Evaluation Concerning the Influence of Myo-inositol Therapy on the Dynamics of Embryo Development in Patients Suffering From PCOS Undergoing ICSI Treatment
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 1
- 主要终点
- Oestradiol (E2) level in blood serum (pg/ml)
研究概览
简要总结
The purpose of this study is to analyse the activity of myo-inositol on pregnancy rate, embryo development dynamics and oestradiol and progesterone concentration in blood serum and Superoxide Dismutase (SOD) and catalase concentration in follicular fluid of patients with Polycystic Ovary Syndrome (PCOS) undergoing Intracytoplasmic Sperm Injection (ICSI).
研究设计
- 研究类型
- Interventional
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 27 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ICSI treatment due to infertility
- •PCOS patients enrolled according to the criteria established by representatives of the American Society of Reproductive Medicine (ASRM) and the European Society of Human Reproduction and Embryology (ESHRE)
排除标准
- •Severe endometriosis BMI <17 and >30 Metabolic diseases Lowered ovarian reserve
结局指标
主要结局
Oestradiol (E2) level in blood serum (pg/ml)
时间窗: Between 11th and 19th day of cycle, when the largest of the oocyte in the evaluation of ultrasound exceeded 17mm diameter,
Catalase activity level in follicular fluid (mIU/mg)
时间窗: On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle
The decision was taken when three conditions are met: the biggest oocyte exceeds 17mm, the endometrium was over 9mm (two layers) and estradiol level was greater than 150
Progesterone (ng/ml) level in blood serum
时间窗: Between 11th and 19th day of cycle, when the largest of the oocyte in the evaluation of ultrasound exceeded 17mm diameter
Superoxide dismutase (SOD) activity level in follicular fluid (mIU/mg)
时间窗: On puncture day or on collection day of oocytes, in practice, between 11th and 19th day of cycle
The decision was taken when three conditions are met: the biggest oocyte exceeds 17mm, the endometrium was over 9mm (two layers) and estradiol level was greater than 150
次要结局
- Period of blastocyst and embryo development(From the moment of puncture, between the 11th and 19th day of the cycle, for a maximum of seven days)
- Pregnancy rate(During the 7th week of pregnancy)
研究者
Artur Wdowiak
MD PhD
Medical University of Lublin