Iron deficiency may play a critical role in human infertility, oocyte quality and may even play a role in endometrial receptivity. By correcting iron deficiency, low ferritin values, in infertile women with intravenous iron supplementation, embryo quality and pregnancy rates may improve. The main objective is to evaluate the effect of intravenous iron supplementation on embryo quality (number of good quality blastocysts). Randomized, double blind, parallel group, cross-over study of ferric carboxymaltose compared to placebo (NaCl infusion).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
62
Infusion prior the start of IVF/ICSI cycle. Dosing according to the summary of product characteristics (SmPC) chart. Placebo infusion before frozen embryo transfer if needed.
Placebo infusion prior the start of IVF/ICSI cycle. Ferric Carboxymaltose infusion before frozen embryo transfer if needed. Dosing according to the summary of product characteristics (SmPC) chart.
Dextra Fertility Clinic
Helsinki, Finland
Number of good quality blastocysts
good quality blastocyst are defined as blastocyst, which are transferable or may be frozen
Time frame: day 5-7 after oocyte pick up
blastulation rate
number of blastocysts /fertilized oocyte
Time frame: day 5-7 after oocyte pick up
ongoing pregnancy/ pregnancy rate
ongoing pregnancy at 12 weeks of gestation/ positive pregnancy test (%)
Time frame: 10 weeks after oocyte pick up,at oocyte pick up it counted to be 2 weeks of gestation.
mature oocyte rate
number of mature oocytes / total number of oocytes (%)
Time frame: 1 day after oocyte pick up
fertilization rate
number of fertilized oocytes/total number of oocytes (%)
Time frame: 1 day after oocyte pick up
implantation rate
number of attached embryos/ embryo transfer (%)
Time frame: 5 weeks after embryo transfer
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