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临床试验/EUCTR2020-000201-84-AT
EUCTR2020-000201-84-AT进行中(未招募)1 期

Oral and intravenous iron substitution for the treatment of iron deficiency symptoms in the context of fertility treatment - an exploratory pilot study

Das Kinderwunsch Institut Schenk GmbH0 个研究点目标入组 48 人开始时间: 2020年1月30日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
48

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
Female

入选标准

  • Patients with iron deficiency (with and without anemia) defined by serum ferritin <30ng / ml and / or transferrin saturation (TSAT) <20%
  • Primarily and secondarily sterile patients
  • Patients with fertility treatment
  • Age 18-40 at the time of enrollment
  • Signed informed consent
  • BMI between 19 and 29.9
  • 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 48
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Patients with severe acute or chronic inflammation
  • hirsutism
  • Mental inability, unwillingness or language barrier that prevents or makes it difficult to understand the declaration of consent or the necessary cooperation
  • Current iron substitution
  • Simultaneous use of other dietary supplements that contain iron
  • Allergies to iron supplements
  • pregnancy
  • Patients taking proton inhibitors
  • Anemia not caused by iron deficiency e.g. (microcytic anemia)
  • Evidence of iron overload or iron disruption

研究者

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