A Randomised Controlled Trial Assessing the Effectiveness of EmbryoGlue® as an Embryo Transfer Medium in IVF Treatment Cycles
试验速览
- 阶段
- 不适用
- 入组人数
- 730
- 试验地点
- 1
- 主要终点
- Live Birth Rate
研究概览
简要总结
In Vitro Fertilisation (IVF) is an increasingly common treatment for infertility. Clinics which offer IVF are continuously trying to improve their success rates, measured by the numbers of IVF cycles which result in the birth of a live baby.
One factor which is thought to have contributed to the success of IVF is the improvements in the embryo culture media, that is, the fluid in which the embryo resides in the laboratory before being replaced into a woman's womb. This trial seeks to identify if IVF cycles in which a particular culture media called EmbryoGlue is used have better results when compared to IVF cycles in which a conventional embryo transfer media is used.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
In terms of blinding, the physician and/or nurses as well as the patients will be blinded and will not know what arm of the study the participant has been allocated too. The embryologists however will be unblinded (as they provide intervention and will have to be aware).
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Couples having embryo transfer for fertility treatment
排除标准
- •Cycles in which elective freezing of all embryos is clinically indicated (e.g. severe risk of OHSS, biopsy patients)
- •Use of donor gametes
- •Having endometrial scratch technique this cycle
- •Concurrent participation in clinical trial(s)
- •Previously randomised to this study
- •Planned self-fund of EmbryoGlue as transfer media
研究组 & 干预措施
EmbryoGlue® (laboratory culture medium)
laboratory culture medium
laboratory embryo culture medium, embryos are placed in this media prior to transfer into uterus via embryo transfer procedure to facilitate IVF. EmbryoGlue contains Hyaluronic acid.
干预措施: EmbryoGlue® (laboratory culture medium) (Biological)
Standard control medium
laboratory culture medium
In standard procedure embryos are placed in a media prior to transfer into uterus via embryo transfer procedure to facilitate IVF.
干预措施: Standard control medium (Biological)
结局指标
主要结局
Live Birth Rate
时间窗: outcome data up to 9 months after intervention
次要结局
- Implantation rate(outcome data up to 9 months after intervention)
- Clinical pregnancy rates,(outcome data up to 9 months after intervention)
- Adverse IVF events.(outcome data up to 9 months after intervention)