InfertilityNCT02066584
The Influence of Different Concentrations of Glucose in Culture Media on In Vitro Fertilization (IVF) Outcome of Sibling Oocytes
An observational study of Infertility, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Sibling oocyte incubation
- How many people
- 600 participants
- Where
- 1 siteIsrael
- Study dates
- Apr 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 42 years
- Women only
- No healthy volunteers
- Adult
Study population: Sibling oocytes retrieved from women who have undergone IVF treatment in our IVF unit.
Who may be able to join
- Sibling oocytes from cycles where at least 4 oocytes were retrieved
Who cannot join
- Less than 4 oocytes retrieved
- Partner has undergone testicular sperm extraction (TESE)
Trial locations and contacts
1 site in 1 country.
Israel1 site
Hillel Yaffe Medical Center
Hadera, 38100
Medeia Michaeli, PhD, medeia_michaeli@yahoo.com
Medeia Michaeli, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Sibling oocyte incubation
- Keywords
- sibling oocytes, glucose, culture media
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sibling oocyte incubationOther
| Study group | Role | What they receive |
|---|---|---|
| Universal IVF Medium | An oocyte culture medium containing 5.55 Mm glucose (Origio, Medi-Cult) Receives: Other: Sibling oocyte incubation | |
| ISM1 Medium | An oocyte culture medium containing 1mM glucose ((Origio, MediCult) Receives: Other: Sibling oocyte incubation | |
| P1 Medium | An oocyte culture medium containing no glucose (Irvine) Receives: Other: Sibling oocyte incubation | |
| ECM Medium | An oocyte culture medium containing 0.5mM glucose (Irvine) Receives: Other: Sibling oocyte incubation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization Rate
Fertilization rates will be retrospectively compared according to culture media in which sibling oocytes were incubated
Measured: 2 years
Secondary outcomes (1)
Embryo Quality
Embryo quality and developmental rate will be retrospectively compared according to culture media in which sibling oocytes were incubated
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016 (estimated)
- Study completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Medeia Michaelo, PhD, Principal investigator, Hellel Yaffe Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066584
- Sponsor's protocol ID
- 0011-14HYMC
- Status last verified
- Feb 2014
- First submitted
- 16 Feb 2014
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Different Concentrations of Glucose in Culture Media on In Vitro Fertilization Outcome of Sibling Oocytes
- ClinicalTrials.gov ID
- NCT02066584
- Acronym / sponsor ID
- 0011-14HYMC
- Conditions
- Infertility
- Keywords
- sibling oocytes, glucose, culture media
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (estimated)
- Study completion
- Apr 2016 (estimated)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Universal IVF Medium | – | Other: Sibling oocyte incubationAn oocyte culture medium containing 5.55 Mm glucose (Origio, Medi-Cult) |
| ISM1 Medium | – | Other: Sibling oocyte incubationAn oocyte culture medium containing 1mM glucose ((Origio, MediCult) |
| P1 Medium | – | Other: Sibling oocyte incubationAn oocyte culture medium containing no glucose (Irvine) |
| ECM Medium | – | Other: Sibling oocyte incubationAn oocyte culture medium containing 0.5mM glucose (Irvine) |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Sibling oocytes retrieved from women who have undergone IVF treatment in our IVF unit.
Key inclusion criteria (1 listed)
- Sibling oocytes from cycles where at least 4 oocytes were retrieved
Key exclusion criteria (2 listed)
- Less than 4 oocytes retrieved
- Partner has undergone testicular sperm extraction (TESE)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sibling oocyte incubation | Other | ECM Medium, ISM1 Medium, P1 Medium, Universal IVF Medium |
Primary outcome
Fertilization Rate
Time frame: 2 years
Fertilization rates will be retrospectively compared according to culture media in which sibling oocytes were incubated
1 secondary outcome
Embryo Quality
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medeia Michaelo, PhD principal investigator
Hellel Yaffe Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Medeia Michaeli, PhD (972-50-6246885, medeia_michaeli@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertilization Rate (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.