Prospective, Open-label, Uncontrolled Clinical Trial Evaluating Multiple Controlled Ovarian Hyperstimulation Cycles in Oocyte Donor, to Assess the Immunogenicity of FSH-IBSA
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- Number of Patients Producing Anti-FSH Antibodies.
研究概览
简要总结
The purpose of the study is to evaluate immunogenic potential of FSH-IBSA in healthy volunteers undergoing controlled ovarian hyperstimulation (COH) in an oocyte donation program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female volunteers undergoing controlled ovarian hyperstimulation for oocyte donation with the following characteristics:
- •Able and willing to sign the Subject Consent Form and adhere to the study visit 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).
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...).
研究组 & 干预措施
FSH
FSH (Follicle stimulation hormone, 75 IU/vial) will be administered to women according to their need and response assessed by the Investigator.
干预措施: FSH (Follicle Stimulating Hormone) (Drug)
结局指标
主要结局
Number of Patients Producing Anti-FSH Antibodies.
时间窗: 4 months.
The immunogenicity potential of FSH in healthy volunteer will be assessed by analysing serum samples collected at different timepoints during two treatment cycle for oocytes donation: cycle 1, serum samples will be collected before treatment start (baseline), after 7-13 days and after 28 days of treatment; Cycle 2: serum samples will be collected before starting the second cycle (baseline 2), after 7-13 days and after 28 days of treatment. Cycle 1 and cycle 2 will be separated by a wash-out period of two months.
次要结局
- Number of Oocytes Retrieved(after 2 weeks of treatment)
- Total Dose of FSH Units Used.(after 2 weeks of treatment)