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

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

Detailed Description
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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.

Official Title
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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?

Conditions
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Oxidative Stress

Intervention / Treatment
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* Device: PICSI
* Procedure: TESA


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed of abnormal male semen parameters such as abnormal sperm parameters according to WHO 2010 or high DNA fragmentation using TUNEL as a cause of couple infertility. Abnormal sORP level on the day of ICSI. Males with mild OTA (oligoteratoasthenozoospermia). Female aged 18-35 years. Normo responder ( > 8 mature oocytes) Male will have to refrain from ejaculation no less than 1 day but no greater than 3 days prior semen specimen production on day of oocyte retrieval Exclusion Criteria: Normal Semen fluid analysis ( WHO 2010) during the initial assessment of the male Normal sORP levelat the day of ICSI Leukocytospermia Presence of varicocele. Known genetic abnormality Use of sperm donation or cryopreserved sperm Use of Oocyte donation Use of gestational carrier Presence of any of the endometrial factors that affect embryo implantation such as hydrosalpings, adenomyosis or previously known uterine infection Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PICSI<br>Physiological ICSI | Device: PICSI<br>* 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.<br>|
| Experimental: TESA<br>Testicular sperm aspiration | Procedure: TESA<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ongoing pregnancy rate | Defined as the proportion of pregnancies that had completed ≥20 weeks of gestation. | 20 weeks of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fertilization rate | Defined as the proportion of 2PNs formed over the injected oocytes | 16-18 hours | 
| Cleavage rate | Defined as the proportion of cleaved embryos on day 3 over the injected oocytes | 3 days | 
| Blastulation rate | Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3 | 5-6 days | 
| Blastocyst quality rate | Defined as the assessment of blastocyst quality according to Gardner's criteria into: good, fair or bad in terms of percentage of the total formed blastocysts | 5-6 days | 
| Pregnancy rate | Defined as clinical pregnancy per embryo(s) transfer | 14 days following embryo transfer | 
| Implantation rate | Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo(s) transferred. | 6- 8 weeks following embryo transfer] | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PICSI, ORP, TESA, seminal oxidation reduction potential