Effect of Metformin With or Without Folate Addiction on Uterine Blood Flow and Trophoblastic Invasion in Pregnant Patients With Polycystic Ovary Syndrome
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Trophoblastic invasion.
研究概览
简要总结
A more recent prospective nonrandomized placebo-controlled double-blind clinical study demonstrated that metformin exerts a slight but significant deleterious effect on serum homocysteine (Hcy) levels in patients with PCOS, and supplementation with folate is useful to increase the beneficial effect of metformin on the vascular endothelium.
详细描述
PCOS (cases) and non-PCOS (controls) pregnant women were enrolled. Cases will be randomized in four treatment groups: metformin plus placebo (group A1), metformin plus folic acid (group A2), placebo plus folic acid (group A3), placebo alone (group A4). Controls will not received any treatment (group B). Clinical and biochemical assessment (including serum markers of implantation), Doppler velocimetry of the uterine arteries, and trophoblastic invasion at histological and immunohistochemical evaluation.
Changes in clinical and biochemical data under treatment, pattern of Doppler velocimetry at the uterine arteries, and trophoblastic invasion were evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnancy
排除标准
- •Risk factors for pregnancy complications
- •Severe obesity
研究组 & 干预措施
Group A1
metformin plus placebo
干预措施: metformin plus placebo (Drug)
Group A2
metformin plus folic acid
干预措施: Metformin plus folic acid (Drug)
Group A3
placebo plus folic acid
干预措施: placebo plus folic acid (Drug)
Group A4
placebo cp, 2 cps daily
干预措施: placebo alone (Drug)
结局指标
主要结局
Trophoblastic invasion.
时间窗: two weeks
Istologic evaluation of trophoblastic ivasion,
次要结局
- Doppler velocimetry measurements of the uterine artery.(two weeks)