ICSI
Conditions
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
Interventions
COMBINATION_PRODUCTA single step culture medium
A single step culture medium (SSCM; Global, Life Global)+5mg/ml life global protein, without supplementation of CYK
Sponsors
Rahem Fertility Center
Mansoura Integrated Fertility Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Multicenter, randomized, double-blinded and prospective study
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients who fitted the medical definition of infertility One year of unprotected intercourse but not pregnant.
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Top quality day 3 embryos | 4 weeks | embryos with seven or eight blastomeres of stage-proper sizes, and \<10% fragmentation by volume |
| 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% |
| Fertilization rate | 4 weeks | Fertilization rate (fertilized oocytes with two pronuclei/ number of MII oocytes) ×100 % |
| Biochemical pregnancy rate | 6 weeks | number of cycles with biochemical pregnancy/number of Cycles with positive HCG) ×100%. |
| 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%. |
| ongoing pregnancy rate | 16 weeks | number of clinical pregnancies after 12 weeks divided by number of embryo transfers multiplied by 100 |
| clinical pregnancy rate | 8 weeks | number of cycles with clinical pregnancy/number of transferred cycles) ×100% |
Countries
Egypt
Outcome results
None listed