Kinetics in Time-lapse Culture of Human Preembryos
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 356
- 试验地点
- 1
- 主要终点
- Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)
研究概览
简要总结
This post-marketing, single-center prospective study will be conducted in an open-label, non-interventional setting, for women seeking fertility treatment and will describe cleavage dynamics in relation to the age of the oocyte and gonadotrophin treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 38 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •IVF/ICSI treatment
- •Regular cycles of 25-35 days
- •Follicle stimulation with Bravelle and/or Menopur
- •Women aged 38-35 years
- •Long agonist or short antagonist treatment
- •Willing and able to understand a Danish, English or German patient information form
- •Willing and able to provide written Informed Consent
排除标准
- •BMI more than 35
- •Presence of hydrosalpinx on ultrasound
- •FSH more than 13 or antral follicle count (AFC) less than 4 at fertility investigation
- •Known allergic reactions to the planned medications
- •Use of testicular sperm
结局指标
主要结局
Time to 2. polar body extrusion in transferred embryos (only Intracellular Sperm Injection)
时间窗: Week 1 after oocyte retrieval
Time for disappearance of pronuclei in transferred embryos
时间窗: Week 1 after oocyte retrieval
Time for first cleavage in transferred embryos
时间窗: Week 1 after oocyte retrieval
Time for cleavage to 3-cell embryo and 4-cell embryo in transferred embryos
时间窗: Week 1 after oocyte retrieval
Scoring of blastomere even-size, fragmentation and multinucleation at 4-cell stage
时间窗: Week 1 after oocyte retrieval
次要结局
- Live birth rate(9 months)
- Number of fertilized and cleaved oocytes(1 month)
- Implantation rate(2 months)
- Number of preembryos with top quality(1 month)
- Ongoing pregnancy rate week 7(3 months)
- Number of oocytes retrieved(1 month)
- Total dose of gonadotrophin used(1 month)
- Gonadotrophin dose per oocyte retrieved(1 month)