Culture, ICSI, IVFNCT02586324
Comparison of Two Embryo Culture Media for IVF and ICSI
A study testing global medium and SSM in people with Culture, ICSI, IVF, run by Centre Hospitalier Universitaire Dijon.
Trial summary
In this research, the two media used are Global medium and SSM medium with serum), which are routinely used in the reproduction biology unit. This study simply consists in setting up a methodology to compare these to media. The only constraint placed on patients is to accept randomization for the type of medium used. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Culture, ICSI, IVF
- What is being tested?
- global medium and SSM
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- Jan 2008to Mar 2009
- Phase
- Interventional
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Any IVF and IVF with ICSI procedure performed in the unit can be included in the study
Who cannot join
- refusal of patients to be randomized. In this case, the biologist chose the medium to be used and the IVF procedure will not be included in the statistical analysis
About this study
Official title: Comparison of Two Embryo Culture Media for IVF (in Vitro Fertilization) and ICSI ( Intracytoplasmic Sperm Injection ): Randomized Prospective Study
In this research, the two media used are Global medium and SSM medium with serum), which are routinely used in the reproduction biology unit. This study simply consists in setting up a methodology to compare these to media. The only constraint placed on patients is to accept randomization for the type of medium used.
- Conditions
- Culture, ICSI, IVF
- Being tested
- global medium, SSM
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
global mediumBiological
SSMBiological
| Study group | Role | What they receive |
|---|---|---|
| global medium | Other | Not described Receives: Biological: global medium |
| SSM | Experimental | Not described Receives: Biological: SSM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of pregnancies and deliveries
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2015 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionMar 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Culture, ICSI, IVFStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586324
- Sponsor's protocol ID
- JIMENEZ 2008
- Status last verified
- Mar 2016
- First submitted
- 23 Oct 2015
- Last updated
- 10 Mar 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Embryo Culture Media for IVF (in Vitro Fertilization) and ICSI ( Intracytoplasmic Sperm Injection ): Randomized Prospective Study
- ClinicalTrials.gov ID
- NCT02586324
- Acronym / sponsor ID
- JIMENEZ 2008
- Conditions
- Culture, ICSI, IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 26 Oct 2015 (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.
In this research, the two media used are Global medium and SSM medium with serum), which are routinely used in the reproduction biology unit. This study simply consists in setting up a methodology to compare these to media. The only constraint placed on patients is to accept randomization for the type of medium used.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| global medium | Other | Biological: global medium |
| SSM | Experimental | Biological: SSM |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Any IVF and IVF with ICSI procedure performed in the unit can be included in the study
Key exclusion criteria (1 listed)
- refusal of patients to be randomized. In this case, the biologist chose the medium to be used and the IVF procedure will not be included in the statistical analysis
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 |
|---|---|---|
| global medium | Biological | global medium |
| SSM | Biological | SSM |
Primary outcome
Rate of pregnancies and deliveries
Time frame: Up to 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2016.
Related trials for Culture, ICSI, IVF
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Evaluation of an Undisturbed Embryo Culture System for Embryo Development in IVF/ICSI Cycles
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Recruiting
Day-4 Embryo Defragmentation: Blastocyst Rate and clInical Outcomes
Female Infertility, Embryo Development
Recruiting
Effect of Antioxydant-enriched Media on Blastocyst Euploidy Rates.
Infertility, In Vitro Fertilization
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing global medium and SSM in people with Culture, ICSI, IVF, run by Centre Hospitalier Universitaire Dijon.
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 1 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: finished, as of the sponsor's last update on 10 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of pregnancies and deliveries (time frame: Up to 9 months). 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 10 Mar 2016.