What is this study trying to find out about embryo selection in IVF?

This study is evaluating a new non-invasive method combining artificial intelligence and Raman spectroscopy to improve embryo selection during IVF treatment. Researchers aim to increase the accuracy of identifying embryos with chromosomal abnormalities to improve pregnancy outcomes. The study is sponsored by the Chinese University of Hong Kong.

Who may be eligible for this reproductive issues clinical trial?

Adults undergoing IVF or ICSI treatment with at least three normally fertilized embryos and planning to use a time-lapse incubator may be eligible. Both men and women can participate if they do not have known genetic diseases and their embryos have clear imaging. Please review eligibility criteria for more details.

Is there any cost to participate in this reproductive issues clinical trial?

Study-related care, including the study procedures and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Phase Not Applicable

All Genders

ID05896709

Non-invasive Embryo Selection for IVF Using AI-Enhanced Morphokinetic and Raman Spectra Analysis

Led by Chinese University of Hong Kong · Updated on 2025-03-21

176

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are exploring a new non-invasive method to select embryos during assisted reproductive technology treatments such as IVF and ICSI. This study evaluates an integrated approach combining artificial intelligence-enhanced morphokinetic MK analysis using time-lapse imaging and Raman spectroscopy RS of the spent culture medium to improve embryo assessment. The goal is to increase the clinical pregnancy rate by accurately identifying embryos with chromosomal abnormalities without the need for invasive genetic testing. The study has two phases. Phase I is a retrospective study collecting data to train the AI model combining MK and RS methods. Phase II is a prospective randomized controlled trial where participants are assigned to one of two groups embryos selected by the MK-RS integrated method or embryos selected by traditional morphological assessment by embryologists. Embryo images are captured every 10 minutes, and spent culture medium is analyzed by RS to detect metabolic markers. The MK-RS method aims to complete embryo assessment within 5-6 days after fertilization. Participants will undergo IVFICSI treatment with embryo culture using a time-lapse incubator. Researchers will collect images and culture medium samples to analyze embryo development and metabolic profiles. The main outcome measured is the clinical pregnancy rate at 6-8 weeks of gestation. Secondary outcomes include miscarriage rate, multiple pregnancy rate, ploidy status, and live birth rate. The study involves monitoring embryo development, collecting biological samples, and evaluating pregnancy outcomes through follow-up.

CONDITIONS

Brief Title

A Novel Integrative Non-invasive Embryo Selection Approach for IVF Based on MK-RS Analysis

Who Can Participate

All Genders

Eligibility Criteria

You may qualify if you...

Patients undergoing IVF or ICSI treatment
Patients receiving their first, second, or third IVF/ICSI treatment cycle
Patients and their partners willing to sign informed consent
Patients having at least three normally fertilized embryos on the day of fertilization check
Consecutive women undergoing IVF treatment
Patients planning to use a time-lapse incubator for embryo culture

You will not qualify if you...

Day one embryos with blurred imaging
Embryos with large obstructions in the embryo area
More than half of the embryo area blocked by the well or degeneration
Patients with more than half of embryos lacking sufficient spent culture medium for Raman spectroscopy analysis
Patients with known genetic diseases

Research Team

PUI WAH JACQUELINE CHUNG

WING IU LI

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