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NCT Number: NCT06021340

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Chinese University of Hong Kong and Prince of Wales Hospital

Hong Kong

Location status: Recruiting

Location contact

Yiu Leung D Chan, DPhil

CONTACT

(852) 3505 3199

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. DNA/RNA sequencing data

    Time frame: 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.

  2. Proteomic profile

    Time frame: 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.

Secondary outcomes

  1. Blastocyst formation rate

    Time frame: 5 days after fertilization

    Number of blastocysts out of fertilized oocytes observed 5 days after fertilization

  2. Clinical pregnancy rate

    Time frame: Around 5 weeks after embryo transfer

    Clinical pregnancy confirmed by ultrasound

  3. Live birth rate

    Time frame: Around 9 months after embryo transfer

    Birth of a living infant after embryo transfer

Study contacts

Contact information is provided by the study sponsor or research team.

Yiu Leung D Chan, DPhil

CONTACT

[email protected]

(852) 3505 3199

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Sep 1, 2023
Registry last updated
Sep 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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