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Semen Processing for ICSI Using Swim-down and Density Gradient Methods

Novel Approach of Semen Preparation to Improve ICSI Outcome.

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02328534
Enrollment
890
Registered
2014-12-31
Start date
2007-03-31
Completion date
2014-01-31
Last updated
2014-12-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Keywords

ICSI/IVF, Semen processing, Semen preparation, Swim down, Density gradient, Silica solution

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.

Interventions

BEHAVIORALBlastocyst Formation Rate

Embryos developed at Day3 cultures, are continued for Day5 culture tho reach blastocyst stage. The percentage of blastocyst produced from cleaved embryos to be evaluated ar rate. The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time.

PROCEDUREBlastocyst Rate

Day 5 embryo transfer achieved pregnancy are compared with total embryo transfer cases at Day5. The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time. Pregnancy confirmed with day 12 after Et and repeated with 48 hours after 1st exam.

PROCEDUREPregnancy Rate

All pregnancy achieved from all ET. Pregnancy confirmed with day 12 after Et and repeated with 48 hours after 1st exam. The evaluation with doe one time using Density Gradient semen one time and Swimming down semen another time.

Sponsors

Ahmad Mustafa Mohamed Metwalley
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 38 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Total Pregnancy Rate3 YearsPercentage of Pregnancies developed after embryo transfer, for maternal age less than 38 years old.

Secondary

MeasureTime frameDescription
Blastulation Rate (BR)3 yearsPercentage of blastocyst embryos produced from cleaved embryos, for maternal age less than 38 YO.
Blastocyst formation Rate (BFR)3 YearsDeveloped embryos developed to Blastocyst stage from cleaved embryos.

Countries

Bahrain, Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026