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临床试验/NCT05356429
NCT05356429Unknown不适用

Study on the Effectiveness of Small Molecule LCDM Combined With Oocyte Activation in Improving GV Oocyte in Vitro Maturation

Peking University People's Hospital0 个研究点目标入组 250 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
250
主要终点
Change from the quality of MII oocytes between the two groups at 48 hours

研究概览

简要总结

Immature eggs obtained during the oocyte retrieval cycle are discarded as medical waste because they cannot complete fertilization, but each egg is important for people with poor clinical outcome. In vitro maturation (IVM) technique allows immature GV and MI eggs to mature in vitro, offering hope for this population to increase the clinical pregnancy rate in a single oocyte retrieval cycle. However, the clinical effectiveness of IVM clinical application is still very low, especially the utilization rate of GV eggs is extremely low. The cocktail of small molecules includes four chemical components of LCDM, which are related to cell proliferation, in vitro maturation of eggs, and protection of cells from oxidative stress. Our preliminary experiments confirmed that the addition of a certain concentration of LCDM in the culture medium can significantly improve the in vitro maturation rate and embryo utilization rate of immature GV eggs. In this study, LCDM immature oocyte culture system was used to carry out in vitro maturation culture of GV oocytes, and combined with oocyte activation technology to verify the clinical safety of LCDM in vitro culture system by observing the in vitro maturation rate, fertilization rate and embryo development results of GV oocytes, so as to provide laboratory data for clinical application of GV oocytes in special patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • ICSI cycle with more than 2 GV oocytes

排除标准

  • The etiological diagnosis is that the man has extremely severe oligoasthenospermia and primary azoospermia. These patients can lead to low fertilization rate due to sperm, so they are excluded from the group.

结局指标

主要结局

Change from the quality of MII oocytes between the two groups at 48 hours

时间窗: 48 hours

The two groups of mature MII eggs were compared, and the chromosome ploidy, spindle integrity and cortical particle distribution were observed respectively to determine the quality of MII eggs in the two groups. The evaluation methods include that the chromosomes of normal mature oocytes are aneuploid, the spindles are arranged orderly, and the cortical particles are distributed in the cortical area.

Number of GV oocyte maturation rate at 48 hours

时间窗: 48 hours

The GV oocyte maturation rate was defined as the number of MII oocytes which were come from GV oocyte during in vitro maturation. The more MII oocytes, the higher the in vitro maturation rate of the patient's oocytes.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Chen Xi

Associate Researcher

Peking University People's Hospital

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