Effect of Metformin on Early Pregnancy Loss in Pregnant Women With Polycystic Ovarian Syndrome
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Miscarriage Rate
研究概览
简要总结
The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with Polycystic ovary syndrome (PCOS).
详细描述
Polycystic ovary syndrome (PCOS) is the most common endocrine disorder in women of reproductive age. PCOS produces symptoms in approximately 5 to 10% of women of reproductive age (12-45 years old) and is thought to be one of the leading causes of the female subfertility
- The aim of this work is to study the effect of metformin use for reducing early pregnancy loss in pregnant patients with PCOS
- Research question:
In pregnant women with PCOS, does metformin use decreases the rate of early pregnancy loss?
-Research hypothesis: In Pregnant women with PCOS, metformin may reduce the rate of early pregnancy loss.
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
- None
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age : 25 -
- •Pregnant patients in their 1st trimester with history of infertility due to PCOS confirmed by at least 2 of the following criteria ( Rotterdam Criteria )
- •At least twelve small follicles 2-9 mm in at least one ovary; diagnosed by ultra sound examination.
- •Symptoms or biochemical evidence of hyperandrogenism; diagnosed by examination and laboratory investigations.
- •Anovulation or oligo-ovulation with fewer than nine menstrual periods every 12 months : diagnosed by thorough history taking.
- •Non diabetic patients who received metformin along with other ovulation-inducing drugs prior to pregnancy.
排除标准
- •patients with other causes of infertility other than PCOS
- •contraindications to metformin : liver impairment , renal failure.
- •Patients with PCOS who didn't receive Metformin with drugs of induction of ovulation before pregnancy.
研究组 & 干预措施
control arm
83 patients will stop metformin at diagnosis of pregnancy ( 5-6 weeks gestation)
干预措施: Metformin (Drug)
metformin arm
83 patients will continue metformin until end of 1st trimester (14 weeks gestation)
干预措施: Metformin (Drug)
结局指标
主要结局
Miscarriage Rate
时间窗: 6 months
次要结局
未报告次要终点
研究者
Islam Dabbous
doctor
Ain Shams University