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

Primary Purpose

Male Infertility, Infertility, Male

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
MicroFluidic Sperm Sorting Chips
Gradient-Density Centrifugation
Sponsored by
Bezmialem Vakif University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Male Infertility focused on measuring microfluid chip, gradient-density, IVF, male factor

Eligibility Criteria

20 Years - 50 Years (Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

  • Bezmialem University
  • Yeditepe University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MicroFluidic Sperm Sorting Chips

gradient-density centrifugation

Arm Description

Sperm Sorting microfluidic chips (for ICSI) will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm

gradient-density centrifugation technique will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm

Outcomes

Primary Outcome Measures

Compare microfluid chip and density-gradient methods in terms of IVF success
measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level.
Compare microfluid chip and density-gradient methods in terms of embryo quality
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.

Secondary Outcome Measures

Full Information

First Posted
December 5, 2018
Last Updated
September 23, 2019
Sponsor
Bezmialem Vakif University
Collaborators
Yeditepe University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03960229
Brief Title
The Evaluation of the Effect of Microfluidic Sperm Sorting Chip 'Labs-on-a-chip' on IVF Success in Male Factor
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
May 23, 2019 (Actual)
Primary Completion Date
July 23, 2019 (Actual)
Study Completion Date
September 23, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bezmialem Vakif University
Collaborators
Yeditepe University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Male Infertility, Infertility, Male
Keywords
microfluid chip, gradient-density, IVF, male factor

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MicroFluidic Sperm Sorting Chips
Arm Type
Experimental
Arm Description
Sperm Sorting microfluidic chips (for ICSI) will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm
Arm Title
gradient-density centrifugation
Arm Type
Active Comparator
Arm Description
gradient-density centrifugation technique will be used when preparing sperm of male partner and microinjection (ICSI) will be made with separated sperm
Intervention Type
Other
Intervention Name(s)
MicroFluidic Sperm Sorting Chips
Intervention Description
sperm selection of IVF treatment
Intervention Type
Other
Intervention Name(s)
Gradient-Density Centrifugation
Intervention Description
sperm selection of IVF treatment
Primary Outcome Measure Information:
Title
Compare microfluid chip and density-gradient methods in terms of IVF success
Description
measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level.
Time Frame
average of 1 year
Title
Compare microfluid chip and density-gradient methods in terms of embryo quality
Description
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.
Time Frame
average of 1 year

10. Eligibility

Sex
Male
Gender Based
Yes
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Bezmialem University
City
Istanbul
ZIP/Postal Code
34746
Country
Turkey
Facility Name
Yeditepe University
City
Istanbul
ZIP/Postal Code
34746
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24753434
Citation
Asghar W, Velasco V, Kingsley JL, Shoukat MS, Shafiee H, Anchan RM, Mutter GL, Tuzel E, Demirci U. Selection of functional human sperm with higher DNA integrity and fewer reactive oxygen species. Adv Healthc Mater. 2014 Oct;3(10):1671-9. doi: 10.1002/adhm.201400058. Epub 2014 Apr 17.
Results Reference
background
PubMed Identifier
23677651
Citation
Tasoglu S, Safaee H, Zhang X, Kingsley JL, Catalano PN, Gurkan UA, Nureddin A, Kayaalp E, Anchan RM, Maas RL, Tuzel E, Demirci U. Exhaustion of racing sperm in nature-mimicking microfluidic channels during sorting. Small. 2013 Oct 25;9(20):3374-84. doi: 10.1002/smll.201300020. Epub 2013 May 16.
Results Reference
background
PubMed Identifier
29089604
Citation
Nosrati R, Graham PJ, Zhang B, Riordon J, Lagunov A, Hannam TG, Escobedo C, Jarvi K, Sinton D. Microfluidics for sperm analysis and selection. Nat Rev Urol. 2017 Dec;14(12):707-730. doi: 10.1038/nrurol.2017.175. Epub 2017 Oct 31.
Results Reference
background

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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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