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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

139 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-23

Study Completion Date

2019-09-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Male Infertility Infertility, Male

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

MicroFluidic Sperm Sorting Chips

Intervention Type OTHER

sperm selection of IVF treatment

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

Group Type ACTIVE_COMPARATOR

Gradient-Density Centrifugation

Intervention Type OTHER

sperm selection of IVF treatment

Interventions

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MicroFluidic Sperm Sorting Chips

sperm selection of IVF treatment

Intervention Type OTHER

Gradient-Density Centrifugation

sperm selection of IVF treatment

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes