Measurement of Midazolam Levels in Follicular Fluid and Correlation of Midazolam Levels in Follicular Fluid and Oocyte Quality, Fertilization Rate, Embryo Development Pattern and Euploid Status
试验速览
- 阶段
- 早期 1 期
- 状态
- 终止
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Midazolam values measured by the time from the injection of Midazolam to the oocyte aspiration .
研究概览
简要总结
To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.
The reason to measure Midazolam levels in larger size follicles in this study is to maximize the chances to get a mature oocyte and therefore develop into a potential embryo to be analyzed.
详细描述
The correlation of Midazolam levels in follicular fluid and euploid status of the embryos is worth exploring as no data exists that suggests any influence on the quality of the embryos from using this substance for IVF since its earliest days. Measuring time lapsed from injection to first oocyte retrieval as well as time lapsed in between first and last oocyte retrieved will grand insight into the rise of levels of Midazolam inside the follicular fluid, correlated with the chromosomal status and the morphokinetic development of the euploid embryos.
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 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Infertility (prim. / sec.)
- •Age >18 - ≤ 38 years.
- •BMI 19-30
- •Stimulation in GnRH-antagonist protocol, using rFSH
- •Expected normal ovarian response (6)
- •At least 4 follicles with the size ≥ than 17 mm on the day of OPU
- •Patients undergoing PGS
- •Able to understand the aim of the study and to provide consent
排除标准
- •History of endometriosis, classified according to the American Fertility Society (AFS) as stage 3 or more.
- •Severe male factor
研究组 & 干预措施
Study group Midazolam group
Sedation will be established by administering Midazolam 1mg, 100mcs of Fentanyl, and 0.5-1mg/kg of body weight of Propofol. Further boluses of Propofol will be given according to the need of the patient and time consumed for oocyte retrieval.
干预措施: Midazolam (Drug)
结局指标
主要结局
Midazolam values measured by the time from the injection of Midazolam to the oocyte aspiration .
时间窗: 6-12 months
To determine the impact of Midazolam levels in follicular fluid on morpho-kinetics and morpho-genetics.
次要结局
未报告次要终点
研究者
Prof Dr. Human Fatemi
Medical Director
ART Fertility Clinics LLC