Blastocyst DisintegrationNCT04124809
Truth or Dare; Artificial Blastocoel Collapse Using Laser Before Blastocyst's Vitrification Versus Non-laser Usage
A study testing laser assisted collapse in people with Blastocyst Disintegration, run by Benha University at 1 site in Egypt.
Trial summary
: This prospective randomized observational study aimed to compare behavior of artificially collapsed blastocysts to blastocysts that were vitrified without artificial collapse. Read more about this study
- Who is it for?
- Ages 20 to 37 years, women only
- Conditions the study is for
- Blastocyst Disintegration
- What is being tested?
- laser assisted collapse
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 5 Jan 2019to 1 Oct 2021
- 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 20 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age limit 20-37 At least 6 good quality blastocysts per case. expansion rate 3-4
Who cannot join
- bad quality blastocysts expansion rate less than 3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Truth or Dare; Artificial Blastocoel Collapse of Human Blastocysts Before Vitrification
: This prospective randomized observational study aimed to compare behavior of artificially collapsed blastocysts to blastocysts that were vitrified without artificial collapse.
Read the detailed description
One arm study of 60 patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) \& control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately \& at 140 min after thawing and compared between two groups.
- Conditions
- Blastocyst Disintegration
- Being tested
- laser assisted collapse
- Keywords
- blastocyst, Vitrification, artificial collapse, survival rate
- Medical subject headings
- Embryo Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser assisted collapseDevice
Apply 1-2 pulses of laser using the Saturn between 2 adjacent trophectoderm cells away from the inner cell mass in the blastocysts
| Study group | Role | What they receive |
|---|---|---|
| Study group (artificially laser-collapsed blastocysts) | Experimental | laser was used as an intervention before blastocyst vitrification to assist rapid blastocyst collapse with vitrification Receives: Device: laser assisted collapse |
| & control group (blastocysts were vitrified, no laser collapse | No intervention | blastocyst were vitrified without laser assisted collapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
survival rate will be assessed immediately after thawing and compared between both groups.
Measured: immediately after thawing
survival rate
survival rate will be assessed at 140 minutes after thawing and compared between both groups.
Measured: 140 min after thawing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start5 Jan 2019
- Primary completion15 Sep 2021
- Study completion1 Oct 2021
Why it stopped: no fund for recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blastocyst DisintegrationStudies of the same condition, open and under way.
- More trials run by Benha UniversityThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) \& control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately \& at 140 min after thawing and compared between two groups.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Collaborators
- Hawaa Fertility Center
- Responsible party
- Principal investigator, Ahmed Saad, Benha University
- Investigators
- sahar A Eissa, Ph. D, Principal investigator, HFC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04124809
- Sponsor's protocol ID
- Hawaa-7
- Status last verified
- Sep 2022
- First submitted
- 8 Oct 2019
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: the main individual characters of the blastocysts and he data after warming
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Truth or Dare; Artificial Blastocoel Collapse of Human Blastocysts Before Vitrification
- ClinicalTrials.gov ID
- NCT04124809
- Acronym / sponsor ID
- Hawaa-7
- Conditions
- Blastocyst Disintegration
- Keywords
- blastocyst, Vitrification, artificial collapse, survival rate
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: no fund for recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Collaborators
- Hawaa Fertility Center
- Study start
- 5 Jan 2019 (actual)
- Primary completion
- 15 Sep 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 11 Oct 2019 (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.
: This prospective randomized observational study aimed to compare behavior of artificially collapsed blastocysts to blastocysts that were vitrified without artificial collapse.
Detailed description
One arm study of 60 patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) \& control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately \& at 140 min after thawing and compared between two groups.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- patients with sibling blastocysts divided into 2 groups: Study group (artificially laser-collapsed blastocysts; n=71) \& control group (blastocysts were vitrified without laser collapse; n=66) then reexpansion speed and survival rate was assessed immediately \& at 140 min after thawing and compared between two groups.
| Arm | Type | Receives |
|---|---|---|
| Study group (artificially laser-collapsed blastocysts) | Experimental | Device: laser assisted collapselaser was used as an intervention before blastocyst vitrification to assist rapid blastocyst collapse with vitrification |
| & control group (blastocysts were vitrified, no laser collapse | No intervention | –blastocyst were vitrified without laser assisted collapse |
Who may qualify
- Ages
- 20 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Age limit 20-37 At least 6 good quality blastocysts per case. expansion rate 3-4
Key exclusion criteria (1 listed)
- bad quality blastocysts expansion rate less than 3
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 |
|---|---|---|
| laser assisted collapseApply 1-2 pulses of laser using the Saturn between 2 adjacent trophectoderm cells away from the inner cell mass in the blastocysts | Device | Study group (artificially laser-collapsed blastocysts) |
Primary outcome
survival rate
Time frame: immediately after thawing
survival rate will be assessed immediately after thawing and compared between both groups.
survival rate
Time frame: 140 min after thawing
survival rate will be assessed at 140 minutes after thawing and compared between both groups.
Results and safety
The study was stopped early (reason given: no fund for recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: Yes. the main individual characters of the blastocysts and he data after warming
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.
sahar A Eissa, Ph. D principal investigator
HFC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laser assisted collapse in people with Blastocyst Disintegration, run by Benha University at 1 site in Egypt.
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: stopped early, as of the sponsor's last update on 21 Sep 2022. 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 Egypt. 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 was stopped early (reason given: no fund for recruitment). Results are not available in the source record.
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?
survival rate (time frame: immediately after thawing). 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 21 Sep 2022.