Actively Recruiting
A Novel Integrative Non-invasive Embryo Selection Approach for IVF Using AI-Enhanced Morphokinetic Analysis and Raman Spectroscopy
Led by Chinese University of Hong Kong · Updated on 2025-03-21
176
Participants Needed
1
Research Sites
39 weeks
Total Duration
On this page
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 IVF/ICSI 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
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration of one IVF/ICSI cycle until embryo selection and transfer
Participants undergo IVF or ICSI treatment with embryo selection performed either by the AI-enhanced MK-RS method or the conventional morphology grading method.
Visits occur during the IVF/ICSI treatment cycle as per routine clinical care
Duration - Up to 40 weeks of gestation
Participants are followed up to assess clinical pregnancy outcomes, miscarriage, multiple pregnancy rates, ploidy status, and live birth outcomes.
Approximately 3 to 5 visits for pregnancy assessment and monitoring
Trial Site Locations
Total: 1 location
1
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Actively Recruiting
Research Team
P
PUI WAH JACQUELINE CHUNG
W
WING IU LI
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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