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Improving Embryogenesis by Adding Growth Factors to In Vitro Human Culture Media (GFSSSCM)

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ClinicalTrials.gov Identifier: NCT02426008
Recruitment Status : Completed
First Posted : April 24, 2015
Last Update Posted : October 2, 2018
Sponsor:
Collaborator:
Banon IVF Center Assiut, Egypt
Information provided by (Responsible Party):
Muhammad Fawzy, Ibn Sina Hospital

Brief Summary:
The investigators suppose that adding growth factors that had been found in the female tubal fluid and uterus to In Vitro single step culture media for human embryos might improve the the embryogenesis In Vitro and the clinical outcome of the resulting off spring.

Condition or disease Intervention/treatment Phase
In Vitro Human Embryo Development Other: Growth Factors and Cytokine adding to embryo culture media Other: No Intervention Not Applicable

Detailed Description:
The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding growth factors ( Insulin-like growth factor I, Insulin-like growth factor II, transforming growth factor-beta and epidermal growth factor ) as a promoting growth factors to Lifeglobal culture media might improve embryo development in vitro so we decide to design a trial to compare the embryogenesis by sibling Oocytes of the same patient between to arm of the same culture media and the same culture condition but with one arm with growth factors and the other is traditional one and closely monitor the outcome within the 2 arms and record the results.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 426 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Growth Factors Supplementation to Single-Step Culture Medium
Actual Study Start Date : May 1, 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Experimental: Culture media with growth factors and Cytokine
Growth factors and Cytokine adding to culture media to detect the deference and monitor the embryological outcome.
Other: Growth Factors and Cytokine adding to embryo culture media
Placebo Comparator: In Vitro culture media
culture media to monitor the embryological outcome as control group
Other: No Intervention
Nothing to Add




Primary Outcome Measures :
  1. Clinical Pregnancy rate ( % ) [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. ongoing Pregnancy rate ( % ) [ Time Frame: 6 months ]
  2. rates of blastocyst formation and quality [ Time Frame: 6 days of culture ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all patients

Exclusion Criteria:

  • over 40 years old

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02426008


Locations
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Egypt
Ibnsina IVF center
Sohag, Egypt
Sponsors and Collaborators
Ibn Sina Hospital
Banon IVF Center Assiut, Egypt
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Responsible Party: Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier: NCT02426008    
Other Study ID Numbers: IbnSina IVF
First Posted: April 24, 2015    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Additional relevant MeSH terms:
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Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action