NCT03809429已完成3 期
A Randomised, Controlled, Open Label, Parallel Group, Multicentre Trial Comparing the Efficacy and Safety of Individualised FE 999049 (Follitropin Delta) Dosing, Using a Long GnRH Agonist Protocol and a GnRH Antagonist Protocol in Women Undergoing Controlled Ovarian Stimulation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 437
- 试验地点
- 16
- 主要终点
- Number of Oocytes Retrieved
研究概览
简要总结
To compare the efficacy and safety of FE 999049 (follitropin delta) and its personalized dosing algorithm in controlled ovarian stimulation for in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) using a long gonadotropin-releasing hormone (GnRH) agonist protocol versus a short GnRH antagonist protocol.
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 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women aged 18-40 undergoing their first IVF/ICSI cycle that are in good physical and mental health and that have been diagnosed with problems in the fallopian tubes, mild endometriosis or have partners with decreased sperm quality.
- •The participants must have a regular menstrual cycle, a normal uterus and 2 normal ovaries.
- •The allowed body mass index is 17.5-32 Kg/m^2.
排除标准
- •Women with very high ovarian reserve, strong preference for either treatment, severe endometriosis, history of repeated miscarriage, couples with known problems in the chromosomes, history or high risk of producing blood cloths, women known to have chronic diseases, women recently participating in trials with non-registered drugs.
研究组 & 干预措施
FE 999049 + GnRH agonist (GONAPEPTYL)
Experimental
干预措施: FE 999049 + GnRH agonist (GONAPEPTYL) (Drug)
FE 999049 + GnRH antagonist (CETROTIDE)
Active Comparator
干预措施: FE 999049 + GnRH antagonist (CETROTIDE) (Drug)
结局指标
主要结局
Number of Oocytes Retrieved
时间窗: On day of oocyte retrieval (up to 22 days after start of stimulation)
The number of oocytes retrieved was recorded at the oocyte retrieval visit.
次要结局
- Number of Follicles(On stimulation day 6 and at end-of-stimulation (up to 20 days))
- Proportion of Subjects With Cycle Cancellation Due to Poor Ovarian Response or Excessive Ovarian Response(At end-of-stimulation (up to 20 days))
- Proportion of Subjects With Blastocyst Transfer Cancellation After Oocyte Retrieval Due to (Risk of) Ovarian Hyperstimulation Syndrome (OHSS)(At end of transfer (up to 4 weeks))
- Proportion of Subjects With <4, 4-7, 8-14, 15-19 and ≥20 Oocytes Retrieved(On day of oocyte retrieval (up to 22 days after start of stimulation))
- Number of Metaphase II Oocytes(On day of oocyte retrieval (up to 22 days after start of stimulation))
- Fertilization Rate(On day 1 after oocyte retrieval (up to 23 days after start of stimulation))
- Circulating Concentrations of Follicle-stimulating Hormone (FSH)(On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation))
- Number of Embryos(On day 3 after oocyte retrieval (up to 25 days after start of stimulation))
- Number of Blastocysts(On day 5 after oocyte retrieval (up to 27 days after start of stimulation))
- Circulating Concentrations of Estradiol(On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation))
- Circulating Concentrations of Luteinizing Hormone (LH)(On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation))
- Ongoing Implantation Rate(10-11 weeks after transfer (up to approximately 4 months after start of stimulation))
- Circulating Concentrations of Progesterone(On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation))
- Circulating Concentrations of Inhibin B(On stimulation day 6, at end-of-stimulation (up to 20 days after start of stimulation) and at oocyte retrieval (up to 22 days after start of stimulation))
- Total Gonadotropin Dose(Up to 20 days)
- Number of Stimulation Days(Up to 20 days)
- Positive Beta Human Chorionic Gonadotropin (βhCG) Rate(13-15 days after transfer (up to approximately 1.5 months after start of stimulation))
- Implantation Rate(5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation))
- Clinical Pregnancy Rate(5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation))
- Vital Pregnancy Rate(5-6 weeks after transfer (up to approximately 2.5 months after start of stimulation))
- Ongoing Pregnancy Rate(10-11 weeks after transfer (up to approximately 4 months after start of stimulation))
- Proportion of Subjects With Early OHSS (Including OHSS of Moderate/Severe Grade)(Up to 9 days after triggering of final follicular maturation)
- Proportion of Subjects With Late OHSS (Including OHSS of Moderate/Severe Grade)(>9 days after triggering of final follicular maturation)
- Frequency of Adverse Events(From time of signing informed consent until the end-of-trial (approximately 7 months))
- Intensity of Adverse Events(From time of signing informed consent until the end-of-trial (approximately 7 months))
- Technical Malfunctions of the Pre-filled Injection Pen(Up to 20 days)
研究者
研究点 (16)
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