Clinical Validation of Embryo Cinematography

Embryo Diagnosis and Selection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01549262
• Other study ID #: 1009-C-088-IR
• Status: Completed
• Phase: N/A
• First received: February 16, 2012
• Last updated: August 4, 2014
• Start date: February 2012
• Est. completion date: July 2013

Study information

• Verified date: August 2014
• Source: Instituto Valenciano de Infertilidad, IVI VALENCIA
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 843
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 38 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Embryo Diagnosis and Selection

Intervention

Device:
• 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.
• Observe embryo development
Observe embryo development in the traditional manner

Locations

Country	Name	City	State
Spain	IVI Valencia	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Valenciano de Infertilidad, IVI VALENCIA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing Pregnancy Rate		confirmed 16-18 weeks after embryo transfer	No