Clinical trial NCT02328534: Semen Processing for ICSI Using Swim-down and Density Gradient Methods
Official title: Novel Approach of Semen Preparation to Improve ICSI Outcome.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infertility
Keywords: ICSI/IVF
Semen processing
Semen preparation
Swim down
Density gradient
Silica solution
Lead sponsor: Al Baraka Fertility Hospital
Sponsor class: OTHER
First posted: 2014-12-31
Enrollment: 890
Sex: ALL
Minimum age (years): 20
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cases collected were submitted for ART treatment using ICSI/IVF procedures. In two different IVF clinics at Manama-Bahrain and Sohag-Egypt. The groups of about 890 couple prepared for treatment.

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.

Eligibility criteria: Inclusion Criteria: all semen samples fresh or frozen that has,

* Cases have semen examination criteria fall within WHO 2010 standards of count
* Cases have semen examination criteria fall within WHO 2010 standards of motility
* Cases have semen examination criteria with all types of abnormal forms
* Cases produced more than 4 mature oocytes (M2) and more

Exclusion Criteria:

* Cases have semen examination criteria with motility less than 5%
* Cases have semen examination criteria with count less than 1.0 million
* Cases with TESE, TESA and EPSA, both fresh and frozen
* Cases produced less than 4 mature oocytes (M2)

Primary outcomes:
measure: Total Pregnancy Rate
timeFrame: 3 Years
Secondary outcomes:
measure: Blastulation Rate (BR)
timeFrame: 3 years
measure: Blastocyst formation Rate (BFR)
timeFrame: 3 Years
Other outcomes:
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, Ms. Genetics
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.