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| Name | Class |
|---|---|
| The Cleveland Clinic | OTHER |
| University of the Western Cape | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICSI | Active Comparator | Physiological ICSI |
|
| TESA | Experimental | Testicular sperm aspiration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PICSI | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ongoing pregnancy rate | Defined as the proportion of pregnancies that had completed ≥20 weeks of gestation. | 20 weeks of gestation |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Male Since Born
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hosam Zaki, MSc, FRCOG | Contact | +201222150018 | hosamz@tedata.net.eg | |
| Eman Hasanen, BSc | Contact | +201282012291 | em.saberh@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Eman Hasanen, BSc | Ganin Fertility Center, Cairo, Egypt | Principal Investigator |
| Hosam Zaki, MSc, FRCOG | Ganin Fertility Center, Cairo, Egypt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ganin Fertility center | Recruiting | Maadi | Cairo Governorate | 12345 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27260688 | Background | Agarwal A, Sharma R, Roychoudhury S, Du Plessis S, Sabanegh E. MiOXSYS: a novel method of measuring oxidation reduction potential in semen and seminal plasma. Fertil Steril. 2016 Sep 1;106(3):566-573.e10. doi: 10.1016/j.fertnstert.2016.05.013. Epub 2016 May 31. | |
| 27839743 | Background | Agarwal A, Roychoudhury S, Sharma R, Gupta S, Majzoub A, Sabanegh E. Diagnostic application of oxidation-reduction potential assay for measurement of oxidative stress: clinical utility in male factor infertility. Reprod Biomed Online. 2017 Jan;34(1):48-57. doi: 10.1016/j.rbmo.2016.10.008. Epub 2016 Oct 20. |
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| TESA | Procedure | 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. |
|
| 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] |
| Khaled Elqusi, BSc |
| Ganin Fertility Center, Cairo, Egypt |
| Principal Investigator |
| Ashok Agarwal, Ph.D | American Center of reproductive medicine, Cleveland Clinic, Ohio, USA | Study Director |
| Ralph Henkel, PhD | University of the Western Cape | Principal Investigator |
| Hanaa Elkhedr, ABB( ELD) | Ganin Fertility Center, Cairo, Egypt | Principal Investigator |
| 21256575 | Background | Natali A, Turek PJ. An assessment of new sperm tests for male infertility. Urology. 2011 May;77(5):1027-34. doi: 10.1016/j.urology.2010.10.005. Epub 2011 Jan 22. |
| Background | T. Cozzubbo, Q.V. Neri, M. Goldstein, Z. Rosenwaks, G.D. Palermo. Topographic mapping of sperm DNA fragmentation within the male genital tract. |