Cytokines Supplementation to Culture Media and ICSI Outcome

June 16, 2023 updated by: Emad Mohamad Sedeek, Mansoura Integrated Fertility Center

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
700

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Mansoura, Egypt, 3311
        • Mansoura Integrated Fertility Center
    • Dekahlia
      • Mansoura, Dekahlia, Egypt
        • Mansoura Integrated Fertility Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 38 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: HSA
A single step culture medium (SSCM; Global, Life Global)+5mg/ml (10% Vol/Vol) life global protein,
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
Experimental: CYK+ high HSA
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).
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
Active Comparator: CYK+low HSA
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).
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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,
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Fertilization rate
Time Frame: 4 weeks
Fertilization rate (fertilized oocytes with two pronuclei/ number of MII oocytes) ×100 %
4 weeks
Top quality day 3 embryos
Time Frame: 4 weeks
embryos with seven or eight blastomeres of stage-proper sizes, and <10% fragmentation by volume
4 weeks
Blastocyst formation rate
Time Frame: 4 weeks
(number of blastocysts/number of cultured embryos for blastocyst formation) ×100%
4 weeks
Top blastocyst rate
Time Frame: 4 weeks
(number of high quality blastocysts/number of formed blastocysts) ×100%
4 weeks
Available embryo rate
Time Frame: 4 weeks
number of transferred and frozen embryos/number of zygotes (2 pronuclei) ×100%
4 weeks
clinical pregnancy rate
Time Frame: 8 weeks
number of cycles with clinical pregnancy/number of transferred cycles) ×100%
8 weeks
Biochemical pregnancy rate
Time Frame: 6 weeks
number of cycles with biochemical pregnancy/number of Cycles with positive HCG) ×100%.
6 weeks
Implantation rate
Time Frame: 8 weeks
number of implanted embryos/number of transferred embryos) ×100%
8 weeks
Early embryo loss rat
Time Frame: 16 weeks
number of early spontaneously aborted embryos/number of transferred embryos) × 100%.
16 weeks
ongoing pregnancy rate
Time Frame: 16 weeks
number of clinical pregnancies after 12 weeks divided by number of embryo transfers multiplied by 100
16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mansoura Integrated Fertility Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rahem Fertility Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emad M Sedeek, MS, MIFC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 14, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Cytokine plus Global Protein

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

all IPD will be shared

IPD Sharing Time Frame

6 months after completion and for 3 months

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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