Clinical Validation of Embryo Cinematography

Instituto Valenciano de Infertilidad, IVI VALENCIA

Status: Completed

Conditions: Embryo Diagnosis and Selection

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01549262

1009-C-088-IR

Details and patient eligibility

About

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.

Enrollment: 843 patients

Sex: Female

Ages: 18 to 38 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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843 participants in 2 patient groups

Standard Incubator

Active Comparator group

Treatment:

Device: Observe embryo development

ESD Time-lapse Monitoring system

Experimental group

Treatment:

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