Evaluation of the Impact of Monophasic vs. Sequential Media on the Reproductive Potential of Embryos Undergoing in Vitro Fertilization (IVF)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates
研究概览
简要总结
To evaluate the impact of two FDA approved culture media on potential of human embryos resulting from IVF (sequential & monophasic media). Half of each patient's embryos will be randomly assigned to grow in monophasic media & the other half in sequential media. All embryos will undergo Comprehensive Chromosome Screening (CCS) & the best euploid embryo from each group will be transferred resulting in a double embryo transfer (DET). If there are only euploid embryos from one group, patient will have single embryo transfer (SET)(fresh or frozen).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient undergoing IVF/CCS (no PGD banking)
- •Patient meets ASRM guidelines for Double Embryo Transfer (DET)
- •Donor Sperm OK
- •AMH ≥ 1.2
- •Max 1 prior failed IVF cycle for patients 35-45 years old
- •Patient <35 years old MUST have 1 prior failed IVF cycle
排除标准
- •Chronic endometrial insufficiency
- •Use of oocyte donor or gestational carriers
- •Medical contraindications to Double Embryo Transfer (DET)
- •Male Factor (<100,000 sperm or surgical sperm)
- •Communicating hydrosalpinx (on HSG)
- •Single gene disorders or sex selection
结局指标
主要结局
Impact of monophasic vs. sequential media on the embryos produced from IVF on pregnancy rates
时间窗: 2 years
To assess if pregnancy rates are impacted by the type of culture media embryos produced by IVF are cultured in
次要结局
未报告次要终点