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CompletedNCT04125017Updated Oct 10, 2023

Atrificial Shrinkage of Blastocyst Before In Vitro Fertilization

An interventional study of ICSI with laser pulse and ICSI with micro needle technique in Infertility, sponsored by Aljazeera Hospital. Completed at 1 site in Egypt. Open to female participants aged 20 Years to 44 Years. Per ClinicalTrials.gov, last updated 2023-10-10.

Sponsored by Aljazeera Hospital · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jan 2019, registered Oct 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
409
Allocation
Randomized
Ages
20 Years to 44 Years
Sex
Female
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Study 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 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

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Conditions studied

  • Infertility

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In context

Infertility

2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.

This study's enrollment of 409 is above the median of 135 across 1,412 interventional studies indexed under Infertility.

Browse Infertility studies →

Lead sponsor

Aljazeera Hospital is the lead sponsor of 64 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years to 44 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • women with infertility from 20 to 44 years

Exclusion criteria

Exclusion Criteria:

  • women with age more than 44 or less than 20
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
409 participants (actual)

Study arms

  • Other
    effect of using LASER pulse

    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

    Device: ICSI with laser pulse · Device: ICSI with micro needle technique

  • Other
    Micro-needle Technique

    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

    Device: ICSI with laser pulse · Device: ICSI with micro needle technique

Interventions

  • DeviceICSI with laser pulse

    Using laser pulse before ICSI

  • DeviceICSI with micro needle technique

    Using micro needle technique before ICSI

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What researchers measure

Primary outcomes

  1. The number of women who will have positive pregnancy test

    The number of women who will come pregnant after each technique

    Time frame: 2 months

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Study locations

1 site
  • Adam
    Giza, Egypt
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References and documents

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 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jan 2019 to primary completion in Jan 2020, 12 months.

Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's 12 months is below that.

Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 10, 2019
First posted
Oct 14, 2019
StartActual
Jan 1, 2019
Primary completionActual
Jan 4, 2020
CompletionActual
Feb 5, 2020
Last update
Oct 10, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04125017
Lead sponsor
Aljazeera Hospital
Collaborators
Adam International Hospital
Responsible party
Mahmoud Alalfy (Consultant of Obstetrics and Gynecology, Aljazeera Hospital) — Principal investigator
First posted
Oct 14, 2019
Start date
Jan 1, 2019
Primary completion
Jan 4, 2020
Completion
Feb 5, 2020
Last update
Oct 10, 2023

Study contacts

manal kamel
principal investigator · Adam hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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