EUCTR2012-000269-19-ES进行中（未招募）不适用
Prospective, open-label, uncontrolled clinical trial evaluating multiple controlled ovarian hyperstimulation cycles in oocyte donor, to assess the immunogenicity of FSH-IBSA
IBSA, Institute Biochimique S.A.0 个研究点开始时间: 2012年10月29日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
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
- •-Able and willing to sign the Subject Consent Form and adhere to the study visitation schedule;
- •->=18 and <35 years old;
- •-Regular menstrual cycle (26 ? 35 days);
- •-BMI between 18 and 30 kg/m2;
- •-First gonadotrophin treatment (i.e naïve Subjects with regard to exposure to human derived or recombinant gonadotrophins);
- •-basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l);
- •-normal TSH levels;
- •-Willing to perform at least two consecutive oocyte retrieval cycles (with a wash out period of two months).
- •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 32
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Age < 18 and >= 35 years;
- •-Endometriosis;
- •-Subjects with evidences of autoimmune or rheumatic diseases;
- •-Hypersensitivity to the active substance or to any of the excipients (lactose);
- •-Abnormal bleeding of undetermined origin;
- •-Subject found to be positive to anti-TSH antibodies (i.e. suffering from thyroidal diseases);
- •-Uncontrolled adrenal dysfunction;
- •-Neoplasia;
- •-Severe impairment of renal and/or hepatic function;
- •-Use of concomitant medications that might interfere with study evaluations (e.g. immunosuppressant, non-study hormonal medications, therapeutics proteins like insulin, growth hormone?).
研究者
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