Blastocyst DisintegrationPhase 2/3NCT03660904
A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst
A Phase 2/3 study testing home made vitrification & thawing kit and commercially made vitrification & thawing kit in people with Blastocyst Disintegration, run by Benha University.
Trial summary
This study was conducted to evaluate and compare cryo-survival, re-expansion, and implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM) according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama protocol)with Global Fast Freeze/Thaw Kits… Read more about this study
- Who is it for?
- Ages 22 to 37 years, women only
- Conditions the study is for
- Blastocyst Disintegration
- What is being tested?
- home made vitrification & thawing kit and commercially made vitrification & thawing kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2015to 15 Jun 2018
- Phase
- Phase 2/3
- 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 22 to 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- age of the patients 22-37
- All vitrified \& thawed blastocyst.
- unexplained cases or ovarian factors for infertility.
Who cannot join
- extremes of age
- cases of uterine factor
- endometriosis
About this study
Official title: A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst Survival, Expansion and Implantation
This study was conducted to evaluate and compare cryo-survival, re-expansion, and implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM) according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama protocol)with Global Fast Freeze/Thaw Kits (LifeGlobal, Canada).
Read the detailed description
Group 1 blastocysts were vitrified with the Vit HM according to shady grove protocol using open system on cryotopvit. device and thawed with gradual thawing technique using HM according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kitusing open system on cryotopvit. device and thawed using Gobal fast thaw kit. Blastocysts were subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.
- Conditions
- Blastocyst Disintegration
- Being tested
- home made vitrification & thawing kit, commercially made vitrification & thawing kit
- Keywords
- vitrification, blastocysts, home-made media
- Medical subject headings
- Embryo Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home made vitrification & thawing kitBiological
home made vitrification was made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too
commercially made vitrification & thawing kitBiological
commercially available vitrification \& thawing kit were made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too
| Study group | Role | What they receive |
|---|---|---|
| Home made media | Experimental | home made vitrification \& thawing kit Receives: Biological: home made vitrification & thawing kit |
| Commercial media | Active comparator | commercially available vitrification \& thawing kit Receives: Biological: commercially made vitrification & thawing kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
blastocyst immediate survival
The effect of Vitrification protocol on the blastocyst immediate survival
Measured: 0 hour at time of thawing
Secondary outcomes (3)
pregnancy rate
clinical pregnancy rate in these cases
Measured: 2 weeks after transfer
live birth rate
live birth rate of positive pregnancy cases
Measured: 9 months
Blastocyst survival at 6 hours
The effect of Vitrification protocol on the blastocyst survival after 6 hours
Measured: 6 hours after thawing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start1 Oct 2015
- Primary completion1 Oct 2017
- Study completion15 Jun 2018
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 2/3
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group 1 blastocysts were vitrified with the Vit (home made) HM according to shady grove protocol using open system on cryotop vit. device and thawed with gradual thawing technique using HM thawing media according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kit using open system on cryotop vit. device and thawed using Global fast thaw kit. Blastocysts were assessed immediately for survival, subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Saad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03660904
- Sponsor's protocol ID
- Hawaa-3
- Status last verified
- Sep 2018
- First submitted
- 2 Sep 2018
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Between Home-made Vitrification & Thawing Media and a Commercially Available Brand on Blastocyst Survival, Expansion and Implantation
- ClinicalTrials.gov ID
- NCT03660904
- Acronym / sponsor ID
- Hawaa-3
- Conditions
- Blastocyst Disintegration
- Keywords
- vitrification, blastocysts, home-made media
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Oct 2015 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 15 Jun 2018 (actual)
- First posted
- 7 Sep 2018 (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 study was conducted to evaluate and compare cryo-survival, re-expansion, and implantation rates of Day 5/6 human blastocysts that were vitrified with home-made media (HM) according to (Shady grove protocol) and warmed with gradual Thawing HM according to (Kuwayama protocol)with Global Fast Freeze/Thaw Kits (LifeGlobal, Canada).
Detailed description
Group 1 blastocysts were vitrified with the Vit HM according to shady grove protocol using open system on cryotopvit. device and thawed with gradual thawing technique using HM according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kitusing open system on cryotopvit. device and thawed using Gobal fast thaw kit. Blastocysts were subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, investigator)
- Number of arms
- 2
- Model description
- Group 1 blastocysts were vitrified with the Vit (home made) HM according to shady grove protocol using open system on cryotop vit. device and thawed with gradual thawing technique using HM thawing media according to Kuwayama protocol. Group 2 blastocysts were cryopreserved with the Global Fast Freeze Kit using open system on cryotop vit. device and thawed using Global fast thaw kit. Blastocysts were assessed immediately for survival, subsequently cultured for 6-8 h, assessed for survival and expansion, then transferred and the percentages of Positive hCG, clinical pregnancy, implantation, multiple pregnancy and abortion were recorded.
| Arm | Type | Receives |
|---|---|---|
| Home made media | Experimental | Biological: home made vitrification & thawing kithome made vitrification \& thawing kit |
| Commercial media | Active comparator | Biological: commercially made vitrification & thawing kitcommercially available vitrification \& thawing kit |
Who may qualify
- Ages
- 22 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age of the patients 22-37
- All vitrified \& thawed blastocyst.
- unexplained cases or ovarian factors for infertility.
Key exclusion criteria (3 listed)
- extremes of age
- cases of uterine factor
- endometriosis
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 |
|---|---|---|
| home made vitrification & thawing kithome made vitrification was made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too | Biological | Home made media |
| commercially made vitrification & thawing kitcommercially available vitrification \& thawing kit were made and prepared for vitrification of blastocysts then thawing with a prepared thawed media too | Biological | Commercial media |
Primary outcome
blastocyst immediate survival
Time frame: 0 hour at time of thawing
The effect of Vitrification protocol on the blastocyst immediate survival
3 secondary outcomes
pregnancy rate
Time frame: 2 weeks after transfer
live birth rate
Time frame: 9 months
Blastocyst survival at 6 hours
Time frame: 6 hours after thawing
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 7 Sep 2018.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing home made vitrification & thawing kit and commercially made vitrification & thawing kit in people with Blastocyst Disintegration, run by Benha University.
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 3 inclusion and 3 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 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
blastocyst immediate survival (time frame: 0 hour at time of thawing). 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 7 Sep 2018.