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Completed

NCT Number: NCT01980225

Implantation Rate of Vitrified-warmed Collapsed Blastocysts

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.

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Key information

Conditions

Implantation Rate of Vitrified Blastocysts Consciousness Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Unconsciousness

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Reproductive Medicine

Brussels, 1090, Belgium

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Collapse

Procedure

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

Other names: artificial shrinkage

Primary outcomes

  1. 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

Secondary outcomes

  1. survival rate of warmed blastocysts

    Time frame: 0-30 minutes

    this is the morphological assessment of survival of the blastocyst after warming

  2. implantation rate per warmed blastocyst

    Time frame: approximately 10 weeks after first frozen transfer

    implantation rate of the transferred embryo per embryo initially warmed in that frozen transfer cycle.

Sponsors and collaborators

Lead sponsor

Centre for Reproductive Medicine, Belgium

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 8, 2013
Registry last updated
Jun 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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