Effect of Hyaluronan-enriched Medium on the Cumulative Ongoing Pregnancy Rate: a Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- number of transfers needed to reach ongoing pregnancy
研究概览
简要总结
Assessing whether the use of hyaluronan-enriched transfer medium can increase the cumulative ongoing pregnancy rate
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
- Double (Participant, Care Provider)
盲法说明
double blind
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Patients with own oocytes/embryos;
- •Patients with female age at 1st OR in the study <40 year;
- •Patients planned for a 2nd oocyte retrieval, with no clinical ongoing pregnancy after the previous oocyte retrieval
- •Patients planned for a 3rd oocyte retrieval with no clinical ongoing pregnancy after previous oocyte retrievals
- •Patients with female age at 1st OR in the study <40 year;
- •Patients with BMI ≤32;
- •Patients with written informed consent;
排除标准
- 未提供
研究组 & 干预措施
study group
Patients receiving an embryo transfer in hyaluronan-enriched transfer medium
干预措施: use of hyaluronan-enriched transfer medium (Other)
control group
Patients receiving an embryo transfer in conventional culture medium
结局指标
主要结局
number of transfers needed to reach ongoing pregnancy
时间窗: ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy
The primary outcome parameter is the number of transfers needed to reach ongoing pregnancy (ongoing defined as a pregancy with a viable fetus with FHB at 12 weeks of pregnancy), as a time-to-event outcome variable. Patients that do not reach pregnancy, are censored at their last transfer.
次要结局
- number of transfers needed to reach clinical pregnancy, life birth, miscarriage, multiple pregnancy(until Live birth: 9 months after ET)