Novel Approach of Semen Preparation to Improve ICSI Outcome.
| Registry | NCT02328534 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 890 (Actual) |
| Sponsor | Ahmad Mustafa Mohamed Metwalley (Other) |
| Conditions | Infertility |
| Interventions | Blastocyst Formation Rate, Blastocyst Rate, Pregnancy Rate (Behavioral, procedure) |
| Dates | start 2007-03-01, primary completion 2013-09-01, completion 2014-01-01, first posted 2014-12-31, last updated 2014-12-31 |
| Locations | 2 sites in Bahrain, Egypt |
Related Papers Related Patents Related Grants Related Experts
All trials for Infertility All trials of Blastocyst Formation Rate All trials of Blastocyst Rate
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Density Gradient semen | Behavioral: Blastocyst Formation Rate; Procedure: Blastocyst Rate; Procedure: Pregnancy Rate | ICSI Cases processed using DG semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate | |
| Swimming down semen | Behavioral: Blastocyst Formation Rate; Procedure: Blastocyst Rate; Procedure: Pregnancy Rate | ICSI Cases processed using SD semen processing and evaluated by Blastocyst Formation Rate Blastocyst Rate Pregnancy Rate |
Sex: All, ages: 20 Years to 38 Years
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)
| Facility | City | Country | Status |
|---|---|---|---|
| Al Baraka Fertility Hospital | Manama, Adliyah | Bahrain | |
| Ibn Sina IVF Center- Ibn Sina Hospital | Sohag, Sohag Governorate | Egypt |