Comparison of the Effect of Microchip and Density Gradient Methods in Intrauterine Insemination Cycles

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2020-07-15

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 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.

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Detailed Description

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The increase in 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 IUI procedures result in a successful pregnancy of around 10-15%, 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 IUI cycles, 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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Infertility Unexplained 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 will be used when preparing sperm of male partner and IUI will be made with separated sperm

Group Type EXPERIMENTAL

MicroFluidic Sperm Sorting Chips

Intervention Type OTHER

sperm selection of IUI treatment

gradient-density centrifugation

gradient-density centrifugation technique will be used when preparing sperm of male partner and IUI will be made with separated sperm

Group Type ACTIVE_COMPARATOR

Gradient-Density Centrifugation

Intervention Type OTHER

sperm selection of IUI treatment

Interventions

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MicroFluidic Sperm Sorting Chips

sperm selection of IUI treatment

Intervention Type OTHER

Gradient-Density Centrifugation

sperm selection of IUI treatment

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes