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临床试验/NCT04053309
NCT04053309终止不适用

Implementation of a Round Spermatid Injection Protocol in a Clinical Infertility Practice

Reproductive Medicine Associates of New Jersey1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2019年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
3
试验地点
1
主要终点
Euploid blastulation rate

研究概览

简要总结

To evaluate embryology outcomes after application of a technique known as round spermatid injection (ROSI) into donor oocytes in a high-volume clinical infertility practice.

详细描述

The objective of this study is to assess embryology outcomes after implementation of a laboratory protocol known as ROSI at a high-volume clinical infertility practice. All samples from enrolled male patients with azoospermia who proceed with surgical sperm extraction (TESE or microTESE) will be evaluated for the presence of round spermatids. These round spermatids will be used as research samples as opposed to being discarded.

The investigators aim to identify whether the injection of round spermatids into donor oocytes can lead to successful fertilization, progression to the blastocyst stage, and euploid status. Performance of ROSI using donor oocytes not intended for implantation will allow the investigators to gain valuable insight regarding fertilization and development without any direct risk to patients or future offspring. These embryos are being generated for research purposes only and will ultimately be destroyed after the study has concluded. The investigators will measure rates of isolation of round spermatids from surgical samples, fertilization rates using donor oocytes, rates of progression to the blastocyst stage, and rates of aneuploidy using the previously described technique of ROSI.

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
Male
接受健康志愿者

入选标准

  • The following are major inclusion criteria:
  • A diagnosis of azoospermia after semen analysis.
  • Indication to proceed with testicular sperm extraction (TESE or microTESE) based on a urologic evaluation.
  • Presence of round spermatids from testicular sperm extraction (TESE or microTESE), irrespective of the presence or absence of mature spermatozoa.
  • Major Exclusion Criteria (must not meet any): The following are exclusion criteria:
  • Under 18 years old
  • All patients who do not voluntarily give their written consent for participation.
  • Men who do not wish to use their gametes (round spermatids) for fertilization of donor oocytes for research purposes.

排除标准

  • 未提供

结局指标

主要结局

Euploid blastulation rate

时间窗: 1-2 weeks

number of fertilized eggs progressing to the blastocyst stage of development which are euploid

次要结局

  • Fertilization Rate(1 day post intracytoplasmic sperm injection procedure)
  • Prevalence of round spermatids in surgical sperm samples(immediately after the TESE or microTESE)
  • Overall blastulation rate(1 week)
  • Aneuploidy rate(2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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