Implantation Rate of Vitrified-warmed Collapsed Blastocysts

NCT ID: NCT01980225

Last Updated: 2015-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2014-08-31

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.

Detailed Description

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Conditions

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Implantation Rate of Vitrified Blastocysts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Collapse

This arm includes the patients where laser-induced collapse (=artificial shrinkage) of all blastocysts is performed before vitrification

Group Type EXPERIMENTAL

Collapse

Intervention Type PROCEDURE

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

control

This control arm includes the patients of which the blastocysts are vitrified without performing collapse

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Collapse

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

Intervention Type PROCEDURE

Other Intervention Names

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artificial shrinkage

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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Centre for Reproductive Medicine, Belgium

OTHER

Sponsor Role lead

Responsible Party

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Lisbet Van Landuyt

klinisch embryoloog

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lisbet Van Landuyt, MSc

Role: PRINCIPAL_INVESTIGATOR

Centre for Reproductive Medicine

Locations

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Centre for Reproductive Medicine

Brussels, , Belgium

Site Status

Countries

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Belgium

References

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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.

Reference Type DERIVED
PMID: 26364080 (View on PubMed)

Other Identifiers

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VanLanduyt2013

Identifier Type: -

Identifier Source: org_study_id

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