This trial is active, not recruiting.

Condition infertility
Sponsor Progyny, Inc.
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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Women undergoing fresh IVF treatment and array-comparative genomic hybridization testing (aCGH), as recommended based on medical need by the clinical site reproductive endocrinologist.

Primary Outcomes

Eeva time-lapse parameters and aCGH testing results
time frame: 5-6 days

Secondary Outcomes

Embryo Implantation Rate
time frame: 6 weeks
Clinical Pregnancy Rate
time frame: 6 weeks
Ongoing pregnancy rate
time frame: 8-12 weeks

Eligibility Criteria

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

Additional Information

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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Progyny, Inc..