Viewing Study NCT02328534


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Study NCT ID: NCT02328534
Status: COMPLETED
Last Update Posted: 2014-12-31
First Post: 2014-12-28
Is Gene Therapy: True
Has Adverse Events: False

Brief Title: Semen Processing for ICSI Using Swim-down and Density Gradient Methods
Sponsor: Ahmad Mustafa Mohamed Metwalley
Organization:

Study Overview

Official Title: Novel Approach of Semen Preparation to Improve ICSI Outcome.
Status: COMPLETED
Status Verified Date: 2014-12
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: The investigators evaluate the feedback of using swim down semen processing method during preparation for ICSI and compare the results of pregnancy and embryos quality with the cases used density gradient method for their semen processing.
Detailed Description: There is different semen processing method, in this study we compared the ICSI output when the investigators used one method with higher separation method and minimum sperm stress or physical interface as swimming down using 100 % silica solution, with other more stressful procedure with high selection power as density gradient.

The routine used method as density gradient (DG) includes about 30 min centrifugation at 1200 RPM, and more working steps with more handling procedures. According to many references the investigators can approve that it is method to be indicated with all cases particularly with those severely decreases semen number or motility.

Using 100 % silica solution for semen processing used for ICSi, shews lesser centrifugation time and minimum processing procedures. As swimming down time is about 30 min followed by 5 min washing and finalized with other 3 minutes last wash. For that total interfering physical action is about 8 minutes compared with 30 min with DG method.

In swimming down we are using the natural sperm behavior and own swimming power for separate itself from other seminal components. As well as only the one normally structure and motility direction the only can penetrate the interface surface of silica solution and swim inside higher density matrix using its speed and power.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: