NCT00615251已完成3 期
A Phase 3, Single-Blind, Randomized Study to Compare DR-2011 to a Progesterone Gel for Luteal Phase Supplementation for In Vitro Fertilization
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
- 1,297
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy
研究概览
简要总结
This is a multi-center study to evaluate the effects of DR-2011 compared to a progesterone gel in women undergoing in vitro fertilization with fresh eggs. The overall study duration will be approximately 12 months and will involve ovarian suppression/stimulation protocols as well as egg retrieval.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pre-menopausal, aged 18-42 old at time of consent
- •At least one cycle without fertility medication prior to screening
- •Tubal, idiopathic, male factor, ovulatory dysfunction or endometriosis- linked infertility
- •Semen analysis (frozen sperm, including donor sperm, may be used, as long as testing done at time of freezing meets standard criteria)
- •Others as indicated by FDA-approved protocol
排除标准
- •Any contraindication to progesterone therapy
- •BMI > 38 kg/m2
- •Clinically significant gynecologic pathology (for example: submucosal fibroids, abnormal uterine cavity, or others)
- •History of more than 1 failed fresh IVF cycles
- •More than 2 consecutive clinical miscarriages (gestational sac observed on ultrasound)
- •Others as indicated by FDA-approved protocol
研究组 & 干预措施
1
Experimental
干预措施: DR-2011 (Drug)
2
Active Comparator
干预措施: Crinone 8% (Drug)
结局指标
主要结局
Clinical pregnancy rate at 8 weeks and 12 weeks of pregnancy
时间窗: 8 weeks of pregnancy (6 weeks after egg retrieval) and 12 weeks of pregnancy (10 weeks after egg retrieval)
次要结局
- Secondary outcome measures will include: live birth rate, cycle cancellation rate, rate of spontaneous abortion, rate of biochemical pregnancy, rate of ectopic pregnancy(Duration of study)
- Adverse events(Duration of study)
研究者
研究点 (1)
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