Implantation Rate of Vitrified-warmed Collapsed Blastocysts

Study Overview
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Brief Summary
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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.

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

Conditions
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Implantation Rate of Vitrified Blastocysts

Intervention / Treatment
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* Procedure: Collapse


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collapse<br>This arm includes the patients where laser-induced collapse (=artificial shrinkage) of all blastocysts is performed before vitrification | Procedure: Collapse<br>* inducing collapse (= artificial shrinkage) by applying 1 or 2 laser pulses between trophectoderm cells of the blastocyst to be vitrified<br>* Other names: artificial shrinkage;|
| No Intervention: control<br>This control arm includes the patients of which the blastocysts are vitrified without performing collapse | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival rate of warmed blastocysts | this is the morphological assessment of survival of the blastocyst after warming | 0-30 minutes | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vitrification, blastocyst, artificial shrinkage, collapse