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

Completed

• Conditions: Infertility
• Interventions: Behavioral: Blastocyst Formation Rate; Procedure: Blastocyst Rate; Procedure: Pregnancy Rate

• Registration Number: NCT02328534
• Lead Sponsor: Ahmad Mustafa Mohamed Metwalley

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.

Study Timeline

• Study Start: 2007-03
• Primary Completion: 2013-09
• Study Completion: 2014-01
• Status Verified: 2014-12
• Study First Submitted: 2014-12-28
• Study First Submitted QC: 2014-12-30
• Last Update Submitted: 2014-12-30
• Study First Posted: 2014-12-31
• Last Update Posted: 2014-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 890

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Density Gradient semen	Blastocyst Rate	ICSI Cases processed using DG semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate
Density Gradient semen	Blastocyst Formation Rate	ICSI Cases processed using DG semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate
Swimming down semen	Blastocyst Rate	ICSI Cases processed using SD semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate
Density Gradient semen	Pregnancy Rate	ICSI Cases processed using DG semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate
Swimming down semen	Blastocyst Formation Rate	ICSI Cases processed using SD semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate
Swimming down semen	Pregnancy Rate	ICSI Cases processed using SD semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate

Primary Outcome Measures

Name	Time	Method
Total Pregnancy Rate	3 Years	Percentage of Pregnancies developed after embryo transfer, for maternal age less than 38 years old.

Secondary Outcome Measures

Name	Time	Method
Blastulation Rate (BR)	3 years	Percentage of blastocyst embryos produced from cleaved embryos, for maternal age less than 38 YO.
Blastocyst formation Rate (BFR)	3 Years	Developed embryos developed to Blastocyst stage from cleaved embryos.

Trial Locations

Locations (2)

Al Baraka Fertility Hospital; 🇧🇭 Manama, Adliyah, Bahrain

Ibn Sina IVF Center- Ibn Sina Hospital; 🇪🇬 Sohag, Egypt