Skip to main content
Clinical Trials/NCT02329704
NCT02329704CompletedNot Applicable

Evaluation Study Between Density Gradient and Swimming Down for Semen Processing

Ahmad Mustafa Mohamed Metwalley2 sites in 2 countries100 target enrollmentStarted: May 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
100
Locations
2
Primary Endpoint
Abnormal forms

Study Overview

Brief Summary

This study evaluates the quality of sperm produced after semen processing using Density Gradient (DG) and swimming down (SD).

Detailed Description

Semen processing to be used for different ART procedures is essential step to isolate dead sperms as well as those abnormally structural or morphology. Semen preparation will maintain to remove the seminal fluids and present cells and contamination pus cells or bacterial cells.

Among different protocols, Density Gradient and swim-up are the most common. For poor motility and number sample Density Gradient is indicated. While final evaluation for produced or separated sperm form processing procedures was not evaluated yet.

Preparation for evaluation study to compare output of main used protocol Density Gradient (DG) with other protocol as swimming down using different study criteria can make more clear evaluation for better processing procedures.

The cases arranged for evaluation were semen samples are within WHO 2010 normal values for motility and count to be more than 5 million/ml. All samples to be divided to two portions for processing by the two preparation techniques.

Post preparation evaluation to be done for the two outputs using: Motility monitoring for 48 hours at 37.0 Dc, abnormal forms, hyaluronan affinity testing and contaminating bacterial growth.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Semen with motility more than 10 % according WHO 2010 standers
  • •Semen with sperm count more than 5 mil/ml according WHO 2010 standers

Exclusion Criteria

  • •Semen volume less than 1.0 ml
  • •Semen with liquefaction time more than 60 min

Outcomes

Primary Outcomes

Abnormal forms

Time Frame: 1 day

Percentage normally stained sperms after processing

HBA

Time Frame: 1 day

Affinity is measured according to percentage of non motile sperm produced from 10 µL of processed sample.

Secondary Outcomes

  • 24 Hour motility(1 day)
  • Final concentration(1 day)
  • 48 Hour motility(2 days)

Investigators

Sponsor
Ahmad Mustafa Mohamed Metwalley
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

Ahmad Mustafa Mohamed Metwalley

IVF unit director

Al Baraka Fertility Hospital

Study Sites (2)

Loading locations...

Similar Trials

Evaluation Study Between Density Gradient... | Clinical Trial