Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage

Completed

• Conditions: Infertility
• Interventions: Device: Eeva System Study

• Registration Number: NCT01369446
• Lead Sponsor: Progyny, Inc.

Brief Summary

The purpose of this study is to demonstrate that the Eeva System may be used to identify embryos on Day 2 that are most likely to form blastocysts.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Study First Submitted: 2011-06-07
• Study First Submitted QC: 2011-06-08
• Study First Posted: 2011-06-09
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-20
• Last Update Posted: 2012-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

Inclusion Criteria

• Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
• At least 18 years of age.
• Total antral follicle count of at least 12 as measured by ultrasound prior to stimulation.
• Basal FSH < 10 IU.
• At least 8 normally fertilized eggs (2PN.)
• Fertilization using only ejaculated sperm (fresh or frozen) - no surgically removed sperm.
• Willing to comply with study protocol and procedures and able to speak English.

Exclusion Criteria

• Planned preimplantation genetic diagnosis or preimplantation genetic screening.
• Gestational carriers.
• Use of reinseminated eggs.
• Concurrent participation in another clinical study.
• Previous enrollment in this clinical study.
• History of cancer.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Women undergoing IVF treatment	Eeva System Study	-

Primary Outcome Measures

Name	Time	Method
Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5.	Embryos cultured through blastocyst stage (Day 5).	Imaging data will be manually analyzed to validate parameters previously determined to be predictive of blastocyst formation.

Secondary Outcome Measures

Name	Time	Method
Pregnancy Outcome	Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12.	Chemical pregnancy outcome will be assessed using a serum pregnancy test at post transfer day 12-14. Clinical pregnancy outcome will be assessed using vaginal ultrasound at post transfer week 5-8 and week 9-12. Results will be recorded as positive or negative.

Trial Locations

Locations (5)

HRC Fertility; 🇺🇸 Encino, California, United States

Stanford University; 🇺🇸 Palo Alto, California, United States

Pacific Fertility Center; 🇺🇸 San Francisco, California, United States

Fertility Physicians of Northern California; 🇺🇸 San Jose, California, United States

Reproductive Science Center; 🇺🇸 San Ramon, California, United States