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Completed

NCT Number: NCT02328534

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

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.

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Key information

Age range

20 year–38 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Al Baraka Fertility Hospital, Manama, Adliyah, Bahrain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Blastocyst Formation Rate

Behavioral

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

Blastocyst Rate

Procedure

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

Pregnancy Rate

Procedure

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

Primary outcomes

  1. Total Pregnancy Rate

    Time frame: 3 Years

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

Secondary outcomes

  1. Blastulation Rate (BR)

    Time frame: 3 years

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

  2. Blastocyst formation Rate (BFR)

    Time frame: 3 Years

    Developed embryos developed to Blastocyst stage from cleaved embryos.

Sponsors and collaborators

Lead sponsor

Ahmad Mustafa Mohamed Metwalley

Other

Registry information

Official study title

Novel Approach of Semen Preparation to Improve ICSI Outcome.

Important dates

Study start
2007
Primary completion
2013
Study completion
2014
First posted
Dec 31, 2014
Registry last updated
Dec 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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