InfertilityNCT04125017
Atrificial Shrinkage of Blastocyst Before In Vitro Fertilization
A study testing ICSI with laser pulse and ICSI with micro needle technique in people with Infertility, run by Aljazeera Hospital at 1 site in Egypt.
Trial summary
Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing Read more about this study
- Who is it for?
- Ages 20 to 44 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- ICSI with laser pulse and ICSI with micro needle technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 409 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2019to 5 Feb 2020
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with infertility from 20 to 44 years
Who cannot join
- women with age more than 44 or less than 20
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study Between Two Techniques for Artificial Shrinkage of Blastocysts Prior to Vitrification: LASER Pulse Versus Micro-needle Technique in Increasing Chemical, Clinical Pregnancy and Live Birth Rates After ICSI
Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing
Read the detailed description
Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing Unlike the slow freezing method, vitrification has better results in a complete elimination of ice crystal inside the cells as well as in the surrounding solution -Also, it has a significantly higher post-thawing survival rate in comparison to slow freezing method
- Conditions
- Infertility
- Being tested
- ICSI with laser pulse, ICSI with micro needle technique
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICSI with laser pulseDevice
Using laser pulse before ICSI
ICSI with micro needle techniqueDevice
Using micro needle technique before ICSI
| Study group | Role | What they receive |
|---|---|---|
| effect of using LASER pulse | Other | effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts as a previous step before vitrification in regarding their effect on embryo viability Receives: Device: ICSI with laser pulse; Device: ICSI with micro needle technique |
| Micro-needle Technique | Other | effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts as a previous step before vitrification in regarding their effect on embryo viability Receives: Device: ICSI with laser pulse; Device: ICSI with micro needle technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of women who will have positive pregnancy test
The number of women who will come pregnant after each technique
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start1 Jan 2019
- Primary completion4 Jan 2020
- Study completion5 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts .
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 409 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aljazeera Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Adam International Hospital
- Responsible party
- Principal investigator, Mahmoud Alalfy, Aljazeera Hospital
- Investigators
- manal kamel, Principal investigator, Adam hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125017
- Sponsor's protocol ID
- blastocyst preparation
- Status last verified
- Oct 2023
- First submitted
- 10 Oct 2019
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kamel Mohamed M, El-Noury MAH, Amer MK, Fakhry E, Alalfy M. Comparative study between two techniques for artificial shrinkage of blastocysts prior to vitrification: LASER pulse versus micro-needle technique in increasing chemical, clinical pregnancy and live birth rates after ICSI, a randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):4910-4917. doi: 10.1080/14767058.2021.1873265. Epub 2021 Feb 28.
PubMed 33645399
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Two Techniques for Artificial Shrinkage of Blastocysts Prior to Vitrification: LASER Pulse Versus Micro-needle Technique in Increasing Chemical, Clinical Pregnancy and Live Birth Rates After ICSI
- ClinicalTrials.gov ID
- NCT04125017
- Acronym / sponsor ID
- blastocyst preparation
- Conditions
- Infertility
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 409 participants (actual)
- Lead sponsor
- Aljazeera HospitalUniversity, hospital or other
- Collaborators
- Adam International Hospital
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 4 Jan 2020 (actual)
- Study completion
- 5 Feb 2020 (actual)
- First posted
- 14 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.
Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing
Detailed description
Vitrification is a modern cryopreservation technique based on sudden cooling of reproductive cells to a temperature of -196 ° C in seconds that produces glass-like solidification of a solution without crystallization, but by extreme elevation in viscosity during freezing Unlike the slow freezing method, vitrification has better results in a complete elimination of ice crystal inside the cells as well as in the surrounding solution -Also, it has a significantly higher post-thawing survival rate in comparison to slow freezing method
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- effect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts .
| Arm | Type | Receives |
|---|---|---|
| effect of using LASER pulse | Other | Device: ICSI with laser pulse, Device: ICSI with micro needle techniqueeffect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts as a previous step before vitrification in regarding their effect on embryo viability |
| Micro-needle Technique | Other | Device: ICSI with laser pulse, Device: ICSI with micro needle techniqueeffect of using LASER pulse versus micro-needle use in the artificial shrinkage of blastocysts as a previous step before vitrification in regarding their effect on embryo viability |
Who may qualify
- Ages
- 20 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- women with infertility from 20 to 44 years
Key exclusion criteria (1 listed)
- women with age more than 44 or less than 20
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 |
|---|---|---|
| ICSI with laser pulseUsing laser pulse before ICSI | Device | Micro-needle Technique, effect of using LASER pulse |
| ICSI with micro needle techniqueUsing micro needle technique before ICSI | Device | Micro-needle Technique, effect of using LASER pulse |
Primary outcome
The number of women who will have positive pregnancy test
Time frame: 2 months
The number of women who will come pregnant after each technique
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 10 Oct 2023.
- Derived from this study: PubMed 33645399Kamel Mohamed M, El-Noury MAH, Amer MK, Fakhry E, Alalfy M. Comparative study between two techniques for artificial shrinkage of blastocysts prior to vitrification: LASER pulse versus micro-needle technique in increasing chemical, clinical pregnancy and live birth rates after ICSI, a randomized controlled trial. J Matern Fetal Neonatal Med. 2022 Dec;35(25):4910-4917. doi: 10.1080/14767058.2021.1873265. Epub 2021 Feb 28.
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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.
manal kamel principal investigator
Adam hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICSI with laser pulse and ICSI with micro needle technique in people with Infertility, run by Aljazeera Hospital 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: finished, as of the sponsor's last update on 10 Oct 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 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 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?
The number of women who will have positive pregnancy test (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04125017, which also lists 1 linked publication.
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 10 Oct 2023.