A randomized clinical trial to evaluate the effect of cytokine supplementation in embryo culture medium with various protein concentrations aiming to evaluate the effects of cytokines (CYK) integration into the human in vitro culture medium with high and low human serum albumin (HSA) concentrations on live birth rates after intracytoplasmic sperm injection (ICSI).
Oocytes were injected, and embryos cultured and transferred in three supplemented culture media. A- A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol), life global protein, without supplementation of CYK (control n=200), B- A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol), life global protein, with 2ng/mL GM-CSF (granulocyte macrophage colony stimulating factor) (G5035 Sigma), 5ng/mL HB-EGF (Heparine Binding Epidermal Growth Factor )(E4643 Sigma),and 5ng/mL LIF (Lukemia Inhbitory Factor) (SRP9001 Sigma)(n=200). C- A single step culture medium (SSCM; Global, Life Global) +2mg/ml (5% Vol/Vol) life global protein, with 2ng/mL GM-CSF (G5035 Sigma), 5ng/mL HB-EGF (E4643 Sigma), and 5ng/mL LIF (SRP9001 Sigma).(n=200) Setting :- - Mansoura Integrated Fertility
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
700
A single step culture medium (SSCM; Global, Life Global)+5mg/ml life global protein, without supplementation of CYK
Mansoura Integrated fertility Center
Al Mansurah, Dekahlia, Egypt
Mansoura Integrated Fertility Center
Al Mansurah, Egypt
live birth rate
the number of deliveries that resulted in at least one live born baby (\>20 weeks gestational age or 500 gm birth weight ) expressed per 100 embryo transfer,
Time frame: 9 months
Fertilization rate
Fertilization rate (fertilized oocytes with two pronuclei/ number of MII oocytes) ×100 %
Time frame: 4 weeks
Top quality day 3 embryos
embryos with seven or eight blastomeres of stage-proper sizes, and \<10% fragmentation by volume
Time frame: 4 weeks
Blastocyst formation rate
(number of blastocysts/number of cultured embryos for blastocyst formation) ×100%
Time frame: 4 weeks
Top blastocyst rate
(number of high quality blastocysts/number of formed blastocysts) ×100%
Time frame: 4 weeks
Available embryo rate
number of transferred and frozen embryos/number of zygotes (2 pronuclei) ×100%
Time frame: 4 weeks
clinical pregnancy rate
number of cycles with clinical pregnancy/number of transferred cycles) ×100%
Time frame: 8 weeks
Biochemical pregnancy rate
number of cycles with biochemical pregnancy/number of Cycles with positive HCG) ×100%.
Time frame: 6 weeks
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Implantation rate
number of implanted embryos/number of transferred embryos) ×100%
Time frame: 8 weeks
Early embryo loss rat
number of early spontaneously aborted embryos/number of transferred embryos) × 100%.
Time frame: 16 weeks
ongoing pregnancy rate
number of clinical pregnancies after 12 weeks divided by number of embryo transfers multiplied by 100
Time frame: 16 weeks