An observational study in Aneuploidy and Infertility, sponsored by ART Fertility Clinics LLC. Status unknown at 2 sites in United Arab Emirates. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by ART Fertility Clinics LLC · Observational
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.
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 (37°C) 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.
73 studies on the registry are indexed under Aneuploidy; 10 are open to participants now.
This study's planned enrollment of 50 is below the median of 325 across 38 observational studies indexed under Aneuploidy.
Browse Aneuploidy studies →ART Fertility Clinics LLC is the lead sponsor of 51 studies on the registry; 20 are open to participants now.
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Patients undergoing a fertility treatment due to primary or secondary infertility at ART Fertility Clinics.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
embryo grading and culture refreshment will be done 67-69 hours post insemination
Behavioral: media refreshment · Behavioral: embryo grading
embryo grading and culture medium refreshment will be done 114-118 hours post insemination
Behavioral: media refreshment · Behavioral: embryo grading
20µL of culture medium is aspirated using Eppendorf PCR tips, and freshly, overnight equilibrated 20µL global total LP will be added to the same well
embryo grading should be done prior to media refreshment
blastocyst ploidy
determined after biopsy of trophectoderm cells, taken from the blastocyst on day 5, 6 or 7 from development.
Time frame: 3 days
cycle ploidy rate
the number of euploid embryos in the group divided by the total number of 2PN
Time frame: 1 day
mosaicism frequency
defined as the rate of mosaic errors in aneuploid embryos. This includes full mosaic embryos or aneuploid embryos with 1 or more mosaic chromosome aberration
Time frame: 1 day
blastocyst quality at time of biopsy
Four Embryo Quality Scores (EQ1, 2, 3, 4) based on the expansion stage of the blastocyst, the grade of the inner cell mass and the grade of the trophectoderm
Time frame: 1 day
blastulation rate
ability of the embryo to form a cavity (=to blastulate) 118hours post ICSI. Number of blastocysts divided by the number of 2PN
Time frame: 5 days
This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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