NCT00598208已完成2 期
A Phase 2, Open Label, Randomized Trial to Investigate the Dose-Response Relationship of a Single Injection of Org 36286 (Corifollitropin Alfa) to Initiate Multiple Follicular Growth in a Controlled Ovarian Hyperstimulation Protocol for IVF or ICSI.
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 325
- 主要终点
- Number of cumulus-oocyte-complexes retrieved
研究概览
简要总结
The primary objective of this trial is to investigate the dose -response relationship of a single injection of Org 38286 to initiate multifollicular growth for the first seven days in a controlled ovarian hyperstimulation (COH) protocol for IVF or ICSI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Females of couples with an indication for COH and IVF or ICSI;
- •>=18 and <=39 years of age at the time of signing informed consent;
- •BMI >=18 and <=29 kg/m^2;
- •Normal menstrual cycle length: 24-35 days;
- •Ejaculatory sperm (use of donated and/or frozen sperm is allowed);
- •Willing and able to sign informed consent.
排除标准
- •History of/or any current (treated) endocrine abnormality;
- •History of ovarian hyperstimulation syndrome (OHSS);
- •History of/or current polycystic ovary syndrome (PCOS) or current polycystic ovaries according to USS (at least 10 follicles of 2-8 mm in each ovary);
- •More than three unsuccessful COH cycles since the last established ongoing pregnancy (if applicable);
- •History of non- or low ovarian response to FSH/hMG treatment;
- •Any clinically relevant hormone value outside the reference range during the early follicular phase (menstrual cycle day 2-7) as measured by the local laboratory (FSH, LH, E2, P, total T, TSH and prolactin):
- •Any clinically relevant abnormal laboratory value;
- •Less than 2 ovaries;
- •Any ovarian and/or abdominal abnormality interfering with ultrasound examination;
- •Contraindications for the use of gonadotropins (e.g. tumors, pregnancy/lactation, undiagnosed vaginal bleeding, hypersensitivity, ovarian cysts);
- •Epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary, or abdominal disease;
- •History of presence of alcohol or drug abuse within 12 months prior to signing informed consent;
- •Previous use of Org 36286;
- •Use of hormonal preparations within 1 month prior to randomization;
- •Hypersensitivity to Org 32489 (Puregon®) and/or Org 37462 (Orgalutran®) and/or Pregnyl® or any of their components;
- •Administration of investigational drugs within three months prior to signing informed consent.
研究组 & 干预措施
1
Experimental
60 µg Org 36286 (corifollitropin alfa)
干预措施: corifollitropin alfa (Drug)
2
Experimental
120 µg Org 36286 (corifollitropin alfa)
干预措施: corifollitropin alfa (Drug)
3
Experimental
180 µg Org 36286 (corifollitropin alfa)
干预措施: corifollitropin alfa (Drug)
4
Active Comparator
Follitropin beta injection
干预措施: Follitropin beta injection (Drug)
结局指标
主要结局
Number of cumulus-oocyte-complexes retrieved
时间窗: 1 cycle
次要结局
- Treatment failure rate(1 cycle)
研究者
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