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临床试验/NCT03760783
NCT03760783已完成不适用

The Effects of Microgravity on Human Sperm

Institut Universitari Dexeus2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年11月20日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
2
主要终点
Change in Sperm motility

研究概览

简要总结

It has been described that microgravity affects cellular and molecular structures. Cell membrane, cytoskeleton, cytoplasm and nucleus have been found to be sensible to gravitational changes. Alterations in the male and female reproductive systems have also been reported in mouse and other animals. The effects of microgravity on human reproductive cells remain unknown.

The main objective of this experimental study is to investigate the effect of simulated microgravity in human male reproductive cells under in vitro conditions. Induced microgravity conditions will be obtained with a smaller single-engine aerobatic aircraft that can provide parabolic flights.

The main parameters to be analyzed are: sperm motility, vitality, DNA fragmentation and apoptosis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Healthy volunteers (men)
  • Who accepted to take part in the study
  • Who gave their written informed consent

排除标准

  • 未提供

结局指标

主要结局

Change in Sperm motility

时间窗: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)

The percentage of normal spermatozoa in terms of motility grades a,b,c according to WHO

Change Sperm Morphology

时间窗: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)

The percentage of normal spermatozoa in terms of morphology is assessed by staining. The lower reference limit for normal forms is 4% (WHO 2010).

Change Sperm Vitality

时间窗: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)

The percentage of live spermatozoa is assessed by identifying those with an intact cell membrane, from dye exclusion. The lower reference limit for vitality (membrane-intact spermatozoa) is 58% (WHO 2010).

Change Sperm APOPTOSIS (Annexin V )

时间窗: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)

Annexin V recognizes an antigen (externalized phosphatidylserine, EPS) in the plasma membrane of apoptotic cells. Apoptotic cell depletion begins with the magnetic labeling of apoptotic cells by the MACS® ART Annexin V Reagent. The labeled cells are then passed through a separation column located in a fixed magnetic field. Unwanted cells are selectively retained in the column. Living spermatozoa are not labeled by the reagent, so they pass through the column and are collected for later use. In our study, after collecting living spermatozoa we also collected the retained apoptotic spermatozoa for comparing the concentration (M/ml) of apoptotic vs no apoptotic cells.

Change in Sperm DNA Fragmentation

时间窗: In earth gravity g=1(<4 hours before Parabolic flight) and after simulated microgravity exposure (<4 hours Post Parabolic Flight)

Sperm DNA fragmentation is evaluated by Halosperm® kit, based on the SCD technique, patented by Halotech. This kit is based on a controlled DNA denaturation process to facilitate the subsequent removal of the proteins contained in each spermatozoon. In this way, normal spermatozoa create halos formed by loops of DNA at the head of the sperm, which are not present in those with damaged DNA. Thresholds for frequency of Sperm DNA Fragmentation (SDF) have been suggested by Dr. Evenson et al. (Evenson and Nixon, Reprod Biomed Online 12:466-472, 2006). The authors reported that couples with no known infertility problems were more likely to achieve a pregnancy/delivery if the DNA fragmentation index (DFI) was \<30%.

次要结局

未报告次要终点

研究者

发起方
Institut Universitari Dexeus
申办方类型
Other
责任方
Principal Investigator
主要研究者

Montserrat Boada

Director of Reproductive Laboratory

Institut Universitari Dexeus

研究点 (2)

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