Implantation Rate of Vitrified Blastocysts Clinical Trial
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.
| Status | Completed |
| Enrollment | 270 |
| Est. completion date | August 2014 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 18 Years to 38 Years |
| Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Centre for Reproductive Medicine | Brussels |
| Lead Sponsor | Collaborator |
|---|---|
| Centre for Reproductive Medicine, Belgium |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | approximately 10 weeks after the first frozen embryo transfer | No |
| Secondary | survival rate of warmed blastocysts | this is the morphological assessment of survival of the blastocyst after warming | 0-30 minutes | No |
| Secondary | implantation rate per warmed blastocyst | implantation rate of the transferred embryo per embryo initially warmed in that frozen transfer cycle. | approximately 10 weeks after first frozen transfer | No |