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Adding Cytokines to In Vitro Human Culture Media to Improve Embryogenesis and Implantation (GHLCSHED)

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ClinicalTrials.gov Identifier: NCT02420886
Recruitment Status : Completed
First Posted : April 20, 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:
Assessment of the embryological benefit of in vitro adding of Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2n/ml) to the culture media and closely monitor its effect on embryogenesis and implantation outcomes.

Condition or disease Intervention/treatment Phase
Infertility Other: Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media Not Applicable

Detailed Description:
The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding the Cytokines (LIF 5ng/ml, HB-EGF 5ng/ml and GM-CSF 2ng/ml) as a growth factor that have multi-ways to 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 two arm of the same culture media and the same culture condition. One arm with Cytokines 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 : 443 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Other
Official Title: The Effects of GM-CSF, HB-EGF and LIF Cytokines Supplementation Need Verification for Human Embryo Development in Vitro
Actual Study Start Date : May 16, 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

Arm Intervention/treatment
Active Comparator: Cytokines supplemented In Vitro single culture media
We will add Cytokines (LIF, HB-EGF and GM-CSF) to LIFEGLOBAL culture media and assess the embryogenesis and pregnancy.
Other: Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media
No Intervention: Traditional Single step culture media



Primary Outcome Measures :
  1. ongoing pregnancy rate ( % ) [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. clinical pregnancy rate ( % ) [ Time Frame: 6 months ]
  2. implantation rate [ Time Frame: 6 months ]
  3. fertilization rate [ Time Frame: 6 days of culture ]
  4. top-quality embryo rate [ Time Frame: 6 days of culture ]
  5. rates for blastocyst formation and quality [ Time Frame: 6 days of culture ]
  6. embryo utilization rate [ 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

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): NCT02420886


Locations
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Egypt
Banon IVF Center
Assiut, Egypt
Ibnsina IVF center
Sohag, Egypt
Sponsors and Collaborators
Ibn Sina Hospital
Banon IVF Center Assiut, Egypt
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Muhammad Fawzy, IVF Laboratory Director, Ibn Sina Hospital
ClinicalTrials.gov Identifier: NCT02420886    
Other Study ID Numbers: Ibnsina IVF center
First Posted: April 20, 2015    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Keywords provided by Muhammad Fawzy, Ibn Sina Hospital:
In Vitro culture of human embryos
Additional relevant MeSH terms:
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Infertility