The main objective is to compare the rate of clinical pregnancy at approximately 5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva predictions with morphology grading to that for Day 3 embryo transfers using morphology grading…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
subfertiliteit
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary Objective: To compare the rate of clinical pregnancy at approximately
5-8 weeks gestational age for the Day 3 embryo transfers that used Eeva
predictions with morphology grading to that for Day 3 embryo transfers using
morphology grading only (from a matched concurrent control group at each
clinical site comprised of year 2011 through the date the last subject is
enrolled in the Eeva Test Group patients).
Secondary outcome
Secondary Objective(s): To compare the following outcomes from the Eeva test
group to the matched control group.
• Implantation rate (# of implanted embryos out of # of total embryos
transferred)
• Ongoing pregnancy rate (gestational week 10-12)
• Multiple pregnancy rate
• Spontaneous miscarriage rate
Background summary
Eeva technology was designed to provide objective information about the
embryo*s potential for development and ensure accurate, consistent embryo
assessments for the embryologists prior to embryo transfer. Based on the
results of the Eeva System study, Eeva is safe, performs according to its
specifications, and shows clinical benefit in accordance with its intended use.
The capability of Eeva to predict which embryo will develop into a blastocyst
may result in fewer implantation failures and fewer unproductive IVF cycles.
The next logical step is to gather data to compare the rate of clinical
pregnancy for the Day 3 embryo transfers that used the Eeva blastocyst
prediction as an adjunct to traditional morphology grading (test group), to
that for the Day 3 embryo transfers that used morphology grading only (matched
control group).
Study objective
The main objective is to compare the rate of clinical pregnancy at
approximately 5-8 weeks gestational age for the Day 3 embryo transfers that
used Eeva predictions with morphology grading to that for Day 3 embryo
transfers using morphology grading only (from a matched concurrent control
group at each clinical site comprised of year 2011 through the date the last
subject is enrolled in the Eeva Test Group patients).
Study design
This is a prospective, observational, single arm, nonrandomized, multicenter
clinical study with a matched concurrent case control data (year 2011 through
the date the last subject is enrolled in the Eeva Test Group patients) from
each clinical site.
Intervention
For all included patients, an Eeva prediction will be used in addition to the
standard morphology to select the embryo for transfer.
Study burden and risks
The potential for risks is very low. The risks identified through the risk
management process which may be associated with the Eeva System were not
observed in the first clinical investigation, and no subject needed additional
medical procedures due to use of the Eeva System to image her embryos.
O'Brien Drive, Suite A 1490
Menlo Park CA 94025
US
O'Brien Drive, Suite A 1490
Menlo Park CA 94025
US
Listed location countries
Inclusion criteria
•Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs.
•IVF cycle attempts are <= 3.
•Planned Day 3 embryo transfer.
•Egg age >= 18 and <= 40 years.
•At least 5 normally fertilized eggs (2PN).
•All 2PN embryos must be imaged by Eeva.
•Normal uterine cavity as evaluated by standard methods.
•Fertilization using only ejaculated sperm (fresh or frozen)
•Willing to comply with study protocol and procedures.
•Willing to provide written informed consent.
Exclusion criteria
•Patients with surgically removed sperm.
•Patients with planned preimplantation genetic diagnosis or preimplantation genetic screening.
•Patients with a planned *freeze all* cycle.
•Patients with concurrent participation in another clinical study.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| ClinicalTrials.gov | NCT01671644 |
| CCMO | NL41843.000.12 |