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临床试验/NCT03323892
NCT03323892已完成不适用

Effect of Abstinence Duration on Embryo Development: a Prospective Sibling Oocyte Study

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2017年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Embryo development (blastocyst stage)

研究概览

简要总结

The aim the investigators study is to analyze the embryo development if oocytes of the participants are injected with sperm from a longer or shorter (2 hours) abstinence duration.

详细描述

Participants undergoing an IVF treatment, are asked to respect an abstinence duration of 2-7 days. This is to obtain a sufficient number of motile sperm. A recent investigation, analyzed the quality (number and motility) of a sperm sample produced after an abstinence duration of 4 to 7 days, followed by a second sperm sample 2 hours later. The second sample (after 2 hours) was able to produce sperm cells with a higher motility. Not only has this short abstinence duration of 2 hours a positive effect on the motility, it will also reduce the sperm DNA damage, which again has a positive effect on embryo development. Because participants need gametes of high quality to obtain embryos with a high quality, the investigators want to investigate what the effect is of abstinence duration on embryo development.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients planned for embryo development up to day 5
  • •at least 6 mature oocytes
  • •fresh ejaculates
  • •fresh embryo transfer or freeze all strategy
  • •all stimulation protocols
  • •concentration of >1x10^6 /ml sperm

排除标准

  • •IVF versus ICSI patients
  • •chirurgical sperm
  • •acceptors of donor oocytes
  • •patients with PGD
  • •patients already enrolled in another study

研究组 & 干预措施

'normal' abstinence duration

Active Comparator

Patients follow the normal abstinence duration as asked by the physician (2-7 days). This sperm will be used to inject half of the oocytes Intervention = second sperm sample

干预措施: second masturbation (Other)

short abstinence duration

Experimental

Patients will be asked to produce a second sperm sample, 2 hours after the first. This sperm will be used to inject the other half of the oocytes.

Intervention = second sperm sample

干预措施: second masturbation (Other)

结局指标

主要结局

Embryo development (blastocyst stage)

时间窗: 1 year

embryo development 5/6 of the preimplantation development

Embryo development (cleavage stage)

时间窗: 1 year

embryo development on day 3 of the preimplantation development

次要结局

  • Clinical Pregnancies(1 year)
  • Utilization rate(1 year)
  • Sperm DNA fragmentation(1 year)
  • Sperm quality(1 year)
  • Fertilization(1 year)

研究者

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

Neelke De Munck

Clinical Embryologist

Universitair Ziekenhuis Brussel

研究点 (1)

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