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Implantation Rate of Vitrified-warmed Collapsed Blastocysts

Randomized Controlled Trial Comparing the Implantation Rate of Vitrified-warmed Blastocysts With and Without Artificial Shrinkage Before Vitrification

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01980225
Enrollment
270
Registered
2013-11-08
Start date
2011-11-30
Completion date
2014-08-31
Last updated
2015-06-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Implantation Rate of Vitrified Blastocysts

Keywords

vitrification, blastocyst, artificial shrinkage, collapse

Brief 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. 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.

Interventions

PROCEDURECollapse

inducing collapse (= artificial shrinkage) by applying 1 or 2 laser pulses between trophectoderm cells of the blastocyst to be vitrified

Sponsors

Centre for Reproductive Medicine, Belgium
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 38 Years
Healthy volunteers
Yes

Inclusion criteria

* female age \<39 years * at least 1 blastocyst available for cryopreservation

Exclusion criteria

* sperm origin: testicular or epididymal sperm extraction * IVM (in-vitro maturation) cycles * PGD cycles (preimplantation genetic diagnosis)

Design outcomes

Primary

MeasureTime frameDescription
implantation rate of the embryo in the first frozen transfer cycleapproximately 10 weeks after the first frozen embryo transferpatients 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

Secondary

MeasureTime frameDescription
survival rate of warmed blastocysts0-30 minutesthis is the morphological assessment of survival of the blastocyst after warming
implantation rate per warmed blastocystapproximately 10 weeks after first frozen transferimplantation rate of the transferred embryo per embryo initially warmed in that frozen transfer cycle.

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026