NCT04144244

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 and IUI cycles 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

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
176

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

October 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 30, 2019

Completed
16 days until next milestone

Study Start

First participant enrolled

November 15, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2020

Completed
Last Updated

February 12, 2020

Status Verified

February 1, 2020

Enrollment Period

6 months

First QC Date

October 28, 2019

Last Update Submit

February 11, 2020

Conditions

Infertility UnexplainedInfertility, Male

Keywords

microfluid chipgradient-densityintrauterine insemination

Outcome Measures

Primary Outcomes (2)

  • Compare microfluid chip and density-gradient methods in terms of IUI success

    measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level

    average of 6 months

  • 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 6 months

Study Arms (2)

MicroFluidic Sperm Sorting Chips

EXPERIMENTAL

Sperm Sorting microfluidic chips will be used when preparing sperm of male partner and IUI 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 IUI will be made with separated sperm

Other: Gradient-Density Centrifugation

Interventions

MicroFluidic Sperm Sorting ChipsOTHER

sperm selection of IUI treatment

MicroFluidic Sperm Sorting Chips
Gradient-Density CentrifugationOTHER

sperm selection of IUI treatment

gradient-density centrifugation

Eligibility Criteria

Age20 Years - 40 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apply to the infertility clinic due to unexplained infertility and mild male factor (total motile sperm count \>5 million)
  • Volunteer

You may not qualify if:

  • Inadequate follicle development with medication
  • Embryo does not have the appropriate quality for transfer
  • Tubal pathology
  • Total motile sperm count \< 5 million
  • Refuse to participate in research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem University

Istanbul, 34746, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • Gode F, Bodur T, Gunturkun F, Gurbuz AS, Tamer B, Pala I, Isik AZ. Comparison of microfluid sperm sorting chip and density gradient methods for use in intrauterine insemination cycles. Fertil Steril. 2019 Nov;112(5):842-848.e1. doi: 10.1016/j.fertnstert.2019.06.037. Epub 2019 Sep 19.

    PMID: 31543253BACKGROUND

  • Yetkinel S, Kilicdag EB, Aytac PC, Haydardedeoglu B, Simsek E, Cok T. Effects of the microfluidic chip technique in sperm selection for intracytoplasmic sperm injection for unexplained infertility: a prospective, randomized controlled trial. J Assist Reprod Genet. 2019 Mar;36(3):403-409. doi: 10.1007/s10815-018-1375-2. Epub 2018 Dec 12.

    PMID: 30542782BACKGROUND

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

Central Study Contacts

Pinar Ozcan, MD, Assoc Prof

CONTACT

+902124531700drpinarozcan@hotmail.com

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

October 28, 2019

First Posted

October 30, 2019

Study Start

November 15, 2019

Primary Completion

May 15, 2020

Study Completion

July 15, 2020

Last Updated

February 12, 2020

Record last verified: 2020-02

Locations

TU(1)