Ignite Creation Date:
2024-05-06 @ 4:22 PM
Last Modification Date:
2024-10-26 @ 2:09 PM
Study NCT ID:
NCT04969575
Status:
RECRUITING
Last Update Posted:
2023-03-24
First Post:
2021-07-11
Brief Title:
A Benchtop Incubator 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 Benchtop Incubator Prospective Study
Status:
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:
The use of extended embryo culture to the blastocyst stage and preimplantation genetic testing for aneuploidy PGT-A has enabled identification and selection of embryos with the best developmental potential and improved in vitro fertilization IVF clinical outcomes While numerous types of commercially available human embryo culture media exist for culture to the blastocyst stage the impact of culture conditions on blastocyst development and aneuploidy formation is not well understood
Culture conditions are very important for the success of the IVF cycle many of the factors involved in the process have been extensively studied including the use of sequential culture medium vs single step culture medium humidified incubators vs dry incubators and refreshing the medium on day 3 vs uninterrupted culture till day 5 However none of the studies investigated the effect on euploid rate in a sibling oocyte design with PGT-A which requires culture till day 7
Culture conditions are very important for the success of the IVF cycle many of the factors involved in the process have been extensively studied including the use of sequential culture medium vs single step culture medium humidified incubators vs dry incubators and refreshing the medium on day 3 vs uninterrupted culture till day 5 However none of the studies investigated the effect on euploid rate in a sibling oocyte design with PGT-A which requires culture till day 7
Detailed Description:
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 Extended culture to day 7 is required in order to perform trophectoderm biopsy required for PGT-A 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
To reduce the rate of evaporation culture droplets are covered with a layer of mineral oil Humidified incubators can also reduce the rate of evaporation However in the case of dry incubators such as benchtop incubators replenishing the culture medium at least once -by moving the embryos to a new culture dish- during these 7 days of culture might be the solution
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 aneuploidymosaicism Investigators aim in this prospective sibling oocyte study to explore which day of culture medium refreshment day 3 or day 5 provides a higher rate of euploid blastocysts
To reduce the rate of evaporation culture droplets are covered with a layer of mineral oil Humidified incubators can also reduce the rate of evaporation However in the case of dry incubators such as benchtop incubators replenishing the culture medium at least once -by moving the embryos to a new culture dish- during these 7 days of culture might be the solution
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 aneuploidymosaicism Investigators aim in this prospective sibling oocyte study to explore which day of culture medium refreshment day 3 or day 5 provides a higher rate of euploid blastocysts
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