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 wetness"infertility 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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
660
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.
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
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.
Affiliated Hospital of Anhui University of Chinese Medicine
Hefei, Anhui, China
ACTIVE_NOT_RECRUITINGAffiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China
ACTIVE_NOT_RECRUITINGGuangzhou Medical School First Affiliated Hospital
Guangzhou, Guangdong, China
RECRUITINGDaqing LongNa Hospital
Daqing, Heilongjiang, China
ACTIVE_NOT_RECRUITINGDaqing Longnan hospital
Daqing, Heilongjiang, China
ACTIVE_NOT_RECRUITINGObstetrics and Gynecology,Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China
RECRUITINGFirst Affliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
ACTIVE_NOT_RECRUITINGMudanjiang maternal and children hospital
Mudanjiang, Heilongjiang, China
ACTIVE_NOT_RECRUITING2nd Affiliated Hospital of Henan University of Chinese Medicine
Zhengzhou, Henan, China
ACTIVE_NOT_RECRUITINGFirst Affiliated Hospital of Hunan University of Chinese
Changsha, Hunan, China
ACTIVE_NOT_RECRUITING...and 8 more locations
Live-birth rate
Time frame: Up to 2 years
Ovulation rate
Time frame: Up to 1 year
Ongoing pregnancy rate at around gestation 8-10 weeks
Time frame: Up to 1 year
Multiple pregnancy rate
Time frame: Up to 1 year.
Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation
Time frame: 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.
Time frame: Up to 1 year
Infant outcome
Time frame: 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)
Time frame: 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)
Time frame: Up to 1 year
Side effect.
Time frame: Up to 1 year
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