A Novel Integrative Non-invasive Embryo Selection Approach for IVF Based on MK-RS Analysis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorChinese University of Hong Kong
About this trial
During assisted reproductive technology treatment, embryo selection is an important process that may affect the clinical pregnancy rate. Many assisted reproductive technology units over the world have tried different approaches to increase the clinical pregnancy rate. Conventionally, the morphology of the embryo is assessed by the embryologist with naked eyes only. Nowadays, artificial intelligence (AI) has been used to assist in morphological assessment of the embryo. Our pilot study showed that the AI-enhanced morphokinetic (MK) analysis increased the accuracy in embryo selection by \~9%, while the detection rate for abnormal chromosomes in embryo has also been increased by Raman spectroscopy (RS) analysis. The combined MK-RS analysis will be able to complete embryo assessment within 5-6 days after fertilization. This method needs shorter time and is at lower cost when compared to invasive preimplantation genetic testing for aneuploidies (PGT-A).
In this study, we have combined the following non-invasive techniques to assist in embryo screening.
1. Using time-lapse imaging (i.e. images of embryo being taken every 10 minutes inside the incubator) with AI)-enhanced MK analysis to assess the entire morphological changes of the embryo. 2. As the embryo releases metabolites during its growth, the spent culture medium will be collected after culture of the embryo and then be used for RS analysis, which is a kind of metabolomics-based non-invasive PGT-A, for screening chromosomal abnormalities of the embryo.
This study will include two phases. In Phase I, it is a retrospective part. We will collect data to train the convolutional neural network (CNN)-enhanced MK with RS method on embryo selection, leading to the integrated approach (MK-RS). In Phase II, it is a randomized controlled trial and participants will be randomised into 2 groups. For the experimental group, embryo selection will be based on the MK-RS method, whereas embryo selection for the control group will rely on the traditional embryo assessment results alone. Then we will assess the clinical pregnancy rate and evaluate the efficacy of our approach finally. Patients who receive in vitro fertilisation (IVF)/ intracytoplasmic sperm injection (ICSI) treatment from The Assisted Reproductive Technology (ART) Unit of The Chinese University of Hong Kong, Prince of Wales Hospital will be recruited.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients undergoing IVF/ ICSI treatment
Patients receiving the first, second or third IVF/ICSI treatment cycle
Patients and their partners willing to sign the informed consent agreement
Patients having at least three normal fertilised embryos on the day of the fertilization check
Disqualifiers
Day one human embryos with blur imaging
Large obstructions in the embryo area
More than half of the embryo area is blocked by the well or degeneration
Patients with more than half of the embryos without sufficient spent culture medium for RS analysis
Trial design
Design model
Parallel
Treatments tested in this trial
MK-RS
Other interventionThe embryos are assessed by the AI-enhanced MK analysis together with RS analysis.
Treatment groups
176 Participants
are divided into 2 treatment groupsGroup A: MK-RSExperimental treatment 1 intervention
Group B: ConventionalNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Clinical pregnancy rate
To assess for the presence of gestational sac using ultrasonography after embryo transfer procedure
Time frame
6-8 weeks of gestationSecondary outcomes
1
Miscarriage rate
To assess for any miscarriage if participants get pregnant after embryo transfer procedure
Time frame
4-24 weeks of gestation of the participants2
Multiple pregnancy rate
To assess for the presence of two or more gestational sacs using ultrasonography after embryo transfer procedure
Time frame
6-8 weeks of gestation3
Ploidy status
To assess the ploidy status of the embryo for patients who have underwent non-invasive prenatal testing (NIPT) or genetic testing during ART treatment or antenatal care
Time frame
Within 10 days after the embryos are fertilised, or 4-40 weeks of gestation4
Live birth rate
To assess whether live babies are born after ART treatment
Time frame
From 24 weeks of gestation up to 40 weeksSponsors and contacts
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Source ClinicalTrials.gov