Implantation Rate of Vitrified BlastocystsNCT01980225
Implantation Rate of Vitrified-warmed Collapsed Blastocysts
A study testing Collapse in people with Implantation Rate of Vitrified Blastocysts, run by Centre for Reproductive Medicine, Belgium at 1 site in Belgium.
Trial summary
In our centre, the implantation rate of frozen blastocysts (cryopreserved using vitrification)was 20,3% (Van Landuyt et al. 2011). This implantation rate is lower when compared to data from other observational studies. Read more about this study
- Who is it for?
- Ages 18 to 38 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Implantation Rate of Vitrified Blastocysts
- What is being tested?
- Collapse
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 1 siteBelgium
- Study dates
- Nov 2011to Aug 2014
- 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 38 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- female age <39 years
- at least 1 blastocyst available for cryopreservation
Who cannot join
- sperm origin: testicular or epididymal sperm extraction
- IVM (in-vitro maturation) cycles
- PGD cycles (preimplantation genetic diagnosis)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing the Implantation Rate of Vitrified-warmed Blastocysts With and Without Artificial Shrinkage Before Vitrification
In our centre, the implantation rate of frozen blastocysts (cryopreserved using vitrification)was 20,3% (Van Landuyt et al. 2011). This implantation rate is lower when compared to data from other observational studies. Retrospective studies have shown that artificial shrinkage of the blastocoelic cavity (also called collapse) and dehydration of the blastocyst just before vitrification can have a positive effect on the survival after warming. This collapse can be induced by using a laser. The study of Iwayama et al. 2010 has shown a similar survival rate but an increase in the implantation rate of collapsed blastocysts compared to non-collapsed blastocysts.
The aim of the study is to investigate the effect of artificial shrinkage by laser-induced collapse on the implantation potential of vitrified-warmed day 5 or day 6 blastocyst stage embryos in a prospective randomised controlled trial.
- Being tested
- Collapse
- Keywords
- vitrification, blastocyst, artificial shrinkage, collapse
- Medical subject headings
- Unconsciousness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CollapseProcedure or surgery
Also called artificial shrinkage
inducing collapse (= artificial shrinkage) by applying 1 or 2 laser pulses between trophectoderm cells of the blastocyst to be vitrified
| Study group | Role | What they receive |
|---|---|---|
| Collapse | Experimental | This arm includes the patients where laser-induced collapse (=artificial shrinkage) of all blastocysts is performed before vitrification Receives: Procedure: Collapse |
| control | No intervention | This control arm includes the patients of which the blastocysts are vitrified without performing collapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
implantation rate of the embryo in the first frozen transfer cycle
patients are enrolled in the study at oocyte retrieval. When patient is not pregnant after fresh embryo transfer, she comes back to use the frozen embryos at least one month after the initial inclusion. After the frozen embryo transfer, poshCG is measured 14 days after transfer. Approximately 10 weeks after transfer, implantation rate of the frozen embryos is assessed. This is the number of intra-uterine gestational sacs seen on ultrasound on the number of embryos transferred
Measured: approximately 10 weeks after the first frozen embryo transfer
Secondary outcomes (2)
survival rate of warmed blastocysts
this is the morphological assessment of survival of the blastocyst after warming
Measured: 0-30 minutes
implantation rate per warmed blastocyst
implantation rate of the transferred embryo per embryo initially warmed in that frozen transfer cycle.
Measured: approximately 10 weeks after first frozen transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study startNov 2011
- Primary completionAug 2014
- Study completionAug 2014
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 Implantation Rate of Vitrified BlastocystsStudies 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
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre for Reproductive Medicine, Belgium
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisbet Van Landuyt, Centre for Reproductive Medicine, Belgium
- Investigators
- Lisbet Van Landuyt, MSc, Principal investigator, Centre for Reproductive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980225
- Sponsor's protocol ID
- VanLanduyt2013
- Status last verified
- Jun 2015
- First submitted
- 28 Oct 2013
- Last updated
- 9 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Van Landuyt L, Polyzos NP, De Munck N, Blockeel C, Van de Velde H, Verheyen G. A prospective randomized controlled trial investigating the effect of artificial shrinkage (collapse) on the implantation potential of vitrified blastocysts. Hum Reprod. 2015 Nov;30(11):2509-18. doi: 10.1093/humrep/dev218. Epub 2015 Sep 12.
