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临床试验/NCT04537481
NCT04537481Unknown不适用

Lipidic Profiles Differences of Sperm Between Normal and Low Fertilization Male Patients in Vitro Fertilization

Tang-Du Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年8月3日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
试验地点
1
主要终点
Normal fertilization rate

研究概览

简要总结

Although in vitro fertilization (IVF) involve the use of semen samples, there is little scientific methodology applied when selecting sperm. To select the most appropriate spermatozoa, first the operator need to define the optimal molecular markers. Sperm lipids may contribute to sperm function, thus the investigator's aim was to compare the lipidic profiles differences of sperm samples used in IVF cycles that ultimately led to normal fertilization or low fertilization.

详细描述

There is increasing evidence that male fertility/infertility and sperm physiology are determined by multiple factors, necessitating the use of numerous molecular biomarkers to precisely assess male reproductive potential. The study has reported that the lipids are special interest as fertility markers and therapeutic targets not only due to their functions in sperm, but also because they are sensitive to external and environmental signals.

Sperm samples from infertile patients after IVF ( normal fertilization group, n=25; low fertilization group, n=25) were collected. Following standard density gradient separation operating procedure, the sample were incubated in 37°C, 5%CO2, for 3 hours. The sample included 10x10^6 spermatozoa after sample preparation and aliquots in 100 μL PBS were analyzed for lipid composition using ultra-high performance liquid chromatography coupled to mass spectrometry. Lipid compositions and levels were compared between the two groups. The results will describe the composition and contents of lipids linked to capacitation of sperm, opening a new possibilities for the development of male fertility diagnostic tools and culture media formulations to improve sperm quality and enhance fertilization result.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

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

入选标准

  • Tubal factor infertility,
  • The women's BMI (Body mass index) ranged from 18.5 to 24,
  • The women's AMH (Anti-Müllerian hormone) ranged from 2 to 6.8 ng/ml,
  • The oocyte mature rate was greater than 75%,
  • 8 ≤ Number of retrieved oocytes ≤
  • Analysis of the spouse's semen conventional parameters showed normal.

排除标准

  • The age is over 35 years old.
  • The women with polycystic ovary syndrome (PCOS).
  • The endocrine function of the women was disordered.
  • The women has metabolic disease.

结局指标

主要结局

Normal fertilization rate

时间窗: 6 months

2PN (two pronuclei and two polar bodies) rate

次要结局

未报告次要终点

研究者

发起方
Tang-Du Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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