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

Ganin Fertility Center

Status: Not yet enrolling

Conditions: Embryo Culture

Treatments: Device: 16 well BIRR dish; Device: Microdrop GPS dish

Study type: Interventional

Funder types: Other

Identifiers

NCT06850909

GFC-0010

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

200 participants in 2 patient groups

Dish no.1

Active Comparator group

Description:

Sibling oocytes were randomly allocated for culture in Dish 1 (Microdrop GPS Dish) from the ICSI procedure until the blastocyst stage.

Treatment:

Device: Microdrop GPS dish

Dish no.2

Active Comparator group

Description:

Sibling oocytes were randomly allocated for culture in Dish 1 (16 well BIRR Dish) from the ICSI procedure until the blastocyst stage.

Treatment:

Device: 16 well BIRR dish