EUCTR2006-000014-20-DE进行中（未招募）不适用
Prospective, double-blind, randomized, placebo-controlled, parallel group, multi-centre phase III study to evaluate the efficacy and safety of a human leukocytic ultrafiltrate (Leukonorm Cytochemia®) applied as supportive immunotherapy within IVF/ICSI-treatment in female patients with repetitive implantation failures during previous IVF or ICSI-cycles - CYCLE
CYTOCHEMIA AG0 个研究点目标入组 208 人开始时间: 2006年1月23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
- 208
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
- •·woman aged 18 to 39 years;
- •·patients with a history of not less than 2 but not more than 3 previous failed IVF/ICSI-cycles (i.e. no constantly high serum-hCG and/or no clinical evidence for at least one embryo sac, determined by transvaginal sonography), with at least 4 morphologically good-looking embryos of the categories A and B according to Steer et al.
- •·stimulation according to the long GnRH-agonist protocol or according to the GnRH-antagonist protocol (for details refer to section 9.5.1.1)
- •·written informed consent obtained.
- •A complete list of all inclusion criteria is given in the protocol section 9.3.2.
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •·patients with known or suspected uterine malformation
- •·patients with known or suspected endometriosis class III and IV, according to rAFS-criteria
- •·known or suspected numerical and/or structural chromosomal anomalies in one or both partners
- •·usage of cryopreserved unfertilized oocytes, oocytes at the pronuclear stage, or embryos
- •·previous low response (< 5 oocytes retrieved) in a gonadotropin stimulation GnRH agonist or anatagonist protocol for IVF or ICSI
- •·clinical significant findings of a severe autoimmune disease, respectively clinical manifested severe autoimmune disease (e.g. rheumatoid arthritis, multiple sclerosis) and/or currently treated autoimmune disease
- •·any kind of organ transplantation
- •·patients receiving immunosuppressive therapy, including systemic corticosteroids, or cytotoxic agents
- •A complete list of all exclusion criteria is given in the protocol section 9.3.3.
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