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

Sponsor
Bezmialem Vakif University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04144244
Collaborator
(none)
176
1
2
8
22

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: MicroFluidic Sperm Sorting Chips
  • Other: Gradient-Density Centrifugation
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
176 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of the Effect of Microfluid Sperm Sorting Chip and Density Gradient Methods on Pregnancy Success in Intrauterine Insemination Cycles ; a Randomised Controlled Study
Actual Study Start Date :
Nov 15, 2019
Anticipated Primary Completion Date :
May 15, 2020
Anticipated Study Completion Date :
Jul 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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

Other: MicroFluidic Sperm Sorting Chips
sperm selection of IUI treatment

Active Comparator: gradient-density centrifugation

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

Other: Gradient-Density Centrifugation
sperm selection of IUI treatment

Outcome Measures

Primary Outcome Measures

  1. 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

  2. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 40 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bezmialem University Istanbul Turkey 34746

Sponsors and Collaborators

  • Bezmialem Vakif University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Bezmialem Vakif University
ClinicalTrials.gov Identifier:
NCT04144244
Other Study ID Numbers:
  • Microchip IUI study
First Posted:
Oct 30, 2019
Last Update Posted:
Feb 12, 2020
Last Verified:
Feb 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Bezmialem Vakif University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 12, 2020