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OpenTrials
Completed

NCT Number: NCT01549262

Clinical Validation of Embryo Cinematography

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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Key information

Conditions

Embryo Diagnosis and Selection

Age range

18 year–38 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

IVI Valencia

Valencia, 46015, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

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

Observe embryo development

Device

Observe embryo development in the traditional manner

Primary outcomes

  1. Ongoing Pregnancy Rate

    Time frame: confirmed 16-18 weeks after embryo transfer

Sponsors and collaborators

Lead sponsor

Instituto Valenciano de Infertilidad, IVI VALENCIA

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 9, 2012
Registry last updated
Aug 5, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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