A Prospective, Open Label, Randomised, Parallel Group, Comparative Pilot Study to Study the Efficacy and Safety of Highly Purified Menotrophin Versus Recombinant FSH (Follitropin Alfa) Administered Subcutaneously to Subfertile Female Patients Undergoing IVF Using Antagonist Downregulation
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 6
- 主要终点
- Number of Participants With an Ongoing Pregnancy
研究概览
简要总结
Prospective open label, randomised, parallel group, comparative pilot.
详细描述
Ongoing pregnancy rate, defined as positive fetal heart action 9 weeks after the first positive pregnancy test. Number/diameter of follicles, number of oocytes retrieved, number of pronuclear oocytes (referred to as zygotes or pre-embryos in the UK), quality of pronuclear stage oocytes, number of embryos transferred, quality of embryos, number of frozen embryos, endometrial thickness and morphology on day of HCG administration, estradiol levels at day of HCG administration, implantation rate, number of days stimulated with gonadotrophins and number of ampoules used, clinical pregnancy rate at 6 weeks after the first positive pregnancy test, pregnancy outcome.
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
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Menotrophin
干预措施: Menotrophin (Drug)
Follitropin alfa
干预措施: Follitropin alfa (Drug)
结局指标
主要结局
Number of Participants With an Ongoing Pregnancy
时间窗: Approx week 13; 9 weeks or more after the 1st positive pregnancy test
Number of participants who met human chorionic gonadotrophin (hCG) criterion, received an embryo transfer, tested positive with a serum pregnancy test 11-14 days after embryo transfer and had an ongoing pregnancy (defined as positive fetal heart action) at ≥ 9 weeks after the first positive pregnancy test.
Percentage of Participants With an Ongoing Pregnancy
时间窗: Approx week 13; 9 weeks or more after the first positive pregnancy test
Percentage of participants who had an ongoing pregnancy ≥ 9 weeks after the first positive pregnancy test, as indicated by positive fetal heart action.
次要结局
- Participants With Varying Numbers of Follicles That Were Greater Than or Equal to 17 Millimeters(Day 7 and, if appropriate, every 2 days thereafter (Days 9/11/13))
- Participants With Varying Numbers of Oocytes Retrieved(Approximately study day 15)
- Participants With Varying Numbers of Pronuclear Stage Oocytes(Approximately study day 15)
- Participants With Varying Numbers of Embryos Transferred(Approximately study day 17)
- Participants With Varying Numbers of Embryos Frozen(Approximately study day 17)
- Mean Number of Days Stimulated With Gonadotrophins(study days 1 - 13)
- Pregnancy Outcomes(Approximately 10 months)
- Mean Endometrial Thickness(Day 7 or 9 or 11 or 13)
- Mean Estradiol Level(Day 7 or 9 or 11 or 13)