NCT01635049CompletedNot Applicable
Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results,Implantation and Live Birth
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Progyny, Inc.
- Enrollment
- 110
- Locations
- 2
- Primary Endpoint
- Eeva time-lapse parameters and CCS
Study Overview
Brief Summary
The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva System parameters with comprehensive chromosome screening (CCS) results, implantation and live birth.
Detailed Description
The present study was designed to determine if there is a correlation between the Eeva System parameters and CCS results. Embryos will be selected for transfer based on CCS results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- — to 43 Years (Child, Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subject is ≤43 years of age.
- •Women undergoing fresh IVF treatment using her own eggs or donor eggs and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist.
- •Fertilization using only ejaculated sperm (fresh or frozen) - no surgically retrieved sperm.
- •Willing to have all 2PN embryos monitored by Eeva
- •Not previously enrolled in this study.
- •No concurrent participation in another clinical study.
- •Willing to comply with study protocol and procedures and able to speak English.
- •Willing to provide written informed consent.
Exclusion Criteria
- •Prior IVF cycle with < 4 x 2PN
- •Diminished ovarian reserve as demonstrated by any one of the following:
- •BAFC < 6 at time of cycle start
- •Maximum prior FSH > 15
- •AMH < 0.5
Outcomes
Primary Outcomes
Eeva time-lapse parameters and CCS
Time Frame: 5-6 days
Analyse the correlation of time-lapse parameters collected by the Eeva System and comprehensive chromosome screening (CCS) results.
Secondary Outcomes
- Correlation of time-lapse parameters collected by the Eeva System and implantation rate.(6 weeks)
- Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate(6 weeks)
- Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate(7 - 8 weeks)
- Correlation of time-lapse parameters collected by the Eeva System and delivery rate(live birth)
- Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate(live birth)
- Correlation of time-lapse parameters collected by the Eeva System and multiple pregnancy rate(live birth)
Investigators
Study Sites (2)
Loading locations...
Similar Trials
Unknown
Not Applicable
Correlating Time-Lapse Parameters With aCGH Testing in IVF Treatment (aCGH Study)InfertilityNCT02141685Progyny, Inc.50
Terminated
Phase 4
Time-lapse Evaluation of Embryo Development After Stimulation With One of Two Different Gonadotrophins.Patients for In Vitro Fertilization(IVF)TreatmentNCT01345812University of Aarhus291
Enrolling By Invitation
Not Applicable
Embryo Assessment Utilizing Timelapse Imaging in Conjunction With Preimplantation Genetic Testing for Aneuploidy With Next Generation SequencingInfertility, FemaleInfertility, MaleInfertilityAneuploidyIVFNCT06419127Gattaca Genomics2,000
Completed
Not Applicable
Use of Time-lapse Morphological Kinetics in the Selection of BlastocystsViabilityNCT02081859The Cleveland Clinic300
Unknown
Not Applicable
A Study Select Top-grade Embryo by Time-lapse ImagingTop-grade EmbryoNCT02965222Shanghai First Maternity and Infant Hospital150