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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03666364
• Other study ID #: IbnSina-MNP
• Status: Completed
• Phase: N/A
• Start date: September 17, 2018
• Est. completion date: October 1, 2019

Study information

• Verified date: November 2019
• Source: Ibn Sina Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1400
• Est. completion date: October 1, 2019
• Est. primary completion date: September 20, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 35 Years to 42 Years

Eligibility

Inclusion Criteria:

• women indicated for ICSI but with teratozoospermia

Exclusion Criteria:

• Women not failing in this group

Related Conditions & MeSH terms

• Infertility
• Teratozoospermia

Intervention

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

Locations

Country	Name	City	State
Egypt	Banon Assiut	Assiut
Egypt	Qena Fertility Center	Qena
Egypt	IbnSina IVF Center	Sohag

Sponsors (2)

Lead Sponsor	Collaborator
Ibn Sina Hospital	Banon IVF Center Assiut, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ongoing pregnancy rate		Twelve weeks of gestation
Secondary	Embryo development after ICSI		Six days of culture