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

• Conditions: Infertility

• Registration Number: NCT02141685
• Lead Sponsor: Progyny, Inc.

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.

Study Timeline

• Study Start: 2014-05
• Study First Submitted: 2014-05-13
• Study First Submitted QC: 2014-05-15
• Study First Posted: 2014-05-19
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-09
• Last Update Posted: 2015-07-13
• Primary Completion: 2016-02
• Study Completion: 2016-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Main Line Fertility; 🇺🇸 Bryn Mawr, Pennsylvania, United States