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

B

Bezmialem Vakif University

Status

Unknown

Conditions

Infertility Unexplained
Infertility, Male

Treatments

Other: Gradient-Density Centrifugation
Other: MicroFluidic Sperm Sorting Chips

Study type

Interventional

Funder types

Other

Identifiers

NCT04144244
Microchip IUI study

Details and patient eligibility

About

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.

Full description

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.

Enrollment

176 estimated patients

Sex

Male

Ages

20 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

176 participants in 2 patient groups

MicroFluidic Sperm Sorting Chips
Experimental group
Description:
Sperm Sorting microfluidic chips will be used when preparing sperm of male partner and IUI will be made with separated sperm
Treatment:
Other: MicroFluidic Sperm Sorting Chips
gradient-density centrifugation
Active Comparator group
Description:
gradient-density centrifugation technique will be used when preparing sperm of male partner and IUI will be made with separated sperm
Treatment:
Other: Gradient-Density Centrifugation

Trial contacts and locations

1

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Central trial contact

Pinar Ozcan, MD, Assoc Prof

Data sourced from clinicaltrials.gov

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