm in diameter per ovary or ovarian volume > 10 mL). 3. Meeting WHO criteria for infertility (failure to conceive after 12 months or more of regular unprotected intercourse); 4. Husbands semen analysis meeting WHO 2021 standards: Sperm concentration = 15×106/mL total sperm count = 39×106 total motility = 40% progressive motility = 32% and normal morphology = 4%; 5. Planning natural conception in the near future and agreeing to maintain regular sexual intercourse during the trial to promote conception; 6. Willing to participate in the study and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Presence of other endocrine disorders mimicking PCOS (e.g. hyperprolactinemia adrenal tumors ovarian tumors untreated thyroid diseases Cushings syndrome congenital adrenal hyperplasia etc.); 2. Known existence of other infertility factors (e.g. bilateral tubal obstruction hydrosalpinx uterine septum uterine anomalies severe intrauterine adhesions significant endometrial damage immune-related infertility etc.); 3. Receipt of acupuncture treatment within the past 3 months; 4. Participation in other clinical trials within the past 3 months; 5. Use of ovulation induction drugs or assisted reproductive technologies within the past 3 years without achieving successful pregnancy; 6. Presence of severe cardiac hepatic or renal diseases; 7. Inability to cooperate with the study protocol including patients with psychiatric disorders or a complex medical history; 8. Presence of inflammation scarring or trauma at the procedural site or any severe systemic infection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical Pregnancy Rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Modified Polycystic Ovary Syndrome Questionnaire (MPCOSQ);ultrasonographic monitoring parameters;Pregnancy Loss Rate;Hospital Anxiety and Depression Scale (HADS);Conception Rate;Modified Ferriman-Gallwey score;time to pregnancy;Fertility Quality of Life scale(FertiQoL);Hormonal Levels;Ovulation Rate;Global Acne Grading System (GAGS);glucose-lipid metabolism indicators;Multiple pregnancy rate; | — |
Countries
China
Contacts
Public ContactShaoyang Cui
Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)
Outcome results
None listed