Infertility Clinical Trial
— CCSOfficial title:
Correlating Time-Lapse Parameters Detected by the Eeva™ System With Comprehensive Chromosome Screening Results,Implantation and Live Birth
Verified date | January 2015 |
Source | Progyny, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | December 2014 |
Est. primary completion date | December 2014 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | N/A to 43 Years |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Reproductive Medicine Associates of New Jersey | Morristown | New Jersey |
United States | Reproductive Medicine Associates of New York | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Progyny, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Eeva time-lapse parameters and CCS | Analyse the correlation of time-lapse parameters collected by the Eeva System and comprehensive chromosome screening (CCS) results. | 5-6 days | No |
Secondary | Correlation of time-lapse parameters collected by the Eeva System and implantation rate. | 6 weeks | No | |
Secondary | Correlation of time-lapse parameters collected by the Eeva System and clinical pregnancy rate | 6 weeks | No | |
Secondary | Correlation of time-lapse parameters collected by the Eeva System and ongoing pregnancy rate | 7 - 8 weeks | No | |
Secondary | Correlation of time-lapse parameters collected by the Eeva System and delivery rate | live birth | No | |
Secondary | Correlation of time-lapse parameters collected by the Eeva System and spontaneous miscarriage rate | live birth | No | |
Secondary | Correlation of time-lapse parameters collected by the Eeva System and multiple pregnancy rate | live birth | No |
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