NCT00829244已完成4 期
A Phase IV Prospective, Multicenter, Randomized, Open-label Trial to Assess the Efficacy and Safety of GONAL f® at a Dose Based on Subject Baseline Characteristics Determined According to the CONSORT Calculator Compared With a Standard Dose of GONAL f® 150 IU Per Day for Ovarian Stimulation in Women Undergoing Assisted Reproductive Technology (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
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Number of Oocytes Retrieved Per Participant
研究概览
简要总结
The overall objective of this trial is to compare the ovarian response in assisted reproductive technology (ART) subjects administered GONAL f® according to the 'Consistency in recombinant follicle stimulating hormone [r-FSH] starting doses for individualized treatment' (CONSORT) calculator versus given a standard GONAL f® dose of 150 International Unit (IU) per day.
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 34 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female subjects justifying an in-vitro fertilization (IVF)/embryo transfer (ET) treatment
- •Have a male partner with semen analysis within the past 6 months prior to randomization considered adequate to proceed with regular insemination or intracytoplasmic sperm injection (ICSI) according to the center's standard practice. If these criteria are not met, the subject can only be entered if donor sperm will be used
- •Between her 18th and 35th birthday (35 not included) at the time of the randomization visit
- •Body mass index (BMI) lower than 30 kilogram per square meter (kg/m^2) where the BMI is calculated according to the formula
- •Have a regular spontaneous ovulatory menstrual cycle between 21 and 35 days in length
- •Have an early follicular phase (Day 2-4) serum level of basal FSH lower than or equal to 12 International Unit per Liter (IU/L) measured in the center's local laboratory during the screening period (i.e. within 2 months prior to down-regulation start)
- •Presence of both ovaries
- •Normal uterine cavity, which in the investigator's opinion is compatible with pregnancy
- •Have a negative cervical papanicolaou (PAP) test within the last 6 months prior to randomization
- •Have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last ART cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotropin releasing hormone (GnRH) agonist therapy
- •Willing and able to comply with the protocol for the duration of the trial
- •Have given written informed consent, prior to any trial-related procedure not part of normal medical care, with the understanding that consent may be withdrawn by the subject at any time without prejudice to her future medical care
排除标准
- •Have greater than or equal to 2 previous ART cycles with a poor response to gonadotrophin stimulation (defined as lower than or equal to 5 mature follicles and/or lower than or equal to 3 oocytes collected) or have greater than or equal to 2 previous ART cycles with a hyper response (defined as greater than or equal to 25 oocytes retrieved)
- •Any medical condition, which in the judgment 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 Merck Serono's Medical responsible
- •Have previous severe ovarian hyperstimulation syndrome (OHSS)
- •Polycystic ovary syndrome (PCOS; Rotterdam criteria) to reduce the risk of the occurrence of OHSS
- •Presence of endometriosis requiring treatment
- •Uterine myoma requiring treatment
- •Any contraindication to being pregnant and/or carrying a pregnancy to term
- •Extra-uterine pregnancy within the last 3 months prior to screening
- •History of 3 or more miscarriages (early or late miscarriages) due to any cause
- •Tumors of the hypothalamus and pituitary gland
- •Ovarian enlargement or cyst of unknown etiology
- •Ovarian, uterine or mammary cancer
- •A clinically significant systemic disease
- •Known infection with Human Immunodeficiency Virus (HIV), Hepatitis B or C virus in the trial subject or her male partner,
- •Abnormal gynecological 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 prior to the screening visit
- •Entered previously into this trial or simultaneous participation in another clinical trial
研究组 & 干预措施
CONSORT Dosing
Experimental
GONAL-f® dose based on subject baseline characteristics determined according to the CONSORT calculator
干预措施: GONAL f® prefilled pen (Drug)
Standard Dosing
Active Comparator
GONAL-f® at a standard dose of 150 IU per day
干预措施: GONAL f® prefilled pen (Drug)
结局指标
主要结局
Number of Oocytes Retrieved Per Participant
时间窗: 34-38 hours post-recombinant human choriogonadotropin (hCG) (OPU)
Mean number of oocytes retrieved on the day of ovum pick up (OPU) was calculated. Oocyte retrieval is a technique used in in-vitro fertilization in order to remove oocytes from the ovary of the female, enabling fertilization outside the body.
次要结局
- Total GONAL-f® Dose(Start of treatment until end of stimulation cycle (approximately 28 days))
- Mean GONAL-f® Daily Dose(Start of treatment until end of stimulation cycle (approximately 28 days))
- Total Number of GONAL-f® Stimulation Treatment Days(Start of treatment until end of stimulation cycle (approximately 28 days))
- Number of Participants With Cancelled Cycles Due to Excessive or Inadequate Response to Treatment(Start of treatment until Day 15-20 post-hCG)
- Percentage of Participants With Biochemical Pregnancies(Start of treatment until Day 15-20 Post-hCG)
- Number of Participants With Fetal Sacs and Fetal Hearts(Day 35-42 Post-hCG)
- Implantation Rate(Day 35-42 Post-hCG)
- Number of Participants With Multiple Pregnancies(Day 35-42 Post-hCG)
- Serum Progesterone (P4) Levels(End of stimulation cycle (approximately 28 days))
- Pregnancy Outcome - Number of Participants With Pregnancy and Their Outcome(up to 9 month (following the end of treatment))
- Percentage of Participants With Clinical Pregnancy(Day 35-42 Post-hCG)
- Number of Participants With OHSS(Start of treatment until Day 15-20 Post-hCG)
研究者
研究点 (1)
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