The Effect of Diane-35 Pretreatment on Endocrine and Clinical Profile for Patients With Polycystic Ovary Syndrome Undergoing In-vitro Fertilization
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- fertilization rate
研究概览
简要总结
Polycystic Ovary Syndrome is the most common endocrine disorder in women, is estimated to affect more than 5% of the population and is associated with chronically elevated serum androgen concentrations.Evidence suggests that polycystic ovary syndrome has a negative impact on pregnancy outcomes, with an increased risk of gestational diabetes, hypertensive disease during pregnancy,and preterm birth,which is partially related with the hyperandrogenic environment.Diane-35 has been proved to be the most effective anti-androgenic drug.At present, there is no direct evidence that Diane-35 has a positive effect on the clinical outcome of polycystic ovary syndrome patients undergoing In-vitro fertilization/Intracytoplasmic sperm injection.
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
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •diagnosed polycystic ovary syndrome patients according to Rotterdam criteria
- •with hyperandrogenism and/or clinical hyperandrogenic manifestations
- •no other oral contraceptives treatment for at least 3 months before this experiment
- •no any other assisted reproductive therapy
- •accompanied with fallopian tube and/or male factors
- •normal hepato-/nephro- function
排除标准
- •oral contraceptive pills contraindications, eg.Deep Venous Thrombosis
- •smoking, drunk
- •exclude other infertile factors, eg.endometriosis, abnormal thyroid function, etc.
研究组 & 干预措施
diane-35
Diane-35 pretreatment from the third day of menstrual cycle
干预措施: Diane-35 pretreatment (Drug)
结局指标
主要结局
fertilization rate
时间窗: up to 2years
次要结局
- implantation rate(up to 2years)
研究者
Zhou Canquan
vice president
First Affiliated Hospital, Sun Yat-Sen University