Polycystic Ovary Syndrome
Conditions
Interventions
1:Pre-treatment + Letrozole
2:acupuncture+ Letrozole
Sponsors
the First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Women aged between 20 and 40 years; 2. Confirmed diagnosis of PCOS according to 2003 modified Rotterdam criteria: Oligo-(an intermenstrual interval >35 days or 90 days), together with (1) polycystic ovarian morphology, i.e. presence of >12 antral follicles (=9mm) and/or ovarian volume>10 ml on transvaginal scanning; and/or (2) clinical and/or biochemical hyperandrogenism. Clinical hyperandrogenism in China Mainland is defined as a Ferriman-Gallwey (FG) score =523; biochemical hyperandrogenism is total testosterone (T) > 2.6 nmol/l and free testosterone =6.0pg/ml24. 3. According to World Health Organization standards (2010), semen analysis of the husband must meet (1) or (2): (1) sperm concentration >=15*10^6/ml and total motility >=40%; (2) Total motile sperm count >=9 million, i.e. semen volume*sperm density*percentage of motile sperm >=9 million; 4. At least one patent tube shown by hysterosalpingogram or diagnostic laparoscopy. The results will be valid for 3 years if the patients do not have a history of abortion or pelvic operation.
Exclusion criteria
Exclusion criteria: 1. Exclusion of other endocrine disorders: (1) Patients with hyperprolactinemia (defined as two prolactin levels at least one week apart 25 ng/mL or greater or as determined by local normative values). The goal of eliminating patients with documented hyperprolactinemia is to decrease the heterogeneity of the PCOS population. These patients may be candidates for ovulation induction with alternate regimens (dopamine agonists). A normal level within the last year or on treatment is adequate for entry; (2) Patients with FSH levels >15 mIU/mL. A normal level within the last year is adequate for entry; (3) Patients with uncorrected thyroid disease (defined as TSH 5.5 mIU/mL). A normal level within the last year is adequate for entry; (4) Patientsdiagnosed with Type I or Type II diabetes who are poorly controlled (defined as a Hb A1c level > 7.0%), or patients receiving antidiabetic medications such as insulin, thiazolidinediones, acarbose, or sulfonylureas likely to confound the effects of study medication; Patients currently receiving metformin XR (extended release) for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded; (5) Patients with suspected Cushing’s syndrome; 2. Use of hormonal or other medication including Chinese Herbal prescriptions which may affect the outcome at least in the past 2 months; 3. Acupuncture the last 2 months; 4. Pregnancy within the past 6 weeks; 5. Within 6 weeks post-abortion or postpartum; 6. Breastfeeding within the last 6 months; 7. Not willing to give written consent to the study; 8. Additional exclusion criteria: (1) Patients with a suspected adrenal or ovarian tumor secreting androgens; (2) Couples with previous sterilization procedures (vasectomy, tubal ligation) which have been reversed. The prior procedure may affect study outcomes, and patients with both a reversed sterilization procedure and PCOS are rare enough that exclusion should not adversely affect recruitment; (3) Subjects who have undergone a bariatric surgery procedure in the recent past ( 2 times normal or totalbilirubin >2.5 mg/dL. Patients with renal disease defined as BUN > 30 mg/dL or serum creatinine> 1.4 mg/dL; (8) Patients with significant anemia (Hemoglobin < 10 g/dL); (9) Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident; (10) Patients with known heart disease that is likely to be exacerbated by pregnancy; (11) Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma. A normal Pap smear or TCT result will be required for women 21 and over; (12) Patients w
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate; | — |
Countries
China
Contacts
Public ContactMa Hongxia
Outcome results
None listed