AzTrials
AzTrials

InfertilitySMARTAINCT06539104

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

An observational study of Infertility and Infertility, Female, run by Charles University, Czech Republic at 4 sites in Czechia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 49 years
What is being tested?
arteficial inteligence evaluation of oocyte and embryo development
How many people
1,000 participants
Where
4 sitesCzechia
Study dates
5 Jan 2024to 31 Mar 2028
Phase
Observational
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 18 to 49 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Infertility couples, where ICSI and PDT are indicated

Who may be able to join

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

Who cannot join

  • Gynecological diseases
  • Genetical diseases of parents

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Jaromir Masata, MD contact

+420603444662

masata@volny.cz

Czechia4 sites, 4 recruiting

  • General University Hospital in Prague

    Prague, 128 08

    Jaromir Masata, MD, +420603444662, masata@volny.cz

    Recruiting

  • Czech Technical University in Prague

    Prague

    Jan Kybic, Prof, +420 2 2435 5721, kybic@fel.cvut.cz

    Recruiting

  • Institute of Physics AS CR

    Prague

    Irena Kratochvilova, Prof., +420266052524, krat@fzu.cz

    Recruiting

  • Biocev As Cr

    Vestec

    Katerina Komrskova, As.prof., +420325873799, katerina.komrskova@ibt.cas.cz

    Recruiting

Other trials in Czechia

About this study

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

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.

Read the detailed description

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.

Being tested
arteficial inteligence evaluation of oocyte and embryo development
Keywords
infertility, humant oocyte, IVF, arteficial inteligence, Sperm count, meiotic spindle, time lapse
Medical subject headings
Infertility, Infertility, Female, Infertility, Male

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • arteficial inteligence evaluation of oocyte and embryo developmentProcedure or surgery

    Also called Preimplantation Genetic Testing (PDT), Computer Assisted Sperm Analysis (CASA), DNA Sperm Fragmentation Index (DFI), Intracytoplasmatic Sperm Injection (ICSI)

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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%.

    Measured: 1 hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Aug 2024
  2. Study start5 Jan 2024
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06539104
Sponsor's protocol ID
NW24-08-00048
Acronym
SMARTAI
Status last verified
Jan 2025
First submitted
1 Aug 2024
Last updated
22 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • van Loendersloot LL, van Wely M, Limpens J, Bossuyt PM, Repping S, van der Veen F. Predictive factors in in vitro fertilization (IVF): a systematic review and meta-analysis. Hum Reprod Update. 2010 Nov-Dec;16(6):577-89. doi: 10.1093/humupd/dmq015. Epub 2010 Jun 25.

    PubMed 20581128

  • Wu B, Shi J, Zhao W, Lu S, Silva M, Gelety TJ. Understanding reproducibility of human IVF traits to predict next IVF cycle outcome. J Assist Reprod Genet. 2014 Oct;31(10):1323-30. doi: 10.1007/s10815-014-0288-y. Epub 2014 Aug 15.

    PubMed 25119191

  • Hanevik HI, Hessen DO. IVF and human evolution. Hum Reprod Update. 2022 Jun 30;28(4):457-479. doi: 10.1093/humupd/dmac014.

    PubMed 35355060

  • Rienzi L, Ubaldi F, Martinez F, Iacobelli M, Minasi MG, Ferrero S, Tesarik J, Greco E. Relationship between meiotic spindle location with regard to the polar body position and oocyte developmental potential after ICSI. Hum Reprod. 2003 Jun;18(6):1289-93. doi: 10.1093/humrep/deg274.

    PubMed 12773461

  • Innocenti F, Fiorentino G, Cimadomo D, Soscia D, Garagna S, Rienzi L, Ubaldi FM, Zuccotti M; SIERR. Maternal effect factors that contribute to oocytes developmental competence: an update. J Assist Reprod Genet. 2022 Apr;39(4):861-871. doi: 10.1007/s10815-022-02434-y. Epub 2022 Feb 15.

    PubMed 35165782

Questions about this trial

What is this clinical trial studying?

An observational study of Infertility and Infertility, Female, run by Charles University, Czech Republic at 4 sites in Czechia.

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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Czechia. 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?

Contact Jaromir Masata, MD (+420603444662, masata@volny.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The relative number of embryos whose ploidy was correctly predicted by AI (time frame: 1 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06539104, which also lists 5 linked publications.

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 22 Jan 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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