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

NCT ID: NCT06850909

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-01

Study Completion Date

2026-03-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Embryo Culture

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Dish no.1

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

Group Type ACTIVE_COMPARATOR

Microdrop GPS dish

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

16 well BIRR dish

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ganin Fertility Center

OTHER

Sponsor Role lead

Responsible Party

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Eman Hasanen

ESHRE certified Clinical Embryologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ganin Fertility Center

Cairo, , Egypt

Site Status

Countries

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Egypt

Facility Contacts

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Hosam Zaki, FRCOG

Role: primary

Other Identifiers

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GFC-0010

Identifier Type: -

Identifier Source: org_study_id

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