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临床试验/NCT04962100
NCT04962100已完成不适用

Capacitation-associated Protein Tyrosine Phosphorylation As a Possible Biomarker of Sperm Selection in Sperm from Patients and Donors

IVI Sevilla2 个研究点 分布在 1 个国家目标入组 335 人开始时间: 2021年6月29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
335
试验地点
2
主要终点
To determine the state of sperm capacitation by assessing the phosphorylation of tyrosine residues

研究概览

简要总结

Sperm undergo complex selection processes and physiological changes as they move through the female reproductive tract. Ejaculated-sperm must undergo a set of molecular and biochemical changes globally named as capacitation in order to acquire the ability to fertilize the oocyte. These changes include post-translational modifications of sperm proteins, with phosphorylation of tyrosine residues being one of the most outstanding characteristics of the capacitation process. In the laboratory, the capacitation process is recreated artificially before performing artificial insemination or in vitro fertilization treatments. The sample is then incubated until it is used in the treatment. Reproductive success rates can be affected by differences in incubation times and levels of capacitation of the sample. In this study, the investigators intend to study the capacitation state of the sample by measuring the levels of phosphorylation of the tyrosine residues of the proteins contained in the sperm that have already been subjected to the capacitation process in vitro.

详细描述

The human male deposits millions of sperm cells in the woman's vagina at the time of ejaculation. However, only a few sperm cells are able to reach the fallopian tubes. In fact, only between 100-1000 sperm will reach the cumulus-oocyte complex and only one will be able to fertilize the oocyte.

The sperm cells from the ejaculate of all mammals are unable to fertilize the oocyte. In order to acquire the fertilization competence, sperm must undergo a process called capacitation. Capacitation has been defined as a complex phenomenon that involves biochemical and physiological changes in the sperm.

These changes are such as:

  • Loss of proteins or replacement by others of lower molecular weight
  • Transformation of phospholipids, decreased cholesterol/phospholipid ratio
  • Changes in the carbohydrate fraction of glycoproteins
  • Lipid and protein mobility

Not all the events involved in the complex capacitation process are known.

研究设计

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

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

  • To have signed the written informed consent before starting any procedure related to the study.
  • Sexual abstinence (2 to 5 days).
  • To be a male patient who delivers a fresh seminal sample for diagnosis or artificial insemination treatment.
  • To be a male donor who delivers a fresh seminal sample for donation or for previous tests to include him in the donation programme.
  • To be a female patient undergoing artificial insemination.

排除标准

  • Use of sperm of testicular or epididymal origin.
  • Cryptozoospermia or oligozoospermia with sperm concentration <1 mill/ml.
  • Ejaculates obtained with more than 5 days of sexual abstinence.
  • Frozen semen samples for artificial insemination cycles with partner's semen.
  • Female patients who present uterine malformations that compromise the viability of the pregnancy (intramural or submucosal fibroids > 3 cm, polyps, adenomyosis or congenital or acquired malformations). Female patients with hydrosalpinx.
  • Patients who have suffered two or more previous abortions (repeated abortions).
  • Patients with a body mass index greater than 30 Kg / m2.

结局指标

主要结局

To determine the state of sperm capacitation by assessing the phosphorylation of tyrosine residues

时间窗: 1 day

Flow cytometry analysis will be carried out to evaluate the levels of phosphorylation of tyrosine residues in sperm proteins of seminal samples capacitated in vitro in order to determine their capacitation statuscytometry of seminal samples capacitated in vitro in order to determine their capacitation status

次要结局

未报告次要终点

研究者

发起方
IVI Sevilla
申办方类型
Other
责任方
Sponsor

研究点 (2)

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