Cytokines Supplementation to Culture Media and ICSI Outcome

ICSI Clinical Trial

Official title:

Impact of Cytokine Supplementation With Various Protein Concentrations Into Human in Vitro Culture Medium on ICSI Cycle Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04547699
• Other study ID #: Cytokine plus Global Protein
• Status: Completed
• Phase: N/A
• 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
• 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)

Related Conditions & MeSH terms

• ICSI

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