Correlating Time-Lapse Parameters With aCGH Testing in IVF Treatment (aCGH Study)

Correlating Time-Lapse Parameters Detected by Eeva™ With Array-Comparative Genomic Hybridization Results and Ongoing Pregnancy Rates (aCGH Study)

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02141685

Enrollment

Registered

2014-05-19

Start date

2014-05-31

Completion date

2016-02-29

Last updated

2015-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

in vitro fertilization, assisted reproduction techniques, noninvasive imaging of embryos, time lapse imaging of embryos, traditional morphological grading of embryos, prediction of blastocysts, infertility, preimplantation genetic diagnosis, array-Comparative Genomic Hybridization

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 parameters with array - Comparative Genomic Hybridization (aCGH) results and ongoing pregnancy rates.

Detailed 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 43 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Eeva time-lapse parameters and aCGH testing results	5-6 days	Analysis of correlation between time-lapse parameters collected by the Eeva System and array-Comparative Genomic Hybridization (aCGH) results

Secondary

Measure	Time frame	Description
Embryo Implantation Rate	6 weeks	Correlation of time-lapse parameters collected by Eeva and implantation rate
Clinical Pregnancy Rate	6 weeks	Correlation of time-lapse parameters collected by Eeva and clinical pregnancy rate
Ongoing pregnancy rate	8-12 weeks	Correlation of time-lapse parameters collected by Eeva and ongoing pregnancy rate

Countries

United States

Outcome results