FertilityWOWNCT02010424
Evaluation of Group Culture in WOW Dishes of Human Embryos in Order to Optimize the Single Embryo Transfer (SET) Strategy.
A study testing Primo Vision embryo culture dish (CE labeled, Vitrolife) in people with Fertility, run by University Hospital, Ghent at 2 sites in Belgium.
Trial summary
In cattle less than 10% of the embryos develop to the blastocyst stage when embryos are cultured individually, however when bovine embryos are cultured in groups a typical 25-35% of blastocysts can be observed. This tendency, i.e. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Fertility
- What is being tested?
- Primo Vision embryo culture dish (CE labeled, Vitrolife)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 2 sitesBelgium
- Study dates
- Jan 2014to Dec 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Sperm obtained by ejaculation
- Conventional IVF/ICSI
- At least 10 fertilized oocytes (2 PN)
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Antwerp University Hospital, Centre for Reproductive Medicine
Edegem, 2650
Ghent University Hospital
Ghent, 9000
About this study
Official title: Multicentric Clinical Trial to Improve Blastocyst Utilisation Rate (in Relation to 2 PN Embryos) by Group Culture of Human Embryos in WOW Dishes.
In cattle less than 10% of the embryos develop to the blastocyst stage when embryos are cultured individually, however when bovine embryos are cultured in groups a typical 25-35% of blastocysts can be observed. This tendency, i.e. improved embryo development in group culture, has also been demonstrated in other mammalian species, such as mouse, cat and human. The main reason for this beneficial outcome of group culture has been ascribed to the presence of autocrine factors, which are factors secreted by preimplantation embryos that act upon the embryo itself or the neighboring embryos .
Although group culture systems are common in in vitro production systems for animal embryos, it is rarely done in human settings, where individual follow-up of the embryo during the whole culture period is of utmost importance. Recently a CE-labelled culture device has been designed for human embryos, that allow to combine the benefits of both group culture approaches and individual culture. The WOW dish is commercially available by Primo Vision and consists of 9 small microwells on the bottom of the plate, so that the embryos can be cultivated individually in a microwell, but covered by the same drop of culture medium.
In this clinical randomized trial, 158 patients will be included of which half of the fertilized oocytes will be cultured individually (standard culture system) and half of the fertilized oocytes will be cultured in group in a WOW dish, both during five days of culture. The aim of this study is to increase the number of blastocysts suitable for transfer or cryopreservation by culturing the embryos in WOW dishes.
- Conditions
- Fertility
- Being tested
- control group, Primo Vision embryo culture dish (CE labeled, Vitrolife)
- Keywords
- reduced fertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
control groupOther
standard IVF protocol
Primo Vision embryo culture dish (CE labeled, Vitrolife)Device
| Study group | Role | What they receive |
|---|---|---|
| Individual culture | Experimental | standard IVF protocol: half of the fertilized oocytes of the patient will be cultured individually in drops of 25 µl Cook cleavage medium till day 3 after fertilization and subsequently in drops of 25 µl Cook blastocyst medium till day 5 after fertilization Receives: Other: control group |
| WOW | Experimental | Half of the fertilized oocytes of the patient will be cultured in group in a WOW dish, each in a separate microwell but covered with one drop of 30 µl of Cook cleavage medium till day 3 after fertilization and subsequently all the embryos will be transferred to a new WOW dish (in the exactly the same position) covered with 30 µl of Cook blastocyst medium till day 5 after fertilization Receives: Device: Primo Vision embryo culture dish (CE labeled, Vitrolife) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst utilisation rate
number of blastocysts out of fertilized oocytes observed 5 days after fertilization that can be used for the patient (fresh transfer or cryopreservation)
Measured: 5 days after fertilization
Secondary outcomes (5)
Morphologic evaluation
Morphologic evaluation according to the Gardner score (Gardner and Schoolcraft, 1999)
Measured: 5 days after fertilization
change in embryo development
morphologic evaluation at day 2, 3 and 4 after fertilization
Measured: at day 2, 3 and 4 after fertilization
pregnancy rate
endocrine pregnancy by measuring hCG in blood sample on day 15 after embryo transfer and clinical pregnancy confirmed by ultrasound, 5 weeks after embryo transfer.
Measured: day 15 and week 5 after embryo transfer
life birth rate
birth of a baby nine months after embryo transfer
Measured: 9 months after embryo transfer
change in secretome
embryo conditioned medium will we collected at day 3 and day 5 after fertilization in eppendorf tubes and kept in -80°C until all samples are collected and they will be analyzed with mass spectrometry to compare the secretome (secreted proteins by the preimplantation embryo).
