Clinical Validation of Embryo Cinematography

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

843 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-07-31

Brief Summary

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The purpose of this study is to determine whether the multivariable model for embryo selection (Meseguer et al. 2012) together with undisturbed controlled conditions obtained by a time-lapse incubator system is effective in improving ongoing pregnancy rate in comparison with standard incubator and an embryo selection process based exclusively in morphology.

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Detailed Description

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Conditions

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Embryo Diagnosis and Selection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Standard Incubator

Group Type ACTIVE_COMPARATOR

Observe embryo development

Intervention Type DEVICE

Observe embryo development in the traditional manner

ESD Time-lapse Monitoring system

Group Type EXPERIMENTAL

Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)

Intervention Type DEVICE

Observation of exact timing of embryo cleavages together with other morphology dynamics parameters.

Interventions

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Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)

Observation of exact timing of embryo cleavages together with other morphology dynamics parameters.

Intervention Type DEVICE

Observe embryo development

Observe embryo development in the traditional manner

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Female patients undergoing assisted reproduction with ICSI, first or second cycle
* 20 to 38 yers old
* BMI (18-25)
* No endometriosis,
* \> 6 Metaphse II oocytes
* Basal FSH \< 12 UI
* AMH \> 7pmol/L