Ignite Creation Date:
2024-05-06 @ 4:11 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04901247
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-24
First Post:
2021-05-20
Brief Title:
A Time-lapse Monitoring Prospective Study
Sponsor:
ART Fertility Clinics LLC
Organization:
ART Fertility Clinics LLC
Study Overview
Official Title:
Exploring Single Step Culture Medium Refreshment Effect on Embryo Ploidy Rate A Time-lapse Monitoring Prospective Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
While numerous types of commercially available human embryo culture media exist for human blastocyst culture the impact of culture conditions on blastocyst development and aneuploidy formation is not fully understood Culture conditions are very important for the success of the in vitro fertilization IVF cycle many of the factors involved in the process have been extensively studied However none of the studies investigated the effect on euploid rate in a sibling oocyte design with preimplantation genetic testing for aneuploidy PGT-A which requires culture till day 7 In addition the clinical outcome implantation will be investigated in a frozen cycle regimen Hence the study will explore which day of media refreshment will result in higher rate of ploidy and would improve clinical outcomes Investigators aim at exploring the best practice that would empower the euploid rate through the comparison of refreshing the single-step medium on day 3 or day 5 in a sibling oocyte prospective design
Detailed Description:
The use of extended embryo culture to the blastocyst stage and PGT-A has enabled identification and selection of embryos with the best developmental potential and improved IVF clinical outcomes It is considered a routine practice to grade the embryos on day 3 of development which will require disturbing the culture conditions by annotating the embryos using inverted microscopes However the application of Time-lapse technology TLS allows annotating the embryos on day 3 without interrupting the culture conditions especially if TLS is combined with single-step culture medium
There are several culture factors that can affect embryo development such as the pH which is controlled through the concentration of CO2 and also the osmolality which is the concentration of solute per liter of solution Evaporation of the solution due to the exposure to high temperature 37C can change the concentrations and hence compromise embryo development
Since single-step medium is designed to sustain embryo development for 5 continuous culture days while some laboratories culture embryos for 7 days refreshing the culture medium is inevitable either on day 3 or day 5 of development
There is no concrete evidence on which of these practices will provide a better environment for embryo development Moreover none of the studies investigated the effect of single-step culture medium changeover on day 3 or day 5 on the chromosomal errors aneuploidy We aim in this study to explore which day of culture medium refreshment day 3 or day 5 provides a higher rate of euploid blastocysts
Summary about data collected Categorical data will be presented in frequency tables and histograms Continuous values will be summarized according the mean standard deviation and confidence interval
There are several culture factors that can affect embryo development such as the pH which is controlled through the concentration of CO2 and also the osmolality which is the concentration of solute per liter of solution Evaporation of the solution due to the exposure to high temperature 37C can change the concentrations and hence compromise embryo development
Since single-step medium is designed to sustain embryo development for 5 continuous culture days while some laboratories culture embryos for 7 days refreshing the culture medium is inevitable either on day 3 or day 5 of development
There is no concrete evidence on which of these practices will provide a better environment for embryo development Moreover none of the studies investigated the effect of single-step culture medium changeover on day 3 or day 5 on the chromosomal errors aneuploidy We aim in this study to explore which day of culture medium refreshment day 3 or day 5 provides a higher rate of euploid blastocysts
Summary about data collected Categorical data will be presented in frequency tables and histograms Continuous values will be summarized according the mean standard deviation and confidence interval
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None