Measured: day 3 and day 5 after fertilization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FertilityStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe 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
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02010424
- Sponsor's protocol ID
- 2013/819
- Acronym
- WOW
- Status last verified
- Nov 2022
- First submitted
- 9 Dec 2013
- Last updated
- 2 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Clinical Trial to Improve Blastocyst Utilisation Rate (in Relation to 2 PN Embryos) by Group Culture of Human Embryos in WOW Dishes.
- ClinicalTrials.gov ID
- NCT02010424
- Acronym / sponsor ID
- WOW / 2013/819
- Conditions
- Fertility
- Keywords
- reduced fertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Study start
- Jan 2014 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 12 Dec 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.
In cattle less than 10% of the embryos develop to the blastocyst stage when embryos are cultured individually, however when bovine embryos are cultured in groups a typical 25-35% of blastocysts can be observed. This tendency, i.e. improved embryo development in group culture, has also been demonstrated in other mammalian species, such as mouse, cat and human. The main reason for this beneficial outcome of group culture has been ascribed to the presence of autocrine factors, which are factors secreted by preimplantation embryos that act upon the embryo itself or the neighboring embryos .
Although group culture systems are common in in vitro production systems for animal embryos, it is rarely done in human settings, where individual follow-up of the embryo during the whole culture period is of utmost importance. Recently a CE-labelled culture device has been designed for human embryos, that allow to combine the benefits of both group culture approaches and individual culture. The WOW dish is commercially available by Primo Vision and consists of 9 small microwells on the bottom of the plate, so that the embryos can be cultivated individually in a microwell, but covered by the same drop of culture medium.
In this clinical randomized trial, 158 patients will be included of which half of the fertilized oocytes will be cultured individually (standard culture system) and half of the fertilized oocytes will be cultured in group in a WOW dish, both during five days of culture. The aim of this study is to increase the number of blastocysts suitable for transfer or cryopreservation by culturing the embryos in WOW dishes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Individual culture | Experimental | Other: control groupstandard IVF protocol: half of the fertilized oocytes of the patient will be cultured individually in drops of 25 µl Cook cleavage medium till day 3 after fertilization and subsequently in drops of 25 µl Cook blastocyst medium till day 5 after fertilization |
| WOW | Experimental | Device: Primo Vision embryo culture dish (CE labeled, Vitrolife)Half of the fertilized oocytes of the patient will be cultured in group in a WOW dish, each in a separate microwell but covered with one drop of 30 µl of Cook cleavage medium till day 3 after fertilization and subsequently all the embryos will be transferred to a new WOW dish (in the exactly the same position) covered with 30 µl of Cook blastocyst medium till day 5 after fertilization |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Sperm obtained by ejaculation
- Conventional IVF/ICSI
- At least 10 fertilized oocytes (2 PN)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| control groupstandard IVF protocol | Other | Individual culture |
| Primo Vision embryo culture dish (CE labeled, Vitrolife) | Device | WOW |
Primary outcome
Blastocyst utilisation rate
Time frame: 5 days after fertilization
number of blastocysts out of fertilized oocytes observed 5 days after fertilization that can be used for the patient (fresh transfer or cryopreservation)
5 secondary outcomes
Morphologic evaluation
Time frame: 5 days after fertilization
change in embryo development
Time frame: at day 2, 3 and 4 after fertilization
pregnancy rate
Time frame: day 15 and week 5 after embryo transfer
life birth rate
Time frame: 9 months after embryo transfer
change in secretome
Time frame: day 3 and day 5 after fertilization
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 2 Dec 2022.
Related trials for Fertility
Not yet recruiting
Application of Autologous Adipose Stromal Vascular Fraction in the Treatment of Diminished Ovarian Reserve
Diminished Ovarian Reserve (DOR)
Enrolling by invitation
Flo Digital Contraceptive Study
Contraception Use
RecruitingObservational study
Impact of Infertility on the Sexual Sphere in Couples Undergoing Assisted Reproduction
Sexual Health Quality of Life, Infertile Patients
Active, not recruiting
Ovarian Tissue Cryopreservation in Children
Cancer
Not yet recruitingObservational study
Perceptions and Acceptance of Grafting of Cryopreserved Testicular Tissue
Fertility, Testicular Tissue Cryopreserved
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 Primo Vision embryo culture dish (CE labeled, Vitrolife) in people with Fertility, run by University Hospital, Ghent 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 3 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 2 Dec 2022. 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?
Blastocyst utilisation rate (time frame: 5 days after fertilization). 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 2 Dec 2022.