Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: a Randomized Trial
1 other identifier
interventional
200
1 country
1
Brief Summary
Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: A Randomized Trial
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2025
CompletedFirst Posted
Study publicly available on registry
February 28, 2025
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2026
CompletedFebruary 28, 2025
February 1, 2025
1.1 years
February 26, 2025
February 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Blastocyst Development rate
Defined as the proportion of blastocysts formed on day 5 or 6
5 - 6 days
Secondary Outcomes (4)
Fertilization rate
1 day
Cleavage rate
3 days
Blastocyst Quality rate
5 - 6 days
High Quality Day 3 rate
3 days
Study Arms (2)
Dish no.1
ACTIVE COMPARATORSibling oocytes were randomly allocated for culture in Dish 1 (Microdrop GPS Dish) from the ICSI procedure until the blastocyst stage.
Dish no.2
ACTIVE COMPARATORSibling oocytes were randomly allocated for culture in Dish 1 (16 well BIRR Dish) from the ICSI procedure until the blastocyst stage.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- Female patients aged 35 years or younger
- A minimum of 15 mature oocytes available for ICSI
- Classified as a good prognosis patient
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ganin Fertility Center
Cairo, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- ESHRE certified Clinical Embryologist
Study Record Dates
First Submitted
February 26, 2025
First Posted
February 28, 2025
Study Start
March 1, 2025
Primary Completion
March 30, 2026
Study Completion
March 30, 2026
Last Updated
February 28, 2025
Record last verified: 2025-02