Clinical Validation of Embryo Cinematography
1 other identifier
interventional
843
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 16, 2012
CompletedFirst Posted
Study publicly available on registry
March 9, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedAugust 5, 2014
August 1, 2014
1.4 years
February 16, 2012
August 4, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Ongoing Pregnancy Rate
confirmed 16-18 weeks after embryo transfer
Study Arms (2)
Standard Incubator
ACTIVE COMPARATORESD Time-lapse Monitoring system
EXPERIMENTALInterventions
Observation of exact timing of embryo cleavages together with other morphology dynamics parameters.
Observe embryo development in the traditional manner
Eligibility Criteria
You may qualify if:
- Female patients undergoing assisted reproduction with ICSI, first or second cycle
- to 38 yers old
- BMI (18-25)
- No endometriosis,
- \> 6 Metaphse II oocytes
- Basal FSH \< 12 UI
- AMH \> 7pmol/L
You may not qualify if:
- Hydrosalpinx
- Recurrent pregnancy loss
- Severe male factor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
IVI Valencia
Valencia, Valencia, 46015, Spain
Related Publications (2)
Insua MF, Cobo AC, Larreategui Z, Ferrando M, Serra V, Meseguer M. Obstetric and perinatal outcomes of pregnancies conceived with embryos cultured in a time-lapse monitoring system. Fertil Steril. 2017 Sep;108(3):498-504. doi: 10.1016/j.fertnstert.2017.06.031.
PMID: 28865550DERIVEDRubio I, Galan A, Larreategui Z, Ayerdi F, Bellver J, Herrero J, Meseguer M. Clinical validation of embryo culture and selection by morphokinetic analysis: a randomized, controlled trial of the EmbryoScope. Fertil Steril. 2014 Nov;102(5):1287-1294.e5. doi: 10.1016/j.fertnstert.2014.07.738. Epub 2014 Sep 11.
PMID: 25217875DERIVED
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Embryologist IVI Valencia
Study Record Dates
First Submitted
February 16, 2012
First Posted
March 9, 2012
Study Start
February 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
August 5, 2014
Record last verified: 2014-08