Infertility
Conditions
Keywords
In vitro fertilization, Assisted reproductive therapy, Time-lapse image recording, Image analysis software
Brief summary
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates.
Detailed description
The purpose of this postmarket study is to gather data to evaluate the impact of using Eeva with traditional morphology grading on clinical pregnancy rates, as compared to a matched case control group that used morphology grading only to select embryos for transfer.
Interventions
None listed
Sponsors
Progyny, Inc.
Study design
Observational model
CASE_CONTROL
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Women undergoing fresh in vitro fertilization treatment using their own eggs or donor eggs. * IVF cycle attempts ≤ 3. * Egg age ≤ 40 years. * Planned Day 3 embryo transfer. * 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) - no surgically removed sperm. * Willing to comply with study protocol and procedures. * Willing to provide written informed consent.
Exclusion criteria
* Planned preimplantation genetic diagnosis. * Planned freeze all cycle (oocytes or embryos). * Concurrent participation in another clinical study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of clinical pregnancy | 5-8 weeks gestational age | 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 2011-2013 patients). |
Secondary
| Measure | Time frame |
|---|---|
| Spontaneous miscarriage rate | Gestational age week 10-12 |
| Multiple pregnancy rate | Gestational weeks 5-8 and 10-12 |
| Implantation rate (# of implanted embryos out of # of total embryos transferred) | 5-8 weeks gestational age. |
| Ongoing Pregnancy Rate (gestational week 10-12) | Gestational age week 10-12 |
Countries
Belgium, Netherlands
Outcome results
None listed