Embryo DevelopmentNCT00718822
Outcome of Embryo Culture at Two Oxygen Tensions
A study testing oxygen concentration in the culture atmosphere in people with Embryo Development, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
The purpose of this study is to assess whether reduced oxygen tension in embryo culture has any effect on clinical outcome. Read more about this study
- Who is it for?
- Ages 22 to 44 years, women only
- Conditions the study is for
- Embryo Development
- What is being tested?
- oxygen concentration in the culture atmosphere
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 647 participants
- Where
- 1 siteSlovenia
- Study dates
- Aug 2006to Sep 2007
- 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 22 to 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- stimulated Intra Cytoplasmic Sperm Injection (ICSI) cycle
Who cannot join
- less than one mature (metaphase II) oocyte at the time of denudation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Does Reduced Oxygen Tension in Embryo Culture Influence Clinical Outcome of ICSI Cycles? A Prospective Randomized Trial
The purpose of this study is to assess whether reduced oxygen tension in embryo culture has any effect on clinical outcome.
- Conditions
- Embryo Development
- Being tested
- oxygen concentration in the culture atmosphere
- Keywords
- clinical outcome, ICSI cycles, low oxygen, poor responders, pregnancy rate, prospective randomized study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygen concentration in the culture atmosphereOther
| Study group | Role | What they receive |
|---|---|---|
| I | Experimental | 5% oxygen concentration in the culture atmosphere Receives: Other: oxygen concentration in the culture atmosphere |
| II | Experimental | 20% oxygen concentration in the culture atmosphere Receives: Other: oxygen concentration in the culture atmosphere |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ongoing pregnancy rate per cycle
Measured: 10-11 weeks after embryo transfer
Secondary outcomes (1)
clinical pregnancy rate, implantation rate, early pregnancy loss, fertilization rate, embryo quality
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startAug 2006
- Primary completionJun 2007
- Study completionSep 2007
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 647 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Collaborators
- Slovenian Research Agency
- Investigators
- Veljko Vlaisavljević, Prof., Study chair, University Medical Centre Maribor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00718822
- Sponsor's protocol ID
- P3-0327
- Status last verified
- Jul 2008
- First submitted
- 17 Jul 2008
- Last updated
- 21 Jul 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Reduced Oxygen Tension in Embryo Culture Influence Clinical Outcome of ICSI Cycles? A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT00718822
- Acronym / sponsor ID
- P3-0327
- Conditions
- Embryo Development
- Keywords
- clinical outcome, ICSI cycles, low oxygen, poor responders, pregnancy rate, prospective randomized study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 647 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Collaborators
- Slovenian Research Agency
- Study start
- Aug 2006
- Primary completion
- Jun 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 21 Jul 2008 (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 assess whether reduced oxygen tension in embryo culture has any effect on clinical outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| I | Experimental | Other: oxygen concentration in the culture atmosphere5% oxygen concentration in the culture atmosphere |
| II | Experimental | Other: oxygen concentration in the culture atmosphere20% oxygen concentration in the culture atmosphere |
Who may qualify
- Ages
- 22 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- stimulated Intra Cytoplasmic Sperm Injection (ICSI) cycle
Key exclusion criteria (1 listed)
- less than one mature (metaphase II) oocyte at the time of denudation
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 |
|---|---|---|
| oxygen concentration in the culture atmosphere | Other | I, II |
Primary outcome
Ongoing pregnancy rate per cycle
Time frame: 10-11 weeks after embryo transfer
1 secondary outcome
clinical pregnancy rate, implantation rate, early pregnancy loss, fertilization rate, embryo quality
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 21 Jul 2008.
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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.
Veljko Vlaisavljević, Prof. study chair
University Medical Centre Maribor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oxygen concentration in the culture atmosphere in people with Embryo Development, run by University Medical Centre Maribor at 1 site in Slovenia.
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 21 Jul 2008. 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 Slovenia. 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?
Ongoing pregnancy rate per cycle (time frame: 10-11 weeks after embryo transfer). 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 21 Jul 2008.