A Phase III, Multi-center, Open-label, Randomized Study to Assess the Efficacy and Safety of Org 37462 Treatment in Chinese Women Undergoing Controlled Ovarian Stimulation for IVF or ICSI, Using a Long Protocol of Triptorelin as a Reference Treatment.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 259
- 主要终点
- The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.
研究概览
简要总结
The primary purpose of this study is to assess that ganirelix is safe and well-tolerated in Chinese women and that a controlled ovarian stimulation (COS) protocol combining recombinant follicle stimulating hormone (recFSH) with ganirelix is efficient in Chinese women undergoing COS for in vitro fertilization (IVF) or intra cytoplasmatic sperm injection (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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •females of infertile couples for whom COS and IVF or ICSI is indicated
- •body mass index between 18 and 29 kg/m2
- •willing and able to give written informed consent.
排除标准
- •More than three previous COS cycles for assisted reproduction since last established ongoing pregnancy (if applicable)
- •History of no or low ovarian response to FSH/human menopausal gonadotropin (hMG) treatment
- •Less than 2 ovaries or any other ovarian abnormality including endometrioma
- •Presence of unilateral or bilateral hydrosalpinx
- •Any ovarian and/or abdominal abnormality that would interfere with adequate ultrasound investigation of at least one ovary
- •History of or current polycystic ovary syndrome (PCOS)
- •History of/or current endocrine abnormality
- •Any clinically relevant hormone value outside the reference range during the early follicular phase
- •Any clinically significant abnormal laboratory value
- •Hypertension or currently treated hypertension
- •Recent history of current epilepsy, diabetes, cardiovascular, gastro-intestinal, hepatic, renal, pulmonary disease
- •Alcohol or drug abuse, or history thereof
- •Current serious allergic symptoms
- •Abnormal cervical smear
- •Known hypersensitivity to gonadotropin releasing hormone (GnRH) or its analogs;
- •Contra-indications for the use of gonadotropins
- •Use of hormonal preparations within 1 month prior to the date of signing consent;
- •Administration of any investigational product within 3 months prior to screening.
研究组 & 干预措施
1
ganirelix
干预措施: ganirelix (Drug)
2
triptorelin
干预措施: triptorelin (Drug)
结局指标
主要结局
The Amount of International Units (IU) of Recombinant Follicle Stimulating Hormone (recFSH) Needed in a Controlled Ovarian Stimulation (COS) Cycle up to the First Day the Human Chorionic Gonadotropin (hCG) Criterion is Met.
时间窗: At completion of ovarian stimulation; maximally after 18 days of recFSH administration.
The hCG criterion is met the first day that 3 follicles \>= 17 mm are observed.
次要结局
未报告次要终点