Does the Time of Starting Progesterone (P4) Luteal Support (LS) Affects Embryo Transfer (ET) in Long Agonist Protocol Down-regulated ICSI Cycles?
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 主要终点
- difficult embryo transfer
研究概览
简要总结
The study aims to know whether starting progesterone luteal support in intra cytoplasmic sperm injection (ICSI) cycles on the day of ovum pickup affects the degree of difficulty of embryo transfer compared with starting luteal support on day of embryo transfer
详细描述
Double blind Randomized Controlled Trial (RCT) : the clinicians and the patents were blinded of the allocation group.
A total of 137 embryo transfers were randomly allocated into either arm I (67 ) starting luteal support as daily IM injections of 100 mg prontogest on day of egg retrieval , or arm II (66) starting the same P4 dose on day of embryo transfer
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
- Double (Participant, Care Provider)
盲法说明
The randomization
入排标准
- 年龄范围
- 18 Years 至 38 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •first ICSI trial, normal uterus, normal cervix, normal ovarian response ,easy mock transfer,patient consenting
排除标准
- •age over 38, difficult mock transfer, low and high ovarian response, patient not consenting
研究组 & 干预措施
Egg retrieval arm
67 ICSI cases are started daily 100 mg IM prontogest on the day of egg retrieval until the day of pregnancy test.
干预措施: Progesterone 100 IM/day (Drug)
Embryo transfer arm
66 ICSI cases are started daily 100 mg IM prontogest on the day of embryo transfer until the day of pregnancy test.
干预措施: Progesterone 100 IM/day (Drug)
结局指标
主要结局
difficult embryo transfer
时间窗: 3 minutes
presence of blood on embryo transfer catheter and or need for sounding or dilating the cervix to pass the embryo transfer catheter to the endometrial cavity
次要结局
- cycle outcome(4 weeks)
研究者
Mohamad Elsaid Ghanem
Professor
Mansoura Integrated Fertility Center