- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02066584
The Influence of Different Concentrations of Glucose in Culture Media on In Vitro Fertilization (IVF) Outcome of Sibling Oocytes
February 18, 2014 updated by: Hillel Yaffe Medical Center
The Influence of Different Concentrations of Glucose in Culture Media on In Vitro Fertilization Outcome of Sibling Oocytes
The importance of glucose in culture media on fertilization and embryo development is still controversial.
Although it has been reported that glucose is essential for fertilization process and biosynthesis of membrane lipid and nucleic acids, comparatively high levels of glucose in culture media may cause developmental arrest of cleavage stage embryos.
The aim of this retrospective study is to examine whether exposure of sibling oocytes to different concentrations of glucose in culture media has any further effect on IVF outcome.
Study Overview
Detailed Description
This retrospective study will include data from either standard IVF or Intracytoplasmic Sperm Injection (ICSI) cycles, in which sibling oocytes were equally divided and incubated separately in one of the following pairs of culture media:
- Universal IVF medium vs. ISM1 medium ( Origio, Medi-Cult)
- P1 medium vs. ECM medium (Irvine).
Fertilization rate,as well as embryo cleavage rate and morphology will be evaluated.
Study Type
Observational
Enrollment (Anticipated)
600
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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Hadera, Israel, 38100
- Hillel Yaffe Medical 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 42 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Sibling oocytes retrieved from women who have undergone IVF treatment in our IVF unit.
Description
Inclusion Criteria:
- Sibling oocytes from cycles where at least 4 oocytes were retrieved
Exclusion Criteria:
- Less than 4 oocytes retrieved
- Partner has undergone testicular sperm extraction (TESE)
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Universal IVF Medium
An oocyte culture medium containing 5.55 Mm glucose (Origio, Medi-Cult)
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ISM1 Medium
An oocyte culture medium containing 1mM glucose ((Origio, MediCult)
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P1 Medium
An oocyte culture medium containing no glucose (Irvine)
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ECM Medium
An oocyte culture medium containing 0.5mM glucose (Irvine)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Fertilization Rate
Time Frame: 2 years
|
Fertilization rates will be retrospectively compared according to culture media in which sibling oocytes were incubated
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2 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Embryo Quality
Time Frame: 2 years
|
Embryo quality and developmental rate will be retrospectively compared according to culture media in which sibling oocytes were incubated
|
2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Medeia Michaelo, PhD, Hellel Yaffe Medical Center
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
April 1, 2014
Primary Completion (Anticipated)
April 1, 2016
Study Completion (Anticipated)
April 1, 2016
Study Registration Dates
First Submitted
February 16, 2014
First Submitted That Met QC Criteria
February 18, 2014
First Posted (Estimate)
February 19, 2014
Study Record Updates
Last Update Posted (Estimate)
February 19, 2014
Last Update Submitted That Met QC Criteria
February 18, 2014
Last Verified
February 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0011-14HYMC
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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