Clinical trial NCT04547699: Cytokines Supplementation to Culture Media and ICSI Outcome
Official title: Impact of Cytokine Supplementation With Various Protein Concentrations Into Human in Vitro Culture Medium on ICSI Cycle Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ICSI
Lead sponsor: Mansoura Integrated Fertility Center
Sponsor class: OTHER
Collaborators: name: Rahem Fertility Center
First posted: 2020-09-14
Enrollment: 700
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multicenter, randomized, double-blinded and prospective study
Primary purpose: TREATMENT

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

Eligibility 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)

Primary outcomes:
measure: live birth rate
timeFrame: 9 months
Secondary outcomes:
measure: Fertilization rate
timeFrame: 4 weeks
measure: Top quality day 3 embryos
timeFrame: 4 weeks
measure: Blastocyst formation rate
timeFrame: 4 weeks
measure: Top blastocyst rate
timeFrame: 4 weeks
measure: Available embryo rate
timeFrame: 4 weeks
measure: clinical pregnancy rate
timeFrame: 8 weeks
measure: Biochemical pregnancy rate
timeFrame: 6 weeks
measure: Implantation rate
timeFrame: 8 weeks
measure: Early embryo loss rat
timeFrame: 16 weeks
measure: ongoing pregnancy rate
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Integrated fertility Center
state: Dekahlia
city: Mansoura
country: Egypt
facility: Mansoura Integrated Fertility Center
Study officials:
affiliation: MIFC
name: Emad M Sedeek, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.