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NCT Number: NCT06850909

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

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Key information

Conditions

Embryo Culture

Age range

20 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Microdrop GPS dish

Device

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.

16 well BIRR dish

Device

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.

Primary outcomes

  1. Blastocyst Development rate

    Time frame: 5 - 6 days

    Defined as the proportion of blastocysts formed on day 5 or 6

Secondary outcomes

  1. Fertilization rate

    Time frame: 1 day

    Defined as the proportion of fertilized oocytes

  2. Cleavage rate

    Time frame: 3 days

    Defined as the proportion of cleaved embryos on day 3

  3. Blastocyst Quality rate

    Time frame: 5 - 6 days

    Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor

  4. High Quality Day 3 rate

    Time frame: 3 days

    proportion of high quality day 3 embryos

Sponsors and collaborators

Lead sponsor

Ganin Fertility Center

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 28, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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