In Vitro FertilizationPhase 2NCT00541892
Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine
A Phase 2 study testing Medium with no human serum albumine added and Conventional medium in people with In Vitro Fertilization and Infertility, run by Sykehuset Telemark at 1 site in Norway.
Trial summary
The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI. Read more about this study
- Who is it for?
- Ages 18 to 38 years
- Conditions the study is for
- In Vitro Fertilization, Infertility
- What is being tested?
- Medium with no human serum albumine added and Conventional medium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2007to Jan 2014
- Phase
- Phase 2
- 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 38 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Couples seeking IVF/ICSI.
- Female under 38 years of age.
- No more than two previous IVF/ICSI treatments without pregnancy.
- Regular menstruation periods.
- No endocrine disease that requires treatment in the female.
- BMI below 30 in the female.
- At least 8 mature follicles upon monitoring or 6 MII oocytes upon ICSI.
- Written informed consent.
Who cannot join
- Low responders to FSH.
- Females in danger of developing OHSS.
- Sperm sample below ICSI-quality.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sibling Oocyte Study of Medium for IVF/ICSI With no Human Serum Albumine
The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.
Read the detailed description
Cells attained in IVF/ICSI procedures are kept in a medium that nurture the cells. Until now all such media have contained human serum albumine. The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.
- Conditions
- In Vitro Fertilization, Infertility
- Being tested
- Medium with no human serum albumine added, Conventional medium
- Keywords
- Cell Culture Techniques
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medium with no human serum albumine addedOther
See above
Conventional mediumOther
See above
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Medium with no human serum albumine added Receives: Other: Medium with no human serum albumine added |
| 2 | Active comparator | Conventional medium Receives: Other: Conventional medium |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertilization
Measured: 24 hours
Cleavage
Measured: 48 hours
Embryo score
Measured: 48 hours
Embryos used
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2007 (estimated)
- Study startSep 2007
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: senior coworker retired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sykehuset Telemark
- Sponsor type
- Other government
- Collaborators
- Cellcura AS, Vekst i Grenland, Innovation Norway
- Responsible party
- Principal investigator, Hans Ivar Hanevik, Sykehuset Telemark
- Investigators
- Jarl Kahn, Dr. Med, Study director, Fertilitetsklinikken Sør
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00541892
- Sponsor's protocol ID
- s-05249
- Other IDs
- 14231(NSD)
- Status last verified
- May 2015
- First submitted
- 9 Oct 2007
- Last updated
- 20 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sibling Oocyte Study of Medium for IVF/ICSI With no Human Serum Albumine
- ClinicalTrials.gov ID
- NCT00541892
- Acronym / sponsor ID
- s-05249
- Conditions
- In Vitro Fertilization, Infertility
- Keywords
- Cell Culture Techniques
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: senior coworker retired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Sykehuset TelemarkOther government
- Collaborators
- Cellcura AS, Vekst i Grenland, Innovation Norway
- Study start
- Sep 2007
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 10 Oct 2007 (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 determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.
Detailed description
Cells attained in IVF/ICSI procedures are kept in a medium that nurture the cells. Until now all such media have contained human serum albumine. The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Medium with no human serum albumine addedMedium with no human serum albumine added |
| 2 | Active comparator | Other: Conventional mediumConventional medium |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Couples seeking IVF/ICSI.
- Female under 38 years of age.
- No more than two previous IVF/ICSI treatments without pregnancy.
- Regular menstruation periods.
- No endocrine disease that requires treatment in the female.
Key exclusion criteria (3 listed)
- Low responders to FSH.
- Females in danger of developing OHSS.
- Sperm sample below ICSI-quality.
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 |
|---|---|---|
| Medium with no human serum albumine addedSee above | Other | 1 |
| Conventional mediumSee above | Other | 2 |
Primary outcome
Fertilization
Time frame: 24 hours
Cleavage
Time frame: 48 hours
Embryo score
Time frame: 48 hours
Embryos used
Time frame: 48 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
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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.
Jarl Kahn, Dr. Med study director
Fertilitetsklinikken Sør
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Medium with no human serum albumine added and Conventional medium in people with In Vitro Fertilization and Infertility, run by Sykehuset Telemark at 1 site in Norway.
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 8 inclusion and 3 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: withdrawn, as of the sponsor's last update on 20 May 2015. 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 Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Fertilization (time frame: 24 hours). The study lists 4 primary outcomes in all. 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 20 May 2015.