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

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)

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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