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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-35
SponsorGanin Fertility Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Female patients aged 35 years or younger

A minimum of 15 mature oocytes available for ICSI

Classified as a good prognosis patient

Disqualifiers

Cases with severe DNA fragmentation

Patients undergoing FNA or TESE procedures

Severe male factor infertility

History of low or failed fertilization in previous cycles

Trial design

Design model

Parallel

Treatments tested in this trial

  • Microdrop GPS dish

    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.

  • 16 well BIRR dish

    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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Dish no.1Active comparator 1 intervention
Group B: Dish no.2Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Blastocyst Development rate

Defined as the proportion of blastocysts formed on day 5 or 6

Time frame
5 - 6 days

Secondary outcomes

1

Fertilization rate

Defined as the proportion of fertilized oocytes

Time frame
1 day
2

Cleavage rate

Defined as the proportion of cleaved embryos on day 3

Time frame
3 days
3

Blastocyst Quality rate

Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or poor

Time frame
5 - 6 days
4

High Quality Day 3 rate

proportion of high quality day 3 embryos

Time frame
3 days

Other outcomes

Sponsors and contacts

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