What is the Best Sperm Source and Way of Sperm Selection in Cases With Abnormal sORP Levels on the Day of ICSI?
NCT ID: NCT03360526
Last Updated: 2019-01-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
820 participants
INTERVENTIONAL
2017-11-20
2019-12-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PICSI
Physiological ICSI
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.
TESA
Testicular sperm aspiration
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
60 Years
MALE
No
Sponsors
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The Cleveland Clinic
OTHER
University of the Western Cape
OTHER
Ganin Fertility Center
OTHER
Responsible Party
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Principal Investigators
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Eman Hasanen, BSc
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center, Cairo, Egypt
Hosam Zaki, MSc, FRCOG
Role: STUDY_CHAIR
Ganin Fertility Center, Cairo, Egypt
Khaled Elqusi, BSc
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center, Cairo, Egypt
Ashok Agarwal, Ph.D
Role: STUDY_DIRECTOR
American Center of reproductive medicine, Cleveland Clinic, Ohio, USA
Ralph Henkel, PhD
Role: PRINCIPAL_INVESTIGATOR
University of the Western Cape
Hanaa Elkhedr, ABB( ELD)
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center, Cairo, Egypt
Locations
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Ganin Fertility center
Maadi, Cairo Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
T. Cozzubbo, Q.V. Neri, M. Goldstein, Z. Rosenwaks, G.D. Palermo. Topographic mapping of sperm DNA fragmentation within the male genital tract.
Other Identifiers
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EMSH25390
Identifier Type: -
Identifier Source: org_study_id
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