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

Study Overview

• Status: Not yet recruiting
• Conditions: Embryo Culture
• Intervention / Treatment: Device: Microdrop GPS dish; Device: 16 well BIRR dish

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.

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Ganin Fertility Center
    • Contact: Hosam Zaki, FRCOG; Phone Number: 16270; Email: hosamganin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dish no.1; Sibling oocytes were randomly allocated for culture in Dish 1 (Microdrop GPS Dish) from the ICSI procedure until the blastocyst stage.	Device: Microdrop 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.
Active Comparator: Dish no.2; Sibling oocytes were randomly allocated for culture in Dish 1 (16 well BIRR Dish) from the ICSI procedure until the blastocyst stage.	Device: 16 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blastocyst Development rate	Defined as the proportion of blastocysts formed on day 5 or 6	5 - 6 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cleavage rate	Defined as the proportion of cleaved embryos on day 3	3 days
Fertilization rate	Defined as the proportion of fertilized oocytes	1 day
Blastocyst Quality rate	Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor	5 - 6 days
High Quality Day 3 rate	proportion of high quality day 3 embryos	3 days

Collaborators and Investigators

• Sponsor: Ganin Fertility Center

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2025
• Primary Completion (Estimated): March 30, 2026
• Study Completion (Estimated): March 30, 2026

Study Registration Dates

• First Submitted: February 26, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: embryo culture; 3D culture dish
• Other Study ID Numbers: GFC-0010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No