Cytokines Supplementation to Culture Media and ICSI Outcome
- Conditions
- ICSI
- Interventions
- Combination Product: A single step culture medium
- Registration Number
- NCT04547699
- Lead Sponsor
- Mansoura Integrated Fertility Center
- Brief Summary
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).
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 700
- Patients who fitted the medical definition of infertility "One year of unprotected intercourse but not pregnant".
- History of ovarian or adnexal surgery.
- Suspicious findings of ovarian malignancy.
- Presence of endocrine disorders such as diabetes mellitus, hyper-prolactinemia, thyroid dysfunction, congenital adrenal hyperplasia, Cushing's syndrome, and adrenal insufficiency.
- Presence of Globozoospermia (100% round-headed spermatozoa)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CYK+ high HSA A single step culture medium A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol) life global protein, supplemented with 2ng/mL GM-CSF (G5035 Sigma), 5ng/mL HB-EGF (E4643 Sigma),and 5ng/mL LIF (SRP9001 Sigma). CYK+low HSA A single step culture medium A single step culture medium (SSCM; Global, Life Global) +2mg/ml (5% Vol/Vol) life global protein, supplemented with 2ng/mL GM-CSF (G5035 Sigma), 5ng/mL HB-EGF (E4643 Sigma), and 5ng/mL LIF (SRP9001 Sigma). HSA A single step culture medium A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol) life global protein,
- Primary Outcome Measures
Name Time Method live birth rate 9 months 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,
- Secondary Outcome Measures
Name Time Method Top quality day 3 embryos 4 weeks embryos with seven or eight blastomeres of stage-proper sizes, and \<10% fragmentation by volume
Implantation rate 8 weeks number of implanted embryos/number of transferred embryos) ×100%
Early embryo loss rat 16 weeks number of early spontaneously aborted embryos/number of transferred embryos) × 100%.
Fertilization rate 4 weeks Fertilization rate (fertilized oocytes with two pronuclei/ number of MII oocytes) ×100 %
Blastocyst formation rate 4 weeks (number of blastocysts/number of cultured embryos for blastocyst formation) ×100%
Top blastocyst rate 4 weeks (number of high quality blastocysts/number of formed blastocysts) ×100%
Available embryo rate 4 weeks number of transferred and frozen embryos/number of zygotes (2 pronuclei) ×100%
clinical pregnancy rate 8 weeks number of cycles with clinical pregnancy/number of transferred cycles) ×100%
ongoing pregnancy rate 16 weeks number of clinical pregnancies after 12 weeks divided by number of embryo transfers multiplied by 100
Biochemical pregnancy rate 6 weeks number of cycles with biochemical pregnancy/number of Cycles with positive HCG) ×100%.
Trial Locations
- Locations (2)
Mansoura Integrated fertility Center
🇪🇬Mansoura, Dekahlia, Egypt
Mansoura Integrated Fertility Center
🇪🇬Mansoura, Egypt