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

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Sperm preparation for ICSI
Sponsored by
Ibn Sina Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infertility

Eligibility Criteria

35 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • women indicated for ICSI but with teratozoospermia

Exclusion Criteria:

  • Women not failing in this group

Sites / Locations

  • Banon Assiut
  • Qena Fertility Center
  • IbnSina IVF Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Magnetic nanoparticle selection for teratozoospermia

Density gradient centrifugation for teratozoospermia

Arm Description

Outcomes

Primary Outcome Measures

Ongoing pregnancy rate

Secondary Outcome Measures

Embryo development after ICSI

Full Information

First Posted
September 9, 2018
Last Updated
November 14, 2019
Sponsor
Ibn Sina Hospital
Collaborators
Banon IVF Center Assiut, Egypt
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1. Study Identification

Unique Protocol Identification Number
NCT03666364
Brief Title
Magnetic Nanoparticle Sperm Separation for Teratozoospermia Male and Women Older Than 35 Years
Official Title
Magnetic Nanoparticle Sperm Separation for ICSI Cycles With Teratozoospermia and Over 35 Years Old Women Age
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
September 17, 2018 (Actual)
Primary Completion Date
September 20, 2019 (Actual)
Study Completion Date
October 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ibn Sina Hospital
Collaborators
Banon IVF Center Assiut, Egypt

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
1400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Magnetic nanoparticle selection for teratozoospermia
Arm Type
Experimental
Arm Title
Density gradient centrifugation for teratozoospermia
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Sperm preparation for ICSI
Intervention Description
A new protocol for sperm preparation for ICSI cycles with teratozoospermia in over 35 years old women
Primary Outcome Measure Information:
Title
Ongoing pregnancy rate
Time Frame
Twelve weeks of gestation
Secondary Outcome Measure Information:
Title
Embryo development after ICSI
Time Frame
Six days of culture

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: women indicated for ICSI but with teratozoospermia Exclusion Criteria: Women not failing in this group
Facility Information:
Facility Name
Banon Assiut
City
Assiut
Country
Egypt
Facility Name
Qena Fertility Center
City
Qena
ZIP/Postal Code
123456
Country
Egypt
Facility Name
IbnSina IVF Center
City
Sohag
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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