IVFNCT06322823
Direct Thawing of Vitrified Human Blastocyst
A study testing direct thawing and Vitrification in people with IVF, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
There are more than million frozen embryo transfers around the world each year; a faster, safer, and cheaper method can save a significant amount of money for patients undergoing IVF treatment worldwide. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- IVF
- What is being tested?
- direct thawing and Vitrification
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jan 2020to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients who are willing to use direct-thawed blastocysts
Who cannot join
- Patients who are not willing to use direct-thawed blastocysts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study on Developing a One-step Direct Thawing Method on Human Blastocysts With Transcriptomic and Methylomic Comparison to Conventional Vitrified-thawing Method
There are more than million frozen embryo transfers around the world each year; a faster, safer, and cheaper method can save a significant amount of money for patients undergoing IVF treatment worldwide.
- Conditions
- IVF
- Being tested
- direct thawing, Vitrification
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
direct thawingProcedure or surgery
Vitrified blastocysts will be thawed directly into 1ml G-TL medium
VitrificationProcedure or surgery
Vitrified blastocysts will be thawed using commercially available one-step media.
| Study group | Role | What they receive |
|---|---|---|
| direct thawing | Experimental | Not described Receives: Procedure: direct thawing |
| commercially available vitrification thawing | Active comparator | Not described Receives: Procedure: Vitrification |
What is being measured
The primary outcome is the main question the study is designed to answer.
blastocysts survival rate
The overall survival rate for thawed blastocysts using different thawing method will be compared.
Measured: up to 6 months
Secondary outcomes (3)
ferilization rate
The fertilization rate of frozen embryos using different thawing methods will be compared.
Measured: up to 12 months
pregnancy rate
The pregnancy rate of patients who will be scheduled for the transfer of frozen embryos using different thawing methods will be compared.
Measured: up to 12 months
live birth rate
The live birth rate of patients who will be scheduled for the transfer of frozen embryos using different thawing methods will be compared.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 Jan 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 116 participants (actual)
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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322823
- Sponsor's protocol ID
- 2010.432
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study on Developing a One-step Direct Thawing Method on Human Blastocysts With Transcriptomic and Methylomic Comparison to Conventional Vitrified-thawing Method
- ClinicalTrials.gov ID
- NCT06322823
- Acronym / sponsor ID
- 2010.432
- Conditions
- IVF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 21 Mar 2024 (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.
There are more than million frozen embryo transfers around the world each year; a faster, safer, and cheaper method can save a significant amount of money for patients undergoing IVF treatment worldwide.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| direct thawing | Experimental | Procedure: direct thawing |
| commercially available vitrification thawing | Active comparator | Procedure: Vitrification |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Patients who are willing to use direct-thawed blastocysts
Key exclusion criteria (1 listed)
- Patients who are not willing to use direct-thawed blastocysts
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| direct thawingVitrified blastocysts will be thawed directly into 1ml G-TL medium | Procedure or surgery | direct thawing |
| VitrificationVitrified blastocysts will be thawed using commercially available one-step media. | Procedure or surgery | commercially available vitrification thawing |
Primary outcome
blastocysts survival rate
Time frame: up to 6 months
The overall survival rate for thawed blastocysts using different thawing method will be compared.
3 secondary outcomes
ferilization rate
Time frame: up to 12 months
pregnancy rate
Time frame: up to 12 months
live birth rate
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing direct thawing and Vitrification in people with IVF, 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 21 Mar 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
blastocysts survival rate (time frame: up to 6 months). 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 21 Mar 2024.