Impact of Luteal Phase Support With Vaginal Progesterone on the Clinical Pregnancy Rate in Intrauterine Insemination Cycles Stimulated With Gonadotrophins: a Prospective Randomized Multicentre Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 393
- 试验地点
- 1
- 主要终点
- clinical pregnancy rate per IUI cycle
研究概览
简要总结
The objective is to test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate (primary outcome) and live birth rate (secondary outcome) when compared to no luteal phase support in a program of intrauterine insemination (IUI) after controlled ovarian stimulation with gonadotrophins. Additionally, the length of the luteal phase will be recorded (secondary outcome) in order to detect luteal phase defects/insufficiencies in the absence of luteal phase suppletion as well as luteal phase prolongation in case of luteal phase support which may be a burden for the patients waiting for the outcome of the treatment.
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 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with an indication for IUI:
- •unexplained infertility
- •mild male factor infertility
- •minimal-mild endometriosis
- •first IUI cycle ever
- •normal ovulatory cycles (26-32d)
- •age<43,BMI≤30
- •presence of at least one patent tube on hysterosalpingography and/or laparoscopy
- •normal uterine cavity (ultrasound, hysterosalpingography, or laparoscopy)
- •Men: Total motile count ≥ 5 Million/ml after capacitation
排除标准
- •Patients with contra-indication for pregnancy , infertility or progesterone use.
研究组 & 干预措施
experimental
Luteal Phase support
干预措施: crinone (progesterone 8%, vaginal application) (Drug)
结局指标
主要结局
clinical pregnancy rate per IUI cycle
时间窗: by ultrasound at ± 5 to 6 weeks after IUI
次要结局
- live birth rate per IUI cycle(40 weeks after IUI)