Is E2 Luteal Support in High Responder Long Gn-RH Agonist ICSI Cycles Detrimental to Cycle Outcome ? A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- cycle pregnancy rate
研究概览
简要总结
Study if supporting luteal phase of high responder (high egg production or high Estradiol level) long Gn_Rh agonist protocol ICSI/IVF cycle by combined Estradiol and progesterone impairs or improves outcome in terms of pregnancy and implanation rates.
详细描述
The role of estradiol (E2) luteal support is still debated after more than a decade of use. Two recent met analyses (Gelbaya et al 2008) &(Jee et al 2010)( ) has shown that the addition of E2 to P4 for luteal phase support in IVF/ICSI cycles has no beneficial effect on pregnancy rates. However they commented that the data in the literature are, limited and heterogeneous, precluding the extraction of clear and definite conclusions. Previous met analysis ( Pritts and Atwood 2002 ) and an update (Fatemi et al 2007 ) and subsequent randomized trials ( Ghanem et al 2009 , Var et al 2011 ) reported beneficial effects of adding E2 to luteal P4 support. Recent retrospective studies have shown that high response in terms of excess egg production ( >15 . ) and or high E2 (Chen et al 2007,Kyrou et al 2009, Sunkara 2011 ) are detrimental to cycle outcome. This prospective randomized trial aims to study whether adding E2 to P4 luteal support in high ovarian responders is detrimental to cycle outcome or not
--------------- Gelbaya TA, KyrgiouM, Tsoumpou I, Nardo LG. The use of estradiol for luteal phase support in in vitro fertilization/intracytoplasmic sperminjec- tion cycles: a systematic review and meta-analysis. Fertil Steril 2008;90: 2116-25.
Jee BC, Suh CS, Kim SH, Kim YB, Moon SY. Effects of estradiol supplementation during the luteal phase of in vitro fertilization cycles: a meta-analysis Fertil Steril. 2010 Feb;93(2):428-36
Pritts EA, Atwood AK. Luteal phase support in infertility treatment: a meta-analysis of randomized trials. Hum Reprod 2002;17:2287-99 Fatemi HM, Popovic-Todorovic B, Papanikolaou E, Donoso P,Devroey P. An update of luteal phase support in stimulated IVF cycles.Hum Reprod Update 2007;13:581.
- Ghanem M E., Ehab E. Sadek, Elboghdady L. A.. Helal A S, Gamal Anas, Eldiasty A Bakre N I., Houssen M .The effect of luteal phase support protocol on cycle outcome and luteal phase hormone profile in long agonist protocol intracytoplasmic sperm injection cycles: a randomized clinical trial , Fertility and Sterility 2009 92: 486-493
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •age 40 years or more,
- •basal FSH 10 mIU/mL or more ,
- •eggs retrieved 15 or less ,
- •E2 level on day of hCG administration 4000 or more pg/ mL or more,
- •repeat ICSI , need for PGD, presence of myoma , hydrosalpinx (unless disconnected)
研究组 & 干预措施
estradiole - progesterone arm
Cases are given estradiole valerate 2mg 3 times /day from day of ovum pick up until the time of pregnancy test two weeks together with daily IM injection of 100 progesterone starting . Single intramuscular 0.1 mg decapeptyl are given on day of transfer
干预措施: estradiol plus progesterone 100 mg IM injection (Drug)
estradiole - progesterone arm
Cases are given estradiole valerate 2mg 3 times /day from day of ovum pick up until the time of pregnancy test two weeks together with daily IM injection of 100 progesterone starting . Single intramuscular 0.1 mg decapeptyl are given on day of transfer
干预措施: Progesterone IM of 100 mg (Drug)
Progesterone only arm
Patient are given 100 mg progesterone daily starting on day of pickup plus single dose of decapeptyl 0.1 mg on day of embryo transfer
干预措施: Progesterone IM of 100 mg (Drug)
结局指标
主要结局
cycle pregnancy rate
时间窗: 6 weeks
pregnancy rate per started cycle
次要结局
- implantation rate, multiple pregnancy rate, ongoing pregnancy rate ,live birth rate(6 weeks)
研究者
Emad Mohamad Sedeek
Dr
Mansoura Integrated Fertility Center