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

NCT ID: NCT03666364

Last Updated: 2019-11-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-17

Study Completion Date

2019-10-01

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Magnetic nanoparticle selection for teratozoospermia

Group Type EXPERIMENTAL

Sperm preparation for ICSI

Intervention Type OTHER

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

Density gradient centrifugation for teratozoospermia

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Sperm preparation for ICSI

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* women indicated for ICSI but with teratozoospermia

Exclusion Criteria

* Women not failing in this group
Minimum Eligible Age

35 Years

Maximum Eligible Age

42 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Banon IVF Center Assiut, Egypt

OTHER

Sponsor Role collaborator

Ibn Sina Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Muhammad Fawzy

IVF Lab Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Qena Fertility Center

Qina, Qena Governorate, Egypt

Site Status

Banon Assiut

Asyut, , Egypt

Site Status

IbnSina IVF Center

Sohag, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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IbnSina-MNP

Identifier Type: -

Identifier Source: org_study_id

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