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

Not Applicable

• Conditions: Infertility, Male; Infertility Unexplained
• Interventions: Other: Gradient-Density Centrifugation; Other: MicroFluidic Sperm Sorting Chips

• Registration Number: NCT04144244
• Lead Sponsor: Bezmialem Vakif University

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2019-10-28
• Study First Submitted QC: 2019-10-28
• Study First Posted: 2019-10-30
• Study Start: 2019-11-15
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-11
• Last Update Posted: 2020-02-12
• Primary Completion: 2020-05-15
• Study Completion: 2020-07-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
gradient-density centrifugation	Gradient-Density Centrifugation	gradient-density centrifugation technique will be used when preparing sperm of male partner and IUI will be made with separated sperm
MicroFluidic Sperm Sorting Chips	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

Primary Outcome Measures

Name	Time	Method
Compare microfluid chip and density-gradient methods in terms of embryo quality	average of 6 months	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.
Compare microfluid chip and density-gradient methods in terms of IUI success	average of 6 months	measure the clinical pregnancy rate by using serum beta-HCG (human chorionic gonadotropin) level

Trial Locations

Locations (1)

Bezmialem University; 🇹🇷 Istanbul, Turkey