CClinicalTrials.gg
CompletedNCT03663634ICSI-CBUpdated Aug 7, 2019

Supplementing Intracytoplasmic Sperm Injection Handling Medium With Cytochalasin B

An interventional study of Cytochalasin B use in ICSI handling medium in Infertility, sponsored by Ibn Sina Hospital. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2019-08-07.

Sponsored by Ibn Sina Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
987
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
Female
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Study summary

Vienna Consensus has identified 10% damage rate after ICSI as a competency value. Despite the highest quality embryologists doing ICSI, degeneration sometimes occurs due to oocyte factors such as the fragile membrane, etc. Cytochalasin B serves to facilitate spindle or pronuclear transfer procedures helping to reduce the damage rate with no harm reported. Using Cytochalasin B during ICSI could serve to rescue some oocytes from the degeneration allowing for more chances of viable zygotes,

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Conditions studied

  • Infertility

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In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 987 is above the median of 120 across 1,698 interventional studies indexed under Infertility.

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Lead sponsor

Ibn Sina Hospital is the lead sponsor of 28 studies on the registry; none are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • All ICSI candidates patients

Exclusion criteria

Exclusion Criteria:

  • No exclusion
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Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
987 participants (actual)

Study arms

  • Experimental
    Handling Medium Supplemented with Cytochalasin B

    Other: Cytochalasin B use in ICSI handling medium

  • No intervention
    Handling Medium as it is.

Interventions

  • OtherCytochalasin B use in ICSI handling medium

    A medium with in-house supplementation of Cytochalasin B to decrease oocyte degeneration after ICSI and improve survival rate

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What researchers measure

Primary outcomes

  1. oocyte survival rate

    number of survived oocyte after intracytoplasmic sperm injection

    Time frame: 6 days of culture

Secondary outcomes

  1. fertilization rate

    number of fertilized oocytes per metaphase II injected

    Time frame: 6 days of culture

  2. blastocyst formation rate

    number of formed blastocyst per fertilized oocyte

    Time frame: 6 days of culture

  3. embryo utilization rate

    number of embryo transferred added to number of those cryopreserved per fertilized oocyte

    Time frame: 6 days of culture

  4. clinical pregnancy rate

    number of women with a heartbeat at week 4 or more after embryo transfer

    Time frame: three months

  5. ongoing pregnancy rate

    number of women with continued pregnancy after twelve weeks of gestation

    Time frame: four months

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Study locations

1 site
  • IbnSina IVF Center
    Sohag, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 7, 2019, 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
NCT03663634
Lead sponsor
Ibn Sina Hospital
Collaborators
Banoon IVF Center
Responsible party
Muhammad Fawzy (IVF Lab Director, Ibn Sina Hospital) — Principal investigator
First posted
Sep 10, 2018
Start date
Sep 16, 2018
Primary completion
Jul 20, 2019
Completion
Aug 1, 2019
Last update
Aug 7, 2019

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 Aug 2019. You cannot join it, but the record below documents what was studied.

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