Low Versus High Volume of Culture Medium During Embryo Transfer: a Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 236
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
The aim of this study was to evaluate if higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.Patients who fulfilled the inclusion criteria and agreed to participate in the study, were randomized, on the day of the embryo transfer, into group A: low volume (20-25 μL) and group B: high volume (40-45 μL)
详细描述
The volume of culture medium used for embryo transfer is a variable that has been speculated to affect the IVF outcome. It is known that ultra high volume (>100 μl) of medium during embryo transfer may result in embryo expulsion out of the uterus or ectopic pregnancy. Similarly, some authors advocate that ultra low volume of transferring medium (<10 μl) may negatively affect pregnancy and implantation rates.
However small differences in the volume of the culture medium may favor the outcome of the embryo transfer. The aim of this study was to evaluate if the use higher volume (40-45μl VS 20-25 μl) of media used for embryo transfer affects the clinical outcomes in fresh IVF cycles.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age ≤ 45y.o.
- •BMI≤36 kg/m2,
- •Baseline FSH concentration <15 IU/l,
- •Ovarian stimulation with the same GnRH antagonist protocol
- •Normal uterine cavity with endometrium thickness >7mm and trilaminar morphology at the Time of transfer and semen
- •Parameters of >1 million /ml motile spermatozoa with >4% physiological morphology -
排除标准
- •Frozen -thaw cycles
- •Natural cycles or patients following different ovarian stimulation protocol were excluded from the study
结局指标
主要结局
Clinical pregnancy rate
时间窗: 25 days after embryo transfer
Number of clinical pregnancies expressed per 100 embryo transfer cycles
次要结局
- Implantation rate(25 days after embryo transfer)
- Ongoing pregnancy rate(20 weeks)
研究者
Georgios Sigalos
Embryologist Bsc, Msc
Aretaieion University Hospital