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The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor

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ClinicalTrials.gov Identifier: NCT03960229
Recruitment Status : Completed
First Posted : May 23, 2019
Last Update Posted : September 24, 2019
Sponsor:
Collaborator:
Yeditepe University Hospital
Information provided by (Responsible Party):
Bezmialem Vakif University

Study Description
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Brief Summary:
Microfluidic chips are one of the methods of sperm separation to eliminate DNA fragmentation in sperm. It is thought that the separation of sperm by centrifugation in the classical gradient density (Percoll) method used in sperm separation in IVF (in vitro fertilization) laboratories leads to the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.

Condition or disease Intervention/treatment Phase
Male Infertility Infertility, Male Other: MicroFluidic Sperm Sorting Chips Other: Gradient-Density Centrifugation Not Applicable

Detailed Description:
The increase in male infertility rate due to environmental and physiological conditions leads to an increase in the use of assisted reproductive techniques. Isolation of living and morphologically normal live sperm is an integrated procedure in commonly used IVF / ICSI(intracytoplasmic sperm injection) / IUI(intrauterine insemination) procedures. Although current IVF / ICSI procedures result in a successful pregnancy of around 50%, the process can be greatly compromised if the selected sperm is abnormal. Microfluidic chips are one of the recommended sperm separation methods to eliminate DNA fragmentation in sperm. It is thought that the separation of the sperm by centrifugation in the classical gradient density (Percoll) method which is used in the separation of sperm in the IVF Laboratories, causes the increase of reactive oxygen radicals in sperm and this leads to sperm DNA fragmentation. Studies comparing Percoll and microfluidic chip method in terms of sperm, embryo quality and pregnancy rates are limited. In this context, it is aimed to investigate the effect of Percoll or Microfluidic Chip Technology on the quality of sperms and embryos obtained with these sperms and their pregnancy rates prospectively.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 139 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor: a Randomized Controlled Trial
Actual Study Start Date : May 23, 2019
Actual Primary Completion Date : July 23, 2019
Actual Study Completion Date : September 23, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Male Infertility

Arms and Interventions
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Arm Intervention/treatment
Experimental: MicroFluidic Sperm Sorting Chips
Sperm Sorting microfluidic chips (for ICSI) will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm
 Other: MicroFluidic Sperm Sorting Chips
sperm selection of IVF treatment
Active Comparator: gradient-density centrifugation
gradient-density centrifugation technique will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm
 Other: Gradient-Density Centrifugation
sperm selection of IVF treatment


Outcome Measures
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Primary Outcome Measures :
  1. Compare microfluid chip and density-gradient methods in terms of IVF success [ Time Frame: average of 1 year ]
    measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level.

  2. Compare microfluid chip and density-gradient methods in terms of embryo quality [ Time Frame: average of 1 year ]
    Embryo morphology will be assessed on day 3 using the standard criteria of the number of blastomeres and extent of fragmentation and blastomere asymmetry. Top quality embryos on day 3 will be designated as embryos with 7-8 cells, ≤10% fragmentation, and symmetric blastomeres. Using these criteria, the rate of top quality embryos will be analyzed.


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Apply to the IVF clinic due to male factor
  • Volunteer

Exclusion Criteria:

  • Inadequate follicle development with medication
  • Embryo does not have the appropriate quality for transfer
  • Female-induced infertility
  • Refuse to participate in research
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): NCT03960229


Locations
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Turkey
Bezmialem University
Istanbul, Turkey, 34746
Yeditepe University
Istanbul, Turkey, 34746
Sponsors and Collaborators
Bezmialem Vakif University
Yeditepe University Hospital
More Information
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Publications:

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Responsible Party: Bezmialem Vakif University
ClinicalTrials.gov Identifier: NCT03960229    
Other Study ID Numbers: BezmialemVU microchip study
First Posted: May 23, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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 Bezmialem Vakif University:
microfluid chip
gradient-density
IVF
male factor
Additional relevant MeSH terms:
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Infertility
Infertility, Male