NCT03360526

What is the Best Sperm Source and Way of Sperm Selection in Cases With Abnormal sORP Levels on the Day of ICSI?

What is the Best Sperm Source and Way of Sperm Selection in Cases With Abnormal Static Oxidation Reduction Potential (sORP) Levels on the Day of ICSI?

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 820 (estimated)
• Sponsor: Ganin Fertility Center · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Does the level of statistic oxidation reduction potential (sORP) affects the choice of sperm source or sperm selection method used during ICSI.

Detailed description

Reactive oxygen species (ROS) are an integral component of sperm developmental physiology, capacitation, and function. Elevated ROS levels, from processes such as infection or inflammation, can be associated with male infertility and also decreases the overall ICSI success rates\[1\]\[2\] Several techniques are available for measuring ROS, but only Mioxsys can measure the imbalance between production of reactive oxygen species (ROS) and activity of the antioxidant defense system in semen in terms of sORP. Mioxsys is a robust test that gives the result in a very short time, so it became applicable to test sORP on day of ICSI \[2\] Injection with sperm selected by PICSI dishes or testicular sperm aspiration (TESA) is thought to decrease or eliminate the unwanted ROS but none of them was reported to be more efficient than the other with regards to the clinical outcomes. A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish), the main substrate of the oocyte zona pellucida, could improve the likelihood of obtaining better sperm for ICSI. It is thought that excessive ROS damages sperm membranes, reduces sperm motility, and induces sperm DNA damage \[3\] The topographic assessment of sperm chromatin integrity throughout the male genital tract suggested that there is a disruption in DNA packing during spermiogenesis that does not allow sperm chromatin to withstand oxidative stressors, possibly compounded by a compromised total antioxidant capacity in the seminal fluid \[4\]. The utilization of testicular spermatozoa may represent a viable option for men with high ROS level in their ejaculates.

Conditions

• Oxidative Stress

Interventions

Type	Name	Description
DEVICE	PICSI	Semen processing is done by double layer density gradient method followed by adding Sperm to the dot of hyaluronan on the PICSI dish, within minutes the bound sperm are attached by their acrosome to the surface of the dot. (Selecting an individual bound sperm with enhanced genetic and developmental integrity ensures that the sperm selected is the optimal sperm from the sample for oocyte injection.
PROCEDURE	TESA	Patients will undergo TESA which is performed by sticking a needle in the testis and aspirating fluid and tissue with negative pressure then examine the sample for presence of motile sperms followed by sample processing and oocyte injection.

Timeline

• Start date: 2017-11-20
• Primary completion: 2019-12-30
• Completion: 2019-12-30
• First posted: 2017-12-04
• Last updated: 2019-01-23

Locations

1 site across 1 country: Egypt