Evaluation Study Between Density Gradient and Swimming Down for Semen Processing
1 other identifier
observational
100
2 countries
2
Brief Summary
This study evaluates the quality of sperm produced after semen processing using Density Gradient (DG) and swimming down (SD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2007
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 28, 2014
CompletedFirst Posted
Study publicly available on registry
January 1, 2015
CompletedJanuary 1, 2015
December 1, 2014
4 months
December 28, 2014
December 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HBA
Affinity is measured according to percentage of non motile sperm produced from 10 µL of processed sample.
1 day
Abnormal forms
Percentage normally stained sperms after processing
1 day
Secondary Outcomes (3)
Final concentration
1 day
24 Hour motility
1 day
48 Hour motility
2 days
Other Outcomes (1)
Bacterial contamination
2 days
Study Arms (2)
Density Gradient processing
Semen portion processed using Density Gradient (80/40 %) Spin on 1200 r.p.m./20min Wash on 1200 r.p.m./5min Rewash on 1200 r.p.m./5min then evaluation to be done using : Diff-Quik staining for morphology evaluation Motility Evaluation for grade A and B Concentration (mil/ml) 24 H half life 48 H half life HBA Testing Bacterial contamination
Swimming down Processing
Semen portion processed using swimming down (100 %) 30 min at room temperature processing for swim down Wash on 1200 r.p.m./5min Rewash on 1200 r.p.m./5min then evaluation to be done using : Diff-Quik staining for morphology evaluation Motility Evaluation for grade A and B Concentration (mil/ml) 24 H half life 48 H half life HBA Testing Bacterial contamination
Interventions
Papanicolaou stain (haematoxylin, orange G6, and EA50) gives a clear difference between basophilic and acidophilic cell constituents and thereby enables a detailed examination of chromatin pattern, which is useful in the evaluation of sperm morphology and assessment of presence of immature spermatozoa. Cytoplasmic staining can vary between red and green dependent on ionic strength, pH, and composition of the cell department and the stain (OG6 and EA50). Morphological assessment for processed portions of semen. As separation process has to minimize the morphological abnormal sperm.
The better separation method will insure more progressive sperms after processing. Grading using A and B scale scored by (WHO 2010) references.
count of isolated sperms Using Makler chamber for count of sperm for each portion post processing.
percentage of active motile to non motile sperms. Microscopic examination for each sample after 24 hours incubation, to evaluate the progressively motile sperm and those non progressive or non motile.
percentage of active motile to non motile sperms. Microscopic examination for each sample after 48 hours incubation, to evaluate the progressively motile sperm and those non progressive or non motile.
The Hyaluronic Binding Assay (HBA®) is an important diagnostic tool for suspected male infertility in the analysis of semen. In a matter of minutes the HBA® slide provides an answer to the proportion of mature binding spermatozoa in the sample (The HBA® score %). By using HBA slide we can count the physiologically active sperms at each sample and calculate percentage of active sperms with reference to post processing count from 3rd investigating arm.
Routine bacterial culture using Blood Agar culture plates for 10 micron finally washed samples, to confirm presence of any bacteria contamination caused by carry over during processing.
Eligibility Criteria
Cases arranged for study were submitted for routine semen analysis. Patient agreements collected as consent form signed during sample submission.
You may qualify if:
- Semen with motility more than 10 % according WHO 2010 standers
- Semen with sperm count more than 5 mil/ml according WHO 2010 standers
You may not qualify if:
- Semen volume less than 1.0 ml
- Semen with liquefaction time more than 60 min
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Al Baraka Fertility Hospital
Manama, Adliyah, 15006, Bahrain
Ibn Sina IVF Center- Ibn Sina Hospital
Sohag, Sohag Governorate, 15006, Egypt
Related Publications (1)
Malvezzi H, Sharma R, Agarwal A, Abuzenadah AM, Abu-Elmagd M. Sperm quality after density gradient centrifugation with three commercially available media: a controlled trial. Reprod Biol Endocrinol. 2014 Dec 2;12:121. doi: 10.1186/1477-7827-12-121.
PMID: 25466430BACKGROUND
Related Links
Biospecimen
Semen samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ahmad M Metwalley
Adliyah
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- IVF unit director
Study Record Dates
First Submitted
December 28, 2014
First Posted
January 1, 2015
Study Start
May 1, 2007
Primary Completion
September 1, 2007
Study Completion
September 1, 2007
Last Updated
January 1, 2015
Record last verified: 2014-12