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

Sponsor
Ahmad Mustafa Mohamed Metwalley (Other)
Overall Status
Completed
CT.gov ID
NCT02328534
Collaborator
(none)
890
2
82.1
445
5.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Blastocyst Formation Rate
  • Procedure: Blastocyst Rate
  • Procedure: Pregnancy Rate

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.

Study Design

Study Type:
Observational
Actual Enrollment :
890 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Novel Approach of Semen Preparation to Improve ICSI Outcome.
Study Start Date :
Mar 1, 2007
Actual Primary Completion Date :
Sep 1, 2013
Actual Study Completion Date :
Jan 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Density Gradient semen

ICSI Cases processed using DG semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate

Behavioral: Blastocyst 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.
Other Names:
  • Blastocyst developed form cleaved embryos
  • Procedure: Blastocyst 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.
    Other Names:
  • Pregnancey produced formblastocyst embryo transfer
  • Procedure: Pregnancy 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.
    Other Names:
  • Pregnancy achieved after all ET
  • Swimming down semen

    ICSI Cases processed using SD semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate

    Behavioral: Blastocyst 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.
    Other Names:
  • Blastocyst developed form cleaved embryos
  • Procedure: Blastocyst 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.
    Other Names:
  • Pregnancey produced formblastocyst embryo transfer
  • Procedure: Pregnancy 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.
    Other Names:
  • Pregnancy achieved after all ET
  • Outcome Measures

    Primary Outcome Measures

    1. Total Pregnancy Rate [3 Years]

      Percentage of Pregnancies developed after embryo transfer, for maternal age less than 38 years old.

    Secondary Outcome Measures

    1. Blastulation Rate (BR) [3 years]

      Percentage of blastocyst embryos produced from cleaved embryos, for maternal age less than 38 YO.

    2. Blastocyst formation Rate (BFR) [3 Years]

      Developed embryos developed to Blastocyst stage from cleaved embryos.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 38 Years
    Sexes Eligible for Study:
    All
    Accepts 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)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Al Baraka Fertility Hospital Manama Adliyah Bahrain 15006
    2 Ibn Sina IVF Center- Ibn Sina Hospital Sohag Egypt 15006

    Sponsors and Collaborators

    • Ahmad Mustafa Mohamed Metwalley

    Investigators

    • Study Director: Ahmad M Metwalley, Ms. Genetics, Adliyah

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Ahmad Mustafa Mohamed Metwalley, Novel Approach of Semen Preparation to Improve ICSI Outcome, Al Baraka Fertility Hospital
    ClinicalTrials.gov Identifier:
    NCT02328534
    Other Study ID Numbers:
    • AlBarakaSD1
    First Posted:
    Dec 31, 2014
    Last Update Posted:
    Dec 31, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Ahmad Mustafa Mohamed Metwalley, Novel Approach of Semen Preparation to Improve ICSI Outcome, Al Baraka Fertility Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 31, 2014