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

August 28, 2023 updated by: Yiu Leung David Chan, Chinese University of Hong Kong
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.

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • The Chinese University of Hong Kong and Prince of Wales Hospital
        • Contact:
          • Yiu Leung D Chan, DPhil
          • Phone Number: (852) 3505 3199

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Through study completion, around 3 year
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.
Through study completion, around 3 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Investigators

  • Principal Investigator: Yiu Leung D Chan, DPhil, CUHK

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

August 23, 2023

First Submitted That Met QC Criteria

August 28, 2023

First Posted (Actual)

September 1, 2023

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023.066

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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