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临床试验/NCT03810001
NCT03810001Unknown不适用

Use of Mechanical Stimulation to Active Oocytes Can Improve the Fertilization in Intracytoplasmic Sperm Injection Cycle

Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2018年11月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
500
试验地点
1
主要终点
Normal fertilization rate

研究概览

简要总结

Most fertilization failures after ICSI are caused by failure of oocyte activation defects. But, to date, there is no effective method to overcome this obstacle. To investigate the effect of mechanical stimulation on fertilization failures, investigators plan to recruit women undergoing ICSI treatment cycles. The retrieved sibling oocytes from the patients were randomly divided into two groups. The control group conducted the standard ICSI procedure, while the experimental group conducted the modified ICSI procedure.Consequently, the fertilization rate, 2PN (two pronuclei) rate, 1PN rate, oocyte degradation rate,and exploitable embryos on D3 were recorded to evaluate ICSI cycle outcomes.

详细描述

Normal fertilization is the critical for the success of ICSI. To investigate the effect of mechanical stimulation on fertilization, investigators plan to recruit women undergoing ICSI treatment cycles. Exclusion criteria: Patients older than 40 years, the maturation oocytes less than 6. The retrieved sibling oocytes from the patient were randomly divided into two groups. The control group conducted the standard ICSI procedure, while the experimental group conducted the modified ICSI procedure. The modified ICSI procedure involved a micromanipulation mechanical stimulation between insertion of the microinjection needle into the oocyte and expulsion of the spermatozoon from the needle to the ooplasm, without additional reagents treatment. Consequently, the fertilization rate, 2PN rate, 1PN rate, oocyte degradation rate, and exploitable embryos on D3 were recorded. The investigators aim to evaluate whether the mechanical stimulation can be used to improve the normal fertilization and embryo quality in ICSI cycles.

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
Single (Participant)

入排标准

年龄范围
22 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • oocytes number ≥ 8;
  • women undergoing intracytoplasmic sperm injection cycle.

排除标准

  • maturation oocytes number less than 6.

研究组 & 干预措施

standard ICSI procedure

No Intervention

a single spermatozoon was injected into the ooplasm

modified ICSI procedure

Experimental

slight mechanical stimulation before standard ICSI procedure

干预措施: Mechanical Stimulation (Behavioral)

结局指标

主要结局

Normal fertilization rate

时间窗: 6 months

2PN (two pronuclei and two polar bodies) rate

次要结局

  • Feasibility and Efficacy of Mechanical Stimulation(6 months)

研究者

发起方
Tang-Du Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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