Cytokines Supplementation to Culture Media and ICSI Outcome

Mansoura Integrated Fertility Center

Status: Completed

Conditions: ICSI

Treatments: Combination Product: A single step culture medium

Study type: Interventional

Funder types: Other

Identifiers

NCT04547699

Cytokine plus Global Protein

Details and patient eligibility

About

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).

Full 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

Enrollment: 700 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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700 participants in 3 patient groups, including a placebo group

HSA

Placebo Comparator group

Description:

A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol) life global protein,

Treatment:

Combination Product: A single step culture medium

CYK+ high HSA

Experimental group

Description:

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).

Treatment:

Combination Product: A single step culture medium

CYK+low HSA

Active Comparator group

Description:

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).

Treatment:

Combination Product: A single step culture medium