Polycystic Ovary Syndrome
Conditions
Keywords
Polycystic Ovary Syndrome
Brief summary
Polycystic ovary syndrome (PCOS) is a heterogeneous disorder affecting almost4%-7% of the female population of reproductive age. Its heterogeneity is characterized by a wide spectrum of features, including ovulatory dysfunction and infertility, hyperandrogenism, hyperinsulinemia, insulin resistance (IR), and progression to type 2 diabetes.Since the Ming Dynasty in China,PCOS has been defined as phlegm and wetnessinfertility in traditional Chinese medicine ,namely metabolic infertility.Chinese herbs have been used to treat PCOS for thousands of years with good effects.Berberine has also been used for diabetic patients in traditional Chinese medicine for hundreds of years. Recent studies have reported its effects on hyperglycemia and dyslipidemia.The purpose of this study is to determine whether Letrozole combined with berberine are effective in the treatment of infertile PCOS patients.
Interventions
DRUGLetrozole -Berberine
Letrozole 2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6. Berberine 1.5g daily for 6 month.
DRUGLetrozole
Letrozole 2.5 mg letrozole daily from day 5 of the menses for 5 days for month 1 to 3, 5.0 mg letrozole daily from day 5 of the menses for 5 days for month 4 to 6. Berberine Placebo 5 tablet tds for 6 months
DRUGBerberine
Berberine 1.5g daily for 6 month. Letrozole placebo 1 tablet daily from day 5 of the menses for 5 days for month 1 to 3, 2 tablets daily from day 5 of the menses for 5 days for month 4 to 6.
Sponsors
Ministry of Science and Technology of the People´s Republic of China
Heilongjiang University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Chinese women * Age between 20 and 40 years. * Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3): 1. Oligo- or anovulation 2. Clinical and/or biochemical signs of hyperandrogenism 3. Polycystic ovaries and exclusion of other etiologies (congenital adrenal hyperplasia, androgen-secreting tumors, Cushing's syndrome) * At least one patent tube and normal uterine cavity shown by hysterosalpingogram, HyCoSi or diagnostic laparoscopy within three years. * Sperm concentration 20×106/mL and progressive motility (grades a and b) ≥50%.
Exclusion criteria
* Use of hormonal drugs or other medications including Chinese herbal prescriptions in the past 3 months. * Patients with known sever organ dysfunction or mental illness. * Pregnancy, post-abortion or postpartum within the past 6 weeks. * Breastfeeding within the last 6 months. * Not willing to give written consent to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live-birth rate | Up to 2 years |
Secondary
| Measure | Time frame |
|---|---|
| Ongoing pregnancy rate at around gestation 8-10 weeks | Up to 1 year |
| Multiple pregnancy rate | Up to 1 year. |
| Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation | Up to 1 year |
| Other pregnancy complications such as early pregnancy loss, gestational diabetes mellitus, pregnancy-induced hypertension and birth of small-for-gestational-age (SGA) babies. | Up to 1 year |
| Ovulation rate | Up to 1 year |
| Changes in metabolic profile: glucose and insulin concentrations, cholesterol, triglycerides, high density lipoprotein (HDL-C) and low density lipoprotein (LDL-C) | Up to 1 year |
| Changes in hormonal profile: Follicle-stimulating hormone (FSH), Luteinizing hormone (LH), total testosterone (T), Sex hormone-binding globulin (SHBG) and Dehydroepiandrosterone sulfate (DHEAS) | Up to 1 year |
| Side effect. | Up to 1 year |
| Infant outcome | Up to 1 year |
Countries
China
Contacts
Primary ContactYan Li, MD.PhD.
Outcome results
None listed