Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results
| Status: | Completed |
|---|---|
| Conditions: | Women's Studies, Infertility |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - 43 |
| Updated: | 10/2/2013 |
| Start Date: | June 2012 |
| End Date: | July 2014 |
| Contact: | Richard T Scott, Jr., MD |
| Email: | ClinicalResearchTeam@rmanj.com |
| Phone: | 973-656-2841 |
Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results,Implantation and Live Birth
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.
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.
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
We found this trial at
2
sites
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