The Effect of Metformin on Fecundability in Obese Women Undergoing ART - the Correlation to Uterine Flow Parameters A Prospective Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 100
- 主要终点
- pregnancy rate
研究概览
简要总结
The basis for obesity's impact on reproduction is not well characterised and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.
Insulin sensitizers ameliorate insulin resistance in obese patients. This study seeks to determine if Metformin helps to increase fecundability by affecting the uterus in women undergoing ART. As a surrogate marker- flows in the uterus will be tested during the treatment.
详细描述
Obesity has been long implicated in reduced reproductive potential and it has been shown to impair conception and implantation. However, the basis for this adverse effect is still obscure and there is a controversy whether the key organ influenced by it are the ovaries or the uterus.
It is well established that insulin resistance is one of the main mechanisms of obesity's negative influences on the reproductive organs in females. Insulin sensitizers ameliorate insulin resistance in obese patients.
This study seeks to determine if Metformin ,an oral antidiabetic and insulin sensitizer, helps to increase fecundability by affecting the uterus in women undergoing frozen-thawed embryo transfer compared to the control group. As a surrogate marker- flows in the uterus will be tested during the treatment.
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
- •Age: from 18-40 years old.
- •BMI > 30
- •Infertile women undergoing frozen-thawed embryo transfer in an ART setting
- •Women with at least one Top graded embryo
- •Normal uterine Doppler indices at time of recruitment.
排除标准
- •Diabetes mellitus - uncontrolled.
- •Hyperprolactinemia- uncontrolled.
- •Hypothyroidism- uncontrolled.
- •women who are already treated with Metformin
- •women with endometrial factor as the cause for infertility
研究组 & 干预措施
treatment
drug: metformin
干预措施: Metformin (Drug)
结局指标
主要结局
pregnancy rate
时间窗: until the blood test for pregnancy, about 4-6 weeks
次要结局
- The changes in Doppler blood flow indices in both uterine arteries(until the blood test for pregnancy, about 4-6 weeks)
- Endometrial Doppler flows measured by power doppler - percentage of endometrium with flows(until the blood test for pregnancy, about 4-6 weeks)
- endometrial thickness change measured by millimeters(until the blood test for pregnancy, about 4-6 weeks)
研究者
nora gorhad
DOCTOR
The Baruch Padeh Medical Center, Poriya