NCT00298025已完成4 期
A Phase IV, Multicenter, Open-label, Randomized Study to Compare the Safety and Efficacy of Cetrotide® 3 mg Versus Antagon™ in the Inhibition of a Premature LH Surge in a r-hFSH/hMG Stimulation Cycle With OCP Programming in Women Undergoing Ovarian Stimulation Prior to ART
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- EMD Serono
- 入组人数
- 185
- 主要终点
- Percentage of subjects without premature luteinizing hormone (LH) surge
研究概览
简要总结
To demonstrate the comparative safety and efficacy of Cetrotide® 3 milligram (mg) and Antagon™ in the inhibition of a premature luteinizing hormone (LH) surge in women undergoing ovarian stimulation with recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) prior to assisted reproductive technology (ART) and utilizing oral contraceptives pill (OCP) for cycle programming.
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
- •Infertile women wishing to conceive whose physician had recommended that she can undergo ART
- •Aged 18-39 years (inclusive)
- •Regular menstrual cycles every 25-35 days
- •Body mass index (BMI) less than 35 kilogram per square meter (kg/m^2)
- •Has a transvaginal pelvic ultrasound scan within 6 weeks prior to OCP administration, as well as an Hysterosalpingography (HSG) or hysterosonogram or hysteroscopy within three years prior to OCP administration showing no clinically significant pelvic and/or uterine abnormality, which, in the Investigator's opinion, could impair ovarian response, embryo implantation or pregnancy continuation
- •Normal cervical cytology, documented by Pap Smear, within six months prior to OCP administration
- •If the subject had prior stimulation cycles, at least a 60-day washout period is required after the last dose of gonadotropin or clomiphene citrate; a 60-day washout is required after the last dose of Lupron® or Lupron Depot® 1-month; a 180-day washout period is required after the last dose of treatment with Depo-Provera® and Lupron Depot® 6-month; a 60-day washout is required after the last dose of oral contraceptives prior to OCP administration in the study
- •Screening laboratory results for follicle stimulating hormone (FSH) that are within the normal limit for the early follicular phase at the local laboratory
- •Is willing and able to comply with the protocol for the duration of the study
- •Has voluntarily provided written informed consent and a subject authorization under Health insurance portability and accountability act (HIPAA), prior to any study-related procedure that is not part of normal medical care, with the understanding that the subject could withdraw consent at any time without prejudice to her future medical care
排除标准
- •Clinically significant systemic disease
- •Known to be infected with Human Immunodeficiency Virus (HIV)
- •Known to be infected with Hepatitis C virus
- •Known to test positive for Hepatitis B surface antigens
- •Any medical condition, which, in the judgment of the Investigator and Sponsor, may interfere with the absorption, distribution, metabolism or excretion of the study drugs
- •Known endometriosis Grade III-IV (American society of reproductive medicine [ASRM] classification)
- •Uni- or bilateral hydrosalpinx
- •Any contraindication to being pregnant and/or carrying pregnancy to term
- •Any previous ART cycle indicating a poor response to gonadotropin stimulation (defined as retrieval of three oocytes or less)
- •If, in a previous ART attempt, there are no motile sperm before or after the sperm processing with ejaculated, epididymal, testicular, fresh or frozen/thawed spermatozoa
- •Three or more previous consecutive ART cycles without a clinical pregnancy
- •An extrauterine pregnancy within the last three months before OCP treatment commences
- •Abnormal, undiagnosed, gynecological bleeding
- •Known allergy or hypersensitivity to human gonadotropin preparations or any other study-related medications
- •Known current substance abuse
- •Previous participation in this study or simultaneous participation in another clinical trial
- •Current smoker
研究组 & 干预措施
Cetrotide®
Experimental
干预措施: Cetrotide® (Drug)
Cetrotide®
Experimental
干预措施: Recombinant human follicle stimulating hormone (r-hFSH) (Drug)
Cetrotide®
Experimental
干预措施: Human Menopausal Gonadotropin (hMG) (Drug)
Cetrotide®
Experimental
干预措施: Recombinant Human Choriogonadotropin (r-hCG) (Drug)
Antagon ™
Active Comparator
干预措施: Antagon ™ (Drug)
Antagon ™
Active Comparator
干预措施: Recombinant human follicle stimulating hormone (r-hFSH) (Drug)
Antagon ™
Active Comparator
干预措施: Human Menopausal Gonadotropin (hMG) (Drug)
Antagon ™
Active Comparator
干预措施: Recombinant Human Choriogonadotropin (r-hCG) (Drug)
结局指标
主要结局
Percentage of subjects without premature luteinizing hormone (LH) surge
时间窗: r-hCG administration day (end of stimulation cycle {approximately 4 days})
次要结局
- Duration of study treatment(Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days}))
- Total dose of recombinant human follicle stimulating hormone/human menopausal gonadotropin (r-hFSH/hMG) administered(Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days}))
- Duration of gonadotropin therapy(Stimulation Day 1 (S1) up to r-hCG administration day (end of stimulation cycle {approximately 4 days}))
- Number of follicles greater than or equal to (>=) 14 millimeter (mm) on day of recombinant human chorionic gonadotropin (r-hCG) administration(r-hCG administration day (end of stimulation cycle {approximately 4 days}))
- Number of oocytes retrieved(Ovum pick-up (OPU) day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}]))
- Number of mature oocytes retrieved(OPU day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}]))
- Number of fertilized oocytes(Day 1 post OPU day (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}]))
- Number and Quality of Embryos(Day 2-3 post OPU (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}]))
- Implantation rate(Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 4 days}))
- Total number of transferred and cryopreserved embryos(Day 2-3 post OPU (34-38 hours post r-hCG administration day [end of stimulation cycle {approximately 4 days}]))
- Percentage of subjects with clinical and biochemical pregnancies(Day 35-42 post r-hCG administration day (end of stimulation cycle {approximately 4 days}))
- Quality of Life assessed by Short Form- 36 (SF-36) Questionnaire(Stimulation Day 1 (S1) and Day 15-18 post r-hCG administration (end of stimulation cycle {approximately 4 days}))
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