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

Sponsor

Chinese University of Hong Kong (Other)

Overall Status

Recruiting

CT.gov ID

NCT06021340

Collaborator

(none)

50

Enrollment

1

Location

46.9

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

Study Type:

Observational

Anticipated 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 :

Jul 4, 2023

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Jun 1, 2027

Outcome Measures

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

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

Locations

	Site	City	State	Country	Postal Code
1	The Chinese University of Hong Kong and Prince of Wales Hospital	Hong Kong		Hong Kong

Sponsors and Collaborators

Chinese University of Hong Kong

Investigators

Principal Investigator: Yiu Leung D Chan, DPhil, CUHK

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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:

Sep 1, 2023

Last Update Posted:

Sep 1, 2023

Last Verified:

Aug 1, 2023

Studies a U.S. FDA-regulated Drug Product:

No

Studies a U.S. FDA-regulated Device Product:

No

Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 1, 2023