What To-be-discard Biomaterials From ART Cycles Can Tell us About the Treatment Cycle Outcome?

Recruiting

• Conditions: IVF; Infertility

• Registration Number: NCT06021340
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Various to-be-discard material from IVF treatment cycle will be collect and examined, aiming to identify potential reasons of successful outcome or cycle failure.

Detailed Description

Usually around 2/3 of IVF material will be discarded at the end of each treatment cycle, including immature oocytes, abnormal fertilized zygotes, poor grading embryos, spent culture medium, etc. Next generation sequencing will be performed for DNA / RNA analysis including the length and the quantity, RNA-seq will be applied for transcriptome profiling, and protein profile will be investigated in a pool sample. By applying various diagnostic tools against those to-be-discard biomaterials, we aim to identify potential underlying reasons of indicating either for an IVF failure or a successful cycle, and try to develop a non-invasive testing method for embryo quality check; better detection of the embryo implantation potential and eventually further increase the IVF clinical outcome.

Study Timeline

• Study Start: 2023-07-04
• Status Verified: 2023-08
• Study First Submitted: 2023-08-23
• Study First Submitted QC: 2023-08-28
• Last Update Submitted: 2023-08-28
• Study First Posted: 2023-09-01
• Last Update Posted: 2023-09-01
• Primary Completion: 2026-12
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Patients attending the Assisted Reproductive Technology (ART) Unit of the Chinese University of Hong Kong for ART treatment.
• Participant able to give voluntary, written, informed consent to participate in the study.

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Exclusion Criteria

• Patient using donor gamete in IVF treatment
• Patient refuses to join and failed to giving consent for any reasons

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proteomic profile	Through study completion, around 3 year	Protein profile will be investigated in a pool sample, treated samples will go for mass spectrometry (MS) data acquisition and finally destined for data analysis and interpretation.
DNA/RNA sequencing data	Through study completion, around 3 year	DNA / RNA analysis including the length and the quantity, RNA-seq will be applied for transcriptome profiling. Next generation sequencing will be performed to determine the sequence of DNA/RNA for our collected samples.

Secondary Outcome Measures

Name	Time	Method
Live birth rate	Around 9 months after embryo transfer	Birth of a living infant after embryo transfer
Clinical pregnancy rate	Around 5 weeks after embryo transfer	Clinical pregnancy confirmed by ultrasound
Blastocyst formation rate	5 days after fertilization	Number of blastocysts out of fertilized oocytes observed 5 days after fertilization

Trial Locations

Locations (1)

The Chinese University of Hong Kong and Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong