IVFNCT06021340
What To-be-discard Biomaterials From ART Cycles Can Tell us About the Treatment Cycle Outcome?
An observational study of IVF and Infertility, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- IVF, Infertility
- How many people
- 50 participants
- Where
- 1 siteHong Kong
- Study dates
- 4 Jul 2023to Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Study population will include patients attending the Assisted Reproductive Technolohy (ART) Unit of the Chinese University of Hong Kong for ART treatment.
Who may be able to join
- 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.
Who cannot join
- Patient using donor gamete in IVF treatment
- Patient refuses to join and failed to giving consent for any reasons
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Hong Kong1 site, 1 recruiting
- Recruiting
The Chinese University of Hong Kong and Prince of Wales Hospital
Hong Kong
Yiu Leung D Chan, DPhil, (852) 3505 3199
About this study
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.
Read the 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.
- Conditions
- IVF, Infertility
- Medical subject headings
- Infertility
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, around 3 year
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.
Measured: Through study completion, around 3 year
Secondary outcomes (3)
Blastocyst formation rate
Number of blastocysts out of fertilized oocytes observed 5 days after fertilization
Measured: 5 days after fertilization
Clinical pregnancy rate
Clinical pregnancy confirmed by ultrasound
Measured: Around 5 weeks after embryo transfer
Live birth rate
Birth of a living infant after embryo transfer
Measured: Around 9 months after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2023
- Study start4 Jul 2023
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IVFStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yiu Leung David Chan, Chinese University of Hong Kong
- Investigators
- Yiu Leung D Chan, DPhil, Principal investigator, CUHK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06021340
- Sponsor's protocol ID
- 2023.066
- Status last verified
- Aug 2023
- First submitted
- 23 Aug 2023
- Last updated
- 1 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What To-be-discard Biomaterials From ART Cycles Can Tell us About the Treatment Cycle Outcome?
- ClinicalTrials.gov ID
- NCT06021340
- Acronym / sponsor ID
- 2023.066
- Conditions
- IVF, Infertility
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 4 Jul 2023 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 1 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study population will include patients attending the Assisted Reproductive Technolohy (ART) Unit of the Chinese University of Hong Kong for ART treatment.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient using donor gamete in IVF treatment
- Patient refuses to join and failed to giving consent for any reasons
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
3 secondary outcomes
Blastocyst formation rate
Time frame: 5 days after fertilization
Clinical pregnancy rate
Time frame: Around 5 weeks after embryo transfer
Live birth rate
Time frame: Around 9 months after embryo transfer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yiu Leung D Chan, DPhil principal investigator
CUHK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of IVF and Infertility, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yiu Leung D Chan, DPhil ((852) 3505 3199, drdcyl16@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DNA/RNA sequencing data (time frame: Through study completion, around 3 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2023.