Comparison of Crinone 8% Intravaginal Gel or Intramuscular Progesterone Supplementation for In Vitro Fertilization (IVF) and Embryo Transfer (ET) Cycles in Women Under Age 40 Years Old
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 1
- 主要终点
- Percentage of Pregnant Patients After IVF Treatments
研究概览
简要总结
The goal of this research study is to compare the pregnancy rates for two different types of progesterone supplementation after in-vitro fertilization (IVF).
详细描述
The aim is to test the hypothesis that the pregnancy rates of women under age 40 undergoing an in vitro fertilization and embryo transfer (IVF-ET) cycle are not different with respect to the administration of progesterone (Crinone 8%, intravaginal gel versus intramuscular progesterone).
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
- 21 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of reproductive age (21-39) with infertility who are appropriate candidates for IVF/ET and have an FSH < 15 mIU/ml
- •Women 21 to 39 years of age who have been assigned to stimulation of 2 to 8 amps of Luteal Lupron/FSH or Luteal Lupron FSH/HMG.
排除标准
- •Women who have had more than 3 previous IVF/ET cycles
研究组 & 干预措施
Crinone 8% Vaginal Gel
Crinone 8% (90 mg of micronized progesterone in a bioadhesive vaginal gel contained in a single use, one piece applicator) once a day beginning the second day following oocyte retrieval (Study Group A) continuing until the pregnancy test is negative or until the 10th week of pregnancy.
干预措施: Crinone 8% Vaginal Gel (Drug)
Intramuscular Progesterone
Progesterone-50 mg intramuscularly once a day beginning the day after oocyte retrieval continuing until the pregnancy test is negative or if positive, switching to Crinone 8% intravaginal gel until the 10th week of pregnancy.
.
干预措施: Intramuscular Progesterone (Drug)
结局指标
主要结局
Percentage of Pregnant Patients After IVF Treatments
时间窗: 16 weeks
Percentage of pregnant patients after IVF treatments who received either Crinone or IM Progesterone after oocyte retrieval
次要结局
未报告次要终点
研究者
Elena Hesina Yanushpolsky, MD
Assistant Professor of Ob/Gyn, BWH and Harvard Medical School
Brigham and Women's Hospital