Embryo CultureNCT06850909
Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: a Randomized Trial
A study testing Microdrop GPS dish and 16 well BIRR dish in people with Embryo Culture, run by Ganin Fertility Center at 1 site in Egypt.
Trial summary
Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: A Randomized Trial Read more about this study
- Who is it for?
- Ages 20 to 35 years
- Conditions the study is for
- Embryo Culture
- What is being tested?
- Microdrop GPS dish and 16 well BIRR dish
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 30 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Female patients aged 35 years or younger
- A minimum of 15 mature oocytes available for ICSI
- Classified as a good prognosis patient
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ganin Fertility Center
Cairo
Hosam Zaki, FRCOG, 16270, hosamganin@hotmail.com
About this study
Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: A Randomized Trial
Read the 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.
- Conditions
- Embryo Culture
- Being tested
- Microdrop GPS dish, 16 well BIRR dish
- Keywords
- 3D culture dish, embryo culture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microdrop GPS dishDevice
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 dishDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Dish no.1 | Active comparator | Sibling oocytes were randomly allocated for culture in Dish 1 (Microdrop GPS Dish) from the ICSI procedure until the blastocyst stage. Receives: Device: Microdrop GPS dish |
| Dish no.2 | Active comparator | Sibling oocytes were randomly allocated for culture in Dish 1 (16 well BIRR Dish) from the ICSI procedure until the blastocyst stage. Receives: Device: 16 well BIRR dish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blastocyst Development rate
Defined as the proportion of blastocysts formed on day 5 or 6
Measured: 5 - 6 days
Secondary outcomes (4)
Fertilization rate
Defined as the proportion of fertilized oocytes
Measured: 1 day
Cleavage rate
Defined as the proportion of cleaved embryos on day 3
Measured: 3 days
Blastocyst Quality rate
Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor
Measured: 5 - 6 days
High Quality Day 3 rate
proportion of high quality day 3 embryos
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2025
- Study start1 Mar 2025 (estimated)
- Primary completion30 Mar 2026 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Embryo CultureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ganin Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Hasanen, Ganin Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06850909
- Sponsor's protocol ID
- GFC-0010
- Status last verified
- Feb 2025
- First submitted
- 26 Feb 2025
- Last updated
- 28 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: a Randomized Trial
- ClinicalTrials.gov ID
- NCT06850909
- Acronym / sponsor ID
- GFC-0010
- Conditions
- Embryo Culture
- Keywords
- 3D culture dish, embryo culture
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ganin Fertility CenterUniversity, hospital or other
- Study start
- 1 Mar 2025 (estimated)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 28 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluating the Influence of 3D Culture Dish Design on Preimplantation Genetic Development in Sibling Oocytes: A Randomized Trial
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dish no.1 | Active comparator | Device: Microdrop GPS dishSibling oocytes were randomly allocated for culture in Dish 1 (Microdrop GPS Dish) from the ICSI procedure until the blastocyst stage. |
| Dish no.2 | Active comparator | Device: 16 well BIRR dishSibling oocytes were randomly allocated for culture in Dish 1 (16 well BIRR Dish) from the ICSI procedure until the blastocyst stage. |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients aged 35 years or younger
- A minimum of 15 mature oocytes available for ICSI
- Classified as a good prognosis patient
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microdrop GPS dishThe 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. | Device | Dish no.1 |
| 16 well BIRR dishThe 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. | Device | Dish no.2 |
Primary outcome
Blastocyst Development rate
Time frame: 5 - 6 days
Defined as the proportion of blastocysts formed on day 5 or 6
4 secondary outcomes
Fertilization rate
Time frame: 1 day
Cleavage rate
Time frame: 3 days
Blastocyst Quality rate
Time frame: 5 - 6 days
High Quality Day 3 rate
Time frame: 3 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microdrop GPS dish and 16 well BIRR dish in people with Embryo Culture, run by Ganin Fertility Center at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blastocyst Development rate (time frame: 5 - 6 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.