New Device to Maintain the Embryo Temperature During Transfer

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

352 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2019-12-31

Brief Summary

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The embryo transfer implies transportation from the incubator where they have been at 37 ° C, to the transfer catheter inside a laminar flow hood whose working surface is also maintained at 37 ° C. . From the laboratory to the operating room the embryo is exposed to a temperature drop, and consequently thermal stress occurs, which may compromise its future viability.

The aim of this study is to assess the possible improvement in the clinical results when the embryos are transported in a stable device to avoid the drop in temperature throughout the transfer process.

With the use of this thermosetting device heated to 37 ° C, researchers expect a 15% increase in pregnancy rates.

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Detailed Description

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Conditions

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Embryo Transfer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Conventional transfer

This arm is the control group (conventional embryo transfer protocol) where there is no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Thermostable device transfer

This arm is the study group: embryo transfer protocol using a new thermostable device.

Group Type EXPERIMENTAL

Thermostable device

Intervention Type DEVICE

Investigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature

Interventions

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Thermostable device

Investigators place the catheter with the loaded embryos into a plastic device at 37ºC in order to maintain the temperature

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Cryo-transfer cycles: transfer of embryos vitrified in previous cycles receiving donated eggs inseminated with either conjugal or donated sperm from Instituto Bernabeu bank.