Back to resultsNovel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cytokine group
Sponsored by
About this trial
This is an interventional basic science trial for Infertility focused on measuring Pregnancy, implantation, Cytokine
Eligibility Criteria
Inclusion Criteria:
- all patients
Exclusion Criteria:
- above 40 years old
Sites / Locations
- Banon IVF center
- Ibnsina IVF center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Cytokine plus Hyalurinan embryo transfer arm
Hyalurinan embryo transfer group
Arm Description
To monitor the pregnancy and implantation of the patients in this arm after adding Cytokine to the embryo transfer medium.
To transfer the embryos using a Hyaluronan enriched medium only
Outcomes
Primary Outcome Measures
Pregnancy rate ( % )
Secondary Outcome Measures
Implantation rate ( % )
Full Information
NCT ID
NCT02422134
First Posted
April 16, 2015
Last Updated
June 28, 2016
Sponsor
Ibn Sina Hospital
Collaborators
Banon IVF Center Assiut, Egypt
1. Study Identification
Unique Protocol Identification Number
NCT02422134
Brief Title
Novel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (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
It was proven that the Cytokine granulocyte-Macrophage clony stimulating factor had been found naturally in reproductive tract so our target is to test its effect if added to embryo transfer medium.
Detailed Description
The IVF embryo transfer media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding Cytokine GM-CSF as an endometrial modifier to already proven successful medium hyaluronan enriched medium to test the efficacy ipon pregnancy and implantation rate in vitro so we decide to design a trial to compare the clinical outcome by sibling embryo to be transferred into 2 groups and the same culture condition but with one arm with Cytokine 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
Pregnancy, implantation, Cytokine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cytokine plus Hyalurinan embryo transfer arm
Arm Type
Active Comparator
Arm Description
To monitor the pregnancy and implantation of the patients in this arm after adding Cytokine to the embryo transfer medium.
Arm Title
Hyalurinan embryo transfer group
Arm Type
No Intervention
Arm Description
To transfer the embryos using a Hyaluronan enriched medium only
Intervention Type
Other
Intervention Name(s)
Cytokine group
Intervention Description
Testing the efficacy of adding Cytokine to embryo transfer medium
Primary Outcome Measure Information:
Title
Pregnancy rate ( % )
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Implantation rate ( % )
Time Frame
9 months
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:
above 40 years old
Facility Information:
Facility Name
Banon IVF center
City
Assiut
Country
Egypt
Facility Name
Ibnsina IVF center
City
Sohag
Country
Egypt
12. IPD Sharing Statement
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Novel Approach for Embryo Transfer Medium by Adding Cytokine to Hyaluronan Enriched Embryo Transfer Medium (Embryo Glue)
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