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临床试验/NCT06156722
NCT06156722进行中(未招募)不适用

The Combination of Sperm Selection by IMSI and Hyaluronic Acid Binding Assay Improves ICSI Outcomes: A Randomized Prospective Sibling-oocytes Study

Meir Medical Center1 个研究点 分布在 1 个国家目标入组 189 人开始时间: 2019年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
189
试验地点
1
主要终点
Pregnancy and delivery rates

研究概览

简要总结

In this prospective randomized sibling-oocytes blinded study, investigators examine the combination of two sperm selection methods that logically seem to complete each other, and potentially may improve ICSI outcomes.

The methods include the selection of the optimal spermatozoa based on its morphology by IMSI, together with its physiological function of binding to HA by Spermslow (SS).

The current study compared a group of ET after sperm selection by IMSI with SS to a group of ET after sperm selection by IMSI-only without SS, and to a mixed ET group where two embryos were transferred, one after IMSI-only and the other one after IMSI with SS.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 38 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • females ages 38 or younger retrieval of at least 5 mature oocytes and fresh ejaculate samples

排除标准

  • frozen embryos surgically extracted sperm preparations embryo-biopsy cycles

结局指标

主要结局

Pregnancy and delivery rates

时间窗: Within up to 10 month from treatment

Pregnancy and delivery rates

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

Yael Yagur

Consultant, Obstetrics and Gynaecology Department. Principal investigator. Lecturer.

Meir Medical Center

研究点 (1)

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