Adding Cytokines to In Vitro Human Culture Media to Improve Embryogenesis and Implantation (GHLCSHED)
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media
Sponsored by
About this trial
This is an interventional other trial for Infertility focused on measuring In Vitro culture of human embryos
Eligibility Criteria
Inclusion Criteria:
- all patients
Exclusion Criteria:
- over 40 years
Sites / Locations
- Banon IVF Center
- Ibnsina IVF center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Cytokines supplemented In Vitro single culture media
Traditional Single step culture media
Arm Description
We will add Cytokines (LIF, HB-EGF and GM-CSF) to LIFEGLOBAL culture media and assess the embryogenesis and pregnancy.
Outcomes
Primary Outcome Measures
ongoing pregnancy rate ( % )
Secondary Outcome Measures
clinical pregnancy rate ( % )
implantation rate
fertilization rate
top-quality embryo rate
rates for blastocyst formation and quality
embryo utilization rate
Full Information
NCT ID
NCT02420886
First Posted
April 15, 2015
Last Updated
September 29, 2018
Sponsor
Ibn Sina Hospital
Collaborators
Banon IVF Center Assiut, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT02420886
Brief Title
Adding Cytokines to In Vitro Human Culture Media to Improve Embryogenesis and Implantation
Acronym
GHLCSHED
Official Title
The Effects of GM-CSF, HB-EGF and LIF Cytokines Supplementation Need Verification for Human Embryo Development in Vitro
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
May 16, 2015 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
Collaborators
Banon IVF Center Assiut, Egypt
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
In Vitro culture of human embryos
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
443 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cytokines supplemented In Vitro single culture media
Arm Type
Active Comparator
Arm Description
We will add Cytokines (LIF, HB-EGF and GM-CSF) to LIFEGLOBAL culture media and assess the embryogenesis and pregnancy.
Arm Title
Traditional Single step culture media
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Adding LIF, HB-EGF and GM-CSF to Lifeglobal human IVF culture media
Primary Outcome Measure Information:
Title
ongoing pregnancy rate ( % )
Time Frame
6 months
Secondary Outcome Measure Information:
Title
clinical pregnancy rate ( % )
Time Frame
6 months
Title
implantation rate
Time Frame
6 months
Title
fertilization rate
Time Frame
6 days of culture
Title
top-quality embryo rate
Time Frame
6 days of culture
Title
rates for blastocyst formation and quality
Time Frame
6 days of culture
Title
embryo utilization rate
Time Frame
6 days of culture
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
all patients
Exclusion Criteria:
over 40 years
Facility Information:
Facility Name
Banon IVF Center
City
Assiut
Country
Egypt
Facility Name
Ibnsina IVF center
City
Sohag
Country
Egypt
12. IPD Sharing Statement
Citations:
PubMed Identifier
31551154
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.
Results Reference
derived
Learn more about this trial
Adding Cytokines to In Vitro Human Culture Media to Improve Embryogenesis and Implantation
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