A Trial of Personalized Acupuncture, Fixed Acupuncture, Letrozole and Placebo on Live Birth in Women With PCOS

Exclusion Criteria

• •1. Exclusion of other endocrine disorders: a. patients with hyperprolactinemia (defined as two prolactin levels at least one week apart ≥ 25 ng/mL); b. Patients with FSH levels \> 15 mIU/mL. A normal level within the last year is adequate for entry; c. Patients with uncorrected thyroid disease (defined as TSH \< 0.2 mIU/mL or \> 5.5 mIU/mL). A normal level within the last year is adequate for entry. d. Patients diagnosed with Type I or Type II diabetes who are poorly controlled (defined as HbA1c level \> 7.0%), or patients receiving antidiabetic medications such as metformin, insulin, thiazolidinediones, acarbose, or sulfonylureas. e. Patients with suspected Cushing's syndrome.
• •2. Use of other TCM treatments including Chinese herbal prescriptions and acupuncture in the past 3 months.
• •3. Use of other western medications known to affect reproductive function or metabolism in the past 2 months.
• •4. Pregnancy within the past 6 weeks.
• •5. Within 6 weeks postabortion or postpartum.
• •6. Breastfeeding within the last 6 months.
• •7. Not willing to give written consent to the study.
• •1. Patients taking other medications known to affect reproductive function or metabolism. These medications include oral contraceptives, depot progestins, hormonal implants (including Implanon), GnRH agonists and antagonists, antiandrogens, gonadotropins, antiobesity drugs, antidiabetic drugs such as metformin and thiazolidinediones, somatostatin, diazoxide, angiotensin-converting-enzyme (ACE) inhibitors, and calcium channel blockers. The washout period on these medicationswill be two months, longer washouts may be necessary for certain depot contraceptive forms or implants, especially where the implants are still in place. A one-month washout will be required for patients on depot progestins.
• •2. Patients with liver disease defined as AST or ALT \> 2 times normal or total bilirubin \> 2.5 mg/dL. Patients with renal disease defined as BUN \> 30 mg/dL or serum creatinine \> 1.4 mg/dL.
• •3. Patients with hemoglobin \< 10 g/dL.
• •4. Patients with a history of deep venous thrombosis, pulmonary embolus, or cerebrovascular accident.
• •5. Patients with known heart disease that is likely to be exacerbated by pregnancy.
• •6. Patients with a history of, or suspected cervical carcinoma, endometrial carcinoma, or breast carcinoma. A normal Pap smear result will be required for women 21 and over.
• •7. Patients with a current history of alcohol abuse. Alcohol abuse is defined as \>14 drinks/week or binge drinking.
• •8. Patients enrolled into other investigative studies that require medications, prescribe the study medications, limit intercourse, or otherwise prevent compliance with the protocol.
• •9. Patients who anticipate taking longer than a one-month break during the protocol should not be enrolled.
• •10. Patients with a suspected adrenal or ovarian tumor secreting androgens.
• •11. 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.
• •12. Subjects who have undergone a bariatric surgery procedure in the recent past (\< 12 months) and are in a period of acute weight loss or have been advised against pregnancy by their bariatric surgeon.
• •13. Patients with untreated poorly controlled hypertension defined as a systolic blood pressure 160 mmHg or a diastolic 100 mm Hg obtained on two measures obtained at least 60 minutes apart.
• •14. Patients with known congenital adrenal hyperplasia.