Sperm Selection by Either PICSI or MACS in Cases With Abnormal Sperm DNA Fragmentation Index for ICSI
NCT ID: NCT03398317
Last Updated: 2020-07-21
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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COMPLETED
NA
396 participants
INTERVENTIONAL
2017-01-01
2019-03-30
Brief Summary
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Detailed Description
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Sperm selection methods like PICSI and MACS have been developed for selecting a healthy mature non apoptotic sperm with healthy membrane for Oocyte injection so as to obtain best embryo quality and achieve higher ongoing pregnancy rates.
A sperm selection technique based on sperm membrane binding to hyaluronic acid (PICSI Dish), the main substrate of the oocyte zonapellucida, could improve the likelihood of obtaining better sperm for ICSI with non fragmented DNA. Another sperm selection technique based on Magnetic activated cell sorting (MACS) that depends on the binding of protein Annexin V to phosphatidylserine which is a marker for apoptosis, giving a resulting (eluted) spermatozoa without DNA fragmentation.
In order to determine which sperm selection technique is better for dealing with DNA fragmentation patients we need to study both techniques on two different groups of patients
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
PICSI
sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index
MACS
Semen processing is done by double layer density gradient method. The resulted pellet is labeled with annexin V microbeads followed by separation on MACS Column, the eluted fraction contains non apoptotic sperm suitable for Oocyte injection.
MACS
sperm selection using MACS for selecting sperm with lower DNA fragmentation index
Interventions
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PICSI
sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index
MACS
sperm selection using MACS for selecting sperm with lower DNA fragmentation index
Eligibility Criteria
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Inclusion Criteria
* Males with mild to moderate OTA (oligoteratoasthenozoospermia).
* Male aged 18-60 years.
* Female aged 18-40 years.
* Normo responder ( \> 5 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
* 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 previous uterine infection
* Any contradictions to undergoing in vitro fertilization or gonadotropin stimulation
18 Years
40 Years
ALL
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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Eman Hasanen
Clinical Embryologist
Principal Investigators
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Hosam Zaki, MSc, FRCOG
Role: STUDY_CHAIR
Ganin Fertility Center, Cairo, Egypt
Eman Hasanen, BSc
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center, Cairo, Egypt
Khaled El Qusi, BSc
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center, Cairo, Egypt
Abd El Ghafar Hussin, BSc
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center, Cairo, Egypt
Salma El Tanbouly, BSc
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center, Cairo, Egypt
Ashok Agarwal, PhD
Role: STUDY_DIRECTOR
American Center of Reproductive Medicine, Cleveland Clinic
Ralph Henkel, PhD
Role: PRINCIPAL_INVESTIGATOR
University of the Western Cape
Hanaa Alkhader
Role: PRINCIPAL_INVESTIGATOR
Ganin Fertility Center, Cairo, Egypt
Locations
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Ganin Fertility Center
Cairo, , Egypt
Countries
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References
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Benchaib M, Braun V, Lornage J, Hadj S, Salle B, Lejeune H, Guerin JF. Sperm DNA fragmentation decreases the pregnancy rate in an assisted reproductive technique. Hum Reprod. 2003 May;18(5):1023-8. doi: 10.1093/humrep/deg228.
Baldi and Muratori (2013) Genitic Damage in Human Spermatozoa. USA, NY : Springer Science & Business Media.
Hasanen E, Elqusi K, ElTanbouly S, Hussin AE, AlKhadr H, Zaki H, Henkel R, Agarwal A. PICSI vs. MACS for abnormal sperm DNA fragmentation ICSI cases: a prospective randomized trial. J Assist Reprod Genet. 2020 Oct;37(10):2605-2613. doi: 10.1007/s10815-020-01913-4. Epub 2020 Aug 8.
Other Identifiers
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GFC - 002
Identifier Type: -
Identifier Source: org_study_id
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