Clinical trial NCT01369446: Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage
Official title: Eeva™ System Study: Noninvasive Recording and Visualization of Individual Embryos Cultured to Blastocyst Stage
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: In vitro fertilization
Assisted reproduction
Noninvasive imaging of embryos
Time lapse imaging of embryos
Traditional morphological grading of embryos
Prediction of blastocysts
Lead sponsor: Progyny, Inc.
Sponsor class: INDUSTRY
First posted: 2011-06-09
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women in the United States who undergo IVF treatment and imaging of their embryos with the Eeva System.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Eeva System correctly predicts on day 2 those embryos that will reach blastocyst stage at day 5.
timeFrame: Embryos cultured through blastocyst stage (Day 5).
Secondary outcomes:
measure: Pregnancy Outcome
timeFrame: Assessed at post embryo transfer day 12-14, post transfer week 5-8, and post transfer week 9-12.
Other outcomes:
Locations:
city: Encino
country: United States
facility: HRC Fertility
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: San Francisco
country: United States
facility: Pacific Fertility Center
state: California
city: San Jose
country: United States
facility: Fertility Physicians of Northern California
state: California
city: San Ramon
country: United States
facility: Reproductive Science Center
state: California
Study officials:
affiliation: Progyny, Inc.
name: Sheua Shen, MD, ELD
role: STUDY_DIRECTOR
References:
citation: Wong CC, Loewke KE, Bossert NL, Behr B, De Jonge CJ, Baer TM, Reijo Pera RA. Non-invasive imaging of human embryos before embryonic genome activation predicts development to the blastocyst stage. Nat Biotechnol. 2010 Oct;28(10):1115-21. doi: 10.1038/nbt.1686. Epub 2010 Oct 3.
citation: Athayde Wirka K, Chen AA, Conaghan J, Ivani K, Gvakharia M, Behr B, Suraj V, Tan L, Shen S. Atypical embryo phenotypes identified by time-lapse microscopy: high prevalence and association with embryo development. Fertil Steril. 2014 Jun;101(6):1637-48.e1-5. doi: 10.1016/j.fertnstert.2014.02.050. Epub 2014 Apr 14.