Clinical trial NCT02329704: Evaluation Study Between Density Gradient and Swimming Down for Semen Processing
Official title: Evaluation Study Between Density Gradient and Swimming Down for Semen Processing
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: IUI/AIH
Semen preparation
Semen processing
ICSI/IVF
ART
Density Gradient
Swimming down
hyaluronan affinity testing
Sperm vitality testin
Lead sponsor: Al Baraka Fertility Hospital
Sponsor class: OTHER
First posted: 2015-01-01
Enrollment: 100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cases arranged for study were submitted for routine semen analysis. Patient agreements collected as consent form signed during sample submission.

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.

In this study we will show drawback effect of physical and time stress interface applied on sperms during processing, and compare the out put results with that results produced from sperm processed without centrifugation interface or more processing time. As the sperm will separate it self by its natural movement and normal behavior.

Evaluation will be on three categories:

1. The final output quality: as net highly progressive sperms and their count number ( sperm morphology, count and motility): as our results showed more phonologically normal sperm retrieved from SD method with higher count and more percentage of progressively motile sperms.
2. The quality of sperm produced: through monitoring sperm vitality testing or sperm motility power among 2 days at 37.0 Ds. Motility will be evaluated after 24 hours and 48 hours. Both readings showed more decrease in sperm motility and vitality with time consuming with portions processed using density gradient. While portions processed using SD showed significant better readings.

   Another functional activity of sperm post processing is using HBA testing slide, as we evaluate the sperm affinity to hyaluronan. This Testing or assay indicate the physiological activity of sperm still maintained. While it showed HBA higher significant results with swimming down group study.
3. Final evaluation, that are used to present the quality of separation: is monitored using the contamination and carry over effect during semen manipulation and processing. Bacterial contamination using routine culture media (Blood agar) to evaluate 5 microns from each portions for presence and absence of any bacterial cells or during processing and manipulation.

Eligibility criteria: 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

Primary outcomes:
measure: HBA
timeFrame: 1 day
measure: Abnormal forms
timeFrame: 1 day
Secondary outcomes:
measure: Final concentration
timeFrame: 1 day
measure: 24 Hour motility
timeFrame: 1 day
measure: 48 Hour motility
timeFrame: 2 days
Other outcomes:
measure: Bacterial contamination
timeFrame: 2 days
Locations:
city: Manama
country: Bahrain
facility: Al Baraka Fertility Hospital
state: Adliyah
city: Sohag
country: Egypt
facility: Ibn Sina IVF Center- Ibn Sina Hospital
Study officials:
affiliation: Adliyah
name: Ahmad M Metwalley
role: STUDY_DIRECTOR
References:
citation: 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.