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NCT Number: NCT04547699

Cytokines Supplementation to Culture Media and ICSI Outcome

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).

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Key information

Conditions

ICSI

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura Integrated fertility Center, Al Mansurah, Dekahlia, Egypt

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About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

A single step culture medium

Combination Product

A single step culture medium (SSCM; Global, Life Global)+5mg/ml life global protein, without supplementation of CYK

Primary outcomes

  1. live birth rate

    Time frame: 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 outcomes

  1. Fertilization rate

    Time frame: 4 weeks

    Fertilization rate (fertilized oocytes with two pronuclei/ number of MII oocytes) ×100 %

  2. Top quality day 3 embryos

    Time frame: 4 weeks

    embryos with seven or eight blastomeres of stage-proper sizes, and <10% fragmentation by volume

  3. Blastocyst formation rate

    Time frame: 4 weeks

    (number of blastocysts/number of cultured embryos for blastocyst formation) ×100%

  4. Top blastocyst rate

    Time frame: 4 weeks

    (number of high quality blastocysts/number of formed blastocysts) ×100%

  5. Available embryo rate

    Time frame: 4 weeks

    number of transferred and frozen embryos/number of zygotes (2 pronuclei) ×100%

  6. clinical pregnancy rate

    Time frame: 8 weeks

    number of cycles with clinical pregnancy/number of transferred cycles) ×100%

  7. Biochemical pregnancy rate

    Time frame: 6 weeks

    number of cycles with biochemical pregnancy/number of Cycles with positive HCG) ×100%.

  8. Implantation rate

    Time frame: 8 weeks

    number of implanted embryos/number of transferred embryos) ×100%

  9. Early embryo loss rat

    Time frame: 16 weeks

    number of early spontaneously aborted embryos/number of transferred embryos) × 100%.

  10. ongoing pregnancy rate

    Time frame: 16 weeks

    number of clinical pregnancies after 12 weeks divided by number of embryo transfers multiplied by 100

Sponsors and collaborators

Lead sponsor

Mansoura Integrated Fertility Center

Other

Collaborators

  • Rahem Fertility Center

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Sep 14, 2020
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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