Clinical Validation of Embryo Cinematography

Not Applicable

Completed

• Conditions: Embryo Diagnosis and Selection
• Interventions: Device: Observe embryo development; Device: Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)

• Registration Number: NCT01549262
• Lead Sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-03-06
• Study First Posted: 2012-03-09
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-04
• Last Update Posted: 2014-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 843

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Incubator	Observe embryo development	-
ESD Time-lapse Monitoring system	Observe embryo development with "Unisense FertiliTech A/S" (EC Certificte DGM - 673)	-

Primary Outcome Measures

Name	Time	Method
Ongoing Pregnancy Rate	confirmed 16-18 weeks after embryo transfer

Trial Locations

Locations (1)

IVI Valencia; 🇪🇸 Valencia, Spain