Impact of Repeated Antioxidant Supplementation of Embryo Culture Media on Blastocyst Utilization and Expansion Rate Under Two Different O2 Concentrations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 293
- 试验地点
- 1
- 主要终点
- Rate of usable blastocysts on day 5
研究概览
简要总结
The goal of this clinical trial is to investigate the impact of repeated antioxidant supplementation on blastocyst utilization and expansion rates in embryos under different oxygen concentrations. The study aims to answer the following main questions:
- Does adding antioxidants every 12 hours to embryo culture media improve usable and expanded blastocyst utilization rates on days 5 and 6?
- How are the O2 concentrations related to the effect of different methods of antioxidants supplementation on blastocysts utilization and expansion rates?
Participants in this study are infertile couples undergoing in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycles.
- Zygotes will be incubated at either 5% or 20% oxygen tension until the blastocyst stage.
- Sibling zygotes will be divided into four groups: Group 1A and 1B: Antioxidants every 12 hours at either 5% or 20% O2 tension, respectively. Group 2A and 2B: Antioxidants only once at the beginning of embryo culture at either 5% or 20% O2 tension, respectively.
Researchers will compare the four groups to determine if the repeated antioxidant supplementation of the culture media leads to improved blastocyst utilization and expansion rates compared to the baseline group.
详细描述
This study is focused on the role of antioxidants (AOXs) in mitigating reactive oxygen species and oxidative stress, which have been associated with failure in in vitro fertilization (IVF) and intracytoplasmic sperm injection (ICSI). The research aimed to evaluate the effect of two different methods of antioxidants supplementation at two O2 tensions on blastocyst utilization and expansion rates. To achieve this, 3603 zygotes from infertile couples undergoing IVF or ICSI were included in the study. The zygotes were divided into two groups: Group 1A and 1B: Antioxidants every 12 hours at either 5% or 20% O2 tension, respectively. Group 2A and 2B: Antioxidants only once at the beginning of embryo culture at either 5% or 20% O2 tension, respectively.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 37 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women with from 18 to 37 years old at the moment of oocyte collection, tubal factor, polycystic ovary syndrome, uterine factor, or unexplained infertility.
- •More than 2 oocytes by conventional in vitro fertilization (cIVF) and intracytoplasmic sperm injection (ICSI).
排除标准
- •Infertile woman in assisted reproduction treatment with less than 2 oocytes collected.
- •Infertile woman in assisted reproduction treatment with less than 2 oocytes fertilized by conventional in vitro fertilization (cIVF) and intracytoplasmic sperm injection (ICSI)
研究组 & 干预措施
EmrbyORP continued at high O2
Antioxidants supplementation Every 12 hours (3.5 μL)
干预措施: EmbryORP® (Drug)
EmrbyORP continued at high O2
Antioxidants supplementation Every 12 hours (3.5 μL)
干预措施: O2 tension 20% (Device)
EmrbyORP at baseline with high O2
Antioxidants supplementation At baseline only (6.5 μL)
干预措施: EmbryORP® (Drug)
EmrbyORP at baseline with high O2
Antioxidants supplementation At baseline only (6.5 μL)
干预措施: O2 tension 20% (Device)
EmrbyORP continued at low 02
Antioxidants supplementation Every 12 hours (3.5 μL)
干预措施: EmbryORP® (Drug)
EmrbyORP continued at low 02
Antioxidants supplementation Every 12 hours (3.5 μL)
干预措施: O2 tension 5% (Device)
EmrbyORP at baseline with low o2
Antioxidants supplementation At baseline only (6.5 μL)
干预措施: EmbryORP® (Drug)
EmrbyORP at baseline with low o2
Antioxidants supplementation At baseline only (6.5 μL)
干预措施: O2 tension 5% (Device)
结局指标
主要结局
Rate of usable blastocysts on day 5
时间窗: 5 days
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 5
Rate of expanded blastocysts on day 6
时间窗: 6 days
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 6
Rate of expanded blastocysts on day 5
时间窗: 5 days
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at day 5
Rate of sable blastocysts on day 6
时间窗: 6 days
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at day 6
Rate of acumulative usable blastocysts
时间窗: 5 - 6 days
Usable blastocysts were defined as vitrified, transferred, and/or biopsied blastocysts at days 5 and 6
Rate of acumulative expanded blastocysts.
时间窗: 5 - 6 days
Expanded blastocysts were defined as usable blastocysts with a 4 to 6 expansion grade at days 5 and 6
次要结局
未报告次要终点
研究者
Liliana Berenice Ramírez Domínguez
Scientific Coordinator
Center of Innovation Technology & Reproductive Medicine