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临床试验/NCT05583370
NCT05583370已完成不适用

The Effect of Aflatoxin Metabolites Concentration in Follicular Fluid on Laboratory and Clinical Outcomes in Intracytoplasmic Sperm Injection Cycles

Assiut University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年1月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
- Clinical pregnancy

研究概览

简要总结

Mycotoxins are secondary toxic metabolites produced by Aspergillus, Penicillium, and Fusarium species of fungi, when they infect and proliferate on various agricultural commodities either in the field and/or during storage. The well-known detrimental health effects of mycotoxins in humans include liver cancer, Balkan endemic nephropathy, child growth impairment, immune suppression, neural tube defects and death in acute exposure. However, growing evidence also suggests that mycotoxins may negatively influence human fertility.

详细描述

Aflatoxins (AFs) contaminate different types of food and feed commodities, especially in hot and humid regions of the world . The major AFs are characterized as B1, B2, G1 and G2, among these four, B1 is best known because of its hepatocarcinogenic nature ]. AFs M1 and M2 are produced by biological metabolism of AFB1 and AFB2 from contaminated feed used by animals and excreted in milk and dairy products.

Natural occurrence of mycotoxins is present in a large part of the world food supply and bear potential threat to food safety and food security . From global perspective of food safety and food security, mycotoxins contamination of foods has gained much attention as potential health hazards for humans and animals.

Studies using animal and cell models indicate that zearalenone, deoxynivalenol, ochratoxin A and aflatoxin B1 can adversely affect fertility, mainly through damage to sex organs, gametes and disruption of steroidogenesis. For instance, animal models have indicated that exposure to the aforementioned mycotoxins can promote adverse effects on spermatozoa, sertoli and Leydig cell function, oocyte maturation, and uterine and ovarian development and function, both in vivo and ex vivo. They may also induce oxidative stress resulting in sperm DNA damage and subsequently, reduced fertilisation rates and lower embryo quality. Furthermore, mycotoxins may act as endocrine disrupters, altering the steroid hormone homeostasis, consequently leading to subfertility or infertility. In humans, zearalenone has been linked to precocious puberty in girls, correlating with extremely high serum oestrogen levels whereas aflatoxin B1 has been linked to poor sperm quality in infertile males. Considering that multiple exposures to these mycotoxins have been reported in humans and that there is a homology in organ systems between animals and humans, these findings may have clinical relevance in human infertility.

研究设计

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

入排标准

年龄范围
18 Years 至 39 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

- Clinical pregnancy

时间窗: 4 weeks from embryo transfer

- Clinical pregnancy: the presence of gestational sac and fetal pole with visible pulsations after 4 weeks from embryo transfer.

次要结局

  • Biochemical pregnancy(2weeks from embryo transfer)
  • Oocyte quality(Immediately after ovum pick up)
  • Embryo quality(3-5 days after ovum pick up)
  • Fertilization rate(16-18 hours after insimination)

研究者

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

Romany Hany

Principal investigator

Assiut University

研究点 (1)

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