Early Progesterone Cessation After in Vitro Fertilization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Number of Bleeding Episodes
研究概览
简要总结
There seems to be a general consensus on the supplementation of progesterone (P4) for luteal phase support (LPS) to all women after in vitro fertilization (IVF) treatment. However, there is no agreement about the precise duration of LPS.
详细描述
The objective of the study is to investigate the effect of early cessation of progesterone for LPS after IVF treatment on the pregnancy outcome, with special interest in determining the miscarriage rate and episodes of bleeding between the date of the first ultrasound (US) and up to 12 weeks of gestation.
Patients start to receive 200 mg twice a day of P4 on the day after oocyte retrieval.
All patients which show a gestational sac in their uterus in the first US are included in this study and randomized.
Inclusion criteria:
- Patients who underwent ovarian stimulation using GnRH analogues,
- Fresh embryo transfer,
- LPS by vaginal micronized P4,
- Clinical pregnancy demonstrated by US and
- Informed consent signed.
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
- •Patients who underwent ovarian stimulation using GnRH analogues,
- •Fresh embryo transfer,
- •LPS by vaginal micronized P4,
- •Clinical pregnancy demonstrated by US and
- •Informed consent signed.
排除标准
- •Patients who had bleeding episodes before their first US because they are likely to continue P4 therapy without medical indication.
结局指标
主要结局
Number of Bleeding Episodes
时间窗: Up to year
Number of bleeding episodes up to a year
次要结局
未报告次要终点
研究者
Graciela Kohls
Gynecologist
IVI Madrid