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临床试验/NCT04758260
NCT04758260撤回不适用

Influence of the Antioxidant Treatment in the Oxidant-reduction Potential in Seminal Plasma in Men Whose Partners Will Undergo Through an Egg Donation Cycle

IVI Bilbao2 个研究点 分布在 1 个国家开始时间: 2019年2月12日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Compare the sORP rate in sperm samples,

研究概览

简要总结

Evaluate the influence of antioxidant men supplements treatment (Fertybiotic Hombre) in the rate of sORP (stactic Oxidation Reduction Potential) defined as the balanced measure between the total oxidant activity (ROS, superoxides, nitric oxide, peroxide) and total reducing activity (alpha tocopherol, β carotene, uric acid) in sperm samples during egg donation cycles.

We will also evaluate the influence of the sORP rate in the embryo development during the egg donation treatments; taking in account the fecundation rate, percentage of blastocyst stage arrival embryos, number of frozen embryos, implantation rate, on-going pregnancy rate and miscarriage rate.

The sperm sample will be measured by electrochemical technology using Mioxsys system for a quantitative measurement in millivolts (mV), in those male patients who participate in an egg donation assisted reproduction treatment.

After 14 days, the pregnancy stage will be available. This information will be obtained from the patient's clinical history using the human chorionic gonadotropin hormone (shCG) in blood. It will be performed either in our Clinic or externally within the usual practice derived from the treatment carried out. These values will be compared with the results obtained from sORP.

研究设计

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

入排标准

年龄范围
18 Years 至 48 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Male Inclusion Criteria
  • Sperm count greater than 2 million per milliliter
  • Sperm origin: ejaculate

排除标准

  • Taking oral antioxidants in the 3 months prior to inclusion in the study
  • Total astenozoospermia or Severe teratozoospermia (including balloonzoospermia)

结局指标

主要结局

Compare the sORP rate in sperm samples,

时间窗: 2.5 months

Compare the sORP rate in sperm samples, obtained by the Mioxsys System, before and after 2.5 months antioxidant men supplements treatment (Fertybiotic MAN).

次要结局

  • Evaluate the influence of the sORP rate in embryo development(1 year)
  • Evaluate the relationship between the sORP rate in sperm samples(1 year)
  • Determinate a reproductive prognosis value based on sORP rate and the different sperm parameters(1 year)

研究者

发起方
IVI Bilbao
申办方类型
Other
责任方
Principal Investigator
主要研究者

FERNANDO QUINTANA FERRAZ

Marcos Ferrando Serrano

IVI Bilbao

研究点 (2)

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