NCT03960229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
139

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

December 5, 2018

Completed
6 months until next milestone

First Posted

Study publicly available on registry

May 23, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

May 23, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 23, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2019

Completed
Last Updated

September 24, 2019

Status Verified

September 1, 2019

Enrollment Period

2 months

First QC Date

December 5, 2018

Last Update Submit

September 23, 2019

Conditions

Male InfertilityInfertility, Male

Keywords

microfluid chipgradient-densityIVFmale factor

Outcome Measures

Primary Outcomes (2)

  • 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.

    average of 1 year

  • 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.

    average of 1 year

Study Arms (2)

MicroFluidic Sperm Sorting Chips

EXPERIMENTAL

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

gradient-density centrifugation

ACTIVE COMPARATOR

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

Interventions

MicroFluidic Sperm Sorting ChipsOTHER

sperm selection of IVF treatment

MicroFluidic Sperm Sorting Chips
Gradient-Density CentrifugationOTHER

sperm selection of IVF treatment

gradient-density centrifugation

Eligibility Criteria

Age20 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Bezmialem University

Istanbul, 34746, Turkey (Türkiye)

Location

Yeditepe University

Istanbul, 34746, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 24753434BACKGROUND

  • 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.

    PMID: 23677651BACKGROUND

  • 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.

    PMID: 29089604BACKGROUND

MeSH Terms

Conditions

Infertility, Male

Interventions

Centrifugation, Density Gradient

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

UltracentrifugationCentrifugationInvestigative TechniquesChemistry Techniques, Analytical

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2018

First Posted

May 23, 2019

Study Start

May 23, 2019

Primary Completion

July 23, 2019

Study Completion

September 23, 2019

Last Updated

September 24, 2019

Record last verified: 2019-09

Locations

TU(2)