Correlating Time-Lapse Parameters With aCGH Testing in IVF Treatment (aCGH Study)
This trial is active, not recruiting.
|Start date||May 2014|
|End date||February 2016|
|Trial size||50 participants|
|Trial identifier||NCT02141685, 2014-AUX-011|
The purpose of this research study protocol is to collect imaging data on embryos followed to blastocyst stage (Day 5-6) and correlate Eeva parameters with array - Comparative Genomic Hybridization (aCGH) results and ongoing pregnancy rates.
Women undergoing fresh IVF treatment and array-comparative genomic hybridization testing (aCGH), as recommended based on medical need by the clinical site reproductive endocrinologist.
Eeva time-lapse parameters and aCGH testing results
time frame: 5-6 days
Embryo Implantation Rate
time frame: 6 weeks
Clinical Pregnancy Rate
time frame: 6 weeks
Ongoing pregnancy rate
time frame: 8-12 weeks
Female participants from 18 years up to 43 years old.
Inclusion Criteria: - Subject is ≤43 years of age. - Women undergoing IVF treatment with planned aCGH testing using her own eggs or donor eggs. - Antral Follicle Count ≥ 6 at time of cycle start - Baseline (day 2-3 of cycling) FSH ≤ 15 mIU/ml - Antimüllerian Hormone level ≥ 0.5 ng/mL - 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. - Willing to comply with study protocol and procedures and able to speak English. - Willing to provide written informed consent. Exclusion Criteria: - BMI ≥ 40 - Prior IVF cycle with < 4 x 2PN - Planned Day 3 Assisted Hatching
|Official title||Correlating Time-Lapse Parameters Detected by Eeva™ With Array-Comparative Genomic Hybridization Results and Ongoing Pregnancy Rates (aCGH Study)|
|Description||The present study was designed to determine if there is a correlation between the Eeva System parameters and aCGH testing results. Embryos will be selected for transfer based on aCGH results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.|
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