Oxidative Stress
Conditions
Keywords
PICSI, ORP, TESA, seminal oxidation reduction potential
Brief 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.
Interventions
DEVICEPICSI
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.
PROCEDURETESA
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.
Sponsors
The Cleveland Clinic
University of the Western Cape
Ganin Fertility Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ongoing pregnancy rate | 20 weeks of gestation | Defined as the proportion of pregnancies that had completed ≥20 weeks of gestation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cleavage rate | 3 days | Defined as the proportion of cleaved embryos on day 3 over the injected oocytes |
| Blastulation rate | 5-6 days | Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3 |
| Fertilization rate | 16-18 hours | Defined as the proportion of 2PNs formed over the injected oocytes |
| Pregnancy rate | 14 days following embryo transfer | Defined as clinical pregnancy per embryo(s) transfer |
| Implantation rate | 6- 8 weeks following embryo transfer] | Defined as number of gestational sacs with fetal heart beat, shown by ultrasound in gestational week 6 over number of embryo(s) transferred. |
| Blastocyst quality rate | 5-6 days | 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 |
Countries
Egypt
Contacts
Primary ContactHosam Zaki, MSc, FRCOG
Backup ContactEman Hasanen, BSc
Outcome results
None listed