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NCT Number: NCT06539104

Aftificial Inteligence in Assisted Reproductive Techniques to Assess Oocyte Quality and Embryo Ploidy

The assisted reproduction success rate is affected by several factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. Imaging of the meiotic spindle may be crucial for determining the oocyte maturation. Artificial intelligence (AI) will be applied to establish the complex oocyte quality, embryo ploidy and pregnancy success probability from the sequence of data, starting with the recording of the meiotic spindle in polarized light, through paternal factors up to the time lapse recording of early embryo development. This strategy should reduce the cost of fertility treatment thanks to increased efficiency in choosing the most promising candidates and reducing the need for costly laboratory analyses.

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Key information

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Czech Technical University in Prague, Prague, Czechia

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About this study

One of the main strategies of infertility treatment is in vitro fertilization (IVF). The IVF success rate is affected by several key factors including the age of the women, oocyte quality and maturation state, as well as sperm quality. It has been suggested that the presence, position and retardance of the optically birefringent meiotic spindle (MS) are related to oocyte developmental competence, affecting the quality of fertilization and embryo development. Artificial intelligence (AI) will be applied to establish the complex oocyte quality, embryo ploidy and pregnancy success probability from the sequence of data, starting with the recording of the meiotic spindle in polarized light, through paternal factors up to the time lapse recording of early embryo development.

Synergic approaches will be used to increase the quality of embryos for implantation: image analysis and machine learning techniques will be applied to the oocyte microscopic images to perform the MS analysis fully automatically and to determine whether some other aspects of the oocyte appearance might correlate with the optimal timing and fertilization and pregnancy success, or genetic defects. An automatic method of embryo evaluation based on time-lapse videos after ICSI and MS imaging plus other scalar parameters (extracted features can be used as inputs for the downstream tasks, e.g. features extracted from oocytes and sperm can serve as additional inputs to the embryo classifier) will be used. This strategy should reduce the cost of fertility treatment thanks to increased efficiency in choosing the most promising candidates and reducing the need for costly laboratory analyses.

The analysis will be performed in cooperation with Czech Technical University and Institute of Physics Academy of Sciences of the Czech Republic who will create a software tool capable of predicting the probability of pregnancy and embryo ploidy status from oocyte images plus time-lapse video of a developing embryo after ICSI. It will be determined whether some other aspects of the oocyte appearance correlate with the fertilization and pregnancy success, or genetic defects.

Time lapse sequences of embryonic development and oocyte images will be acquired from VFN and from cooperating IVF centres (Gynem, s.r.o., Repromeda, s.r.o.). The sequences will be stored and paired with outcome (ploidy status, pregnancy) and also with previously acquired oocyte images. BIOCEV (Academy of sciences of the Czech Republic) will evaluate sperm parameters with respect to oocyte fertilization rate and early embryonic development.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Intracytoplasmatic Sperm Injection
  • Preimplantation genetic testing
  • Time lapse embryo record
  • Singned informed consent

Exclusion criteria

  • Gynecological diseases
  • Genetical diseases of parents

Treatment and study plan

arteficial inteligence evaluation of oocyte and embryo development

Procedure

apply AI to find out the complex oocyte quality, embryo development, embryo ploidy and pregnancy success probability from the sequence of the data starting from the recording of the meiotic spindle in polarized light, through paternal factors up to the time lapse record of early embryo development.

Other names: Preimplantation Genetic Testing (PDT), Computer Assisted Sperm Analysis (CASA), DNA Sperm Fragmentation Index (DFI), Intracytoplasmatic Sperm Injection (ICSI)

Primary outcomes

  1. The relative number of embryos whose ploidy was correctly predicted by AI

    Time frame: 1 hour

    Using an AI based non-invasive method of selecting a high-quality and genetically healthy embryos will undoubtably improve clinical and diagnostic practice and reduce costs in the field of infertility treatment. Both the segmentation and classification training will be based on expert annotations. The approach should lead to a classification accuracy at least 70%.

Study contacts

Contact information is provided by the study sponsor or research team.

Jaromir Masata, MD

CONTACT

[email protected]

+420603444662

Sponsors and collaborators

Lead sponsor

Charles University, Czech Republic

Other

Collaborators

  • Czech Academy of Sciences
  • Czech Technical University in Prague
  • General University Hospital, Prague

Registry information

Official study title

Scanning the Meiotic Spindle in Assisted Reproductive Techniques to Assess Oocyte Quality and Embryo Ploidy Evaluated by Artificial Intelligence (SMARTAI Study)

Acronym: SMARTAI

Important dates

Study start
2024
Primary completion
2027
Study completion
2028
First posted
Aug 6, 2024
Registry last updated
Jan 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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