Treatment of Abnormally Multinucleated Zygotes Before Before Division Starting.
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Normal Embryos Developed
研究概览
简要总结
In this newly developed protocol, and idea, is to manage those abnormally developed zygotes from different ART procedures.
The investigators developed the plan and requirements needed to select the target extra nucleus or pronuclei to be extruded from fertilized egg in order to maintain developing healthy normal embryo.
详细描述
As approved by Dyban and Baranov et al, about 15-18% of abortions caused by triploidy fertilization. One of sources for maternally triploidy is failure in the first meiotic division (Jacobs et al., 1978).
One of Digynic triploidy is developed by fertilized giant oocyte (Dyban and Baranov, 1987) {nuclear but no cytoplasmic division in an oogonium or cytoplasmic fusion of two oogonia (Austin, 1960)}.
Giant oocyte characterized with bigger diameter and will distinguished polar bodies at metaphase II.
B. Rosenbusch et. al. 2002, cytogenetic study showed that extra haploid maternal copy associated with MII (46,XX/ 2N ) giant oocytes as well as triploidy with fertilized giant oocytes (3N with 69,XXX or 69,XXY).
First Mitotic division plane with polar axes studies by Scott, 2001 , shows that Pn developed closer to 2nd polar body is the maternal origin PN.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Giant oocytes
- •3 PNs developed embryos at day 1 post ICSI.
排除标准
- •Patient refused to involving their abnormal oocytes at our study.
研究组 & 干预措施
Giant Oocytes after ICSI
abnormally produced oocyte after ART or Controlled ovarian stimulation. Correction of abnormally fertilized oocytes using nucleus removal.
干预措施: Correction of abnormally fertilized oocytes (Procedure)
3PNs zygotes developed after ICSI
Abnormally developed embryos these produced 3PNs. Correction of abnormally fertilized oocytes using nucleus removal.
干预措施: Correction of abnormally fertilized oocytes (Procedure)
结局指标
主要结局
Normal Embryos Developed
时间窗: Day 1 or 18 hours post ICSI nucleus removal
At 18 hours after ICSi nucleus to be removed in-order to make genetic correction for abnormally developed embryos. Final result is normal embryos produced with 2PNs evaluated by FSIH study for 5 chromosomes. This indicated the genetic correction process was successful process, and applicable to produce normal growing embryos.
次要结局
- Day 3 embryo available for blastomer biopsy(1 Year)
- 5 chromosomes FISH study(1 Year)
研究者
Ahmad Mustafa Mohamed Metwalley
IVF unit director
Al Baraka Fertility Hospital