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临床试验/NCT04286633
NCT04286633Unknown不适用

The Influence of Lead and Cadmium Seminal Plasma Level on Intracytoplasmic Sperm Injection (ICSI) Outcome

Assiut University0 个研究点目标入组 50 人开始时间: 2022年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
主要终点
The influence of lead and cadmium seminal plasma level on intracytoplasmic sperm injection (ICSI) outcome

研究概览

简要总结

To evaluate the influence of lead (pb) and cadmium (cd) seminal plasma level on embryo development and pregnancy rate during intracytoplasmic sperm injection (ICSI).

详细描述

The inability to have children, both by natural procreation and medically assisted reproduction, is not only a challenge for medical science but also an economic and social problem. Infertility is a complex disorder with multiple genetic and environmental causes (Gill et al.,2018) One of the factors that may be responsible for this phenomenon is contamination of the environment with heavy metals Two of the most widely-recognized reproductive toxins are lead (Pb) and cadmium (Cd) (Wdowiak et al., 2018).

Food, water and tobacco and smoking are the primary source of baseline exposure to lead and cadmium (Tong et al., 2000; Bernard, 2008) Each of cadmium and lead were inversely correlated with semen parameters as, ejaculate volume, sperm count, sperm concentration, live sperms and rapid mobility. ( Zaki et al.,2018).

Reproductive contaminants found in follicular fluid (FF) and seminal plasma may compromise the quality of oocytes and or sperm, which may become one of the risk factors for reproductive outcome. The data available suggests certain chemicals or their metabolite reaches the seminal plasma and/or FF, indicating their possible impact in In Vitro fertilization (IVF) outcome ,However, more studies are needed with regard to relationship between exposure level and affected parameters. (Kumar et al., 2010).

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 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Isolated male infertility (oligozoospermia, astenozoospermia, teratozoospermia)
  • First ICSI cycle
  • Female partner ≤ 35 y-old

排除标准

  • • Wife age > 35 years
  • Frozen semen samples
  • Male partner with severe oligoasthenoteratozoospermia <5 × 106 / mL and 5% progressive motility, included globozoospermia and pinhead samples, and surgically retrieved sperms
  • Poor responder women
  • Women with abnormal endometrium at hCG trigger day.
  • Women with BMI > 31
  • Women with PCOS
  • Previous failed ICSI
  • OHSS)overian hyperstimulation syndrome)
  • Patients with systemic diseases affecting fertility
  • Patients on radiotherapy or receiving medications with gonadotoxic effect eg., chemotherapy

结局指标

主要结局

The influence of lead and cadmium seminal plasma level on intracytoplasmic sperm injection (ICSI) outcome

时间窗: baseline

evaluate the influence of lead (pb) and cadmium (cd) seminal plasma level on embryo development and pregnancy rate during intracytoplasmic sperm injection (ICSI).

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

Shaimaa Mostafa Atef Abdul-Rahman

Doctor

Assiut University

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