Biopsy Rate, Blastocyst Quality, Fertilization Rate, ICSI, Incubator Stay, Ploidy Rate, Total Blastulation
Conditions
Brief summary
IVF incubators are essential for maintaining the micro-environment required for embryo development. Incubator technology has progressed from early humidified box systems to benchtop and now time-lapse platforms, driving the development of dry incubator chambers. Both humidified and dry systems have specific pros and cons. Evidence to date suggests that humidified chambers may support better blastocyst development in certain "no-refresh" continuous culture conditions, but current data are limited and study designs remain weak. This study aims to compare sibling oocytes cultured in dry versus humidified chambers within a GERI time-lapse incubator under continuous culture conditions, assessing effects on viability and developmental outcomes. Findings may inform optimal incubation strategies to improve IVF success rates while supporting uninterrupted workflows and potentially improving cost-benefit efficiency in the IVF laboratory.
Interventions
DEVICEK- system incubator
Following oocyte retrieval, collected oocytes will be incubated in Global Total for Fertilization within a K-Systems incubator until the time of denudation and intracytoplasmic sperm injection (ICSI). All mature (MII) oocytes will undergo ICSI at 39-41 hours post-trigger. After insemination, sibling oocytes will be divided as equally as possible and randomly allocated into two separate Geri incubator chambers: Group 1 will be cultured in the dry chamber, and Group 2 will be cultured in the humidified chamber. A predefined randomization list will determine allocation, including cases with an uneven number of oocytes, where the additional oocyte will be assigned according to the list. Both groups will use Global TotalR (GT, CooperSurgical) single-step medium. Embryo culture will be carried out in continuous culture conditions until the blastocyst stage, following the manufacturer's GT protocol, with no Day 3 media refreshment. To minimize procedural variability, one operator will ideally
Sponsors
ART Fertility Clinics LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 43 Years
Healthy volunteers
Yes
Inclusion criteria
* PGT-A cycles with more than at least 4 mature oocytes * ICSI * maternal age 18- 43 years old * PGT-A intended cycles with trophectoderm biopsies on day 5 /6/7 * patients with more than 8 oocytes expected for ICSI * BMI \<35 * fresh and frozen ejaculated sperm
Exclusion criteria
* PGT-M /PGT-SR cycles * fresh and frozen testicular sperm * IVF insemination * previous history of fertilization failure
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Day 5 blastulation versus total blastulation | Day 5 post-insemination | Day 5 blastulation versus total blastulation refers to comparing the proportion of embryos that reach the blastocyst stage specifically by Day 5 against the overall number of embryos that eventually form blastocysts |
| Blastocyst quality at time of biopsy based on modified Gardner's criteria. | Day 5 post-insemination | Blastocyst quality at the time of biopsy will be assessed using the modified Gardner's grading system, which evaluates three key components of the blastocyst: the degree of expansion, the quality of the inner cell mass (ICM), and the quality of the trophectoderm (TE). This standardized scoring allows objective comparison of embryo morphology and developmental competence at the moment of trophectoderm biopsy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total blastulation rates per MII and 2PN. | Day 5 post-insemination | Total blastulation rates per MII and per 2PN refer to the proportion of inseminated mature oocytes (MII) and normally fertilized zygotes (2PN) that successfully develop into blastocysts, regardless of whether they reach this stage on Day 5 or Day 6. This measurement reflects the overall efficiency of embryo development from both the point of maturation and normal fertilization. |
| Ploidy rate/biopsy and types of aneuploidies (segmental and mosaic) | Day 5 post-insemination | Ploidy rate per biopsy refers to the proportion of biopsied blastocysts that return a euploid, aneuploid, mosaic or segmental result after PGT-A testing. This includes reporting the distribution of chromosomal abnormalities identified, distinguishing between full aneuploidies (whole chromosome gain or loss), segmental aneuploidies (partial chromosome changes) and mosaic patterns (mixed normal and abnormal cell lines). This outcome reflects the chromosomal competence of embryos generated under each culture condition. |
| Blastocyst utilization rate | 30 days | Blastocyst utilization rate refers to the proportion of blastocysts that are suitable for clinical use-meaning those that are either transferred, frozen for future use, or biopsied for PGT-A. |
| Rate of day 5 biopsy | Day 5 post-insemination | Rate of Day 5 biopsy refers to the proportion of blastocysts that reach the biopsy stage specifically on Day 5, relative to the total number of blastocysts biopsied. |
Countries
United Arab Emirates
Contacts
CONTACTJONALYN EDADES, EMBA Healthcare Management
STUDY_DIRECTORBARBARA LAWRENZ, PhD
ART Fertility Clinics LLC
Outcome results
None listed