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

Progyny, Inc.50 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Infertility

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 43 Years

Medical Language ↔ Plain English

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

Locations (1)

Main Line Fertility

Bryn Mawr, Pennsylvania, United States

Outcomes

Primary Outcomes

Eeva time-lapse parameters and aCGH testing results

Analysis of correlation between time-lapse parameters collected by the Eeva System and array-Comparative Genomic Hybridization (aCGH) results

Time frame: 5-6 days

Secondary Outcomes

Embryo Implantation Rate

Correlation of time-lapse parameters collected by Eeva and implantation rate

Time frame: 6 weeks

Clinical Pregnancy Rate

Correlation of time-lapse parameters collected by Eeva and clinical pregnancy rate

Time frame: 6 weeks

Ongoing pregnancy rate

Correlation of time-lapse parameters collected by Eeva and ongoing pregnancy rate

Time frame: 8-12 weeks

Data from ClinicalTrials.gov

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