Research of Intensive Metabolic Intervention Before Pregnancy in Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Improvement of pregnant rate after intensive metabolic intervention
研究概览
简要总结
To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.
详细描述
To investigate whether intensive metabolic intervention of PCOS women before pregnancy can improve pregnancy outcome.Besides, the investigators aim to investigate the best therapy strategy of metabolic intervention before pregnancy.The investigators plan to recruit PCOS women with IGR / DM not effective of metformin treatment at childbearing age. By using acarbose, GLP-1 analogue, berberin et al. the investigators will intervent the participants' metabolic statues for 3 months before pregnancy and to compare outcome in each group.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS women at Childbearing Age
- •PCOS: Clinical hyperandrogenism and/or hyperandrogenemia, menstrual dysfunction (oligomenorrhea or amenorrhea) and exclusion of other known disorders. PCOS will be diagnosed using the 2003 Rotterdam criteria.
排除标准
- •Past or present history of a medical disorder or medication known to affect body composition, insulin secretion and sensitivity, or the growth hormone (GH)-insulin-like growth factor 1 (IGF1) axis (eg steroid hormone or thyroid replacement).
- •History of current or past pregnancy
- •Hormonal contraceptive or metformin use within 3 months of enrollment
- •Nonclassical congenital adrenal hyperplasia
研究组 & 干预措施
control
metformin(1000-1500mg/d) treated for 6 months, reverse to normal glucose tolerance
干预措施: Metformin (Drug)
acarbose
metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with acarbose (100mg tid ) for 3 months
干预措施: Acarbose 100 MG (Drug)
Exenatide
metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Exenatide 10μg/bid ) for 3 months
干预措施: Exenatide (Drug)
Orlistat
metformin(1000-1500mg/d) treated for 6 months, can not reverse to normal glucose tolerance, then treat with Orlistat(0.12mg/tid ) for 3 months
干预措施: Orlistat (Drug)
结局指标
主要结局
Improvement of pregnant rate after intensive metabolic intervention
时间窗: up to 24 weeks
To compare the pregnant rate of four groups after treatment
次要结局
- Improvement of stillborn foetus rate after intensive metabolic intervention(up to 24 weeks)
- Improvement of obsorbtion rate after intensive metabolic intervention(up to 24 weeks)
- Improvement of hyperandrogenism(up to 24 weeks)
- Improvement of intravenous blood glucose from impaired glucose regulation to normal glucose regulation(up to 24 weeks)
- Improvement of triglyceride(up to 24 weeks)