Is Adding E2 to P4 Luteal Support In High Responder Long Gn-RH Agonist ICSI Cycles Detrimental to Outcome? RCT
Condition: IVF; Infertility
MeSH terms: Infertility
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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

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Intervention name(s): estradiol plus progesterone 100 mg IM injection; Progesterone IM of 100 mg
Intervention type(s): Drug; Drug
Intervention description(s): estradile valaerate 2mg plus progesterone 100 mg/day support arm :E2 valerate 2mg three times /day are given to the arm cases plus P4 100 IM/day for 14 days starting on day of ovum pickup and single IM injection of 0.1 mg decapeptyl on day of ET; Starting on day of ovum pickup ICSI cases are given prontogest 100 mg IM /day plus single dose dose of treptorline 0.1mg is given sc on day of embryo transfer
Other intervention name(s): estradiole valerate 2mg,; Prontogest 100 mg; prontogest 100 mg ampoles
Intervention MeSH terms: Estradiol; Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: luteal support; high responder; ICSI; cycle outcome