Actively Recruiting

Age: 18Years - 49Years
All Genders
ID06539104

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

Led by Charles University, Czech Republic · Updated on 2025-01-22

1000

Participants Needed

4

Research Sites

13 weeks

Total Duration

On this page

Sponsors

C

Charles University, Czech Republic

Lead Sponsor

C

Czech Academy of Sciences

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying infertility in men and women to improve assisted reproductive techniques using artificial intelligence (AI). The study focuses on key factors affecting in vitro fertilization (IVF) success, such as the age of the woman, oocyte quality, maturation state, and sperm quality. AI will analyze a sequence of data starting with imaging the meiotic spindle in the oocyte, followed by paternal factors and early embryo development to predict embryo ploidy and pregnancy success. This approach aims to increase treatment efficiency and reduce costs by selecting the most promising candidates and minimizing the need for expensive laboratory tests. The intervention involves applying AI to automatically analyze microscopic images of oocytes and time-lapse videos of embryo development after intracytoplasmic sperm injection (ICSI). The study uses image analysis and machine learning to assess the meiotic spindle and other oocyte features that may correlate with fertilization, pregnancy success, or genetic defects. Collaboration with technical and scientific institutes aims to develop software capable of predicting pregnancy probability and embryo ploidy status from these images and videos. Participants will undergo procedures including ICSI, preimplantation genetic testing, and time-lapse embryo recording. Data collected will be paired with pregnancy outcomes and embryo ploidy status. Researchers will evaluate sperm parameters in relation to fertilization and early embryo development. The primary outcome measured is the accuracy of AI in predicting embryo ploidy. The study involves detailed image and video analysis but does not involve treatment randomization. Participants' involvement will include consent, image recording, and genetic testing, with the study expected to continue through March 2028.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 49Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Undergoing intracytoplasmic sperm injection (ICSI)
  • Undergoing preimplantation genetic testing
  • Having time-lapse embryo recording
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Presence of gynecological diseases
  • Genetic diseases in either parent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 day

Participants undergo imaging and data recording including meiotic spindle imaging, sperm parameter evaluation, and time-lapse embryo recording to assess oocyte quality and embryo development using artificial intelligence.

1 visit (in-person)

Long-term Monitoring

Duration - Up to several months until study completion

Participants are observed over time to correlate AI predictions with embryo ploidy status and pregnancy outcomes.

Visit schedule depends on routine clinical care; no additional visits required for the study

Trial Site Locations

Total: 4 locations

1

General University Hospital in Prague

Prague, Czechia, 128 08

Actively Recruiting

2

Czech Technical University in Prague

Prague, Czechia

Actively Recruiting

3

Institute of Physics AS CR

Prague, Czechia

Actively Recruiting

4

Biocev As Cr

Vestec, Czechia

Actively Recruiting

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Research Team

J

Jaromir Masata, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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Published Research Related To This Trial

Relationship between meiotic spindle location with regard to the polar body position and oocyte developmental potential after ICSI.

L Rienzi, F Ubaldi, F Martinez...

https://pubmed.ncbi.nlm.nih.gov/12773461