Polycystic ovarian syndrome
Conditions
Interventions
A:Acupuncture treatment 1 plus CC
B:Acupuncture treatment 2 plus CC
C:Acupuncture treatment 1 plus CC placebo
D:Acupuncture treatment 2 plus CC placebo
Sponsors
Heilongjiang University of Chinese Medicine
Eligibility
Sex/Gender
Female
Age
20 Years to 40 Years
Inclusion criteria
Inclusion criteria: 1. Age between 20 and 40 years. 2. Confirmed diagnosis of PCOS according to the modified Rotterdam criteria and all subjects must have anovulation plus either polycystic ovaries and/or hyperandrogenism. 3. One tube patent and a normal uterine cavity by hysterosalpingogram, HyCosi or diagnostic laparoscopy. 4. Normal semen analysis of the husband according to the criteria of World Health Organization (2010) i.e. sperm concentration of at least 15 million per milliliter, forward motility of at least 32% and normal morphology of at least 4%.
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 known 21-hydroxylase deficiency or other enzyme deficiency leading to the phenotype of congenital adrenal hyperplasia; (3) Patients with FSH levels > 15 mIU/mL. A normal level within the last year is adequate for entry; (4) Patients with uncorrected thyroid disease (defined as TSH 5.5 mIU/mL). A normal level within the last year is adequate for entry; (5) Patients diagnosed with Type I or Type II diabetes who are poorly controlled (defined as a glycohemoglobin 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 for a diagnosis of Type I or Type II diabetes or for PCOS are also specifically excluded; (6) 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 3 months; 3. Pregnancy within the past 6 weeks; 4. Within 6 weeks post-abortion or postpartum; 5. Breastfeeding within the last 6 months; 6. Acupuncture within the last 6 months; 7. Not willing to give written consent to the study; 8. Specific Exclusion Criteria; (1) Patients on oral contraceptives, depot progestins, or hormonal implants (including Implanon). A two month washout period will be required prior to screening for patients on these agents. 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 oral cyclic 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 significant anemia (Hemoglobin 14 drinks/week or binge drinking. (8) Patients enrolled simultaneously into other investigative studies that require medications, proscribe 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 taking other medications known to affect reproductive function or metabolism. These medications include oral contraceptives, GnRH agonists and antagonists, antiandrogens, gonadotropins, anti-obesity drugs, Chinese herbal formula, anti-diabeteic drugs such as metformi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live birth rate; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ovulation rate;Ongoing pregnancy rate;Multiple pregnancy rate;Miscarriage rate;Hormonal profile: Testosterone(T), Sex hormone-binding globulin (SHBG), Follicle stimulating hormone;Metabolic profile includes: Serum glucose concentration, Insulin concentration, cholesterol;Side effects of CC include hot flashes, mood changes, bloating, formation of ovarian cysts, and pain; | — |
Countries
China
Contacts
Public ContactXIAOKE WU
Outcome results
None listed