NCT05896709

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. 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Jul 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Jul 2023Dec 2026

First Submitted

Initial submission to the registry

May 10, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 9, 2023

Completed
1 month until next milestone

Study Start

First participant enrolled

July 17, 2023

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

March 21, 2025

Status Verified

March 1, 2025

Enrollment Period

2.6 years

First QC Date

May 10, 2023

Last Update Submit

March 18, 2025

Conditions

Reproductive IssuesSubfertilityIVF

Keywords

non-invasivein vitro fertilizationtime-lapse imagingartificial intelligencemorphokinetic analysisRaman spectroscopyembryo selection

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate

    To assess for the presence of gestational sac using ultrasonography after embryo transfer procedure

    6-8 weeks of gestation

Secondary Outcomes (4)

  • Miscarriage rate

    4-24 weeks of gestation of the participants

  • Multiple pregnancy rate

    6-8 weeks of gestation

  • Ploidy status

    Within 10 days after the embryos are fertilised, or 4-40 weeks of gestation

  • Live birth rate

    From 24 weeks of gestation up to 40 weeks

Study Arms (2)

MK-RS

EXPERIMENTAL

Patients' embryos will be selected by MK-RS integrative analytical method.

Other: MK-RS

Conventional

NO INTERVENTION

Patients' embryos will be selected by conventional method (i.e by embryologists).

Interventions

MK-RSOTHER

The embryos are assessed by the AI-enhanced MK analysis together with RS analysis.

MK-RS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Consecutive women undergoing IVF treatment
  • Patients planning to use a time-lapse incubator for embryo culture

You may not qualify if:

  • 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
  • Patients with known genetic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Officials

  • PUI WAH JACQUELINE CHUNG

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

PUI WAH JACQUELINE CHUNG

CONTACT

+852 35051537jacquelinechung@cuhk.edu.hk

WING IU LI

CONTACT

+852 35051764wingiuli@cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 10, 2023

First Posted

June 9, 2023

Study Start

July 17, 2023

Primary Completion

March 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 21, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)