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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04547699
Other study ID # Cytokine plus Global Protein
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date July 1, 2022

Study information

Verified date June 2023
Source Mansoura Integrated Fertility Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Completed
Enrollment 700
Est. completion date July 1, 2022
Est. primary completion date July 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 38 Years
Eligibility 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)

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Mansoura Integrated fertility Center Mansoura Dekahlia
Egypt Mansoura Integrated Fertility Center Mansoura

Sponsors (2)

Lead Sponsor Collaborator
Mansoura Integrated Fertility Center Rahem Fertility Center

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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, 9 months
Secondary Fertilization rate Fertilization rate (fertilized oocytes with two pronuclei/ number of MII oocytes) ×100 % 4 weeks
Secondary Top quality day 3 embryos embryos with seven or eight blastomeres of stage-proper sizes, and <10% fragmentation by volume 4 weeks
Secondary Blastocyst formation rate (number of blastocysts/number of cultured embryos for blastocyst formation) ×100% 4 weeks
Secondary Top blastocyst rate (number of high quality blastocysts/number of formed blastocysts) ×100% 4 weeks
Secondary Available embryo rate number of transferred and frozen embryos/number of zygotes (2 pronuclei) ×100% 4 weeks
Secondary clinical pregnancy rate number of cycles with clinical pregnancy/number of transferred cycles) ×100% 8 weeks
Secondary Biochemical pregnancy rate number of cycles with biochemical pregnancy/number of Cycles with positive HCG) ×100%. 6 weeks
Secondary Implantation rate number of implanted embryos/number of transferred embryos) ×100% 8 weeks
Secondary Early embryo loss rat number of early spontaneously aborted embryos/number of transferred embryos) × 100%. 16 weeks
Secondary ongoing pregnancy rate number of clinical pregnancies after 12 weeks divided by number of embryo transfers multiplied by 100 16 weeks
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