A Phase IIIB/IV, Open Label Study to Assess the Efficacy and Safety of a Pre-defined, Fixed Dose of Gonal-f® (Filled-by-Mass in a Prefilled Pen) Based on Subject Baseline Characteristics, for Ovarian Stimulation in Subjects Undergoing in Vitro Fertilization (IVF)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 166
- 试验地点
- 1
- 主要终点
- Number of Oocytes Retrieved
研究概览
简要总结
Clinical validation of the assisted reproductive technology (ART) treatment guidelines, which determine the optimal dose of recombinant human follicle stimulating hormone (r-hFSH) based on subject baseline characteristics/predictors of ovarian response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Had 2 previous ART cycles with a poor response to gonadotrophin stimulation, defined as less than or equal to (<=) 5 mature follicles and/or <=3 oocytes collected in any previous IVF cycle or hyper response, defined as >=25 oocytes retrieved.
- •Any medical condition, which in the judgement of the investigator may interfere with the absorption, distribution, metabolism or excretion of the drug. In case of doubt, the subject in question should be discussed with Serono's Therapeutic Director.
- •Had previous severe ovarian hyperstimulation syndrome (OHSS).
- •A body mass index (BMI) greater than (>) 30 kilogram per square meter (kg/m^2)
- •Any contraindication to being pregnant and/or carrying a pregnancy to term.
- •Extra-uterine pregnancy within the last 3 months.
- •History of 3 or more miscarriages (early or late miscarriages) due to any cause.
- •Tumours of the hypothalamus and pituitary gland.
- •Ovarian enlargement or cyst of unknown aetiology.
- •Ovarian, uterine or mammary cancer.
- •A clinically significant systemic disease.
- •Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus.
- •Abnormal gynaecological bleeding of undetermined origin.
- •Known allergy or hypersensitivity to human gonadotrophin preparations.
- •Any active substance abuse or history of drug, medication or alcohol abuse in the past 5 years.
- •Entered previously into this study or simultaneous participation in another clinical trial
研究组 & 干预措施
Gonal-f 112.5 IU
干预措施: Gonal-f (Drug)
Gonal-f 150 IU
干预措施: Recombinant human chorionic gonadotrophin (r-hCG) (Drug)
Gonal-f 112.5 IU
干预措施: Recombinant human chorionic gonadotrophin (r-hCG) (Drug)
Gonal-f 37.5 IU
干预措施: Gonal-f (Drug)
Gonal-f 37.5 IU
干预措施: Recombinant human chorionic gonadotrophin (r-hCG) (Drug)
Gonal-f 75 IU
干预措施: Gonal-f (Drug)
Gonal-f 75 IU
干预措施: Recombinant human chorionic gonadotrophin (r-hCG) (Drug)
Gonal-f 150 IU
干预措施: Gonal-f (Drug)
Gonal-f 187.5 IU
干预措施: Gonal-f (Drug)
Gonal-f 187.5 IU
干预措施: Recombinant human chorionic gonadotrophin (r-hCG) (Drug)
Gonal-f 225 IU
干预措施: Gonal-f (Drug)
Gonal-f 225 IU
干预措施: Recombinant human chorionic gonadotrophin (r-hCG) (Drug)
Gonal-f 262.5 IU
干预措施: Gonal-f (Drug)
Gonal-f 262.5 IU
干预措施: Recombinant human chorionic gonadotrophin (r-hCG) (Drug)
Gonal-f 300 IU
干预措施: Gonal-f (Drug)
Gonal-f 300 IU
干预措施: Recombinant human chorionic gonadotrophin (r-hCG) (Drug)
结局指标
主要结局
Number of Oocytes Retrieved
时间窗: Ovum pick up day (34 to 38 hours post r-hCG administration)
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval was a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body. As per statistical analysis plan, efficacy analysis were performed for only those dose groups (Gonal-f 75 IU, Gonal-f 112.5 IU, Gonal-f 150 IU, Gonal-f 187.5 IU and Gonal-f 225 IU) which included more than 5 subjects.
次要结局
- Mean Number of Ovarian Stimulation Days(up to end of stimulation cycle (approximately 31 days))
- Percentage of Cycles Cancelled Due to Excessive or Inadequate Response to r-hFSH(up to end of stimulation cycle (approximately 31 days))
- Number of Subjects Needing Dose Adjustment(6 days post r-hFSH treatment)
- Mean Daily Recombinant Human Follicle Stimulating Hormone (r-hFSH) Dose(up to end of stimulation cycle (approximately 31 days))
- Total Dose of Recombinant Human Follicle Stimulating Hormone (r-hFSH)(up to end of stimulation cycle (approximately 31 days))
- Overall Pregnancy Rate, Clinical Rate and Multiple Pregnancy Rate(35-42 days post r-hCG administration)
- Embryo Implantation Rate(35-42 days post r-hCG administration)