SurvivalNCT01952184
Oocyte Survival After Vitrification in an Open or Closed Device With Closed Storage.
A study testing CBSvit HS device and Cryotop SC device in people with Survival and Embryo Quality, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
Trial summary
The survival rate (and embryo quality) of donor oocytes with two commercially available devices. Read more about this study
- Who is it for?
- Ages 18 to 36 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Survival, Embryo Quality
- What is being tested?
- CBSvit HS device and Cryotop SC device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2013to Jul 2015
- 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 36 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Donor: ≤36 years old on day of oocyte retrieval
- Donor: ≥ 6 mature oocytes
Who cannot join
- Donor: < 6 mature oocytes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oocyte Survival After Vitrification in an Open or Closed Commercial Device: Study on Sibling Donor Oocytes.
The survival rate (and embryo quality) of donor oocytes with two commercially available devices.
Read the detailed description
Donor sibling oocytes will be vitrified with two commercially available devices. The first device is closed vitrification with closed storage and the second device is open vitrification with closed storage. Oocyte acceptors receive oocytes from both devices. With the increase in cooling rate generated by the open vitrification (second device), we expect to get an increase in survival rate of 10%. Besides this, embryo quality will be assessed with oocytes obtained from both devices.
- Conditions
- Survival, Embryo Quality
- Being tested
- CBSvit HS device, Cryotop SC device
- Keywords
- vitrification, oocyte, donor, open, closed
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBSvit HS deviceDevice
closed vitrification with closed storage
Cryotop SC deviceDevice
open vitrification with closed storage
| Study group | Role | What they receive |
|---|---|---|
| closed vitrification with closed storage | Active comparator | Half of the oocytes of every donor will be vitrified with the Cryo Bio Systems High Security vitrification (CBSvit HS) device; the standard device in our lab. Receives: Device: CBSvit HS device |
| open vitrification with closed storage | Experimental | Half of the oocytes of every donor will be vitrified with the Cryotop closed system (Cryotop SC). Receives: Device: Cryotop SC device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival rate
The purpose is to assess the survival rate of donor oocytes with the two vitrification devices.
Measured: up to 6 days after every warming cycle
Secondary outcomes (1)
Embryo development
The purpose is to analyse the pre-implantation development of donor oocytes vitrified with two different devices.
Measured: up to 6 days after every warming cycle
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SurvivalStudies of the same condition, open and under way.
- More trials run by Universitair Ziekenhuis BrusselThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neelke De Munck, Universitair Ziekenhuis Brussel
- Investigators
- Neelke De Munck, MSc., Principal investigator, Centrum voor Reproductieve Geneeskunde, UZBrussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01952184
- Sponsor's protocol ID
- 2013/777
- Status last verified
- Dec 2015
- First submitted
- 24 Sep 2013
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
De Munck N, Santos-Ribeiro S, Stoop D, Van de Velde H, Verheyen G. Open versus closed oocyte vitrification in an oocyte donation programme: a prospective randomized sibling oocyte study. Hum Reprod. 2016 Feb;31(2):377-84. doi: 10.1093/humrep/dev321. Epub 2016 Jan 2.
PubMed 26724798
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oocyte Survival After Vitrification in an Open or Closed Commercial Device: Study on Sibling Donor Oocytes.
- ClinicalTrials.gov ID
- NCT01952184
- Acronym / sponsor ID
- 2013/777
- Conditions
- Survival, Embryo Quality
- Keywords
- vitrification, oocyte, donor, open, closed
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 27 Sep 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 survival rate (and embryo quality) of donor oocytes with two commercially available devices.
Detailed description
Donor sibling oocytes will be vitrified with two commercially available devices. The first device is closed vitrification with closed storage and the second device is open vitrification with closed storage. Oocyte acceptors receive oocytes from both devices. With the increase in cooling rate generated by the open vitrification (second device), we expect to get an increase in survival rate of 10%. Besides this, embryo quality will be assessed with oocytes obtained from both devices.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| closed vitrification with closed storage | Active comparator | Device: CBSvit HS deviceHalf of the oocytes of every donor will be vitrified with the Cryo Bio Systems High Security vitrification (CBSvit HS) device; the standard device in our lab. |
| open vitrification with closed storage | Experimental | Device: Cryotop SC deviceHalf of the oocytes of every donor will be vitrified with the Cryotop closed system (Cryotop SC). |
Who may qualify
- Ages
- 18 to 36 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Donor: ≤36 years old on day of oocyte retrieval
- Donor: ≥ 6 mature oocytes
Key exclusion criteria (1 listed)
- Donor: < 6 mature oocytes
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 |
|---|---|---|
| CBSvit HS deviceclosed vitrification with closed storage | Device | closed vitrification with closed storage |
| Cryotop SC deviceopen vitrification with closed storage | Device | open vitrification with closed storage |
Primary outcome
Survival rate
Time frame: up to 6 days after every warming cycle
The purpose is to assess the survival rate of donor oocytes with the two vitrification devices.
1 secondary outcome
Embryo development
Time frame: up to 6 days after every warming cycle
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 3 Dec 2015.
- Derived from this study: PubMed 26724798De Munck N, Santos-Ribeiro S, Stoop D, Van de Velde H, Verheyen G. Open versus closed oocyte vitrification in an oocyte donation programme: a prospective randomized sibling oocyte study. Hum Reprod. 2016 Feb;31(2):377-84. doi: 10.1093/humrep/dev321. Epub 2016 Jan 2.
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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.
Neelke De Munck, MSc. principal investigator
Centrum voor Reproductieve Geneeskunde, UZBrussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBSvit HS device and Cryotop SC device in people with Survival and Embryo Quality, run by Universitair Ziekenhuis Brussel at 1 site 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 2 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 3 Dec 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 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?
Survival rate (time frame: up to 6 days after every warming cycle). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01952184, which also lists 1 linked publication.
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 3 Dec 2015.