Iron Deficiency as an Ignored Cause of Infertility
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Number of good quality blastocysts
研究概览
简要总结
Iron deficiency may play a critical role in human infertility, oocyte quality and may even play a role in endometrial receptivity. By correcting iron deficiency, low ferritin values, in infertile women with intravenous iron supplementation, embryo quality and pregnancy rates may improve.
The main objective is to evaluate the effect of intravenous iron supplementation on embryo quality (number of good quality blastocysts).
Randomized, double blind, parallel group, cross-over study of ferric carboxymaltose compared to placebo (NaCl infusion).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patient's 18 to 42 years and in full consent
- •Ferritin ≤ 30 ug/l
- •Anti-mullerian hormone (AMH) > 1ug/l
- •Planned for IVF/ ICSI treatment
- •Diagnosis for treatment: tubal factor, male factor or unexplained infertility (NUD)
排除标准
- •Endometriosis
- •Poor responder
- •Inflammatory bowel disease (IBD), colitis ulcerosa
- •Rheumatoid arthritis
- •Renal insufficiency
- •Cardiac insufficiency
- •Body Mass Index (BMI) over 35
- •Known hypersensitivity to the active substance, to ferric carboxymaltose or any of its excipients, or to other parental iron products
- •Clinical evidence of iron overload or disturbances in the utilization of iron
- •use of atosiban or filgrastim during stimulation or embryo transfer
研究组 & 干预措施
Experimental group
- infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)
- infusion is NaCl
干预措施: Ferric Carboxymaltose Injection (Drug)
Experimental group
- infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)
- infusion is NaCl
干预措施: NaCl infusion (Drug)
NaCl infusion group
- infusion is NaCl
- infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)
干预措施: Ferric Carboxymaltose Injection (Drug)
NaCl infusion group
- infusion is NaCl
- infusion is ferric carboxymaltose, dosage according to the summary of product characteristics (SmPC)
干预措施: NaCl infusion (Drug)
结局指标
主要结局
Number of good quality blastocysts
时间窗: day 5-7 after oocyte pick up
good quality blastocyst are defined as blastocyst, which are transferable or may be frozen
次要结局
- blastulation rate(day 5-7 after oocyte pick up)
- ongoing pregnancy/ pregnancy rate(10 weeks after oocyte pick up,at oocyte pick up it counted to be 2 weeks of gestation.)
- mature oocyte rate(1 day after oocyte pick up)
- fertilization rate(1 day after oocyte pick up)
- implantation rate(5 weeks after embryo transfer)