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

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ClinicalTrials.gov Identifier: NCT06021340
Recruitment Status : Recruiting
First Posted : September 1, 2023
Last Update Posted : September 1, 2023
Sponsor:
Information provided by (Responsible Party):
Yiu Leung David Chan, Chinese University of Hong Kong

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease
IVF Infertility

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 Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: What To-be-discard Biomaterials From ART Cycles Can Tell us About the Treatment Cycle Outcome?
Actual Study Start Date : July 4, 2023
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : June 2027
Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
IVF cycle to-be-discard biomaterials including follicular fluid, seminal plasma, immature oocytes, abnormal fertilized zygote, unfertilized zygote, arrested embryos, poor quality blastocysts, spent culture medium.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Study population will include patients attending the Assisted Reproductive Technolohy (ART) Unit of the Chinese University of Hong Kong for ART treatment.
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06021340


Contacts
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Contact: Yiu Leung D Chan, DPhil (852) 3505 3199 drdcyl16@cuhk.edu.hk

Locations
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Hong Kong
The Chinese University of Hong Kong and Prince of Wales Hospital Recruiting
Hong Kong, Hong Kong
Contact: Yiu Leung D Chan, DPhil    (852) 3505 3199      
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: Yiu Leung D Chan, DPhil CUHK
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Yiu Leung David Chan, Assited Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT06021340    
Other Study ID Numbers: 2023.066
First Posted: September 1, 2023    Key Record Dates
Last Update Posted: September 1, 2023
Last Verified: August 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Genital Diseases
Urogenital Diseases