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

Novel Approach of Semen Preparation to Improve ICSI Outcome.

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.

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 890

Contacts and Locations

Study Locations

• Bahrain
  • Adliyah
    • Manama, Adliyah, Bahrain, 15006
      • Al Baraka Fertility Hospital
• Egypt
  • Sohag, Egypt, 15006
    • Ibn Sina IVF Center- Ibn Sina Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Pregnancy Rate	Percentage of Pregnancies developed after embryo transfer, for maternal age less than 38 years old.	3 Years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Ahmad Mustafa Mohamed Metwalley
• Investigators: Study Director: Ahmad M Metwalley, Ms. Genetics, Adliyah

Publications and helpful links

General Publications

• 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.

Helpful Links

• Semen procession recommended procedures.
• Density Gradient procedures description

Study record dates

Study Major Dates

• Study Start: March 1, 2007
• Primary Completion (Actual): September 1, 2013
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: December 28, 2014
• First Submitted That Met QC Criteria: December 30, 2014
• First Posted (Estimate): December 31, 2014

Study Record Updates

• Last Update Posted (Estimate): December 31, 2014
• Last Update Submitted That Met QC Criteria: December 30, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: Semen preparation; Semen processing; ICSI/IVF; Density gradient; Swim down; Silica solution
• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: AlBarakaSD1