Cumulus Cell Mitochondrial Activity as a Non-invasive Marker of Embryo Quality
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Live birth rate after one frozen embryo transfer cycle
研究概览
简要总结
This study aims to test the extent of association of FLIM parameters of cumulus cells with clinical outcomes (clinical pregnancy, ongoing pregnancy at 12 weeks, and live birth) of the embryos that result from the enclosed oocytes.
详细描述
This study aims to test the extent of association of FLIM parameters of cumulus cells with clinical outcomes (clinical pregnancy, ongoing pregnancy at 12 weeks, and live birth) of the embryos that result from the enclosed oocytes.
Participants will be consented to and pre-signed following standard regimens of IVFMD, My Duc Hospital and IVFMD PN, My Duc Phu Nhuan Hospital. The standard is for patients with at least 8 follicles ≥ 10 mm on ultrasonography at the induced ovulation date.
Cumulus samples (CCs) will be collected following the protocol on the day of oocyte pick up (OPU), being assigned with the same number as the oocyte from which it was collected, and vitrified with a Cryotech kit until FLIM measurements are performed.
Insemination will be performed by using ICSI, 3 - 4 hours after oocyte retrieval. A sample of CCs will be sliced off the cumulus mass of each oocyte judged to be mature based on the cumulus mass disposition (absence of tight corona layers). The remaining cumulus cells will be stripped from the OCCs using hyaluronidase. Only mature oocytes will be inseminated.
The fertilization check will be performed under an inverted microscope for a period of 16-18 hours after insemination. On day 3, embryo evaluation will be performed at a fixed time point 66±2 hours after fertilization and, for day 5/6 transfers at 116±2 hours or 140±2 hours, respectively, using the Istanbul consensus. Freeze-all strategy for day 5 embryo will be applied and the first frozen embryo transfer cycle is single embryo transfer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Having any number of IVF/ICSI attempts
- •Ovarian stimulation with any stimulation protocol
- •Patients with at least 8 follicles ≥ 10 mm on ultrasonography at induced ovulation date
- •Agreed to freeze-all day 5-6 embryos
- •Agreed to have a single day 5-6 embryo transfer.
- •Agreed to participate in the research (signed the consent form)
排除标准
- •In vitro maturation (IVM) cycles
- •Cycles using testicular biopsy or epididymal sperm
- •Cycles not having an oocyte freeze-all cycle
- •Cycles using standard insemination
- •Participating in another research
研究组 & 干预措施
Infertile women have IVF/ICSI cycle
All Vietnamese infertile women who have IVF/ICSI cycle with at least 8 follicles ≥ 10 mm on ultrasonography at induced ovulation date agreed to freeze-all day 5-6 embryos at IVFMD and IVFMD PN will be enrolled in the study.
干预措施: FLIM parameters (Genetic)
结局指标
主要结局
Live birth rate after one frozen embryo transfer cycle
时间窗: After 24 week's gestation
The birth of at least one newborn, after 24 week's gestation that exhibits any sign of life, such as respiration, heartbeat, umbilical pulsation, or movement of voluntary muscles
次要结局
- Ongoing pregnancy(At 10 weeks after embryo placement)
- Positive pregnancy test(At 2 weeks after embryo placement)
- Implantation rate(3 weeks after the first transfer)
- Clinical pregnancy(7 week's gestation)