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临床试验/NCT05383599
NCT05383599招募中不适用

Characterization of Sperm Population Following Different Selection Procedures

Universitair Ziekenhuis Brussel1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2022年7月16日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
DNA Fragmentation Index

研究概览

简要总结

The present study aims to determine which of the sperm selection techniques used in IVF (In Vitro Fertilization) laboratory leads to selection of the best/healthiest sperm population based on their morpho-functional parameters. Different procedures are currently used in our laboratory to select the sperm population that will be used to inseminate the oocytes: Density Gradient Centrifugation (DGC), DGC in combination with Magnetic Activated Sperm Sorting (MACS), and Microfluidic Sperm Sorting (MSS). The sperm cells selected by these techniques will be evaluated for specific morpho-functional features such as, motility, morphological abnormalities, and apoptotic status [phosphatidylserine translocation (early stages of apoptosis)] and DNA (Deoxyribonucleic Acid) fragmentation as an indicator of stages of apoptosis.

详细描述

Different procedures are currently available to select the sperm population that will be used to inseminate the oocytes during Medical Assisted Reproduction (MAR). The selected population should contain fully functional spermatozoa that possess the ability to reach the fertilization site and allow optimal fertilization and embryo development. These abilities are strictly dependent on specific sperm morpho-functional features such as, but not limited to, motility, morphological abnormalities, apoptotic status [phosphatidylserine translocation (early stages of apoptosis)] and DNA fragmentation (later stages of apoptosis), The present study aims to determine which of the sperm selection techniques used in our IVF laboratory lead to selection of the best/healthy sperm population based on their morpho-functional parameters. For this purpose, unused raw semen after routine diagnostic analysis will be split in 3 fractions and will be processed immediately by different sperm preparation methods: 1) DGC, 2) DGC and MACS, and 3) MSS.

The sperm cells selected by each method will be analyzed for morphological and functional parameters.

Initial sperm concentration (×106/ml) will be assessed using a counting chamber.

Sperm motility will be evaluated on 200 spermatozoa under 40× magnifications and the results will be expressed as percentages.

After each selection procedure, concentration and motility will be determined with the use of a Neubauer counting chamber.

研究设计

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

入排标准

性别
Male
接受健康志愿者
否

入选标准

  • •semen volume ≥1.5ml
  • •sperm concentration >20 x 106 spermatozoa/ml
  • •≥30% progressive motility

排除标准

  • •semen samples processed for immediate or later use in Assisted Reproductive Medicine

结局指标

主要结局

DNA Fragmentation Index

时间窗: 1 year

percentage of sperm cells with DNA fragmentation out of selected sperm cells

Progressive Motility Index

时间窗: 1 year

percentage of sperm cells with progressive motility out of selected sperm cells

Early Apoptosis Index

时间窗: 1 year

percentage of early apoptotic sperm cells out of selected sperm cells

Concentration

时间窗: 1 year

number of sperm cells per ml of ejaculated semen sample

Normal Morphology Index

时间窗: 1 year

percentage of morphological normal sperm cells out of selected sperm cells

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

Ileana Mateizel

Principal Investigator

Universitair Ziekenhuis Brussel

研究点 (1)

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