Cytokines Supplementation to Culture Media and ICSI Outcome
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: HSA A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol) life global protein, |
Combination Product: A single step culture medium
A single step culture medium (SSCM; Global, Life Global)+5mg/ml life global protein, without supplementation of CYK
|
| Experimental: CYK+ high HSA 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). |
Combination Product: A single step culture medium
A single step culture medium (SSCM; Global, Life Global)+5mg/ml life global protein, without supplementation of CYK
|
| Active Comparator: CYK+low HSA 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). |
Combination Product: A single step culture medium
A single step culture medium (SSCM; Global, Life Global)+5mg/ml life global protein, without supplementation of CYK
|
Outcome Measures
Primary Outcome Measures
- 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
- Fertilization rate [4 weeks]
Fertilization rate (fertilized oocytes with two pronuclei/ number of MII oocytes) ×100 %
- 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%
- clinical pregnancy rate [8 weeks]
number of cycles with clinical pregnancy/number of transferred cycles) ×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
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Mansoura Integrated fertility Center | Mansoura | Dekahlia | Egypt | |
| 2 | Mansoura Integrated Fertility Center | Mansoura | Egypt | 3311 |
Sponsors and Collaborators
- Mansoura Integrated Fertility Center
- Rahem Fertility Center
Investigators
- Principal Investigator: Emad M Sedeek, MS, MIFC
Study Documents (Full-Text)
None provided.More Information
Publications
- Fawzy M, Emad M, Elsuity MA, Mahran A, Abdelrahman MY, Fetih AN, Abdelghafar H, Sabry M, Nour M, Rasheed SM. Cytokines hold promise for human embryo culture in vitro: results of a randomized clinical trial. Fertil Steril. 2019 Nov;112(5):849-857.e1. doi: 10.1016/j.fertnstert.2019.07.012. Epub 2019 Sep 21.
- Fukui Y, Hirota Y, Matsuo M, Gebril M, Akaeda S, Hiraoka T, Osuga Y. Uterine receptivity, embryo attachment, and embryo invasion: Multistep processes in embryo implantation. Reprod Med Biol. 2019 May 24;18(3):234-240. doi: 10.1002/rmb2.12280. eCollection 2019 Jul. Review.
- Guzeloglu-Kayisli O, Kayisli UA, Taylor HS. The role of growth factors and cytokines during implantation: endocrine and paracrine interactions. Semin Reprod Med. 2009 Jan;27(1):62-79. doi: 10.1055/s-0028-1108011. Epub 2009 Feb 5. Review.
- Cytokine plus Global Protein