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临床试验/NCT07504575
NCT07504575招募中不适用

Effect of Platelet-rich Plasma (PRP) on the Quality of Donor Semen During Cryopreservation

Instituto Valenciano de Infertilidad, IVI Alicante1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年2月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
20
试验地点
1
主要终点
Progressive sperm motility after thawing

研究概览

简要总结

Sperm cryopreservation allows the preservation of sperm biological function for long periods of time for later use in assisted reproductive techniques (ART). However, the freezing and thawing process causes structural and functional damage to sperm, leading to decreased motility and vitality, a loss of plasma membrane integrity and even DNA damage.

In recent years, various strategies have been studied to protect sperm from cryodamage, including the optimization of freezing processes, the design of freezing devices, and improved freezing media.

One possible measure to mitigate the cryodamage suffered by sperm is the addition of PRP, or platelet-rich plasma, to the freezing medium. In previous studies, PRP components have been shown to have positive effects on semen quality, improving motility, viability, and plasma membrane integrity after cryopreservation. In light of these positive results, this study will evaluate the possibility of incorporating PRP into sperm cryopreservation media and its potential future benefits for patients and clinical outcomes. To this end, each semen sample after a previous spermiogram will be aliquoted, and 0%, 1%, 2%, and 5% PRP will be added to the cryopreservation medium according to the sperm group to which the belong. A spermiogram will be performed after cryopreservation to assess various semen quality parameters, including sperm count, motility, morphology, vitality, and chromatin dispersion. The data must be processed through statistical analysis to obtain results that allow determining, primarily, whether there is a beneficial effect on sperm quality after sperm motility and sperm during cryopreservation with the addition of PRP.

详细描述

The main objective of this study will be to detect whether there is a significant difference in progressive mobility between the control group and the cryopreserved samples with 5% autologous PRP.

The secondary objectives will be as follows:

Detect significant differences in progressive mobility between the control group and the cryopreserved samples with autologous PRP at concentrations of 1% or 2%; Determine if there are significant differences in the values of the semen quality parameters according to the categorical concentration of PRP used in cryopreservation.; Determine if there is a correlation between the numerical concentration of PRP and the semen quality parameters; Check if the platelet count, that is, the concentration of platelets present in the autologous plasma which has a higher concentration of platelets than the original sample, is correlated with the semen parameters analyzed post-thawing.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 35 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Age from 18 to 35 years
  • Concentration higher than 50 million progressively motile sperm.
  • Morphology: more than 4% normal sperm shapes.

排除标准

  • Presence of personal or hereditary pathology.
  • Presence of psychological or behavioral disorder.
  • Semen parameters below those indicated in the inclusion criteria.

研究组 & 干预措施

control

No PRP treatment

1%

1% PRP treatment

2%

2% PRP treatment

5%

5% PRP treatment

结局指标

主要结局

Progressive sperm motility after thawing

时间窗: Immediately after thawing of the semen samples.

Percentage of progressively motile spermatozoa in semen samples after cryopreservation, comparing control samples with samples cryopreserved with 5% autologous platelet-rich plasma (PRP).

次要结局

未报告次要终点

研究者

发起方
Instituto Valenciano de Infertilidad, IVI Alicante
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elena Sellés Soriano

Principal Investigator

Instituto Valenciano de Infertilidad, IVI Alicante

研究点 (1)

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