Sperm Selection by Either PICSI or MACS in Cases With Abnormal Sperm DNA Fragmentation Index for ICSI
PICSI vs. MACS for Abnormal Sperm DNA Fragmentation ICSI Cases: a Prospective Randomized Trial
1 other identifier
interventional
396
1 country
1
Brief Summary
On the day of ICSI, choosing the best sperm by either PICSI or magnetic activated cell sorting (MACS) in cases with abnormal DNA is not fully investigated. This study helps in solving this problem by using two known techniques to achieve that purpose.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
January 7, 2018
CompletedFirst Posted
Study publicly available on registry
January 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2019
CompletedJuly 21, 2020
July 1, 2020
2.2 years
January 7, 2018
July 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Ongoing pregnancy rate
Defined as the proportion of pregnancies that completed more than 20 weeks of gestation
20 weeks of gestation
Secondary Outcomes (5)
Comparison of cleavage rate
3 days
Comparison of Blastulation rate
5-6 days
Comparison of Blastocyst quality rate
5-6 days
Comparison of Pregnancy rate
14 days following embryo transfer
Comparison of implantation rate
6- 8 weeks following embryo transfer
Study Arms (2)
PICSI
EXPERIMENTALSemen 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
MACS
ACTIVE COMPARATORSemen 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.
Interventions
Eligibility Criteria
You may qualify if:
- Males diagnosed of abnormal DNA fragmentation index ( \> 19%).
- 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
You may not qualify if:
- Males with normalDNA fragmentation index (\<19%)at the initial assessment.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ganin Fertility Centerlead
- The Cleveland Cliniccollaborator
- University of the Western Capecollaborator
Study Sites (1)
Ganin Fertility Center
Cairo, Egypt
Related Publications (3)
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.
PMID: 12721180BACKGROUNDBaldi and Muratori (2013) Genitic Damage in Human Spermatozoa. USA, NY : Springer Science & Business Media.
BACKGROUNDHasanen 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.
PMID: 32772268DERIVED
Study Officials
- STUDY CHAIR
Hosam Zaki, MSc, FRCOG
Ganin Fertility Center, Cairo, Egypt
- PRINCIPAL INVESTIGATOR
Eman Hasanen, BSc
Ganin Fertility Center, Cairo, Egypt
- PRINCIPAL INVESTIGATOR
Khaled El Qusi, BSc
Ganin Fertility Center, Cairo, Egypt
- PRINCIPAL INVESTIGATOR
Abd El Ghafar Hussin, BSc
Ganin Fertility Center, Cairo, Egypt
- PRINCIPAL INVESTIGATOR
Salma El Tanbouly, BSc
Ganin Fertility Center, Cairo, Egypt
- STUDY DIRECTOR
Ashok Agarwal, PhD
American Center of Reproductive Medicine, Cleveland Clinic
- PRINCIPAL INVESTIGATOR
Ralph Henkel, PhD
University of the Western Cape
- PRINCIPAL INVESTIGATOR
Hanaa Alkhader
Ganin Fertility Center, Cairo, Egypt
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Embryologist
Study Record Dates
First Submitted
January 7, 2018
First Posted
January 12, 2018
Study Start
January 1, 2017
Primary Completion
March 30, 2019
Study Completion
March 30, 2019
Last Updated
July 21, 2020
Record last verified: 2020-07