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Sperm Selection by Either PICSI or MACS in Cases With Abnormal Sperm DNA Fragmentation Index for ICSI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03398317
Recruitment Status : Completed
First Posted : January 12, 2018
Last Update Posted : July 21, 2020
Sponsor:
Collaborators:
The Cleveland Clinic
University of the Western Cape
Information provided by (Responsible Party):
Eman Hasanen, Ganin Fertility Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Sperm DNA Fragmentation Other: PICSI Other: MACS Not Applicable

Detailed Description:

Sperm DNA fragmentation has shown a negative correlation with fertilization rate, embryo quality, and implantation rate. And a positive correlation with miscarriage rate in the 1st trimester.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 396 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: PICSI vs. MACS for Abnormal Sperm DNA Fragmentation ICSI Cases: a Prospective Randomized Trial
Actual Study Start Date : January 1, 2017
Actual Primary Completion Date : March 30, 2019
Actual Study Completion Date : March 30, 2019
Arms and Interventions
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Arm Intervention/treatment
Experimental: 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
 Other: PICSI
sperm selection using PICSI dish for selecting sperm with lower DNA fragmentation index
Active Comparator: 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.
 Other: MACS
sperm selection using MACS for selecting sperm with lower DNA fragmentation index


Outcome Measures
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Primary Outcome Measures :
  1. Ongoing pregnancy rate [ Time Frame: 20 weeks of gestation ]
    Defined as the proportion of pregnancies that completed more than 20 weeks of gestation


Secondary Outcome Measures :
  1. Comparison of cleavage rate [ Time Frame: 3 days ]
    Defined as the proportion of cleaved embryos on day 3 over the injected oocytes

  2. Comparison of Blastulation rate [ Time Frame: 5-6 days ]
    Defined as the proportion of blastocysts formed on day 5 or 6 over the cleaved embryos on day 3

  3. Comparison of Blastocyst quality rate [ Time Frame: 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

  4. Comparison of Pregnancy rate [ Time Frame: 14 days following embryo transfer ]
    Defined as clinical pregnancy per transfer

  5. Comparison of implantation rate [ Time Frame: 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 transferred.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03398317


Locations
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Egypt
Ganin Fertility Center
Cairo, Egypt
Sponsors and Collaborators
Ganin Fertility Center
The Cleveland Clinic
University of the Western Cape
Investigators
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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
More Information
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Publications:
Baldi and Muratori (2013) Genitic Damage in Human Spermatozoa. USA, NY : Springer Science & Business Media.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Eman Hasanen, Clinical Embryologist, Ganin Fertility Center
ClinicalTrials.gov Identifier: NCT03398317    
Other Study ID Numbers: GFC - 002
First Posted: January 12, 2018    Key Record Dates
Last Update Posted: July 21, 2020
Last Verified: July 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eman Hasanen, Ganin Fertility Center:
SDF
DFI
sperm selection
PICSI
MACS