NCT05896709 A Novel Integrative Non-invasive Embryo Selection Approach for IVF Based on MK-RS Analysis
| NCT ID | NCT05896709 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chinese University of Hong Kong |
| Condition | Reproductive Issues |
| Study Type | INTERVENTIONAL |
| Enrollment | 176 participants |
| Start Date | 2023-07-17 |
| Primary Completion | 2026-03 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 176 participants in total. It began in 2023-07-17 with a primary completion date of 2026-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Patients undergoing IVF/ ICSI treatment 2. Patients receiving the first, second or third IVF/ICSI treatment cycle 3. Patients and their partners willing to sign the informed consent agreement 4. Patients having at least three normal fertilised embryos on the day of the fertilization check 5. Consecutive women undergoing IVF treatment 6. Patients planning to use a time-lapse incubator for embryo culture Exclusion Criteria: 1. Day one human embryos with blur imaging 2. Large obstructions in the embryo area 3. More than half of the embryo area is blocked by the well or degeneration 4. Patients with more than half of the embryos without sufficient spent culture medium for RS analysis 5. Patients with known genetic diseases
Contact & Investigator
PUI WAH JACQUELINE CHUNG
PRINCIPAL INVESTIGATOR
Chinese University of Hong Kong
Frequently Asked Questions
Who can join the NCT05896709 clinical trial?
This trial is open to participants of all sexes, studying Reproductive Issues. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05896709 currently recruiting?
Yes, NCT05896709 is actively recruiting participants. Contact the research team at jacquelinechung@cuhk.edu.hk for enrollment information.
Where is the NCT05896709 trial being conducted?
This trial is being conducted at Hong Kong, Hong Kong.
Who is sponsoring the NCT05896709 clinical trial?
NCT05896709 is sponsored by Chinese University of Hong Kong. The principal investigator is PUI WAH JACQUELINE CHUNG at Chinese University of Hong Kong. The trial plans to enroll 176 participants.