Infertility
Conditions
Keywords
in vitro fertilization, assisted reproduction techniques, noninvasive imaging of embryos, time lapse imaging of embryos, traditional morphological grading of embryos, prediction of blastocysts, infertility, preimplantation genetic diagnosis, comprehensive chromosome screening
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 System parameters with comprehensive chromosome screening (CCS) results, implantation and live birth.
Detailed description
The present study was designed to determine if there is a correlation between the Eeva System parameters and CCS results. Embryos will be selected for transfer based on CCS results and morphology. The Clinical site will have no access to the Eeva analysis at the time of the transfer.
Interventions
None listed
Sponsors
Progyny, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 43 Years
Healthy volunteers
No
Inclusion criteria
* Subject is ≤43 years of age. * Women undergoing fresh IVF treatment using her own eggs or donor eggs and undergoing CCS, as recommended based on medical need by the clinical site reproductive endocrinologist. * 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. * No concurrent participation in another clinical 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 * Diminished ovarian reserve as demonstrated by any one of the following: * BAFC \< 6 at time of cycle start * Maximum prior FSH \> 15 * AMH \< 0.5
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Eeva time-lapse parameters and CCS | 5-6 days | Analyse the correlation of time-lapse parameters collected by the Eeva System and comprehensive chromosome screening (CCS) results. |
Secondary
| Measure | Time frame |
|---|---|
| Correlation of time-lapse parameters collected by the Eeva System and implantation rate. | 6 weeks |
| Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate | 7 - 8 weeks |
| Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate | 6 weeks |
| Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate | live birth |
| Correlation of time-lapse parameters collected by the Eeva System and multiple pregnancy rate | live birth |
| Correlation of time-lapse parameters collected by the Eeva System and delivery rate | live birth |
Countries
United States
Outcome results
None listed