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CompletedNCT03666364Updated Nov 18, 2019

Magnetic Nanoparticle Sperm Separation for Teratozoospermia Male and Women Older Than 35 Years

An interventional study of Sperm preparation for ICSI in Infertility, sponsored by Ibn Sina Hospital. Completed at 3 sites in Egypt. Open to female participants aged 35 Years to 42 Years. Per ClinicalTrials.gov, last updated 2019-11-18.

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

Phase
Not applicable
Study type
Interventional
Enrollment
1,400
Allocation
Randomized
Ages
35 Years to 42 Years
Sex
Female
01

Study summary

Women over 35 years old are likely to suffer from impaired oocyte repair capacity. Teratozoospermia is a condition reflects morphological affection of sperm. These spermatozoa would add an extra burden on the oocyte after ICSI. Whether selecting mature sperm by magnetic nanoparticle protocol would provide a more competent sperm to a likely affected oocyte would improve ICSI outcomes is the question of this research.

02

Conditions studied

  • Infertility

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03

In context

Infertility

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

This study's enrollment of 1,400 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
35 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • women indicated for ICSI but with teratozoospermia

Exclusion criteria

Exclusion Criteria:

  • Women not failing in this group
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
1,400 participants (actual)

Study arms

  • Experimental
    Magnetic nanoparticle selection for teratozoospermia

    Other: Sperm preparation for ICSI

  • No intervention
    Density gradient centrifugation for teratozoospermia

Interventions

  • OtherSperm preparation for ICSI

    A new protocol for sperm preparation for ICSI cycles with teratozoospermia in over 35 years old women

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What researchers measure

Primary outcomes

  1. Ongoing pregnancy rate

    Time frame: Twelve weeks of gestation

Secondary outcomes

  1. Embryo development after ICSI

    Time frame: Six days of culture

07

Study locations

3 sites
  • Banon Assiut
    Assiut, Egypt
  • Qena Fertility Center
    Qena, 123456, Egypt
  • IbnSina IVF Center
    Sohag, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03666364
Lead sponsor
Ibn Sina Hospital
Collaborators
Banon IVF Center Assiut, Egypt
Responsible party
Muhammad Fawzy (IVF Lab Director, Ibn Sina Hospital) — Principal investigator
First posted
Sep 11, 2018
Start date
Sep 17, 2018
Primary completion
Sep 20, 2019
Completion
Oct 1, 2019
Last update
Nov 18, 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 Nov 2019. You cannot join it, but the record below documents what was studied.

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