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

• Sponsor: Ibn Sina Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03666364
• Collaborator: Banon IVF Center Assiut, Egypt (Other)
• Enrollment: 1,400
• Locations: 3
• Arms: 2
• Actual Duration (Months): 12.5
• Patients Per Site: 466.7
• Patients Per Site Per Month: 37.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Other: Sperm preparation for ICSI	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 1400 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Outcomes Assessor)
• Primary Purpose: Other
• Official Title: Magnetic Nanoparticle Sperm Separation for ICSI Cycles With Teratozoospermia and Over 35 Years Old Women Age
• Actual Study Start Date: Sep 17, 2018
• Actual Primary Completion Date: Sep 20, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Ongoing pregnancy rate [Twelve weeks of gestation]

Secondary Outcome Measures

1. Embryo development after ICSI [Six days of culture]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 42 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• women indicated for ICSI but with teratozoospermia

Exclusion Criteria:

• Women not failing in this group

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Banon Assiut	Assiut		Egypt
2	Qena Fertility Center	Qena		Egypt	123456
3	IbnSina IVF Center	Sohag		Egypt

Sponsors and Collaborators

• Ibn Sina Hospital
• Banon IVF Center Assiut, Egypt

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Muhammad Fawzy, IVF Lab Director, Ibn Sina Hospital
• ClinicalTrials.gov Identifier: NCT03666364
• Other Study ID Numbers: IbnSina-MNP
• First Posted: Sep 11, 2018
• Last Update Posted: Nov 18, 2019
• Last Verified: Nov 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infertility; Teratozoospermia

Study Results

No Results Posted as of Nov 18, 2019