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Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: a Randomized Trial

Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: a Randomized Trial

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06850909
Enrollment
200
Registered
2025-02-28
Start date
2025-03-01
Completion date
2026-03-30
Last updated
2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embryo Culture

Keywords

3D culture dish, embryo culture

Brief summary

Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: A Randomized Trial

Detailed description

The configuration of culture dishes plays a crucial role in preimplantation embryo development by influencing key culture conditions such as media distribution, oxygen exchange, and embryo spacing, all of which directly impact embryonic growth, fertilization, blastocyst formation, and overall blastocyst quality. Traditional 2D culture dishes provide a flat surface for embryo development, whereas 3D culture dishes create a microenvironment that better mimics in vivo conditions by optimizing nutrient availability and reducing stress from environmental fluctuations. In this study, we compare the effects of two different 3D culture dishes-Dish 1 (Microdrop GPS Dish) and Dish 2 (16-Well BIRR Dish)-on preimplantation genetic outcomes. Using a sibling oocyte split design, oocytes were randomly divided after intracytoplasmic sperm injection (ICSI) and cultured in either dish, ensuring that each patient serves as their own internal control. Embryo development was closely monitored from fertilization to blastocyst formation, to determine whether dish design has a significant impact on preimplantation embryo development.

Interventions

DEVICEMicrodrop GPS dish

The µDrop GPS® micro-wells dish is specifically designed for oocyte and embryo handling and culture. The sloped concave micro-well bottoms of the µDrop GPS® dish allow oocytes and embryos to settle at a central location away from the well walls. The concave nature of the wells provides the thinnest well bottom possible, helping to reduce refraction and allow for optimal visualization. The wells may reduce droplet collapsing/mixing, offer better orientation/optics, and reduce set-up/observation time.

DEVICE16 well BIRR dish

The 16-Well BIRR Dish is a high-quality 3D culture dish designed for optimal embryo handling and identification in IVF. It features well-numbering (1-16) for clear tracking, a large labeling area, and an expanded working space for better accessibility. Its 16 wells allow for increased wash drops and single embryo culture, reducing the number of dishes needed per IVF cycle. Rigorously tested (MEA+, LAL, and SMA per lot), it ensures safe and efficient embryo culture.

Sponsors

Ganin Fertility Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 35 Years
Healthy volunteers
No

Inclusion criteria

* Female patients aged 35 years or younger * A minimum of 15 mature oocytes available for ICSI * Classified as a good prognosis patient

Exclusion criteria

* Cases with severe DNA fragmentation * Patients undergoing FNA or TESE procedures * Severe male factor infertility * History of low or failed fertilization in previous cycles * Any contraindications to gonadotropin stimulation * Presence of leukocytospermia

Design outcomes

Primary

MeasureTime frameDescription
Blastocyst Development rate5 - 6 daysDefined as the proportion of blastocysts formed on day 5 or 6

Secondary

MeasureTime frameDescription
Fertilization rate1 dayDefined as the proportion of fertilized oocytes
Cleavage rate3 daysDefined as the proportion of cleaved embryos on day 3
Blastocyst Quality rate5 - 6 daysDefined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor
High Quality Day 3 rate3 daysproportion of high quality day 3 embryos

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026