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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06021340
• Other study ID #: 2023.066
• Status: Recruiting
• Start date: July 4, 2023
• Est. completion date: June 2027

Study information

• Verified date: August 2023
• Source: Chinese University of Hong Kong
• Contact: Yiu Leung D Chan, DPhil
• Phone: (852) 3505 3199
• Email: drdcyl16[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2027
• Est. primary completion date: December 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infertility
• IVF

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong and Prince of Wales Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	DNA/RNA sequencing data	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.	Through study completion, around 3 year
Primary	Proteomic profile	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.	Through study completion, around 3 year
Secondary	Blastocyst formation rate	Number of blastocysts out of fertilized oocytes observed 5 days after fertilization	5 days after fertilization
Secondary	Clinical pregnancy rate	Clinical pregnancy confirmed by ultrasound	Around 5 weeks after embryo transfer
Secondary	Live birth rate	Birth of a living infant after embryo transfer	Around 9 months after embryo transfer