Comparison of G-Series Media System With Antioxidants Versus Standard G-Series Media System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Vitrolife
- 入组人数
- 128
- 试验地点
- 4
- 主要终点
- Percentage of good quality blastocyst (GQB) per fertilized oocyte on day 5
研究概览
简要总结
Upon collection, human oocytes are fertilized and culture up to the blastocyst stage, followed by transfer and / or cryopreservation. Culture media systems have been developed that support each step of this process. Although these culture media systems try to mimic the natural environment, several components of the in-vivo situation are not present in today´s media. One such component is anti-oxidants that may protect embryos against damage by reactive oxygen species.
This investigation aims to compare blastocyst development using 2 different types of culture media systems, one of which contains antioxidants. Patients having at least eight oocytes and meeting other inclusion criteria can be included in this investigation.
It is a prospective randomized multicenter study randomly dividing oocytes into two groups and assessing parameters of embryo development from fertilization up to blastocyst formation until day six. Embryos with acceptable developmental characteristics can be transferred into the uterus or cryopreserved for later use.
The investigation is designed as a superiority study comparing utilization rate of blastocysts per normally fertilized oocyte using both media systems. In patients receiving embryo transfer in the fresh treatment cycle, detection of clinical pregnancy by ultrasound after 12 weeks gestation is the final endpoint of the investigation.
详细描述
Study objective:
Study comparing blastocyst development on the same cohort of oocytes using two different media systems, sequential G-Series media versus sequential G-Series media supplemented with antioxidants.
Primary endpoint:
Percentage of good quality blastocysts (GQB) per fertilized oocyte on day 5.
Secondary endpoints:
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)
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
- •Minimum eight cumulus-oocyte-complexes.
- •Couples with female, male or unexplained infertility intending to undergo IVF
- •The couple should have received verbal and written information/consent about the study.
- •Blastocyst culture and embryo transfer is decided.
- •If the couple fulfills the criteria above their consent to participate must be given and documented in the couple's medical journal.
排除标准
- •Previous participation in the study
- •Surgically retrieved sperm cells (TESA / TESE)
- •If split IVF is needed
- •Less than eight cumulus-oocyte-complexes
- •More than thirty cumulus-oocyte-complexes
研究组 & 干预措施
Control
Sequential culture media without addition of antioxidants
Treatment
Sequential culture media with the addition of antioxidants
干预措施: Antioxidants (Biological)
结局指标
主要结局
Percentage of good quality blastocyst (GQB) per fertilized oocyte on day 5
时间窗: 7 months
次要结局
- Embryo development on day 3, 5 & 6(7 months)
- Embryo quality on day 3, 5 & 6(7 months)
- Total blastocyst rate(7 months)
- Blastocyst utilization rate per fertilized oocyte(7 months)
- Biochemical pregnancy rate(8 months)
- Clinical pregnancy rate(9 months)
- Implantation rate(8 months)