PubMed 26364080
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing the Implantation Rate of Vitrified-warmed Blastocysts With and Without Artificial Shrinkage Before Vitrification
- ClinicalTrials.gov ID
- NCT01980225
- Acronym / sponsor ID
- VanLanduyt2013
- Keywords
- vitrification, blastocyst, artificial shrinkage, collapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Centre for Reproductive Medicine, BelgiumUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 8 Nov 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 our centre, the implantation rate of frozen blastocysts (cryopreserved using vitrification)was 20,3% (Van Landuyt et al. 2011). This implantation rate is lower when compared to data from other observational studies. Retrospective studies have shown that artificial shrinkage of the blastocoelic cavity (also called collapse) and dehydration of the blastocyst just before vitrification can have a positive effect on the survival after warming. This collapse can be induced by using a laser. The study of Iwayama et al. 2010 has shown a similar survival rate but an increase in the implantation rate of collapsed blastocysts compared to non-collapsed blastocysts.
The aim of the study is to investigate the effect of artificial shrinkage by laser-induced collapse on the implantation potential of vitrified-warmed day 5 or day 6 blastocyst stage embryos in a prospective randomised controlled trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collapse | Experimental | Procedure: CollapseThis arm includes the patients where laser-induced collapse (=artificial shrinkage) of all blastocysts is performed before vitrification |
| control | No intervention | –This control arm includes the patients of which the blastocysts are vitrified without performing collapse |
Who may qualify
- Ages
- 18 to 38 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- female age <39 years
- at least 1 blastocyst available for cryopreservation
Key exclusion criteria (3 listed)
- sperm origin: testicular or epididymal sperm extraction
- IVM (in-vitro maturation) cycles
- PGD cycles (preimplantation genetic diagnosis)
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 |
|---|---|---|
| CollapseAlso: artificial shrinkageinducing collapse (= artificial shrinkage) by applying 1 or 2 laser pulses between trophectoderm cells of the blastocyst to be vitrified | Procedure or surgery | Collapse |
Primary outcome
implantation rate of the embryo in the first frozen transfer cycle
Time frame: approximately 10 weeks after the first frozen embryo transfer
patients are enrolled in the study at oocyte retrieval. When patient is not pregnant after fresh embryo transfer, she comes back to use the frozen embryos at least one month after the initial inclusion. After the frozen embryo transfer, poshCG is measured 14 days after transfer. Approximately 10 weeks after transfer, implantation rate of the frozen embryos is assessed. This is the number of intra-uterine gestational sacs seen on ultrasound on the number of embryos transferred
2 secondary outcomes
survival rate of warmed blastocysts
Time frame: 0-30 minutes
implantation rate per warmed blastocyst
Time frame: approximately 10 weeks after first frozen transfer
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 9 Jun 2015.
- Derived from this study: PubMed 26364080Van Landuyt L, Polyzos NP, De Munck N, Blockeel C, Van de Velde H, Verheyen G. A prospective randomized controlled trial investigating the effect of artificial shrinkage (collapse) on the implantation potential of vitrified blastocysts. Hum Reprod. 2015 Nov;30(11):2509-18. doi: 10.1093/humrep/dev218. Epub 2015 Sep 12.
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.
Lisbet Van Landuyt, MSc principal investigator
Centre for Reproductive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collapse in people with Implantation Rate of Vitrified Blastocysts, run by Centre for Reproductive Medicine, Belgium 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 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: finished, as of the sponsor's last update on 9 Jun 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?
implantation rate of the embryo in the first frozen transfer cycle (time frame: approximately 10 weeks after the first frozen embryo transfer). 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 NCT01980225, 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 9 Jun 2015; AzTrials last refreshed its copy on 7 Nov 2026.