Clinical Validation of Embryo Cinematography

Clinical Validation of Embryo Culture and Selection by Morphokinetic Analysis; a Randomized Controlled Trial by Time-lapse System

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01549262

Enrollment

843

Registered

2012-03-09

Start date

2012-02-29

Completion date

2013-07-31

Last updated

2014-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embryo Diagnosis and Selection

Brief summary

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.

Interventions

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

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

DEVICEObserve embryo development

Observe embryo development in the traditional manner

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 38 Years

Healthy volunteers

Yes

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

Exclusion criteria

* Hydrosalpinx * Recurrent pregnancy loss * Severe male factor

Design outcomes

Primary

Measure	Time frame
Ongoing Pregnancy Rate	confirmed 16-18 weeks after embryo transfer

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026