Timing of Estrogen Support During the Luteal Phase of IVF / Intracytoplasmic Sperm Injection Cycle: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 301
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
To test the hypothesis that adding estradiol (E2) to progesterone supplementation later in the luteal phase of in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) cycles, rather than earlier in the luteal phase, improves clinical pregnancy rates (PRs).
详细描述
Several studies reported that elevated E2 may have a detrimental effect on endometrial receptivity and embryo. This conflict was the starting point of our study. The investigators thought that this luteal decrease in E2 level could be prevented by adding estradiol just before the receptivity window is open, instead of adding earlier in the luteal phase which could result in defective embryo implantation.
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 (Investigator)
入排标准
- 年龄范围
- — 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients on long GnRH agonist protocol with controlled ovarian hyperstimulation who were seen in our IVF clinic between February and November 2008, and who have E2 levels on the day of hCG administration >2500 pg/dl
排除标准
- •Presence of azoospermia requiring testicular sperm extraction procedure
- •endometriosis greater than stage II
- •unilateral oophorectomy, polycystic ovarian syndrome (PCOS)
- •secondary infertility
- •age greater than 40 yrs and a basal follicle stimulating hormone (FSH) level higher than 12 mIU/ml were exclusion criteria
研究组 & 干预措施
Progesterone+Early Estradiol group
received 2 mg estradiol tablets orally two times daily beginning from the first day after hCG injection, in addition to vaginal progesterone gel
干预措施: estradiol tablet (Drug)
Progesterone+Late estradiol group
received 2 mg estradiol tablets orally two times daily beginning from the fifth day after hCG injection, in addition to vaginal progesterone gel
干预措施: estradiol tablet (Drug)
结局指标
主要结局
Clinical pregnancy rate
时间窗: sixth gestational week.
Clinical pregnancies were detected with the confirmation of positive fetal cardiac activities by transvaginal sonography in the sixth gestational week.
次要结局
未报告次要终点