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

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 Overview

• Status: Completed
• Conditions: Implantation Rate of Vitrified Blastocysts
• Intervention / Treatment: Procedure: Collapse

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1090
    • Centre for Reproductive Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 34 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Centre for Reproductive Medicine, Belgium
• Investigators: Principal Investigator: Lisbet Van Landuyt, MSc, Centre for Reproductive Medicine

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: October 28, 2013
• First Submitted That Met QC Criteria: November 4, 2013
• First Posted (Estimate): November 8, 2013

Study Record Updates

• Last Update Posted (Estimate): June 9, 2015
• Last Update Submitted That Met QC Criteria: June 8, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Keywords: vitrification, blastocyst, artificial shrinkage, collapse
• Other Study ID Numbers: VanLanduyt2013