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

Infertility Clinical Trial

Official title:

Novel Approach of Semen Preparation to Improve ICSI Outcome.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02328534
• Other study ID #: AlBarakaSD1
• Status: Completed
• Phase: N/A
• First received: December 28, 2014
• Last updated: December 30, 2014
• Start date: March 2007
• Est. completion date: January 2014

Study information

• Verified date: December 2014
• Source: Al Baraka Fertility Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bahrain: Ethics CommitteeEgypt: Ministry of Health and Population
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 890
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 38 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Infertility

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
Bahrain	Al Baraka Fertility Hospital	Manama	Adliyah
Egypt	Ibn Sina IVF Center- Ibn Sina Hospital	Sohag

Sponsors (1)

Lead Sponsor	Collaborator
Ahmad Mustafa Mohamed Metwalley

Countries where clinical trial is conducted

Bahrain,  Egypt, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Pregnancy Rate	Percentage of Pregnancies developed after embryo transfer, for maternal age less than 38 years old.	3 Years	Yes
Secondary	Blastulation Rate (BR)	Percentage of blastocyst embryos produced from cleaved embryos, for maternal age less than 38 YO.	3 years	Yes
Secondary	Blastocyst formation Rate (BFR)	Developed embryos developed to Blastocyst stage from cleaved embryos.	3 Years	Yes

External Links

•   Density Gradient procedures description
•   Semen procession recommended procedures.