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临床试验/NCT02877992
NCT02877992已完成不适用

Development of a New Diagnostic Tool to Assess Oocyte Quality Based on Tachykinin and Kisspeptin Expression Analysis in Human Granulosa and Cumulus Cells

IVI Sevilla4 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
236
试验地点
4
主要终点
Expression level of neurokinin A (NKA)

研究概览

简要总结

The purpose of this project is to study the presence of expression differences - at RNA and protein level - of different members of the tachykinin family and kisspeptin and their receptors, between fertile women and infertile patients with different etiologies.

研究设计

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

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Two groups of subjects (each one with different criteria):
  • Oocyte donors
  • Inclusion Criteria:
  • Age between 18 and 34 years
  • Normal caryotype
  • Normal psychological test

排除标准

  • Presence of hereditary diseases
  • Beta-thalassemia
  • Cystic fibrosis
  • Human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV)
  • Infertility patients
  • Inclusion Criteria:
  • Age between 18 and 45 years
  • One of the following etiologies:
  • Patient with PCOS according to Rotterdam Criteria or
  • Patients with endometriosis stage I-IV or
  • Patients with low ovarian response according to Bologna criteria or
  • Patients with advances maternal age (between 38 and 45 years)

结局指标

主要结局

Expression level of neurokinin A (NKA)

时间窗: 4 years

Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

Expression level of hemokinin 1 (HK-1)

时间窗: 4 years

Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

Expression level of kisspeptin 1 (KISS1)

时间窗: 4 years

Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

Expression level of Substance P (SP)

时间窗: 4 years

Expression analysis at mRNA (mRNA = messenger ribonucleic acid) and protein level using techniques of real time quantitative PCR (PCR = polymerase chain reaction), immunocytochemistry and western blot

Expression level of neurokinin B (NKB)

时间窗: 4 years

Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

Expression level of neurokinin 1 receptor (NK1R)

时间窗: 4 years

Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

Expression level of kisspeptin 1 receptor (KISS1R)

时间窗: 4 years

Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

Expression of neurokinin 2 receptor (NK2R)

时间窗: 4 years

Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

Expression level of neurokinin 3 receptor (NK3R)

时间窗: 4 years

Expression analysis at mRNA and protein level using techniques of real time quantitative PCR, immunocytochemistry and western blot

次要结局

  • Years of infertility(4 years)
  • Fertilization rate(4 years)
  • Embryo quality(4 years)
  • Daily and total dose of FSH (FSH = follicle stimulating hormone)(4 years)
  • Patient or donor age(4 years)
  • Estradiol level (day of ovulation induction)(4 years)
  • Patient or donor body mass index(4 years)
  • Progesterone level (day of ovulation induction)(4 years)
  • Number of oocytes retrieved in the ovarian puncture(4 years)
  • Daily and total dose of HMG (HMG = human menopausal gonadotropin)(4 years)
  • Number of mature oocytes (metaphase II) obtained in the ovarian puncture(4 years)
  • Type of ovulation induction(4 years)

研究者

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

Manuel Fernandez-Sanchez

Dr

IVI Sevilla

研究点 (4)

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