Letrozole and Berberine in Infertile PCOS Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 660
- 试验地点
- 18
- 主要终点
- Live-birth rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Chinese women
- •Age between 20 and 40 years.
- •Confirmed diagnosis of PCOS according to the Rotterdam 2003 criteria (2 out of 3):
- •Oligo- or anovulation
- •Clinical and/or biochemical signs of hyperandrogenism
- •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%.
排除标准
- •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.
研究组 & 干预措施
Letrozole -Berberine
干预措施: Letrozole -Berberine (Drug)
Letrozole
干预措施: Letrozole (Drug)
Berberine
干预措施: Berberine (Drug)
结局指标
主要结局
Live-birth rate
时间窗: Up to 2 years
次要结局
- Ovulation rate(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)
- Multiple pregnancy rate(Up to 1 year.)
- Side effect.(Up to 1 year)
- Ongoing pregnancy rate at around gestation 8-10 weeks(Up to 1 year)
- Miscarriage rate: loss of an intrauterine pregnancy before 20 completed weeks of gestation(Up to 1 year)
- Infant outcome(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)
研究者
Xiaoke Wu
Professor and Department Chairman of Obstetrics and Gynecology
Heilongjiang University of Chinese Medicine