Is Adding E2 to P4 Luteal Support In High Responder Long Gn-RH Agonist ICSI Cycles Detrimental to Outcome? RCT

Is E2 Luteal Support in High Responder Long Gn-RH Agonist ICSI Cycles Detrimental to Cycle Outcome ? A Randomized Clinical Trial

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.

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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Inclusion criteria

• age<40 years,
• first ICSI cycle,
• third day FSH< 10 mIU/mL,
• serum E2 level on day of hCG administration <4,000 pg/mL,
• number of ova obtained >15

Exclusion Criteria:

• 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)