Embryo DevelopmentNCT01767805
Impact of Culture Conditions on the Embryo Quality
A study testing Standard incubator, Mini incubator and 5% oxygen in people with Embryo Development, run by University Hospital, Gasthuisberg at 2 sites in Belgium.
Trial summary
The purpose of this study is to compare different culture conditions. The effect of the type of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5% versus 20%) will be evaluated on the embryo quality Read more about this study
- Who is it for?
- Ages 1 day to 3 daysHealthy volunteers can take part
- Conditions the study is for
- Embryo Development
- What is being tested?
- Standard incubator, Mini incubator and 5% oxygen
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 790 participants
- Where
- 2 sitesBelgium
- Study dates
- Jun 2009to Sep 2011
- 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 1 day to 3 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- embryos of patients younger than 36 years old
Who cannot join
- embryos of patients older than 36 years old
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
University Hospital Leuven, Catholic University Leuven
Leuven, Leuven, 3000
University Hospital Leuven, Catholic University Leuven
Leuven
About this study
The purpose of this study is to compare different culture conditions. The effect of the type of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5% versus 20%) will be evaluated on the embryo quality
- Conditions
- Embryo Development
- Being tested
- Standard incubator, Mini incubator, 5% oxygen, 20% oxygen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard incubatorProcedure or surgery
Mini incubatorProcedure or surgery
5% oxygenProcedure or surgery
20% oxygenProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Type of incubator | Other | Embryos are cultured in a standard incubator or a mini-incubator Receives: Procedure: Standard incubator; Procedure: Mini incubator |
| Oxygen concentration | Other | Embryos are cultured in an incubator with a gas mixture with 20% oxygen or with 5% oxygen Receives: Procedure: 5% oxygen; Procedure: 20% oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
embryo quality
Measured: day 1- day 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2013 (estimated)
- Study startJun 2009
- Primary completionSep 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo DevelopmentStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 790 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gasthuisberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas D'Hooghe, University Hospital, Gasthuisberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01767805
- Sponsor's protocol ID
- ML4563
- Status last verified
- Jan 2013
- First submitted
- 8 Jan 2013
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Culture Conditions on the Embryo Quality
- ClinicalTrials.gov ID
- NCT01767805
- Acronym / sponsor ID
- ML4563
- Conditions
- Embryo Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 790 participants (actual)
- Lead sponsor
- University Hospital, GasthuisbergUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 14 Jan 2013 (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 purpose of this study is to compare different culture conditions. The effect of the type of incubator (standard versus mini-incubator) and the effect of the oxygen concentration (5% versus 20%) will be evaluated on the embryo quality
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type of incubator | Other | Procedure: Standard incubator, Procedure: Mini incubatorEmbryos are cultured in a standard incubator or a mini-incubator |
| Oxygen concentration | Other | Procedure: 5% oxygen, Procedure: 20% oxygenEmbryos are cultured in an incubator with a gas mixture with 20% oxygen or with 5% oxygen |
Who may qualify
- Ages
- 1 day to 3 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- embryos of patients younger than 36 years old
Key exclusion criteria (1 listed)
- embryos of patients older than 36 years old
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 |
|---|---|---|
| Standard incubator | Procedure or surgery | Type of incubator |
| Mini incubator | Procedure or surgery | Type of incubator |
| 5% oxygen | Procedure or surgery | Oxygen concentration |
| 20% oxygen | Procedure or surgery | Oxygen concentration |
Primary outcome
embryo quality
Time frame: day 1- day 3
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 14 Jan 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard incubator, Mini incubator and 5% oxygen in people with Embryo Development, run by University Hospital, Gasthuisberg at 2 sites in Belgium.
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 14 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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?
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?
embryo quality (time frame: day 1- day 3). 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 14 Jan 2013.