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临床试验/EUCTR2010-020240-35-DE
EUCTR2010-020240-35-DE进行中(未招募)不适用

Significance of the FSH receptor polymorphism p.N680S for the efficacy of FSH therapy of idiopathic male infertility: a pharmacogenetic approach.

niversity of Modena and Reggio Emilia0 个研究点目标入组 100 人开始时间: 2011年12月19日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
100

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
Male

入选标准

  • - age 20-50 years
  • - idiopathic male factor infertility for at least one year;
  • - homozygous FSHR allele at codon 680 (wild type: Asn/Asn or Ser/Ser);
  • - sperm DNA fragmentation index (DFI) > 15%;
  • - normal serum FSH levels (< 8 IU/L)
  • - normal serum LH, testosterone, prolactin and estradiol levels
  • - normal ovulatory female partner
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 100
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - azoospermia
  • - all known aetiologies of male infertility (endocrine disorders, genetic disorders, chromosome abnormalities, congenital bilateral absence of the vas deferens, microdeletions within the AZF regions of the Y chromosome, varicocele, cryptorchidism, infections, immunological infertility, and obstructive infertility)
  • - all known aetiologies of female infertility in the partner (tubal blockage, endocrine abnormalities including anovulation and PCO, anatomical abnormalities, infections)
  • - heterozygous FSHR allele at codon 680
  • - drug abuse and major systemic diseases
  • - testicular insufficiency

研究者

发起方
niversity of Modena and Reggio Emilia

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