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临床试验/NCT03991286
NCT03991286已完成不适用

The Effect of Astaxanthin on Oxidative Stress Indices in Serum, and Induction of Signaling Pathways in Granulosa Cells in Patients With Polycystic Ovary Syndrome

Tehran University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2020年1月20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
48
试验地点
1
主要终点
Serum and follicular fluid oxidative stress biomarkers levels

研究概览

简要总结

Polycystic ovary syndrome (PCOS) is the most common endocrinopathy affecting women of reproductive age It is hypothesized that ∼20 fold increase in reactive oxygen species (ROS) generation in Follicular fluid (FF) and granulosa cells of PCOS women plays an adverse role in affecting the IVF success rate. Astaxanthin (3,3'-dihydroxy-β,β'-carotene-4,4'-dione) is a nonprovitamin A carotenoid classified as a xanthophyll and is found in high amounts in the red pigment of crustacean shells (e.g., crabs, shrimp), salmon, trout, and asteroides. It has been demonstrated that astaxanthin displays a wide variety of biological activities, including anti-oxidative, anticancer, and anti-inflammatory effects.

investigators aim to investigate the effect on Astaxanthin administrating on reducing of ROS in FF and induction of antioxidant response elements in PCOS women.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Diagnosed PCOS cases according to the National Institute of Health criteria (NIH consensus criteria) and Rotterdam criteria

排除标准

  • Menopause, pregnant or lactating females
  • individuals with diabetes
  • those with hepatic,renal, thyroid or cardiovascular disorders
  • patients with elevated levels of prolactin
  • those who were taking antioxidant supplements within the last 3 months

结局指标

主要结局

Serum and follicular fluid oxidative stress biomarkers levels

时间窗: 8 months

This parameter will measure using Enzyme-Linked. Immunosorbent Assays (ELISAs)

次要结局

  • Number of oocytes retrieved(Day1(from the day of oocyte retrieval to fertilization confirmation))
  • Number of mature(MII) oocyte(Day1(from the day of oocyte retrieval to fertilization confirmation))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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