Prospective Randomized Study to Evaluate the Effect of Embryonic Observation on the Live Birth Rate (LBR)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 193
- 试验地点
- 2
- 主要终点
- Live Birth Rate
研究概览
简要总结
In a conventional in vitro fertilization (IVF) cycle, daily microscopic observation of embryos outside the incubator to assess their morphology and establish a selection process is performed. In this way it is possible to know which embryo or embryos have greater implantantion capacity and will be transferred to the uterus to obtain a viable pregnancy. However, these observations can produce deleterious effects on embryo development due to changes in temperature, pH and osmolarity of the culture media, as well as a negative effect of direct light microscope for observation. This project aims to test the hypothesis that non-embryonic observation produces a beneficial effect on embryo quality until day 5 of development (blastocyst stage) and, therefore, on rates of implantation and ongoing gestation, compared with the conventional protocol of observations under the inverted microscope on days two, three and five of development.
详细描述
The present study is a prospective double-blind randomised controlled trial (RCT) approved by a local Ethics Committe. Summarily, in the control group we did three embryo observations outside the incubator as we usually do in our conventional protocol: day 2, day 3 and day 5, just before ET; in the study group we performed a unique embryo observation on day 5 before ET. All the subjects that participated in the study were informed and gave us their consent to take part on it.
The inclusion criteria of the study were: first cycle of ART treatment with conventional IVF or ICSI with donated eggs, normal uterine cavity and a single or double embryo transfer, always performed on day 5 at blastocyst stage.
The exclusion criteria were the following: patients above 50 years old, patients that were diagnosed with recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL) or uterine pathologies, body mass index >30 kg/m2, the use of seminal samples coming from donors or testicular origin and cycles that included preimplantational genetic testing (PGT).
LBR was the main outcome of our study, defined as the number of deliveries that resulted in a live born neonate, expressed per 100 embryo transfers (Zegers- Hochschild et al., 2009). Secondary efficacy endpoints were positive hCG rate (>5 mUI/mL, assessed in serum 14 days after oocyte retrieval), implantation rate (number of gestational sacs observed divided by the number of embryos transferred, expressed as a percentage, %), ongoing pregnancy rate, defined as a pregnancy with a detectable heart rate at 12 weeks of gestation or beyond and miscarriage (loss of a pregnancy after 12 weeks of gestation).
In addition, we assessed the next IVF laboratory parameters: fertilization rate, blastocyst formation rate on day 5, blastocyst quality, number of transferred embryos and number of usable blastocysts (number of blastocysts transferred and frozen).
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •First cycle of ART treatment with conventional IVF or ICSI with donated eggs.
- •Normal uterine cavity and a single or double embryo transfer, always performed on day 5 at blastocyst stage.
排除标准
- •Patients above 50 years old, patients that were diagnosed with recurrent implantation failure (RIF) and/or recurrent pregnancy loss (RPL) or uterine pathologies,
- •Body mass index >30 kg/m
- •The use of seminal samples coming from donors or testicular origin.
- •Cycles that included preimplantational genetic testing (PGT).
结局指标
主要结局
Live Birth Rate
时间窗: Nine months after treatment.
The number of deliveries that resulted in a live born neonate, expressed per 100 embryos
次要结局
- Miscarriage rate(From 12 weeks after gestation to delivery)
- Blastocyst quality(5 days after microinjection or insemination.)
- Implantation rate(6-7 weeks after oocyte retrieval.)
- Positive hCG rate(14 days after oocyte retrieval.)
- Number of usable blastocysts(5 days after microinjection or insemination.)
- Ongoing pregnancy rate(12 weeks after B-hCG positive test)
- Blastocyst formation rate on day 5(5 days after microinjection or insemination.)
- Fertilization rate(16-18 hours after microinjection or insemination)
研究者
Jorge Ten Morro
Ph.D. Embryologist
Instituto Bernabeu