- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02420171
Adding Insulin to IVF Culture Media Significantly Improve Outcome
July 11, 2016 updated by: Muhammad Fawzy, Ibn Sina Hospital
Add insulin to a single step culture media for IVF embryo culture from day 0 to day 5/6 of In Vitro culture and detect the the effect upon embryo quality and implantation potential.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The IVF culture media design and upgrade underwent many ideas during the last 3 decades, we suppose that adding insulin as a hormon and growth factor 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 yhe same culture condition but with one arm with insulin and the other is traditional one and closely monitor the outcome within the 2 arms abd record the results
Study Type
Interventional
Enrollment (Actual)
360
Phase
- 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
-
-
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Assiut, Egypt
- Banon IVF center
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Sohag, Egypt
- IbnSina IVF Center
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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
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- normal responder
- PCOS
- Tubal factor infertility
- mild asthenozoospermia
Exclusion Criteria:
- patient over 40
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: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: In Vitro culture media with insulin
We will add insulin to the single step culture media to monitor the embryogenesis
|
We will add insulin for in vitro culture of human embryos
|
No Intervention: In Vitro culture media without insulin m
The embryos will be cultured in the media without insulin and compare this arm as the control arm with the interventional one.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
clinical Pregnancy rate ( % )
Time Frame: 6 months
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Blastocyst rate ( % )
Time Frame: 6 months
|
6 months
|
Blastocyst quality rate ( % )
Time Frame: 6 months
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
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
January 1, 2015
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
April 14, 2015
First Submitted That Met QC Criteria
April 16, 2015
First Posted (Estimate)
April 17, 2015
Study Record Updates
Last Update Posted (Estimate)
July 13, 2016
Last Update Submitted That Met QC Criteria
July 11, 2016
Last Verified
July 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ibnsina IVF center Sohag
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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