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

November 14, 2019 updated by: Muhammad Fawzy, Ibn Sina Hospital

Magnetic Nanoparticle Sperm Separation for ICSI Cycles With Teratozoospermia and Over 35 Years Old Women Age

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • women indicated for ICSI but with teratozoospermia

Exclusion Criteria:

  • Women not failing in this group

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Magnetic nanoparticle selection for teratozoospermia
Other: Sperm preparation for ICSI
A new protocol for sperm preparation for ICSI cycles with teratozoospermia in over 35 years old women
No Intervention: Density gradient centrifugation for teratozoospermia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ongoing pregnancy rate
Time Frame: Twelve weeks of gestation
Twelve weeks of gestation

Secondary Outcome Measures

Outcome Measure
Time Frame
Embryo development after ICSI
Time Frame: Six days of culture
Six days of culture

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ibn Sina Hospital

Collaborators

Banon IVF Center Assiut, Egypt

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 17, 2018

Primary Completion (Actual)

September 20, 2019

Study Completion (Actual)

October 1, 2019

Study Registration Dates

First Submitted

September 9, 2018

First Submitted That Met QC Criteria

September 9, 2018

First Posted (Actual)

September 11, 2018

Study Record Updates

Last Update Posted (Actual)

November 18, 2019

Last Update Submitted That Met QC Criteria

November 14, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IbnSina-MNP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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